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Wikipedia:Scientific peer review/recent reviews I have asked for scientific peer-review of this article. I would appreciate any ideas to improve or to correct any mistakes there may be. -- Garrondo 08:40, 1 September 2007 (UTC)
It's a good idea to off-load this article. Thanks for doing it! InvictaHOG 19:16, 28 October 2006 (UTC)
I`m trying to clean up the article. It does not have proper references and the format varies from one section to other. It was specially bad written the investigation section where severel non NPOV could be found. I have divided it in two sections: investigations in II and III phase clinical trials and basic investigation.
Cleaning up I have eliminated the following paragraph:
The reason to eliminate it is that I can´t really understand what it talks about; and neither can I find the articles it talks about in pubmed. If anybody understands it and can help to improve it be welcome... If not it will be lost
After a whole month working in the article I think I have finished improving it. I have added more than 60 references, reordered much of it and moved some information very similar to lists to secondary articles. I think is a much better article than a month before. Therefore I'm thinking of nominating it for "good article"; however it may be difficult to get it becouse it doesn't have any pictures. The problem is that I can't think of any pictures that fit. Any ideas? Does anybody think it has some possibilities? -- Garrondo 14:22, 31 August 2007 (UTC)
I have nominated the article as a good article candidate. I would be thankful to anybody who who helped in the good article review (See: Wikipedia:Good article candidates If you have not contributed significantly to this article, feel free to evaluate it according to the good article criteria and then pass or fail the article as outlined on the candidates page. -- Garrondo 13:27, 5 September 2007 (UTC)
In consideration of the 500,000+ hits on Google when searching for tai chi and multiple sclerosis, I think it behooves those looking to create a comprehensive, GA-status article to do some investigating and potentially include a mention. It would seem that many published works also touch upon the practice as an MS therapy, as do more scholarly sources. VanTucky Talk 23:29, 12 September 2007 (UTC)
This article is very well written, with relatively easy to understand prose, and sufficient reference citations. It has a good, well-written, lead section, and good use of images. As written, I beliee this article meets the Good Article criteria, and will be listed.
A couple of areas of improvement: first, the section headers seem to be kind of long and wordy. Perhaps they could be reduced or paraphrased a bit. Although they do seem to be an accurate description of their contents, so I'm not sure how to go about reducing them. Maybe something as simple as combining the 'management of...' headers into one main section, with subsections, would reduce the repetition of the 'management of...' line, making it a bit easier to read?
Second, under 'Management of relapsing-remitting MS', the second to last paragraph, dealing with ease of use, price and side effects, is unsourced. As some information on the frequency of injections is provided, a reference should be added (though, given the well-sourced nature of the article as a whole, I won't withhold GA status over this one issue). I think that the earlier references for the drugs, a few paragraphs up, probably have this information anyway, so they could be used here.
I like the look of the chemical structure of methylprednisolone, and compared to the structure of mitoxantrone, the lines used in the structure of the latter are much weaker and less apparent than the former. Perhaps the structure of mitoxantrone could be improved a bit in the
image file to use darker lines, and maybe increasing the size of the image just a bit, so more closely match the look of methylprednisolone.
Also, a suitable image for the upper right-hand corner, to be used as an intro, would help to better grab the attention of the reader. I don't think an infobox is needed here, but a good lead image would be nice.
Hope this helps improve the article even more! Good work so far! Dr. Cash 21:03, 18 September 2007 (UTC)
I have nominated the article for featured article after working on it after it become a GA. If you think the article is good enough please vote for it. Any comments for improvement will also be welcomed. Garrondo 13:41, 25 October 2007 (UTC)
I would suggest moving this page to Treatment of multiple sclerosis, consistent with articles such as Treatment of Crohn's disease, Treatment of bipolar disorder and others. If nobody objects I will go ahead and rename the article. -- WS ( talk) 23:33, 16 November 2007 (UTC)
"Some studies also show benefits on physical variables" ... what the heck does that mean? Isn't there a more straightforward way of saying it? Leotohill ( talk) 05:53, 24 January 2008 (UTC)
I can't quite figure out this sentence: "After some years, many of the people who have this subtype begin to experience neurologic decline without acute relapses as the secondary progressive subtype. "
I've spent several minutes here trying to write up what it might mean, without success. What is it that is the "secondary progressive subtype"? What is it secondary to? Are there other secondary types that are not progressive?
Call me confused. 24.39.174.1 ( talk) 14:31, 24 January 2008 (UTC) That was me - I forgot to login. Leotohill ( talk) 19:00, 24 January 2008 (UTC)
I'm going to remove that confusing clause and see who objects. Leotohill ( talk) 19:01, 24 January 2008 (UTC)
Im a little shocked that BVT (bee venom therapy) has not been brought up, especially considering the success stories with them.
Bee Venom Therapy at Discovery [1]
ODNation ( talk) 01:54, 25 January 2008 (UTC)
A pennsylvania doctor has recently found a cure for ms that has not yet been widely accepted. He uses fluconazol and a 2 week no sugar diet to treat patients. He has cleared a whole wing of a hospital which dealt with MS by using this treatment. I am friends with one of his patients who could not walk but within a few months of seeing this doctor she went trick or treating with her kids
someone should post this —Preceding unsigned comment added by 141.152.238.229 ( talk) 15:40, 25 January 2008 (UTC)
I propose the following:
1. A brief discussion on the Relative Efficacy of the disease-modifying drugs.
The article is informative about the difference of administration in the DMDs, right down to specifying the dosage intervals; it also goes into detail about the greatly-varying side effects. However, the article is completely silent on what is most important, which is the spectrum of what is cinically proven, and to what extent, and what is not. Instead the article states that all DMDs have been shown to be "modestly effective in reducing attacks and slowing disability progression" - which is in fact erroneous.
2. Deleting what is currently reference # 27, a page from the obscure "PeaveHealth" which is both obsolete and already inferior to the Wiki page. io-io ( talk) 02:17, 27 January 2008 (UTC)
Medical Name | Brand Name | Safety limits long-term use | Dosing Schedule | Lesion Reduction | Advantage (2 years) in Lesion Reduction | Relapse Reduction | Advantage (2 years) in Relapse Reduction | Disability Progression Reduction | Advantage (2 years) in Disability Progression |
---|---|---|---|---|---|---|---|---|---|
Glatiramer acetate [1] [2] | Copaxone | No | 1 x day subcutaneous injection | Yes | Vs placebo | Yes | 29% vs placebo | No | n/a |
Interferon beta-1a [3] | Avonex | No | 1 x week intramuscular injection | Yes | Yes | 29% vs placebo | Yes | 37% vs placebo | |
Interferon beta-1a [4] | Rebif | No | 3 x week subcutaneous injection | Yes | 80% vs placebo | Yes | 27% vs placebo | Yes | Vs placebo |
Interferon beta-1b [5] [6] | Betaseron/ Betaferon | No | 1 x 2 days subcutaneous injection | Yes | 80% vs placebo | Yes | 34% vs placebo | No | n/a |
Mitoxantrone [7] | Novantrone | Yes | 1 x 3 months infusion | Yes | Vs placebo | Yes | Vs placebo | Yes | Vs placebo |
Natalizumab [8] [9] | Tysabri | No | 1 x month intravenous infusion | Yes | 96% vs placebo | Yes | 68% vs placebo | Yes | 54% vs placebo |
::Wow...you have done a great work. It´s a great improvement to the article. I only have some minor improvements:
*I don`t like the colur use, specially the blue for letters, since they seem internal links. I would rather prefer black as in all articles. Yellow might also be too strong
*I would add internal links to medications, type of injections, and any other word difficult to understand
*I would also writte completely sub-cutaneous, since just sub-c would not be understood by some non medical readers. DONE
*I would eliminate the "?" after safety limits... In no other title you have added it. DONE
*I suppuse v is versus. Im not english, but, is it not better understood as vs? DONE
*Interferon 1-b is betaseron in US, but betaferon in all Europe, both names should appear.DONE
*Add all the refs with diberris tool: http://diberri.dyndns.org/wikipedia/templates/ to continue with the format used in the articleDONE
Other changes done:
A question: are quantities at relapse reduction really needed? -- Garrondo ( talk) 10:43, 7 March 2008 (UTC)
I have not done the research so I don´t know if this is absolutly correct, but maybe a way to simplify the table was only to put the long term comparisons against placebo. It would look something like this. What do you think (Specially io-io)? -- Garrondo ( talk) 10:27, 8 March 2008 (UTC)
Medical Name | Brand Name | Safety Limits Long-Term Use | Dosing Schedule | Results after Treatment for Two Years Relative to Placebo | ||
---|---|---|---|---|---|---|
Improved Relapse Rate Reduction | Delayed Disability Progression | |||||
Glatiramer acetate [1] [10] | Copaxone | No restriction | 1 x day
subcutaneous injection |
29% | Not shown | |
Interferon beta-1a [3] | Avonex | No restriction | 1 x week
intramuscular injection |
18% | 37% | |
Interferon beta-1a [4] | Rebif | No restriction | 3 x week
subcutaneous injection |
29%* | 22%* | |
Interferon beta-1b [5] [6] | Betaseron / Betaferon | No restriction | 1 x 2 days
subcutaneous injection |
31% | Not shown** | |
Mitoxantrone [7] | Novantrone | Yes (absolute max 3 yrs) | 1 x 3 months
intravenous infusion |
67%*** | Yes*** | |
Natalizumab [11] [12] | Tysabri | No restriction | 1 x month
intravenous infusion |
68% | 54% |
Notes - *Results are shown for the 22mg or most common dose of Rebif (interferon beta-1a). Results for a 44mg dose, which is less well tolerated, were not significantly better. **In RRMS, interferon beta-1b has not proven that it can delay disability progression. However, in SPMS, it has proven that it cuts the risk of disability progression by 16% over 2 years. ***Most patients in the mitoxantrone trials were SPMS, not RRMS. In a trial with some RRMS patients, it did achieve a proven advantage in relapse rate reduction of 67%, but did not use the same measures of disability progression. In the sum of trials with mostly SPMS and PRMS patients it did however show cuts the risk of disability progression by 66% over 2 years.
