Multiple Sclerosis

The shameful story of Rituximab in Multiple Sclerosis

Two weeks ago a few collegues from Spain and  I attended the 3rd Preceptorship Program in MS at Steven Hauser’s department in UCSF. The scientific program and the overall quality of the course were outstanding. We had the opportunity to hear and ask those that have been ahead of MS research in the last years (Oksenberg, Goodin, Cree, Baranzini and, of course, Hauser). We heard beautiful stories of genetics, Vitamin D, EB virus, in vivo imaging and, what matters most at last, new treatments. It really was an extraordinary experience. But this is not the topic i wanted to  talk about…

One of the treatment stories was one we heard before in 2010 ISNI meeting in Sitges (SPAIN), the one about Rituximab and MS.  Apart from the commercial history of Idec, Biogen, Genentech and so on, the important thing is that it all ended up in an phase II clinical trial. A revolutionary clinical trial.

It was revolutionary because it challenged the “MS-is-(for-sure)-a-T-cell-mediated-disease” dogma showing that a B cell therapy was able to achieve unbelivable results in MS. But most importantly it was revolutionary because it got a striking 91% reduction in new enhancing lessions compared to placebo and, despite being a phase II trial, achieved a 50% reduction in relapse rates compared to placebo in less than a year. These are Natalizumab-level results, but with a quite safer profile than Natalizumab. At least, the experience with other diseases yields a progressive multifocal leukoencephalopathy (PML) rate much lower to that of Natalizumab. Just 6 reumathoid arthritis (in which Rituximab is used routinely) patients have suffered PML over more than 120000 patients treated despite RA patients having used much more frequently concomitant immunessuppresants than MS patients do usually.

The results achieved in the study deserved a NEJM paper and, for sure, a phase III trial. But that won’t happen. At least not in the short term.

It turns out that Rituximab patent expires in the US in 2015. This means that, by the time the phase III is over, the patent will be over too. So, no profit then in doing such an investment. To surpass this inconvenience Genentech invented a new drug, antiCD20 as well, but humanized (Rituximab is chimeric), called Ocrelizumab, and started the whole process again. Then, obviously, we got a phase II trial with ocrelizumab in MS. Results have not been  published yet but have been presented at 2010 ECTRIMS meeting and show,as expected, an almost equal efficacy profile to that of rituximab. But a patient died on the ocrelizumab arm from an unexpected “systemic inflammatory syndrome”. That could be chance and still hope larger studies to be assured… but it was not chance. Several rheumatoid arthritis trials with ocrelizumab have been terminated because “the overall benefit to risk profile of ocrelizumab was not favorable in RA” what it really means that 7 patients died unexpectedly in the high ocrelizumab dose arms of the trials.

So, what have we now? Rituximab, an extraordinarily effective therapy, used for quite a long time now, pretty safe but that will never be approved for MS if phase III trials are not performed (and phase III trials are not planned to be performed) because that drug has become unprofitable. On the other hand we have an equally effective therapy, tested in phase II trials, to date showing a pretty less safe profile (to the point of having been stopped in other diseases) but potentially profitable if the company overcomes the safety issues. Guess wich one will be approved in a few years.

This is terrible. We don’t have so many choices to give our patients to throw away the best ones or have to wait several more years. But it’s terrible not only for MS patients… Rituximab has been tested in small case series of myasthenia gravis, neuromyelitis optica, NMDAR encephalitisLambert Eaton myasthenic syndrome, CIDP, anti-MAG neuropathy… diseases that, if MS may not have rituximab phase III trials, they won’t for sure. And, in those case series, it has shown pretty good results that need to be confirmed in order to be approved and used routinely. If a bad commercial decision halts rituximab development or commercialization for all those diseases, MS included, it will be the most shameful story in neuroimmunology. So, if not big pharma, a consortium of neuroimmunology departments should perform that expected phase III trial and bring rituximab back to neuroimmunology therapy.

If, in the meantime, ocrelizumab, ofatumumab or any other treatment can be developed and results positive it will be welcomed, but not a single effective drug should be left behind.

70 replies on “The shameful story of Rituximab in Multiple Sclerosis”


The same thing just happened with ME/CFS! A phase II placebo controlled study just got published which showed benefit in the treatment groups but the drug maker isn’t interested in doing further studies because Rituximab’s patent is set to expire!

Benefit from B-Lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-Blind and Placebo-Controlled Study

Intesting article I did not know about. CFS is a largely unknown disease but those results could not only help in therapy but also in finding its cause.
I feel that sooner or later Rituximab will be out for MS. The shame here is that its use cold be delayed because of private interests.

Thank you for your comment and the reference!

There should be public/insurance co. funding for stage III trials of medications that are nearing or at the end of patent protection. The money spent thus would be saved by the lower cost of generic drug treatment. Another candidate is Naltrexone, in the low dose form, which many patients find helpful in MS and in ME.

It is high time society was organised for the benefit of its citizens, and not just for the financial gain of the 1% elite.