After looking up various trials and labels, I decided to eliminate the column for "lesion reduction", for 2 reasons. First, the various trials soemtimes report total lesions, and others report only "gandolonium-enhancing" lesions", and it does not seem possible to give a consistent numerical category. Second, it is not a "clinical effect", only an MRI measure, and only moderately correlated with patient perception and outcome....Also I improved column-widths, to increase the importance of the efficacy comparison itself (last 2 columns)..... io-io ( talk) 21:59, 9 March 2008 (UTC)
I prefer this design
Medical Name | Brand Name | Safety Limits Long-Term Use | Dosing Schedule | Results after Treatment for Two Years Relative to Placebo | ||
---|---|---|---|---|---|---|
Improved Relapse Rate Reduction | Delayed Disability Progression | |||||
Glatiramer acetate [1] [13] | Copaxone | No | 1 x day subcutaneous injection | 29% | Not shown | |
Interferon beta-1a [3] | Avonex | No | 1 x week intramuscular injection | 18% | 37% | |
Interferon beta-1a [4] | Rebif | No | 3 x week subcutaneous injection | 29%* | 22%* | |
Interferon beta-1b [5] [6] | Betaseron / Betaferon | No | 1 x 2 days subcutaneous injection | 31% | Not shown** | |
Mitoxantrone [7] | Novantrone | Yes (max 3 yrs) | 1 x 3 months intravenous infusion | 67%*** | Yes*** | |
Natalizumab [14] [15] | Tysabri | No | 1 x month intravenous infusion | 68% | 54% | |
Notes
+Results are shown for the 22mg dose. Results for a 44mg dose, which is less tolerated, were similar [16]. ++In RRMS, interferon beta-1b has not proven that it can delay disability progression. However, in SPMS trials, it has been shown to cut the risk of disability progression by 16% [17]. +++Most patients in the mitoxantrone trials were SPMS. In a trial with RRMS patients, it achieved an advantage in relapse reduction of 67%, but did not use the same disability progression measures. In the sum of trials with SPMS and PRMS patients it did cut the risk of disability progression by 66% [18]. |
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Limits to Disability Progression claims for these treatments is disputed - some of the referred articles are very old indeed (1995 & 1996 i.e. before proper disclosure rules were introduced and when beta interferon treatments were extremely new). Many professional neurologists would not subscribe to these evaluations. I think one has to be very cautious when claiming that any of these treatments limit disease progression especially in view of more recent meta-studies that dispute such claims, particularly in the case of the interferons (see Cochrane reviews). Additionally, natalizumab is a very recent drug with too little data to clearly establish whether it limits progression. Conventional MRI has been shown to imperfectly represent disease activity and yet, in these earlier studies, is taken as a definitive bench-mark. One of the other quoted texts is an expert opinion and not a study. I wonder why one particular editor has been so determined (for some little while) to show the efficacy of these treatments against progression. One has to be careful of (undisclosed and undectable) conflict of interest in Wikipedia articles, which are not subject to the same rigour and professional criticism as medical articles. Ultimately, patients are the ones making important and expensive decisions as to whether to undergo these drug regimes. Wikipedia is very high on the search engines and has a duty to present impartial information - it is the reponsibility of editors (both professional and amateur) to police this. Often that means checking the references. Better still, I believe that Wikipedia should desist from addressing drug treatments for multiple sclerosis - there are better and more rigorous sources. If editors do conclude that Wikipedia is a valid forum for discussion of treatment efficacy then I believe that proper and rigorous checks and balances are introduced. Laetoli ( talk) 08:04, 10 April 2008 (UTC)
It seems to me like the main issue is with the table in the 'Relapsing-remitting MS' section, which has specific data on percentages for reducing relapse remission and limiting disease progression. The table is the result of talk page discussion (see the preceding two sections), so this third section is now effectively extending that same discussion, eh? ;-)
It is clear that a lot of work has been put into the table, and I think that looks very good. However, I do have to question whether this falls under original research. Because it appears to me that the table is not published in its entirety in a single source, and rather, pieced together from multiple sources. And that is great from the perspective of an author(s) writing a review article for a scholarly journal or something, but that's not what wikipedia is for. The biggest issue I see with the data in the table is that, with data coming from multiple sources like this, trying to establish reasonably accurate measures for relapse rate and disease progression is going to be very difficult, and quite possibly wildly inaccurate from a statistical standpoint as well. In order for these statistics to be even close to believable, far more information on the studies conducted is needed, as there are far too many factors involved here that could throw off these percentages. If the table in question was all from one source, we could put it in and cite that source, and individuals interested in the specifics of the study could click on that to read it if they want. But as it stands, a table that's been concocted from multiple sources with details of said studies that are unclear,... I've got to call WP:OR on this one. Dr. Cash ( talk) 21:23, 14 April 2008 (UTC)
to: Laetoli - OK, using up all the ammunition now, because I will be away for a day - now I will address what User:Laetoli wrote, under separate sections. I already told him that I was most sympathetic to the other action he took - putting a big WARNING up on Drug pages because anyone can edit and skew a Med article here, and that medical advice should be sought elsewhere - because reality IS that some small percentage of patients who have long-term therapy choices in front of them WILL read these various drug pages and will be influenced by what they read. However, the reason the page started is that it appears ridiculous that, with today a fairly large of treatment choices, and with the fearful side-effects and unpleasantness shown in relative comparison, then at least the regulatory efficacy numbers should be compared too. After all, the #ONE thing a patient wants taking a Drug is efficacy. But more about numbers later.
because it MIGHT work - Laetoli, you didnt answer my questions, but you write "take anything because it MIGHT work is the most irresponsible thing I have yet read on Wikipedia" - well I didnt say "it MIGHT work" at all - I was sensitive to the problem that they dont work for some patients (in fact for many, it is NEVER known if they helped to some degree, because relapse rates vary and are intermittent), as you can see from what I wrote. But in FACT this is the case with ALL these serious progressive diseases - there is no cure, and the very best drugs do NOT have a uniform result, nor close to it. Take Hepatitis C for example - the drugs are awful, and for 50% it's almost a cure, and the other 50% simply go back to the end of the line. In fact more so for Hep C than MS, "it might work" is the cruel paradigm.
Neurologists - you write that "Many professional neurologists would not subscribe to these evaluations" - and yet you base your evidence on the Cochrane reviews, written by a handful. And what do they the Cochrane reviewers do in their practices, do you think they refuse to prescribe DMDs? The fact is that in the USA, some 70% of MS-ers are on one of these DMDs, and probably another 15% are off them only because they failed them. In the EU, the percentages vary wildly between the countries, I think I saw that in Sweden it may be 75% and in Poland 1%-3%. But these numbers show that in the developed countries the overwhelming majority of neurologists DO prescribe DMDs to their patients.
Patients - #1 - I noticed from your first ever entry your remarkably accurate comment that MS patients have "a lot on their hands" - I could not have said it better. To compound matters, upwards of 50% have cognitive issues to some degree, which can unfortunately mean that the potential for adverse effects (which the doctors MUST tell them about) is the over-riding concern. If you had MS, you too would be faced with the same fear, and would want to know what are your chances, as the adverse profile (anything from the drudgery of daily injections to PML) will be fully explained. Therefore my view is that, for the inevitable number of MS patients who look on these pages at the very moment that they have been presented with treatment decisions, that they get a perspective on the MAIN issues - you can already see on the page that side effects get 20 lines or so - are side effects the main issue. Absolutely not, and you said it yourself, it is Disability (and it's pre-cursor, Relapse Rate). So for those who still have a wide choice, information and balance is vital.
Patients - #2 - I dont know where you are (UK I assume, given your NICE cites) but the consensus among MS patients is absolutely make the DMD choices available, and THEY and their doctors will decide. Two examples - in the UK, after the NICE negative evaluation (effectively a Government-paid consultant) of interferons and copaxone, such was the outcry from MS patients that eventually the NIH had to do a U-turn - now generally they are FREE to MS-ers. Another obvious example was in the USA where natalizumab was before a Public Hearing, and such was the fear among MS patients that the safety-obsessed (ie politically-pressured) FDA would prevent its return, the planned couple of hours of "public testimony" went for a full day, forcing a second day of hearings. Once again, your patients DO want to know, and DO want better drugs.
Patients - #3 - Cost – You speak several times to the patients’ pockets, etc, but I believe this is the least important factor. Overwhelmingly in the developed countries the patients do not pay for these drugs at all, or at most, a small percentage. Even for patients in the USA who have no insurance, there are programs whereby they can get them. Finally, there is little difference in cost between the drugs (with the possible exception of novantrone, which is an older chemotherapy drug).
"evidence-based medical science" - This is where, in my opinion you are technically wrong in a way that has impressed others here, but unduly:
Finally, I want to point out to you that, as you said, the most important issue to an MS patient is Disability Progression. Certainly two of the drugs have had over 10 years to prove a Disability advantage, and yet they have failed to do so - I think that it is quite OK if that shows up, because the oldest drugs have had the most chances; but the other interferons have also succeeded to the design standard of their day-at-court. When I first saw this page, I thought that both what the DMDs can do, and what they relatively achieve, were lost on the page. I believe MS patients are looking for Efficacy as the #1 priority – that is why I made the Table. Original idea? Well I don’t know, there is that paper I referenced. Original research? Not at all, it is basically a list of numbers, the official numbers too, and all RRMS. io_editor ( talk) 03:19, 17 April 2008 (UTC)
I will leave others to discuss the ins-and-outs of these drugs since it is all beyond my ken. To me, however, the key issue is the way that individual studies' treatment efficacy results were presented, and in fact 'compared' inappropriately in a table. By way of explanation I will give an Wikipedia example from my own field.
An editor, who incidentally had a COI, made this edit [5] giving percentage reductions in stuttering following 3 different kinds of treatment: Treatment A 48%, Treatment B 63% and Treatment C 71%. Makes it look like Treatment C is the best, right? The thing the editor didn't report was that the studies repeatedly said that the differences between treatments were not statistically significant. He took actual facts from the study and synthesized them together to prove a point of his own. In this case, all the treatments were offered within the same study, the subjects randomly assigned to treatment groups, exactly the same measures of outcome used etc.
In the case of these drugs we have multiple different studies, likely with different ways of measuring outcome and with different subject pools. Presenting average 'improvements' is thus even more inappropriate than it was in the stuttering example above. It is original synthesis and contrary to these reliable sources guidelines [6]
How reliable a single study is considered depends on the field, with studies relating to very complex and not entirely-understood fields, such as medicine, being less definitive. If single studies in such fields are used, care should be taken to respect their limits, and not to give undue weight to their results. Meta-analyses and systematic reviews, which combine the results of multiple studies, are preferred (where they exist).
which suggests we should be using the meta-analyses and systematic reviews as the primary source of information here. Slp1 ( talk) 17:25, 19 April 2008 (UTC)
Based on your other edits on this and other pages, you seem to have some sort of soft spot for natalizumab. Your table synthesises reliable sources together and ends up making natalizumab look like the best possible treatment. This is synthesis pure and simple and is not allowed. You need to find a peer-reviewed study that explicitly compares these different drugs. The issue seems to be a problem in understanding the difference between academic writing, and writing for an encyclopedia. This is not an academic paper where we are encouraged to be creative and do these kinds of innovative things and comparisons. This is Wikipedia, a very boring place where we only report, in summary form, what others have written and directly compared. Sometimes learning to understand the difference between academic writing and encyclopedia writing is a challenge, I realize. But these drugs have not been compared by reliable sources in the way you have tried compare them. And if they haven't made the comparisons, neither can we. Slp1 ( talk) 21:25, 20 April 2008 (UTC)Material can often be put together in a way that constitutes original research even if its individual elements have been published by reliable sources. Synthesizing material occurs when an editor tries to demonstrate the validity of his or her own conclusions by citing sources that when put together serve to advance the editor's position. If the sources cited do not explicitly reach the same conclusion, or if the sources cited are not directly related to the subject of the article, then the editor is engaged in original research.
I agree with Slp1 - we can only report findings and try to interpret them accurately taking into account conflicting views between professionals working in the field. This also involves clearly distinguishing between measures of 'disease severity' during a relapse and 'abatements in clinical progression over a patient's lifetime'. It is easy for the patient to confuse the two and as Ropper has explained, none of the DMDs have been shown to achieve the latter. Laetoli ( talk) 13:37, 24 April 2008 (UTC)
I have read the Ropper article and the full sentence mentioned says the following: A further compelling result was the abatement of clinical progression (17 percent of patients receiving natalizumab had progression vs. 29 percent of those receiving placebo) and a similar prolongation of the interval before neurologic deterioration. It is tempting to project these improvements over a patient's lifetime, but there are no data yet to support such a view. As I understand it there has been a decrease in disease progression, and it is said verbatim in the reference, even if it is only during the years of the study. Of course longer longitudinal studies are needed to see if this decrease mantains over time or after some time MS patients on Natalizumab recatch patients on the other treatments groups. Would be a solution to say something as "preliminary data points to a effect in disease progression, but studies on the long-term effects are needed."-- Garrondo ( talk) 07:46, 25 April 2008 (UTC)
"Patients with PPMS have also been included in trials of . . . cladribine. However, no treatment in these trials has been shown to modify the course of the disease."
Should this be updated in light of this [11]? Jh39 ( talk) 22:13, 30 April 2009 (UTC)
I agree with Polarlys that the use of Image:Cannabis sativa.jpg in Treatment of multiple sclerosis #Alternative treatments is problematic and raises WP:WEIGHT issues. Cannabis doesn't have good evidence for MS; it would be better to give an image of an alternative treatment that is better supported by scientific evidence (vitamin D, for example). Better yet would be an image specific to MS, rather than some stock shot of a plant or a pill. Eubulides ( talk) 07:37, 8 June 2009 (UTC)
There are some additional new therapies approved. DGG ( talk ) 00:53, 16 December 2012 (UTC)
My name is Florian Schaub at Merck KGaA. My aim is to make some changes in this article, because we have identified some misleading information. I have provided clearly arranged suggestions that you can see below on the talk page. They all follow the same pattern:
• Current Version
• Suggested Revision (Suggested changes are bold)
• Reason
• Suggested Reference (if needed)
Please let me know if anyone has concerns.
_Current Version:
“Newer treatments feature intravenous (IV) infusions (shown above) at 1 to 3-month intervals.”
Suggested Reviosion:
“Treatments feature intravenous (IV) infusions (shown above) at 1- to 12-month intervals, and oral drugs, taken daily or twice-daily.”
Reason 1:
IV treatments have been used for many years, while newer treatments tend to focus on the oral route of administration.
Reason 2:
We have suggested the change to the treatment interval as Lemtrada infusions are administered 12 months apart.
Reference 1: Multiple Sclerosis (MS). Treatment.
http://www.multiplesclerosis.com/us/treatment.php [Accessed 03 Jun 2016].
Reference 2: Lemtrada US product label
_Current Version:
As of November 2014, nine disease-modifying treatments have been approved by regulatory agencies of different countries…”
Suggested Reviosion:
As of June 2016, 14 disease-modifying treatments have been approved by regulatory agencies of different countries…”
Reason:
Updated for June 2016.
Reference:
National Multiple sclerosis society. Medications.
http://www.nationalmssociety.org/Treating-MS/Medications [Accessed 03 Jun 2016].
_Current Version:
“…and the Japanese Pharmaceuticals and Medical Devices agency (PMDA).”
Suggested Revision:
We suggest changing the link URL to:
/info/en/?search=Pharmaceuticals_and_Medical_Devices_Agency
Reason:
The current link directs to an incorrect page.
_Current Version:
“Interferon beta-1a is injected either weekly (intramuscular injection) or three times a week (subcutaneous injection) depending on commercial formulations, while interferon beta-1b is injected subcutaneously every second day.”
Suggested Revision:
“Interferon beta-1a is injected, either weekly (intramuscularly), three times a week or every other week (subcutaneously) depending on the commercial formulation, while interferon beta-1b is injected subcutaneously every second day.”
Reason:
Suggested text to account for Plegridy injections, which are administered every other week.
Suggested Reference:
US and EU Rebif, Avonex, Plegridy and Betaferon product labels
_Current Version:
“Another oral drug, cladribine, was approved in Russia and Australia in 2010. Its application was rejected by the FDA and EMEA in 2011 due to safety concerns in spite of the promising efficacy of the drug. This led the pharmaceutical to discontinue commercialization and withdraw all marketing applications.”
Suggested Revision:
“Another oral drug, cladribine, was approved in Russia and Australia in 2010. Its application was rejected by the FDA and EMEA in 2011 due to safety concerns, in spite of the promising efficacy of the drug. This led the pharmaceutical company to discontinue commercialization and withdraw all marketing applications. Merck KGaA announced its intention to submit cladribine for EU approval in September 2015, following additional data which allowed a better characterization of cladribine’s benefit–risk profile.”
Reason:
The current text is out of date.
Suggested Reference:
Cladribine press release:
http://www.merckgroup.com/en/media/extNewsDetail.html?newsId=1C517A71C016A43BC1257EBC006B50C3&newsType=1
_Current Version:
“PML is an opportunistic infection with neurological progressive symptoms caused by the replication of the JC virus in the glial cells of the brain. All 3 initial cases were taking natalizumab in combination with interferon beta-1a. After a safety review the drug was returned to the market in 2006 as a monotherapy for MS under a special prescription program. As of May 2011, over 130 cases of PML had been reported, all in patients who had taken natalizumab for more than a year. While none of them had taken the drug in combination with other disease-modifying treatments, previous use of MS treatments increases the risk of PML between 3 and 4-fold. The estimated prevalence of PML is 1.5 cases per thousand natalizumab users. Around 20% of MS patients with PML die, while most of the remaining are importantly disabled.”
Suggested Revision:
“Soon after its approval, natalizumab was withdrawn from the market by its manufacturer after it was linked with three cases of the rare but hazardous neurological condition called progressive multifocal leukoencephalopathy (PML). PML is an opportunistic infection with neurological progressive symptoms caused by the replication of the John Cunningham (JC) virus in the glial cells of the brain. In all three initial cases, patients were taking natalizumab in combination with interferon beta-1a. After a safety review the drug was returned to the market in 2006 as a monotherapy for MS under a special prescription program. As of September 2014, there were 495 confirmed cases of PML. While none of them had taken the drug in combination with other disease-modifying treatments, previous use of MS treatments increases the risk of PML between 3- and 4-fold. The estimated prevalence of PML is 1.5 cases per thousand natalizumab users.[23] Around 20% of MS patients with PML die, while most of the remaining are importantly disabled.”
Reason:
We suggest the addition of this source, as it the most recent data showing the number of patients receiving Tysabri who have developed PML.
Suggested Reference:
https://www.bostonglobe.com/business/2014/10/22/biogen-idec-reports-death-patient-that-had-taken-its-multiple-sclerosis-pill-tecfidera/xrAtOBsxA7eHZN3BB0phxJ/story.html
_Current Verison:
“Teriflunomide is considered a very safe drug.”
Suggested Revision:
“Teriflunomide is also subject to warnings in the US for hepatotoxicity and risk of birth defects if used during pregnancy.”
Reason:
The US prescribing information contains a black box warning for hepatotoxicity and teratogenicity. The paragraph goes on to say “there have been reports of liver failure, and PML. Teriflunomide is also known to be dangerous for fetal development”. It is contradictory to include this information and claim that teriflunomide is a safe drug.
Suggested Reference:
US Aubagio product label
_Current Version:
“Moreover, fumaric acid is also used to treat psoriasis, another autoimmune disorder, and there is long term safety data from over 14 years of use without any indication of further dangerous secondary effects.”
Suggested Revision:
“Moreover, fumaric acid is also used to treat psoriasis, another autoimmune disorder, and there is long-term safety data from over 14 years of use. However, four cases of PML have been observed in patients treated with Tecfidera.”
Reason:
To include information on the risks associated with fumaric acid esters.
Suggested Reference:
US and EU product labels
http://www.medscape.com/viewarticle/856148
_Current Version:
“Natalizumab and mitoxantrone are considered highly effective both in terms of relapse rate reduction and halting disability progression…”
Suggested Revision:
“Natalizumab and mitoxantrone are considered highly effective, both in terms of relapse rate reduction and reduction of disability progression…”
Suggested Reference:
Kornek B, Patient Prefer Adherence 2015; 9: 675–84
Martinelli Boneschi M et al. Cochrane Database Syst Rev 2013; 5: CD002127
_Current Version:
“While some believe that they will probably reduce the usage of first-line treatments the long-term safety of interferons and glatiramer acetate will probably slow this trend. It has been recommended that at the moment oral treatments should be mainly offered in those cases where patients do not use existing treatments due to needle phobia or other reasons such as perceived inefficacy of interferons and glatiramer acetate.”
Suggested Revision:
“While some believe that they will probably reduce the usage of first-line treatments, the long-term safety of interferons and glatiramer acetate will probably slow this trend. Oral treatments may be attractive in cases where patients do not use existing treatments due to needle phobia or for other reasons such as perceived inefficacy of interferons and glatiramer acetate.”
Reason:
We have suggested removing the first sentence, as it was not supported by the reference.
The reference has been misquoted – it does not recommend oral treatments for any patient group. This change will bring the text in line with the reference used.
_Current Version:
“Dimethyl fumarate is potentially one of the most interesting oral drugs due to the long term data from use in psoriasis which points towards a very good safety profile.”
Suggested Revision:
“Dimethyl fumarate is potentially one of the most interesting oral drugs due to the long-term data from use in psoriasis, which distinguishes it from fingolimod, teriflunomide and laquinimod.”
Reason:
The reference gives a number of common AEs related to DMF treatment initiation. Gastrointestinal events and flushing are described as very common in the EU and US regulatory labels for this drug, and 4 cases of PML have been reported in MS patients taking DMF (with additional cases n patients taking DMF for other indications). We therefore feel that it is perhaps inaccurate to say that it has a very good safety profile. However, the reference does state that long term safety data distinguishes DMF from a number of drugs, and so the text has been suggested to reflect this.
_Current Version:
“Studies on the use of Interferon-beta-1b in secondary progressive and progressive relapsing MS do not support that it slows progression of the disease, although it is effective in reducing the number of relapses.”
Suggested Revision:
“Studies show that interferon beta-1b slows disability progression in relapsing secondary progressive MS, but not in non-relapsing secondary progressive and progressive relapsing MS, although it is effective in reducing the number of relapses.
Studies show a difference in time to disability progression between interferon beta-1a and placebo in a subgroup of secondary progressive MS patients with relapses, but not in the whole patient population.”
Reason:
Information suggested to clarify the impact of interferon beta-1b in SPMS.
Content suggested to include information on interferon beta-1a.
Suggested Reference:
Betaferon EU label
SPECTRIMS Study Group. Neurology 2001; 56:1496–1504
US and EU product labels
_Current Verison:
Therapies under investigation [section header]
Suggested Revision:
Suggest removing all references to alemtuzumab from the section.
Reason:
Alemtuzumab is now approved for treatment of MS.
_Current Version:
Such is the case the PEGylated version of interferon-β-1a, that has a longer life than normal interferon and therefore it is being studied if given at less frequent doses has a similar efficacy than the existing product. With the completion of a robust two-year study, it is shown that the PEGylated interferon beta-1a has greater efficacy in decreasing relapse rate and disability progression compared to placebo for MS patients.
Suggested Revision:
Suggest moving this section from the ‘Therapies under investigation’ section to the ‘Medications’ section.
Reason:
PEGylated interferon beta-1a has been approved for treatment of MS, and thus is no longer under investigation.
-- Florian Schaub at Merck KGaA ( talk) 16:00, 08 July 2016 (UTC)
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My name is Florian Schaub from Merck KGaA. My aim is to make some changes in this article because we have found some misleading information. I've compiled the suggested changes which you can find herinafter. They all follow one pattern:
• Current text
• Suggested revision
• Reason
• Suggested reference
If someone has objections please let me know.
_Current text
Disease-modifying treatments are expensive and most require frequent (up-to-daily) injections, under the skin or into the muscle.
_Suggested revision
Disease-modifying treatments are expensive compared with therapies that only help ease MS symptoms (e.g. medications for pain, fatigue and muscle spasms). Most require frequent (ranging from every day to every 4th week) injections (under the skin [subcutaneous], into the muscle [intramuscular] or into veins [intravenous]), or oral treatment.
_Reason
To clarify what the costs of DMTs are compared to and to accommodate the range of treatment frequencies.
_Suggested reference
“Disease-Modifying Therapies for MS” https://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-The-MS-Disease-Modifying-Medications.pdf. Updated May 2017
_Current text
Newer treatments feature intravenous (IV) infusions (shown above) at 1 to 3-month intervals.
_Suggested revision
Treatments feature intravenous infusions (shown above) at 1- to 12-month intervals, and oral drugs, taken once- or twice-daily.
_Reason
IV treatments have been used for many years, while newer treatments tend to focus on the oral route of administration. The change to treatment interval was suggested as Lemtrada® infusions are administered 12 months apart.
_Suggested reference
Multiple Sclerosis (MS). Treatment. https://www.multiplesclerosis.com/us/treatment.php [Retrieved on 18 July 2017].
Lemtrada® US Prescribing Information. Genzyme Corporation (July 2016). http://products.sanofi.us/Lemtrada/Lemtrada.pdf [Retrieved on 18 July 2017]
_Current text
Interferon beta-1a is injected either weekly (intramuscular injection) or three times a week (subcutaneous injection) depending on commercial formulations,[15][16] while interferon beta-1b is injected subcutaneously every second day.[17]
_Suggested revision
Interferon beta-1a is injected either weekly (intramuscular injection) or three times a week (subcutaneous injection) depending on commercial formulations,[15][16] while interferon beta-1b is injected subcutaneously every second day.[17][18]
_Reason
References are from 2007 and may contain out of date information. More recent references with more up to date information are suggested.
_Suggested reference
[15] Avonex® US Prescribing Information. Biogen, Inc. (March 2016). https://www.avonex.com/content/dam/commercial/multiple-sclerosis/avonex/pat/en_us/pdf/Avonex%20US%20%20Prescribing%20Information.pdf [Retrieved on 18 July 2017]
[16] Rebif® US Prescribing Information. EMD Serono, Inc. (November 2015). http://emdserono.com/ms.country.us/en/images/Rebif_PI_tcm115_140051.pdf?Version [Retrieved on 18 July 2017]
[17] Betaseron® US Prescribing Information. Bayer HealthCare Pharmaceuticals, Inc. (April 2016). http://labeling.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf [Retrieved on 18 July 2017]
[18] Extavia® US Prescribing Information. Novartis Pharmaceuticals Corporation (May 2016). https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/extavia.pdf [Retrieved on 18 July 2017]
_Current text
Another oral drug, cladribine, was approved in Russia and Australia in 2010. Its application was rejected by the FDA and EMEA in 2011 due to safety concerns in spite of the promising efficacy of the drug. This led the pharmaceutical to discontinue commercialization and withdraw all marketing applications.[31]
_Suggested revision
On 25th August 2017, Merck Serono Europe announced that the European Commission (EC) granted marketing authorization for MAVENCLAD® 10 mg (Cladribine Tablets) for the treatment of highly active RMS in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland [1].