Sure! My claim is not only directed to governments that have an opportunity to improve people’s lives with lower costs but, mostly, to MS specialists and “study groups” that should lead research in free, cost-effective drugs as well.

Ah, you had me until the 1% drivel. Patent expiration dates should be extended for biologic drugs to encourage the type of innovation desired by the author. Greed is a symptom of shortsighted regulation, not the disease. In other words, it’s the government, stupid!

I don’t think government is the solution for innovation, at all. But I neither think extending patent expiration dates would contribute to innovation in the field. A classic study ( on patents shows that they kill innovation. In fact extending patent expiry dates makes drug companies to invest more on marketing (on their drugs secured by a patent) than to lead a field to leave competitors back again. Those that innovate have an advantage over competitors (bigger on products difficult to be copied, such as biologics) but patents make them relax and kill innovation.
So, for drugs like the one we discuss here maybe drug companies and governments could share costs (pharma could pay the drug, agencies the study design and infrastructure) because, at last, both and, most importantly, patients, will benefit.

Hello Elaine,

You can have an estimation on the costs of clinical trials in this link

However, when funded by national agencies those trials are much cheaper. It depends on the effect you expect to see because on that depends the size of the sample (patients to test) and then the cost.

However studies with a drug already on the market are cheaper because you already know many side effects and protocols to avoid them, you can use protocols from other diseases… Rituximab is a well known drug, so probably test it woul be cheaper than testing ocrelizumab. Biologic drugs are difficult to copy so probably for Roche/Biogen would be better to start testing Rituximab. A safer bet.

Which is the actual patent? I would like to read it. Does the patent contain the exact formula for Rituximab? Does the patent describe Rituximab precisely or does it just explain the procedure for discovering it and manufacturing it? Is the precise formula actually known (i.e. as DNA or amino acid sequence)? Is it a trade secret, contained in some cultured cell line? Is Reditux exactly the same as Rituximab, or just a different mAB produce by a very similar procedure?

Also, how much Rituximab would be required? I think I remember the Rituximab study did 2000mg, but for Ocrelizumab it was both 600mg & 2000mg. Also how often would that dose be required? (Many people could afford 600mg per year at current prices, not so much 4000mg a year.)

Would the lesser humanization of Rituximab result in patient immunity to Rituximab, which then might also carry over to over more humanized versions of the same mAB that became available later?

I think I partly answered my own question, by finding the concept of “Biosimilar” monoclonal AntiBodies, i.e. similar to a patented mAB where the patent has expired, but created, tested and manufactured separately.

Also, this paper from 2010 seems to report a less favourable result for the treatment of MS by rituximab: (“OLYMPUS” trial).


The comments you write are very important. Although patents in conventional treatments avoided competition from other manufacturers, once the patent expired they could cheaply produce those therapies. And then sell them cheaply as well. Biological therapies are different. They are equally protected by law but also by their own manufacturing costs and their own nature. In this sense we have a clear example inside MS. Interferon patents have already expired. But there’s no generic alternative several years later. That means that is not easy/not cheap to produce them and then small pharma companies don’t take the risk.

Moreover, although we may know the exact aminoacid sequence of Rituximab (i don’t know if the patent contains that specifically), probably the whole process can not be reproduced exactly as the first time it was done. And, if it is possible, it could take a long time, lots of comprobations and too much money. But that one should be another reason for Biogen/Roche to give rituximab a chance and organize a trial. They are not protected by the patent but they are by the investment they did in the first place.

Regarding Reditux… it is an antiCD20 chimeric antibody. That does not mean equal safety and effectiveness. Unless a trial or an independent study (institutional or private) show its homology with Rituxan/Mabthera we can not recommend it under any circumstance.

And regarding Olympus trial… Olympus trial studies the Primary Progressive form of MS. This subtype does not respond to date to any other therapy already commercialized or in trial and has clinical features that are very different to relapsing remitting MS, the typical and most frequent one and the one to which we refer by default.

Thank you very much for your comments

The price is an issue for sure, but not the main one…Other more expensive treatments are approved by governments and insurance companies (and if they stop relapses in MS cost-effectiveness will go in favour of Rituximab/OCrelizumab). The problem is that if the phase III trial is not done there’s no way of approving the treatment for regular use and to include it in guidelines as a first-line option.
Now it can be used, at least in Spain where i work, but only under very specific circumstances always considering it a compassionate-use treatment

Thank you for this interesting post. Like the poster John, I am excited about the possibilities of Rituximab in treating ME (“CFS”). There have been successful case studies published previously and now this very promising Norwegian study. Thankfully, the government of Norway has pledged approx. $400K for follow-up trials. Unfortunately, this is of course nowhere near the amount needed.

So far NIH hasn’t said anything about funding this. NIH only funds ME in the $3M range per year despite having a similar incidence, morbidity and pathophysiology to MS which receives somewhere in the ballpark of $100-$300M per year. And much of this NIH ME money is spent on psychological studies of limited or dubious merit.