_Reason
To update text and provide up-to-date references in line with Wikipedia style (i.e. no original research articles).
_Suggested reference
[1] European Commission Grants Approval for Mavenclad (Cladribine Tablets) http://ec.europa.eu/health/documents/community-register/2017/20170822138481/dec_138481_en.pdf [Accessed 01 September 2017] TYSABRI® (natalizumab): PML in Patients Receiving TYSABRI (USA TYSABRI PML Update). Biogen, Inc. (21 June 2017). https://medinfo.biogen.com/secure/download?doc=workspace%3A%2F%2FSpacesStore%2Fded9df8f-d785-444a-ae89-888bef72aa7e&type=pmldoc&path=null&dpath=null&mimeType=null [Retrieved on 18 July 2017]
_Current text
As of May 2011, over 130 cases of PML had been reported, all in patients who had taken natalizumab for more than a year.[25]
_Suggested revision
As of 6 June 2017, there have been 731 confirmed PML cases (728 patients being treated for MS, 3 patients treated for Crohn’s disease). The number of natalizumab doses prior to PML diagnosis ranged from 8 to 134, with a mean treatment duration of 49 months.
_Reason
We suggest the addition of this source, as it is the most recent data showing the number of patients receiving Tysabri® who have developed PML.
_Suggested reference
TYSABRI® (natalizumab): PML in Patients Receiving TYSABRI (USA TYSABRI PML Update). Biogen, Inc. (21 June 2017). https://medinfo.biogen.com/secure/download?doc=workspace%3A%2F%2FSpacesStore%2Fded9df8f-d785-444a-ae89-888bef72aa7e&type=pmldoc&path=null&dpath=null&mimeType=null [Retrieved on 18 July 2017]
_Current text
During clinical trials fingolimod gave rise to side effects such as hypertension and bradycardia, macular edema, elevated liver enzymes or reduction in lymphocite levels
_Suggested revision
During clinical trials fingolimod gave rise to side effects such as hypertension and bradycardia, macular edema, elevated liver enzymes or reduction in lymphocyte levels
PML has also been reported under fingolimod treatment since marketing authorisation
_Reason
Corrected the spelling of lymphocyte
We suggest the additional information from the EU SmPC to reflect the cases of PML, with additional reference
_Suggested reference
Gilenya® EU Summary of Product Characteristics. Novartis. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002202/WC500104528.pdf [Retrieved on 07 August 2017]
_Current text
Teriflunomide is considered a very safe drug. Nevertheless, there have been reports of liver failure, and PML. Teriflunomide is also known to be dangerous for fetal development.
_Suggested revision
Teriflunomide is also subject to warnings in the US for hepatotoxicity and birth defects if used during pregnancy.
_Reason
The US Prescribing Information contains a black box warning for hepatotoxicity and teratogenicity. It is contradictory to include this information and claim that teriflunomide is a safe drug.
_Suggested reference
Aubagio® US Prescribing Information. Genzyme Corporation (November 2016). http://products.sanofi.us/aubagio/aubagio.pdf [Retrieved on 18 July 2017]
_Current text
Moreover, fumaric acid is also used to treat psoriasis, another autoimmune disorder, and there is long term safety data from over 14 years of use without any indication of further dangerous secondary effects.[28]
_Suggested revision
Moreover, fumaric acid is also used to treat psoriasis, another autoimmune disorder, and there is long-term safety data from over 14 years of use. [28] However, PML has been observed in patients treated with dimethyl fumarate.
_Reason
To include information on the risks associated with fumaric acid esters.
_Suggested reference
Tecfidera® US Prescribing Information. Biogen, Inc. (January 2017). https://www.tecfidera.com/content/dam/commercial/multiple-sclerosis/tecfidera/pat/en_us/pdf/full-prescribing-info.pdf [Retrieved on 18 July 2017]
_Current text
Treatment with interferons or glatiramer acetate after an initial attack decreases the risk of developing clinical definite MS.[5][38]
_Suggested revision
Treatment with interferons or glatiramer acetate after an initial attack decreases the risk of developing clinical definite MS.[5][38] However, no oral treatments have been licensed for treatment of CIS.
_Reason
Suggestion made for clarity regarding treatment options for CIS.
_Current text
While some believe that they will probably reduce the usage of first-line treatments the long-term safety of interferons and glatiramer acetate will probably slow this trend.[28] It has been recommended that at the moment oral treatments should be mainly offered in those cases where patients do not use existing treatments due to needle phobia or other reasons such as perceived inefficacy of interferons and glatiramer acetate.[28]
_Suggested revision
While some believe that they will probably reduce the usage of first-line treatments, the long-term safety of interferons and glatiramer acetate will probably slow this trend.[28] Oral treatments may be attractive in cases where patients do not use existing treatments due to needle phobia, or for other reasons such as perceived inefficacy of interferons or glatiramer acetate.[28]
_Reason
The reference does not recommend oral treatments for any patient group. This change will bring the text in line with the reference used.
_Current text
Dimethyl fumarate is potentially one of the most interesting oral drugs due to the long term data from use in psoriasis which points towards a very good safety profile.[28]
_Suggested revision
Dimethyl fumarate is potentially one of the most interesting oral drugs due to the long term data from use in psoriasis, which distinguishes it from fingolimod, teriflunomide, and laquinimod.[28]
_Reason
The reference gives a number of common adverse events related to dimethyl fumarate treatment initiation. Gastrointestinal events and flushing are described as very common in the EU and US regulatory labels for this drug, and 4 cases of PML have been reported in MS patients taking DMF. It may be inaccurate to say that it has a very good safety profile. However, the reference does state that long-term safety data distinguish DMF from a number of drugs, and the suggested text reflects this.
_Current text
Studies on the use of Interferon-beta-1b in secondary progressive and progressive relapsing MS do not support that it slows progression of the disease, although it is effective in reducing the number of relapses.[47]
_Suggested revision
Studies show that interferon beta-1b decreases the number of relapses in relapsing-remitting and secondary progressive MS, and in one study it slowed disability progression in secondary progressive MS.[1][2] In patients with relapsing-remitting MS, one study has shown a difference in time to disability progression between those treated with interferon beta-1a and those treated with placebo. [3]
_Reason
Information suggested to clarify impact of interferon beta-1b in SPMS. Content suggested to include information on interferon beta-1a.
_Suggested reference
[1] Extavia® US Prescribing Information. Novartis Pharmaceuticals Corporation (May 2016). https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/extavia.pdf [Retrieved on 18 July 2017]
[2] Betaferon® EU Summary of Product Characteristics. Bayer Global Pharma AG (April 2017). http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000081/WC500053225.pdf [Retrieved on 18 July 2017]
[16] Rebif® US Prescribing Information. EMD Serono, Inc. (November 2015). http://emdserono.com/ms.country.us/en/images/Rebif_PI_tcm115_140051.pdf?Version [Retrieved on 18 July 2017]
_Current text
Research [section header]
_Suggested revision
Suggest removing all references to alemtuzumab (once in text, and the image of the structure of alemtuzumab) and daclizumab. Both drugs are now approved for treatment of MS
_Reason
Factual correction.
_Current text
Such is the case the PEGylated version of interferon-β-1a, that has a longer life than normal interferon and therefore it is being studied if given at less frequent doses has a similar efficacy than the existing product.[136][137] With the completion of a robust two-year study, it is shown that the PEGylated interferon beta-1a has greater efficacy in decreasing relapse rate and disability progression compared to placebo for MS patients.[138]
_Suggested revision
Suggest moving this to the “Medications” section, as PEGylated interferon beta-1a has been approved for treatment of MS.
_Reason
Factual correction.
--
Florian Schaub at Merck KGaA (
talk) 13:37, 18 October 2017 (UTC)
We do not write like this "MAVENCLAD® 10 mg (Cladribine Tablets)" Doc James ( talk · contribs · email) 20:04, 18 October 2017 (UTC)
We would suggest writing it like this: "Mavenclad 10mg (Cladribine Tablets)". Is this the correct way? -- Florian Schaub at Merck KGaA ( talk) 08:35, 7 November 2017 (UTC)
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As can be seen in the Featured version, the citation style used in this article was the long-standing and well established Diberri format, vancouver style authors, more than five authors truncated to three. I have restored, per WP:CITEVAR, and to make it easier to edit without having to work around endless unused citation template parameters. SandyGeorgia ( Talk) 06:41, 6 September 2020 (UTC)
This article is a 2007 FA that has not been maintained to standard. Many sections have become listy and taken on WP:PROSELINE, the Research section (and possibly more) is outdated, there are numerous maintenance tags, there are copyedit issues, there is WP:CITATION OVERKILL on non-controversial statements, some of the sections are poorly organized and contain information that would better belong in a History section, Further reading needs to be pruned or content added to article, and there are MOS issues like faulty dashes/hyphens and incorrect use of italics and bolding. Unless someone can restore this article to standard, it should be submitted to Featured article review. SandyGeorgia ( Talk) 00:20, 10 November 2020 (UTC)
Excess detail removed from the main article, which should use summary style; this content could be worked in here if not already included.
They are interferon beta-1a, interferon beta-1b, [1] glatiramer acetate, mitoxantrone, natalizumab, [2] fingolimod, [3] teriflunomide, [4] [5] dimethyl fumarate, [6] [7] alemtuzumab, [8] [9] ocrelizumab, [10] [11] siponimod, [11] [12] [13] cladribine, [11] [14] ozanimod, [15] [16] and ponesimod. better source needed [17]
Natalizumab reduces the relapse rate more than first-line agents; however, due to issues of adverse effects is a second-line agent reserved for those who do not respond to other treatments
[18] or with severe disease.
[19]
[2] Mitoxantrone, whose use is limited by severe adverse effects, is a third-line option for those who do not respond to other medications.
[18]
In March 2017, the FDA approved ocrelizumab, a humanized anti- CD20 monoclonal antibody, as a treatment for RRMS, [20] [21] with requirements for several Phase IV clinical trials. [22]
As of 2017
[update],
rituximab was widely used off-label to treat RRMS.
[23] There is a lack of high quality randomised control trials examining rituximab versus placebo or other disease-modifying therapies, and as such the benefits of rituximab for relapsing remitting multiple sclerosis remain inconclusive.
[24]
References
Tsang2011
was invoked but never defined (see the
help page).Hassan2011
was invoked but never defined (see the
help page).Ocrevus FDA label
was invoked but never defined (see the
help page).Based on prior advice, I think it would be conflict of interest for me to add it, but I wanted to flag that there are a couple of recent sources that relate to updated evidence for treatments and comparisons between treatments:
Gonzalez-Lorenzo M, Ridley B, Minozzi S, Del Giovane C, Peryer G, Piggott T, Foschi M, Filippini G, Tramacere I, Baldin E, Nonino F. Immunomodulators and immunosuppressants for relapsing‐remitting multiple sclerosis: a network meta‐analysis. Cochrane Database of Systematic Reviews 2024, Issue 1. Art. No.: CD011381. DOI: 10.1002/14651858.CD011381.pub3. Accessed 10 January 2024.
Tramacere I, Virgili G, Perduca V, Lucenteforte E, Benedetti MD, Capobussi M, Castellini G, Frau S, Gonzalez-Lorenzo M, Featherstone R, Filippini G. Adverse effects of immunotherapies for multiple sclerosis: a network meta‐analysis. Cochrane Database of Systematic Reviews 2023, Issue 11. Art. No.: CD012186. DOI: 10.1002/14651858.CD012186.pub2. Accessed 10 January 2024.
The WHO also recently added treatments for MS (rituximab, glatiramer acetate and cladribine) to the Essential Medicines List for the first time, not sure the right source type for this, but here's the announcement: https://www.who.int/news/item/26-07-2023-who-endorses-landmark-public-health-decisions-on-essential-medicines-for-multiple-sclerosis — Preceding unsigned comment added by YetiHed ( talk • contribs) 13:49, 10 January 2024 (UTC)
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Wikipedia:Scientific peer review/recent reviews I have asked for scientific peer-review of this article. I would appreciate any ideas to improve or to correct any mistakes there may be. -- Garrondo 08:40, 1 September 2007 (UTC)
It's a good idea to off-load this article. Thanks for doing it! InvictaHOG 19:16, 28 October 2006 (UTC)
I`m trying to clean up the article. It does not have proper references and the format varies from one section to other. It was specially bad written the investigation section where severel non NPOV could be found. I have divided it in two sections: investigations in II and III phase clinical trials and basic investigation.
Cleaning up I have eliminated the following paragraph:
The reason to eliminate it is that I can´t really understand what it talks about; and neither can I find the articles it talks about in pubmed. If anybody understands it and can help to improve it be welcome... If not it will be lost
After a whole month working in the article I think I have finished improving it. I have added more than 60 references, reordered much of it and moved some information very similar to lists to secondary articles. I think is a much better article than a month before. Therefore I'm thinking of nominating it for "good article"; however it may be difficult to get it becouse it doesn't have any pictures. The problem is that I can't think of any pictures that fit. Any ideas? Does anybody think it has some possibilities? -- Garrondo 14:22, 31 August 2007 (UTC)
I have nominated the article as a good article candidate. I would be thankful to anybody who who helped in the good article review (See: Wikipedia:Good article candidates If you have not contributed significantly to this article, feel free to evaluate it according to the good article criteria and then pass or fail the article as outlined on the candidates page. -- Garrondo 13:27, 5 September 2007 (UTC)
In consideration of the 500,000+ hits on Google when searching for tai chi and multiple sclerosis, I think it behooves those looking to create a comprehensive, GA-status article to do some investigating and potentially include a mention. It would seem that many published works also touch upon the practice as an MS therapy, as do more scholarly sources. VanTucky Talk 23:29, 12 September 2007 (UTC)
This article is very well written, with relatively easy to understand prose, and sufficient reference citations. It has a good, well-written, lead section, and good use of images. As written, I beliee this article meets the Good Article criteria, and will be listed.
A couple of areas of improvement: first, the section headers seem to be kind of long and wordy. Perhaps they could be reduced or paraphrased a bit. Although they do seem to be an accurate description of their contents, so I'm not sure how to go about reducing them. Maybe something as simple as combining the 'management of...' headers into one main section, with subsections, would reduce the repetition of the 'management of...' line, making it a bit easier to read?
Second, under 'Management of relapsing-remitting MS', the second to last paragraph, dealing with ease of use, price and side effects, is unsourced. As some information on the frequency of injections is provided, a reference should be added (though, given the well-sourced nature of the article as a whole, I won't withhold GA status over this one issue). I think that the earlier references for the drugs, a few paragraphs up, probably have this information anyway, so they could be used here.
I like the look of the chemical structure of methylprednisolone, and compared to the structure of mitoxantrone, the lines used in the structure of the latter are much weaker and less apparent than the former. Perhaps the structure of mitoxantrone could be improved a bit in the
image file to use darker lines, and maybe increasing the size of the image just a bit, so more closely match the look of methylprednisolone.
Also, a suitable image for the upper right-hand corner, to be used as an intro, would help to better grab the attention of the reader. I don't think an infobox is needed here, but a good lead image would be nice.
Hope this helps improve the article even more! Good work so far! Dr. Cash 21:03, 18 September 2007 (UTC)
I have nominated the article for featured article after working on it after it become a GA. If you think the article is good enough please vote for it. Any comments for improvement will also be welcomed. Garrondo 13:41, 25 October 2007 (UTC)
I would suggest moving this page to Treatment of multiple sclerosis, consistent with articles such as Treatment of Crohn's disease, Treatment of bipolar disorder and others. If nobody objects I will go ahead and rename the article. -- WS ( talk) 23:33, 16 November 2007 (UTC)
"Some studies also show benefits on physical variables" ... what the heck does that mean? Isn't there a more straightforward way of saying it? Leotohill ( talk) 05:53, 24 January 2008 (UTC)
I can't quite figure out this sentence: "After some years, many of the people who have this subtype begin to experience neurologic decline without acute relapses as the secondary progressive subtype. "
I've spent several minutes here trying to write up what it might mean, without success. What is it that is the "secondary progressive subtype"? What is it secondary to? Are there other secondary types that are not progressive?
Call me confused. 24.39.174.1 ( talk) 14:31, 24 January 2008 (UTC) That was me - I forgot to login. Leotohill ( talk) 19:00, 24 January 2008 (UTC)
I'm going to remove that confusing clause and see who objects. Leotohill ( talk) 19:01, 24 January 2008 (UTC)
Im a little shocked that BVT (bee venom therapy) has not been brought up, especially considering the success stories with them.
Bee Venom Therapy at Discovery [1]
ODNation ( talk) 01:54, 25 January 2008 (UTC)
A pennsylvania doctor has recently found a cure for ms that has not yet been widely accepted. He uses fluconazol and a 2 week no sugar diet to treat patients. He has cleared a whole wing of a hospital which dealt with MS by using this treatment. I am friends with one of his patients who could not walk but within a few months of seeing this doctor she went trick or treating with her kids
someone should post this —Preceding unsigned comment added by 141.152.238.229 ( talk) 15:40, 25 January 2008 (UTC)
I propose the following:
1. A brief discussion on the Relative Efficacy of the disease-modifying drugs.
The article is informative about the difference of administration in the DMDs, right down to specifying the dosage intervals; it also goes into detail about the greatly-varying side effects. However, the article is completely silent on what is most important, which is the spectrum of what is cinically proven, and to what extent, and what is not. Instead the article states that all DMDs have been shown to be "modestly effective in reducing attacks and slowing disability progression" - which is in fact erroneous.
2. Deleting what is currently reference # 27, a page from the obscure "PeaveHealth" which is both obsolete and already inferior to the Wiki page. io-io ( talk) 02:17, 27 January 2008 (UTC)
Medical Name | Brand Name | Safety limits long-term use | Dosing Schedule | Lesion Reduction | Advantage (2 years) in Lesion Reduction | Relapse Reduction | Advantage (2 years) in Relapse Reduction | Disability Progression Reduction | Advantage (2 years) in Disability Progression |
---|---|---|---|---|---|---|---|---|---|
Glatiramer acetate [1] [2] | Copaxone | No | 1 x day subcutaneous injection | Yes | Vs placebo | Yes | 29% vs placebo | No | n/a |
Interferon beta-1a [3] | Avonex | No | 1 x week intramuscular injection | Yes | Yes | 29% vs placebo | Yes | 37% vs placebo | |
Interferon beta-1a [4] | Rebif | No | 3 x week subcutaneous injection | Yes | 80% vs placebo | Yes | 27% vs placebo | Yes | Vs placebo |
Interferon beta-1b [5] [6] | Betaseron/ Betaferon | No | 1 x 2 days subcutaneous injection | Yes | 80% vs placebo | Yes | 34% vs placebo | No | n/a |
Mitoxantrone [7] | Novantrone | Yes | 1 x 3 months infusion | Yes | Vs placebo | Yes | Vs placebo | Yes | Vs placebo |
Natalizumab [8] [9] | Tysabri | No | 1 x month intravenous infusion | Yes | 96% vs placebo | Yes | 68% vs placebo | Yes | 54% vs placebo |
::Wow...you have done a great work. It´s a great improvement to the article. I only have some minor improvements:
*I don`t like the colur use, specially the blue for letters, since they seem internal links. I would rather prefer black as in all articles. Yellow might also be too strong
*I would add internal links to medications, type of injections, and any other word difficult to understand
*I would also writte completely sub-cutaneous, since just sub-c would not be understood by some non medical readers. DONE
*I would eliminate the "?" after safety limits... In no other title you have added it. DONE
*I suppuse v is versus. Im not english, but, is it not better understood as vs? DONE
*Interferon 1-b is betaseron in US, but betaferon in all Europe, both names should appear.DONE
*Add all the refs with diberris tool: http://diberri.dyndns.org/wikipedia/templates/ to continue with the format used in the articleDONE
Other changes done:
A question: are quantities at relapse reduction really needed? -- Garrondo ( talk) 10:43, 7 March 2008 (UTC)
I have not done the research so I don´t know if this is absolutly correct, but maybe a way to simplify the table was only to put the long term comparisons against placebo. It would look something like this. What do you think (Specially io-io)? -- Garrondo ( talk) 10:27, 8 March 2008 (UTC)
Medical Name | Brand Name | Safety Limits Long-Term Use | Dosing Schedule | Results after Treatment for Two Years Relative to Placebo | ||
---|---|---|---|---|---|---|
Improved Relapse Rate Reduction | Delayed Disability Progression | |||||
Glatiramer acetate [1] [10] | Copaxone | No restriction | 1 x day
subcutaneous injection |
29% | Not shown | |
Interferon beta-1a [3] | Avonex | No restriction | 1 x week
intramuscular injection |
18% | 37% | |
Interferon beta-1a [4] | Rebif | No restriction | 3 x week
subcutaneous injection |
29%* | 22%* | |
Interferon beta-1b [5] [6] | Betaseron / Betaferon | No restriction | 1 x 2 days
subcutaneous injection |
31% | Not shown** | |
Mitoxantrone [7] | Novantrone | Yes (absolute max 3 yrs) | 1 x 3 months
intravenous infusion |
67%*** | Yes*** | |
Natalizumab [11] [12] | Tysabri | No restriction | 1 x month
intravenous infusion |
68% | 54% |
Notes - *Results are shown for the 22mg or most common dose of Rebif (interferon beta-1a). Results for a 44mg dose, which is less well tolerated, were not significantly better. **In RRMS, interferon beta-1b has not proven that it can delay disability progression. However, in SPMS, it has proven that it cuts the risk of disability progression by 16% over 2 years. ***Most patients in the mitoxantrone trials were SPMS, not RRMS. In a trial with some RRMS patients, it did achieve a proven advantage in relapse rate reduction of 67%, but did not use the same measures of disability progression. In the sum of trials with mostly SPMS and PRMS patients it did however show cuts the risk of disability progression by 66% over 2 years.
After looking up various trials and labels, I decided to eliminate the column for "lesion reduction", for 2 reasons. First, the various trials soemtimes report total lesions, and others report only "gandolonium-enhancing" lesions", and it does not seem possible to give a consistent numerical category. Second, it is not a "clinical effect", only an MRI measure, and only moderately correlated with patient perception and outcome....Also I improved column-widths, to increase the importance of the efficacy comparison itself (last 2 columns)..... io-io ( talk) 21:59, 9 March 2008 (UTC)
I prefer this design
Medical Name | Brand Name | Safety Limits Long-Term Use | Dosing Schedule | Results after Treatment for Two Years Relative to Placebo | ||
---|---|---|---|---|---|---|
Improved Relapse Rate Reduction | Delayed Disability Progression | |||||
Glatiramer acetate [1] [13] | Copaxone | No | 1 x day subcutaneous injection | 29% | Not shown | |
Interferon beta-1a [3] | Avonex | No | 1 x week intramuscular injection | 18% | 37% | |
Interferon beta-1a [4] | Rebif | No | 3 x week subcutaneous injection | 29%* | 22%* | |
Interferon beta-1b [5] [6] | Betaseron / Betaferon | No | 1 x 2 days subcutaneous injection | 31% | Not shown** | |
Mitoxantrone [7] | Novantrone | Yes (max 3 yrs) | 1 x 3 months intravenous infusion | 67%*** | Yes*** | |
Natalizumab [14] [15] | Tysabri | No | 1 x month intravenous infusion | 68% | 54% | |
Notes
+Results are shown for the 22mg dose. Results for a 44mg dose, which is less tolerated, were similar [16]. ++In RRMS, interferon beta-1b has not proven that it can delay disability progression. However, in SPMS trials, it has been shown to cut the risk of disability progression by 16% [17]. +++Most patients in the mitoxantrone trials were SPMS. In a trial with RRMS patients, it achieved an advantage in relapse reduction of 67%, but did not use the same disability progression measures. In the sum of trials with SPMS and PRMS patients it did cut the risk of disability progression by 66% [18]. |
References
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Limits to Disability Progression claims for these treatments is disputed - some of the referred articles are very old indeed (1995 & 1996 i.e. before proper disclosure rules were introduced and when beta interferon treatments were extremely new). Many professional neurologists would not subscribe to these evaluations. I think one has to be very cautious when claiming that any of these treatments limit disease progression especially in view of more recent meta-studies that dispute such claims, particularly in the case of the interferons (see Cochrane reviews). Additionally, natalizumab is a very recent drug with too little data to clearly establish whether it limits progression. Conventional MRI has been shown to imperfectly represent disease activity and yet, in these earlier studies, is taken as a definitive bench-mark. One of the other quoted texts is an expert opinion and not a study. I wonder why one particular editor has been so determined (for some little while) to show the efficacy of these treatments against progression. One has to be careful of (undisclosed and undectable) conflict of interest in Wikipedia articles, which are not subject to the same rigour and professional criticism as medical articles. Ultimately, patients are the ones making important and expensive decisions as to whether to undergo these drug regimes. Wikipedia is very high on the search engines and has a duty to present impartial information - it is the reponsibility of editors (both professional and amateur) to police this. Often that means checking the references. Better still, I believe that Wikipedia should desist from addressing drug treatments for multiple sclerosis - there are better and more rigorous sources. If editors do conclude that Wikipedia is a valid forum for discussion of treatment efficacy then I believe that proper and rigorous checks and balances are introduced. Laetoli ( talk) 08:04, 10 April 2008 (UTC)
It seems to me like the main issue is with the table in the 'Relapsing-remitting MS' section, which has specific data on percentages for reducing relapse remission and limiting disease progression. The table is the result of talk page discussion (see the preceding two sections), so this third section is now effectively extending that same discussion, eh? ;-)
It is clear that a lot of work has been put into the table, and I think that looks very good. However, I do have to question whether this falls under original research. Because it appears to me that the table is not published in its entirety in a single source, and rather, pieced together from multiple sources. And that is great from the perspective of an author(s) writing a review article for a scholarly journal or something, but that's not what wikipedia is for. The biggest issue I see with the data in the table is that, with data coming from multiple sources like this, trying to establish reasonably accurate measures for relapse rate and disease progression is going to be very difficult, and quite possibly wildly inaccurate from a statistical standpoint as well. In order for these statistics to be even close to believable, far more information on the studies conducted is needed, as there are far too many factors involved here that could throw off these percentages. If the table in question was all from one source, we could put it in and cite that source, and individuals interested in the specifics of the study could click on that to read it if they want. But as it stands, a table that's been concocted from multiple sources with details of said studies that are unclear,... I've got to call WP:OR on this one. Dr. Cash ( talk) 21:23, 14 April 2008 (UTC)
to: Laetoli - OK, using up all the ammunition now, because I will be away for a day - now I will address what User:Laetoli wrote, under separate sections. I already told him that I was most sympathetic to the other action he took - putting a big WARNING up on Drug pages because anyone can edit and skew a Med article here, and that medical advice should be sought elsewhere - because reality IS that some small percentage of patients who have long-term therapy choices in front of them WILL read these various drug pages and will be influenced by what they read. However, the reason the page started is that it appears ridiculous that, with today a fairly large of treatment choices, and with the fearful side-effects and unpleasantness shown in relative comparison, then at least the regulatory efficacy numbers should be compared too. After all, the #ONE thing a patient wants taking a Drug is efficacy. But more about numbers later.
because it MIGHT work - Laetoli, you didnt answer my questions, but you write "take anything because it MIGHT work is the most irresponsible thing I have yet read on Wikipedia" - well I didnt say "it MIGHT work" at all - I was sensitive to the problem that they dont work for some patients (in fact for many, it is NEVER known if they helped to some degree, because relapse rates vary and are intermittent), as you can see from what I wrote. But in FACT this is the case with ALL these serious progressive diseases - there is no cure, and the very best drugs do NOT have a uniform result, nor close to it. Take Hepatitis C for example - the drugs are awful, and for 50% it's almost a cure, and the other 50% simply go back to the end of the line. In fact more so for Hep C than MS, "it might work" is the cruel paradigm.
Neurologists - you write that "Many professional neurologists would not subscribe to these evaluations" - and yet you base your evidence on the Cochrane reviews, written by a handful. And what do they the Cochrane reviewers do in their practices, do you think they refuse to prescribe DMDs? The fact is that in the USA, some 70% of MS-ers are on one of these DMDs, and probably another 15% are off them only because they failed them. In the EU, the percentages vary wildly between the countries, I think I saw that in Sweden it may be 75% and in Poland 1%-3%. But these numbers show that in the developed countries the overwhelming majority of neurologists DO prescribe DMDs to their patients.
Patients - #1 - I noticed from your first ever entry your remarkably accurate comment that MS patients have "a lot on their hands" - I could not have said it better. To compound matters, upwards of 50% have cognitive issues to some degree, which can unfortunately mean that the potential for adverse effects (which the doctors MUST tell them about) is the over-riding concern. If you had MS, you too would be faced with the same fear, and would want to know what are your chances, as the adverse profile (anything from the drudgery of daily injections to PML) will be fully explained. Therefore my view is that, for the inevitable number of MS patients who look on these pages at the very moment that they have been presented with treatment decisions, that they get a perspective on the MAIN issues - you can already see on the page that side effects get 20 lines or so - are side effects the main issue. Absolutely not, and you said it yourself, it is Disability (and it's pre-cursor, Relapse Rate). So for those who still have a wide choice, information and balance is vital.
Patients - #2 - I dont know where you are (UK I assume, given your NICE cites) but the consensus among MS patients is absolutely make the DMD choices available, and THEY and their doctors will decide. Two examples - in the UK, after the NICE negative evaluation (effectively a Government-paid consultant) of interferons and copaxone, such was the outcry from MS patients that eventually the NIH had to do a U-turn - now generally they are FREE to MS-ers. Another obvious example was in the USA where natalizumab was before a Public Hearing, and such was the fear among MS patients that the safety-obsessed (ie politically-pressured) FDA would prevent its return, the planned couple of hours of "public testimony" went for a full day, forcing a second day of hearings. Once again, your patients DO want to know, and DO want better drugs.
Patients - #3 - Cost – You speak several times to the patients’ pockets, etc, but I believe this is the least important factor. Overwhelmingly in the developed countries the patients do not pay for these drugs at all, or at most, a small percentage. Even for patients in the USA who have no insurance, there are programs whereby they can get them. Finally, there is little difference in cost between the drugs (with the possible exception of novantrone, which is an older chemotherapy drug).
"evidence-based medical science" - This is where, in my opinion you are technically wrong in a way that has impressed others here, but unduly:
Finally, I want to point out to you that, as you said, the most important issue to an MS patient is Disability Progression. Certainly two of the drugs have had over 10 years to prove a Disability advantage, and yet they have failed to do so - I think that it is quite OK if that shows up, because the oldest drugs have had the most chances; but the other interferons have also succeeded to the design standard of their day-at-court. When I first saw this page, I thought that both what the DMDs can do, and what they relatively achieve, were lost on the page. I believe MS patients are looking for Efficacy as the #1 priority – that is why I made the Table. Original idea? Well I don’t know, there is that paper I referenced. Original research? Not at all, it is basically a list of numbers, the official numbers too, and all RRMS. io_editor ( talk) 03:19, 17 April 2008 (UTC)
I will leave others to discuss the ins-and-outs of these drugs since it is all beyond my ken. To me, however, the key issue is the way that individual studies' treatment efficacy results were presented, and in fact 'compared' inappropriately in a table. By way of explanation I will give an Wikipedia example from my own field.
An editor, who incidentally had a COI, made this edit [5] giving percentage reductions in stuttering following 3 different kinds of treatment: Treatment A 48%, Treatment B 63% and Treatment C 71%. Makes it look like Treatment C is the best, right? The thing the editor didn't report was that the studies repeatedly said that the differences between treatments were not statistically significant. He took actual facts from the study and synthesized them together to prove a point of his own. In this case, all the treatments were offered within the same study, the subjects randomly assigned to treatment groups, exactly the same measures of outcome used etc.
In the case of these drugs we have multiple different studies, likely with different ways of measuring outcome and with different subject pools. Presenting average 'improvements' is thus even more inappropriate than it was in the stuttering example above. It is original synthesis and contrary to these reliable sources guidelines [6]
How reliable a single study is considered depends on the field, with studies relating to very complex and not entirely-understood fields, such as medicine, being less definitive. If single studies in such fields are used, care should be taken to respect their limits, and not to give undue weight to their results. Meta-analyses and systematic reviews, which combine the results of multiple studies, are preferred (where they exist).
which suggests we should be using the meta-analyses and systematic reviews as the primary source of information here. Slp1 ( talk) 17:25, 19 April 2008 (UTC)
Based on your other edits on this and other pages, you seem to have some sort of soft spot for natalizumab. Your table synthesises reliable sources together and ends up making natalizumab look like the best possible treatment. This is synthesis pure and simple and is not allowed. You need to find a peer-reviewed study that explicitly compares these different drugs. The issue seems to be a problem in understanding the difference between academic writing, and writing for an encyclopedia. This is not an academic paper where we are encouraged to be creative and do these kinds of innovative things and comparisons. This is Wikipedia, a very boring place where we only report, in summary form, what others have written and directly compared. Sometimes learning to understand the difference between academic writing and encyclopedia writing is a challenge, I realize. But these drugs have not been compared by reliable sources in the way you have tried compare them. And if they haven't made the comparisons, neither can we. Slp1 ( talk) 21:25, 20 April 2008 (UTC)Material can often be put together in a way that constitutes original research even if its individual elements have been published by reliable sources. Synthesizing material occurs when an editor tries to demonstrate the validity of his or her own conclusions by citing sources that when put together serve to advance the editor's position. If the sources cited do not explicitly reach the same conclusion, or if the sources cited are not directly related to the subject of the article, then the editor is engaged in original research.
I agree with Slp1 - we can only report findings and try to interpret them accurately taking into account conflicting views between professionals working in the field. This also involves clearly distinguishing between measures of 'disease severity' during a relapse and 'abatements in clinical progression over a patient's lifetime'. It is easy for the patient to confuse the two and as Ropper has explained, none of the DMDs have been shown to achieve the latter. Laetoli ( talk) 13:37, 24 April 2008 (UTC)
I have read the Ropper article and the full sentence mentioned says the following: A further compelling result was the abatement of clinical progression (17 percent of patients receiving natalizumab had progression vs. 29 percent of those receiving placebo) and a similar prolongation of the interval before neurologic deterioration. It is tempting to project these improvements over a patient's lifetime, but there are no data yet to support such a view. As I understand it there has been a decrease in disease progression, and it is said verbatim in the reference, even if it is only during the years of the study. Of course longer longitudinal studies are needed to see if this decrease mantains over time or after some time MS patients on Natalizumab recatch patients on the other treatments groups. Would be a solution to say something as "preliminary data points to a effect in disease progression, but studies on the long-term effects are needed."-- Garrondo ( talk) 07:46, 25 April 2008 (UTC)
"Patients with PPMS have also been included in trials of . . . cladribine. However, no treatment in these trials has been shown to modify the course of the disease."
Should this be updated in light of this [11]? Jh39 ( talk) 22:13, 30 April 2009 (UTC)
I agree with Polarlys that the use of Image:Cannabis sativa.jpg in Treatment of multiple sclerosis #Alternative treatments is problematic and raises WP:WEIGHT issues. Cannabis doesn't have good evidence for MS; it would be better to give an image of an alternative treatment that is better supported by scientific evidence (vitamin D, for example). Better yet would be an image specific to MS, rather than some stock shot of a plant or a pill. Eubulides ( talk) 07:37, 8 June 2009 (UTC)
There are some additional new therapies approved. DGG ( talk ) 00:53, 16 December 2012 (UTC)
My name is Florian Schaub at Merck KGaA. My aim is to make some changes in this article, because we have identified some misleading information. I have provided clearly arranged suggestions that you can see below on the talk page. They all follow the same pattern:
• Current Version
• Suggested Revision (Suggested changes are bold)
• Reason
• Suggested Reference (if needed)
Please let me know if anyone has concerns.
_Current Version:
“Newer treatments feature intravenous (IV) infusions (shown above) at 1 to 3-month intervals.”
Suggested Reviosion:
“Treatments feature intravenous (IV) infusions (shown above) at 1- to 12-month intervals, and oral drugs, taken daily or twice-daily.”
Reason 1:
IV treatments have been used for many years, while newer treatments tend to focus on the oral route of administration.
Reason 2:
We have suggested the change to the treatment interval as Lemtrada infusions are administered 12 months apart.
Reference 1: Multiple Sclerosis (MS). Treatment.
http://www.multiplesclerosis.com/us/treatment.php [Accessed 03 Jun 2016].
Reference 2: Lemtrada US product label
_Current Version:
As of November 2014, nine disease-modifying treatments have been approved by regulatory agencies of different countries…”
Suggested Reviosion:
As of June 2016, 14 disease-modifying treatments have been approved by regulatory agencies of different countries…”
Reason:
Updated for June 2016.
Reference:
National Multiple sclerosis society. Medications.
http://www.nationalmssociety.org/Treating-MS/Medications [Accessed 03 Jun 2016].
_Current Version:
“…and the Japanese Pharmaceuticals and Medical Devices agency (PMDA).”
Suggested Revision:
We suggest changing the link URL to:
/info/en/?search=Pharmaceuticals_and_Medical_Devices_Agency
Reason:
The current link directs to an incorrect page.
_Current Version:
“Interferon beta-1a is injected either weekly (intramuscular injection) or three times a week (subcutaneous injection) depending on commercial formulations, while interferon beta-1b is injected subcutaneously every second day.”
Suggested Revision:
“Interferon beta-1a is injected, either weekly (intramuscularly), three times a week or every other week (subcutaneously) depending on the commercial formulation, while interferon beta-1b is injected subcutaneously every second day.”
Reason:
Suggested text to account for Plegridy injections, which are administered every other week.
Suggested Reference:
US and EU Rebif, Avonex, Plegridy and Betaferon product labels
_Current Version:
“Another oral drug, cladribine, was approved in Russia and Australia in 2010. Its application was rejected by the FDA and EMEA in 2011 due to safety concerns in spite of the promising efficacy of the drug. This led the pharmaceutical to discontinue commercialization and withdraw all marketing applications.”
Suggested Revision:
“Another oral drug, cladribine, was approved in Russia and Australia in 2010. Its application was rejected by the FDA and EMEA in 2011 due to safety concerns, in spite of the promising efficacy of the drug. This led the pharmaceutical company to discontinue commercialization and withdraw all marketing applications. Merck KGaA announced its intention to submit cladribine for EU approval in September 2015, following additional data which allowed a better characterization of cladribine’s benefit–risk profile.”
Reason:
The current text is out of date.
Suggested Reference:
Cladribine press release:
http://www.merckgroup.com/en/media/extNewsDetail.html?newsId=1C517A71C016A43BC1257EBC006B50C3&newsType=1
_Current Version:
“PML is an opportunistic infection with neurological progressive symptoms caused by the replication of the JC virus in the glial cells of the brain. All 3 initial cases were taking natalizumab in combination with interferon beta-1a. After a safety review the drug was returned to the market in 2006 as a monotherapy for MS under a special prescription program. As of May 2011, over 130 cases of PML had been reported, all in patients who had taken natalizumab for more than a year. While none of them had taken the drug in combination with other disease-modifying treatments, previous use of MS treatments increases the risk of PML between 3 and 4-fold. The estimated prevalence of PML is 1.5 cases per thousand natalizumab users. Around 20% of MS patients with PML die, while most of the remaining are importantly disabled.”
Suggested Revision:
“Soon after its approval, natalizumab was withdrawn from the market by its manufacturer after it was linked with three cases of the rare but hazardous neurological condition called progressive multifocal leukoencephalopathy (PML). PML is an opportunistic infection with neurological progressive symptoms caused by the replication of the John Cunningham (JC) virus in the glial cells of the brain. In all three initial cases, patients were taking natalizumab in combination with interferon beta-1a. After a safety review the drug was returned to the market in 2006 as a monotherapy for MS under a special prescription program. As of September 2014, there were 495 confirmed cases of PML. While none of them had taken the drug in combination with other disease-modifying treatments, previous use of MS treatments increases the risk of PML between 3- and 4-fold. The estimated prevalence of PML is 1.5 cases per thousand natalizumab users.[23] Around 20% of MS patients with PML die, while most of the remaining are importantly disabled.”
Reason:
We suggest the addition of this source, as it the most recent data showing the number of patients receiving Tysabri who have developed PML.
Suggested Reference:
https://www.bostonglobe.com/business/2014/10/22/biogen-idec-reports-death-patient-that-had-taken-its-multiple-sclerosis-pill-tecfidera/xrAtOBsxA7eHZN3BB0phxJ/story.html
_Current Verison:
“Teriflunomide is considered a very safe drug.”
Suggested Revision:
“Teriflunomide is also subject to warnings in the US for hepatotoxicity and risk of birth defects if used during pregnancy.”
Reason:
The US prescribing information contains a black box warning for hepatotoxicity and teratogenicity. The paragraph goes on to say “there have been reports of liver failure, and PML. Teriflunomide is also known to be dangerous for fetal development”. It is contradictory to include this information and claim that teriflunomide is a safe drug.
Suggested Reference:
US Aubagio product label
_Current Version:
“Moreover, fumaric acid is also used to treat psoriasis, another autoimmune disorder, and there is long term safety data from over 14 years of use without any indication of further dangerous secondary effects.”
Suggested Revision:
“Moreover, fumaric acid is also used to treat psoriasis, another autoimmune disorder, and there is long-term safety data from over 14 years of use. However, four cases of PML have been observed in patients treated with Tecfidera.”
Reason:
To include information on the risks associated with fumaric acid esters.
Suggested Reference:
US and EU product labels
http://www.medscape.com/viewarticle/856148
_Current Version:
“Natalizumab and mitoxantrone are considered highly effective both in terms of relapse rate reduction and halting disability progression…”
Suggested Revision:
“Natalizumab and mitoxantrone are considered highly effective, both in terms of relapse rate reduction and reduction of disability progression…”
Suggested Reference:
Kornek B, Patient Prefer Adherence 2015; 9: 675–84
Martinelli Boneschi M et al. Cochrane Database Syst Rev 2013; 5: CD002127
_Current Version:
“While some believe that they will probably reduce the usage of first-line treatments the long-term safety of interferons and glatiramer acetate will probably slow this trend. It has been recommended that at the moment oral treatments should be mainly offered in those cases where patients do not use existing treatments due to needle phobia or other reasons such as perceived inefficacy of interferons and glatiramer acetate.”
Suggested Revision:
“While some believe that they will probably reduce the usage of first-line treatments, the long-term safety of interferons and glatiramer acetate will probably slow this trend. Oral treatments may be attractive in cases where patients do not use existing treatments due to needle phobia or for other reasons such as perceived inefficacy of interferons and glatiramer acetate.”
Reason:
We have suggested removing the first sentence, as it was not supported by the reference.
The reference has been misquoted – it does not recommend oral treatments for any patient group. This change will bring the text in line with the reference used.
_Current Version:
“Dimethyl fumarate is potentially one of the most interesting oral drugs due to the long term data from use in psoriasis which points towards a very good safety profile.”
Suggested Revision:
“Dimethyl fumarate is potentially one of the most interesting oral drugs due to the long-term data from use in psoriasis, which distinguishes it from fingolimod, teriflunomide and laquinimod.”
Reason:
The reference gives a number of common AEs related to DMF treatment initiation. Gastrointestinal events and flushing are described as very common in the EU and US regulatory labels for this drug, and 4 cases of PML have been reported in MS patients taking DMF (with additional cases n patients taking DMF for other indications). We therefore feel that it is perhaps inaccurate to say that it has a very good safety profile. However, the reference does state that long term safety data distinguishes DMF from a number of drugs, and so the text has been suggested to reflect this.
_Current Version:
“Studies on the use of Interferon-beta-1b in secondary progressive and progressive relapsing MS do not support that it slows progression of the disease, although it is effective in reducing the number of relapses.”
Suggested Revision:
“Studies show that interferon beta-1b slows disability progression in relapsing secondary progressive MS, but not in non-relapsing secondary progressive and progressive relapsing MS, although it is effective in reducing the number of relapses.
Studies show a difference in time to disability progression between interferon beta-1a and placebo in a subgroup of secondary progressive MS patients with relapses, but not in the whole patient population.”
Reason:
Information suggested to clarify the impact of interferon beta-1b in SPMS.
Content suggested to include information on interferon beta-1a.
Suggested Reference:
Betaferon EU label
SPECTRIMS Study Group. Neurology 2001; 56:1496–1504
US and EU product labels
_Current Verison:
Therapies under investigation [section header]
Suggested Revision:
Suggest removing all references to alemtuzumab from the section.
Reason:
Alemtuzumab is now approved for treatment of MS.
_Current Version:
Such is the case the PEGylated version of interferon-β-1a, that has a longer life than normal interferon and therefore it is being studied if given at less frequent doses has a similar efficacy than the existing product. With the completion of a robust two-year study, it is shown that the PEGylated interferon beta-1a has greater efficacy in decreasing relapse rate and disability progression compared to placebo for MS patients.
Suggested Revision:
Suggest moving this section from the ‘Therapies under investigation’ section to the ‘Medications’ section.
Reason:
PEGylated interferon beta-1a has been approved for treatment of MS, and thus is no longer under investigation.
-- Florian Schaub at Merck KGaA ( talk) 16:00, 08 July 2016 (UTC)
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My name is Florian Schaub from Merck KGaA. My aim is to make some changes in this article because we have found some misleading information. I've compiled the suggested changes which you can find herinafter. They all follow one pattern:
• Current text
• Suggested revision
• Reason
• Suggested reference
If someone has objections please let me know.
_Current text
Disease-modifying treatments are expensive and most require frequent (up-to-daily) injections, under the skin or into the muscle.
_Suggested revision
Disease-modifying treatments are expensive compared with therapies that only help ease MS symptoms (e.g. medications for pain, fatigue and muscle spasms). Most require frequent (ranging from every day to every 4th week) injections (under the skin [subcutaneous], into the muscle [intramuscular] or into veins [intravenous]), or oral treatment.
_Reason
To clarify what the costs of DMTs are compared to and to accommodate the range of treatment frequencies.
_Suggested reference
“Disease-Modifying Therapies for MS” https://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-The-MS-Disease-Modifying-Medications.pdf. Updated May 2017
_Current text
Newer treatments feature intravenous (IV) infusions (shown above) at 1 to 3-month intervals.
_Suggested revision
Treatments feature intravenous infusions (shown above) at 1- to 12-month intervals, and oral drugs, taken once- or twice-daily.
_Reason
IV treatments have been used for many years, while newer treatments tend to focus on the oral route of administration. The change to treatment interval was suggested as Lemtrada® infusions are administered 12 months apart.
_Suggested reference
Multiple Sclerosis (MS). Treatment. https://www.multiplesclerosis.com/us/treatment.php [Retrieved on 18 July 2017].
Lemtrada® US Prescribing Information. Genzyme Corporation (July 2016). http://products.sanofi.us/Lemtrada/Lemtrada.pdf [Retrieved on 18 July 2017]
_Current text
Interferon beta-1a is injected either weekly (intramuscular injection) or three times a week (subcutaneous injection) depending on commercial formulations,[15][16] while interferon beta-1b is injected subcutaneously every second day.[17]
_Suggested revision
Interferon beta-1a is injected either weekly (intramuscular injection) or three times a week (subcutaneous injection) depending on commercial formulations,[15][16] while interferon beta-1b is injected subcutaneously every second day.[17][18]
_Reason
References are from 2007 and may contain out of date information. More recent references with more up to date information are suggested.
_Suggested reference
[15] Avonex® US Prescribing Information. Biogen, Inc. (March 2016). https://www.avonex.com/content/dam/commercial/multiple-sclerosis/avonex/pat/en_us/pdf/Avonex%20US%20%20Prescribing%20Information.pdf [Retrieved on 18 July 2017]
[16] Rebif® US Prescribing Information. EMD Serono, Inc. (November 2015). http://emdserono.com/ms.country.us/en/images/Rebif_PI_tcm115_140051.pdf?Version [Retrieved on 18 July 2017]
[17] Betaseron® US Prescribing Information. Bayer HealthCare Pharmaceuticals, Inc. (April 2016). http://labeling.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf [Retrieved on 18 July 2017]
[18] Extavia® US Prescribing Information. Novartis Pharmaceuticals Corporation (May 2016). https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/extavia.pdf [Retrieved on 18 July 2017]
_Current text
Another oral drug, cladribine, was approved in Russia and Australia in 2010. Its application was rejected by the FDA and EMEA in 2011 due to safety concerns in spite of the promising efficacy of the drug. This led the pharmaceutical to discontinue commercialization and withdraw all marketing applications.[31]
_Suggested revision
On 25th August 2017, Merck Serono Europe announced that the European Commission (EC) granted marketing authorization for MAVENCLAD® 10 mg (Cladribine Tablets) for the treatment of highly active RMS in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland [1].
_Reason
To update text and provide up-to-date references in line with Wikipedia style (i.e. no original research articles).
_Suggested reference
[1] European Commission Grants Approval for Mavenclad (Cladribine Tablets) http://ec.europa.eu/health/documents/community-register/2017/20170822138481/dec_138481_en.pdf [Accessed 01 September 2017] TYSABRI® (natalizumab): PML in Patients Receiving TYSABRI (USA TYSABRI PML Update). Biogen, Inc. (21 June 2017). https://medinfo.biogen.com/secure/download?doc=workspace%3A%2F%2FSpacesStore%2Fded9df8f-d785-444a-ae89-888bef72aa7e&type=pmldoc&path=null&dpath=null&mimeType=null [Retrieved on 18 July 2017]
_Current text
As of May 2011, over 130 cases of PML had been reported, all in patients who had taken natalizumab for more than a year.[25]
_Suggested revision
As of 6 June 2017, there have been 731 confirmed PML cases (728 patients being treated for MS, 3 patients treated for Crohn’s disease). The number of natalizumab doses prior to PML diagnosis ranged from 8 to 134, with a mean treatment duration of 49 months.
_Reason
We suggest the addition of this source, as it is the most recent data showing the number of patients receiving Tysabri® who have developed PML.
_Suggested reference
TYSABRI® (natalizumab): PML in Patients Receiving TYSABRI (USA TYSABRI PML Update). Biogen, Inc. (21 June 2017). https://medinfo.biogen.com/secure/download?doc=workspace%3A%2F%2FSpacesStore%2Fded9df8f-d785-444a-ae89-888bef72aa7e&type=pmldoc&path=null&dpath=null&mimeType=null [Retrieved on 18 July 2017]
_Current text
During clinical trials fingolimod gave rise to side effects such as hypertension and bradycardia, macular edema, elevated liver enzymes or reduction in lymphocite levels
_Suggested revision
During clinical trials fingolimod gave rise to side effects such as hypertension and bradycardia, macular edema, elevated liver enzymes or reduction in lymphocyte levels
PML has also been reported under fingolimod treatment since marketing authorisation
_Reason
Corrected the spelling of lymphocyte
We suggest the additional information from the EU SmPC to reflect the cases of PML, with additional reference
_Suggested reference
Gilenya® EU Summary of Product Characteristics. Novartis. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002202/WC500104528.pdf [Retrieved on 07 August 2017]
_Current text
Teriflunomide is considered a very safe drug. Nevertheless, there have been reports of liver failure, and PML. Teriflunomide is also known to be dangerous for fetal development.
_Suggested revision
Teriflunomide is also subject to warnings in the US for hepatotoxicity and birth defects if used during pregnancy.
_Reason
The US Prescribing Information contains a black box warning for hepatotoxicity and teratogenicity. It is contradictory to include this information and claim that teriflunomide is a safe drug.
_Suggested reference
Aubagio® US Prescribing Information. Genzyme Corporation (November 2016). http://products.sanofi.us/aubagio/aubagio.pdf [Retrieved on 18 July 2017]
_Current text
Moreover, fumaric acid is also used to treat psoriasis, another autoimmune disorder, and there is long term safety data from over 14 years of use without any indication of further dangerous secondary effects.[28]
_Suggested revision
Moreover, fumaric acid is also used to treat psoriasis, another autoimmune disorder, and there is long-term safety data from over 14 years of use. [28] However, PML has been observed in patients treated with dimethyl fumarate.
_Reason
To include information on the risks associated with fumaric acid esters.
_Suggested reference
Tecfidera® US Prescribing Information. Biogen, Inc. (January 2017). https://www.tecfidera.com/content/dam/commercial/multiple-sclerosis/tecfidera/pat/en_us/pdf/full-prescribing-info.pdf [Retrieved on 18 July 2017]
_Current text
Treatment with interferons or glatiramer acetate after an initial attack decreases the risk of developing clinical definite MS.[5][38]
_Suggested revision
Treatment with interferons or glatiramer acetate after an initial attack decreases the risk of developing clinical definite MS.[5][38] However, no oral treatments have been licensed for treatment of CIS.
_Reason
Suggestion made for clarity regarding treatment options for CIS.
_Current text
While some believe that they will probably reduce the usage of first-line treatments the long-term safety of interferons and glatiramer acetate will probably slow this trend.[28] It has been recommended that at the moment oral treatments should be mainly offered in those cases where patients do not use existing treatments due to needle phobia or other reasons such as perceived inefficacy of interferons and glatiramer acetate.[28]
_Suggested revision
While some believe that they will probably reduce the usage of first-line treatments, the long-term safety of interferons and glatiramer acetate will probably slow this trend.[28] Oral treatments may be attractive in cases where patients do not use existing treatments due to needle phobia, or for other reasons such as perceived inefficacy of interferons or glatiramer acetate.[28]
_Reason
The reference does not recommend oral treatments for any patient group. This change will bring the text in line with the reference used.
_Current text
Dimethyl fumarate is potentially one of the most interesting oral drugs due to the long term data from use in psoriasis which points towards a very good safety profile.[28]
_Suggested revision
Dimethyl fumarate is potentially one of the most interesting oral drugs due to the long term data from use in psoriasis, which distinguishes it from fingolimod, teriflunomide, and laquinimod.[28]
_Reason
The reference gives a number of common adverse events related to dimethyl fumarate treatment initiation. Gastrointestinal events and flushing are described as very common in the EU and US regulatory labels for this drug, and 4 cases of PML have been reported in MS patients taking DMF. It may be inaccurate to say that it has a very good safety profile. However, the reference does state that long-term safety data distinguish DMF from a number of drugs, and the suggested text reflects this.
_Current text
Studies on the use of Interferon-beta-1b in secondary progressive and progressive relapsing MS do not support that it slows progression of the disease, although it is effective in reducing the number of relapses.[47]
_Suggested revision
Studies show that interferon beta-1b decreases the number of relapses in relapsing-remitting and secondary progressive MS, and in one study it slowed disability progression in secondary progressive MS.[1][2] In patients with relapsing-remitting MS, one study has shown a difference in time to disability progression between those treated with interferon beta-1a and those treated with placebo. [3]
_Reason
Information suggested to clarify impact of interferon beta-1b in SPMS. Content suggested to include information on interferon beta-1a.
_Suggested reference
[1] Extavia® US Prescribing Information. Novartis Pharmaceuticals Corporation (May 2016). https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/extavia.pdf [Retrieved on 18 July 2017]
[2] Betaferon® EU Summary of Product Characteristics. Bayer Global Pharma AG (April 2017). http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000081/WC500053225.pdf [Retrieved on 18 July 2017]
[16] Rebif® US Prescribing Information. EMD Serono, Inc. (November 2015). http://emdserono.com/ms.country.us/en/images/Rebif_PI_tcm115_140051.pdf?Version [Retrieved on 18 July 2017]
_Current text
Research [section header]
_Suggested revision
Suggest removing all references to alemtuzumab (once in text, and the image of the structure of alemtuzumab) and daclizumab. Both drugs are now approved for treatment of MS
_Reason
Factual correction.
_Current text
Such is the case the PEGylated version of interferon-β-1a, that has a longer life than normal interferon and therefore it is being studied if given at less frequent doses has a similar efficacy than the existing product.[136][137] With the completion of a robust two-year study, it is shown that the PEGylated interferon beta-1a has greater efficacy in decreasing relapse rate and disability progression compared to placebo for MS patients.[138]
_Suggested revision
Suggest moving this to the “Medications” section, as PEGylated interferon beta-1a has been approved for treatment of MS.
_Reason
Factual correction.
--
Florian Schaub at Merck KGaA (
talk) 13:37, 18 October 2017 (UTC)
We do not write like this "MAVENCLAD® 10 mg (Cladribine Tablets)" Doc James ( talk · contribs · email) 20:04, 18 October 2017 (UTC)
We would suggest writing it like this: "Mavenclad 10mg (Cladribine Tablets)". Is this the correct way? -- Florian Schaub at Merck KGaA ( talk) 08:35, 7 November 2017 (UTC)
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As can be seen in the Featured version, the citation style used in this article was the long-standing and well established Diberri format, vancouver style authors, more than five authors truncated to three. I have restored, per WP:CITEVAR, and to make it easier to edit without having to work around endless unused citation template parameters. SandyGeorgia ( Talk) 06:41, 6 September 2020 (UTC)
This article is a 2007 FA that has not been maintained to standard. Many sections have become listy and taken on WP:PROSELINE, the Research section (and possibly more) is outdated, there are numerous maintenance tags, there are copyedit issues, there is WP:CITATION OVERKILL on non-controversial statements, some of the sections are poorly organized and contain information that would better belong in a History section, Further reading needs to be pruned or content added to article, and there are MOS issues like faulty dashes/hyphens and incorrect use of italics and bolding. Unless someone can restore this article to standard, it should be submitted to Featured article review. SandyGeorgia ( Talk) 00:20, 10 November 2020 (UTC)
Excess detail removed from the main article, which should use summary style; this content could be worked in here if not already included.
They are interferon beta-1a, interferon beta-1b, [1] glatiramer acetate, mitoxantrone, natalizumab, [2] fingolimod, [3] teriflunomide, [4] [5] dimethyl fumarate, [6] [7] alemtuzumab, [8] [9] ocrelizumab, [10] [11] siponimod, [11] [12] [13] cladribine, [11] [14] ozanimod, [15] [16] and ponesimod. better source needed [17]
Natalizumab reduces the relapse rate more than first-line agents; however, due to issues of adverse effects is a second-line agent reserved for those who do not respond to other treatments
[18] or with severe disease.
[19]
[2] Mitoxantrone, whose use is limited by severe adverse effects, is a third-line option for those who do not respond to other medications.
[18]
In March 2017, the FDA approved ocrelizumab, a humanized anti- CD20 monoclonal antibody, as a treatment for RRMS, [20] [21] with requirements for several Phase IV clinical trials. [22]
As of 2017
[update],
rituximab was widely used off-label to treat RRMS.
[23] There is a lack of high quality randomised control trials examining rituximab versus placebo or other disease-modifying therapies, and as such the benefits of rituximab for relapsing remitting multiple sclerosis remain inconclusive.
[24]
References
Tsang2011
was invoked but never defined (see the
help page).Hassan2011
was invoked but never defined (see the
help page).Ocrevus FDA label
was invoked but never defined (see the
help page).Based on prior advice, I think it would be conflict of interest for me to add it, but I wanted to flag that there are a couple of recent sources that relate to updated evidence for treatments and comparisons between treatments:
Gonzalez-Lorenzo M, Ridley B, Minozzi S, Del Giovane C, Peryer G, Piggott T, Foschi M, Filippini G, Tramacere I, Baldin E, Nonino F. Immunomodulators and immunosuppressants for relapsing‐remitting multiple sclerosis: a network meta‐analysis. Cochrane Database of Systematic Reviews 2024, Issue 1. Art. No.: CD011381. DOI: 10.1002/14651858.CD011381.pub3. Accessed 10 January 2024.
Tramacere I, Virgili G, Perduca V, Lucenteforte E, Benedetti MD, Capobussi M, Castellini G, Frau S, Gonzalez-Lorenzo M, Featherstone R, Filippini G. Adverse effects of immunotherapies for multiple sclerosis: a network meta‐analysis. Cochrane Database of Systematic Reviews 2023, Issue 11. Art. No.: CD012186. DOI: 10.1002/14651858.CD012186.pub2. Accessed 10 January 2024.
The WHO also recently added treatments for MS (rituximab, glatiramer acetate and cladribine) to the Essential Medicines List for the first time, not sure the right source type for this, but here's the announcement: https://www.who.int/news/item/26-07-2023-who-endorses-landmark-public-health-decisions-on-essential-medicines-for-multiple-sclerosis — Preceding unsigned comment added by YetiHed ( talk • contribs) 13:49, 10 January 2024 (UTC)