Incidently, you would really be doing a service if you could blog about the neuro-immune disease ME (including the political aspects if appropriate for your blog). It is too little covered and is misunderstood due to CDC, NIH and the UK govts’ attempts to falsely paint it as psychogenic. The 2011 International ME Consensus Criteria are a good place to start, as is Prof. Hooper’s site: Pls feel free to contact me for more info. Happy New Year!

Thanks for your comments Justin

I must say that in Spain, where i work and live, rheumatologists are the ones who visit patients with CFS/ME. The reason is that CFS/ME care is traditionally linked to fybromylagia. In Barcelona for example there are several departments specialized in fybromyalgia and CFS/ME with doctors dedicated full-time to them. That means that we, neurologists, are neither used to deal with ME nor read ME literature. That’s the main reason i do not post about ME in this blog.
Another different reason, that in my case is not relevant, is that, although some studies point to the immunological ethiological hypothesis, the immune origin of the disease is far from being clear. I don’t know (nobody does) the exact cause and pathophysiology but i don’t think we are sure of ME being autoimmune. And that’s why, although i’m very interested in receiving comments from any immunology field, i’m not planning to post about ME in the near future.

Anyway i like your suggestions and views and find them interesting for my own field. Happy New Year for you too!

In the U.S., the disease M.E. (“CFS”) has been completely orphaned by all specialties. Neurologists, rheumatologists, immunologists, endocrinologists, etc. have all turned their backs on M.E. patients. Even my so-called primary care provider insists my illness is “primarily psychological”, even while sending me to the Emergency Room for a saline IV to somewhat help with POTS symptoms.

“M.E. isn’t in my specialty (or anybody else’s) so I’m not going to write about it” is very disappointing. While casting stones at Big Pharma (who deserve many stones, and much worse) is certainly worthwhile, one may want to keep an eye on one’s own glass house.

If neurologists know little about the illness how do they know none of their patients have it? Many of our symptoms are neurological. Is it truly acceptable to refer suspect patients to psychiatry, like my own neurologist?

I don’t wish to be aggressive and insulting, but worldwide millions of people are suffering for decades and dying from this illness while physicians are actively neglecting us or even harming us by promoting harmful exercise regimes and referrals to the shrinks.

I truly hope you will spend some time looking into the sordid history of the burial of this disease. Here is some well-researched information on the deliberate policy to not research M.E.:

Your disappointment about rituximab not getting a phase III trial is understandable. But it’s an old story, and of course, pharma companies want to have long patent lives on the drugs they investigate in large, expensive trials. That’s how our system works after all.

But NIAID, NINDS or some foundation should have some interest in supporting such a trial, unless, perhaps, most people in the field think the that the published phase II pretty much answered the efficacy question. (The safety questions, which are the ones that phase III is required for, are much less sexy to work on.)

I note above that the Norway gov is willing to contribute 400K to the cause. That’s actually a good chunk of what would be needed, perhaps half of the amount. Someone in the field should check whether NIH would be willing to pony up the rest.

I am one of the ME/CFS “chronic fatigue syndrome” patients who are keeping their fingers diligently crossed , in hopes that Rituximab will someday course through my veins. However, upon reading your article, I was shocked and dismayed to see the drug will be discontinued next year! Yes, shameful….as it has shown enormous promise for ME sufferers as well (Melle and Flugge Study in Bergen Norway).
**2 patients in the trial have made full recoveries, and are no longer ill**

So far Rituximab has been the only light I’ve seen at the end of the proverbial ME/CFS tunnel. Your article has doused the flame.

Do you think a generic version of Rituximab will be forthcoming? What will the researchers in Norway have to work with once the patent is expired? I believe they are now into phase 2.
“The research group in Norway are following up this work with a new open-label phase 2 trial that will investigate treatment with two infusions two weeks apart followed by maintenance infusions at 3, 6, 10 and 15 months.
There is also a need to carry out further trials involving other research groups to see if they reach similar conclusions regarding efficacy and safety.”

Can you please help me understand this better? Understandably, the article emphasizes the use with M.S. patients. I would like clear insight, as ME/CFS patients are a population who often feel maligned, and swept under the rug…. Thank You

PS: I second Justin Reilly’s request to have querolus delve into the ME/CFS world. We need more neuro-immunologists interested, and persuaded that ME/CFS needs more serious attention. Justin also makes relevant points, again emphasizing, the lack of interest/funding (ie NIH) for ME/CFS.

Additionally, the Melle/Flugge study in Bergen has been able to define ME/CFS as auto-immune.

Hello and welcome to the blog,

First of all, let me apologize, because i’m not an expert in ME/CFS. In Spain, where i worked before going to the US, ME/CFS is a disease that usually Rheumatologists treat and care. That’s because there are specialized units in CFS and fibromyalgia and they are in charge of them. I talk about Rituximab in multiple sclerosis that is my field and it wouldn’t be fair if i talked about ME because it’s not my area of expertise.
Second thing i must say is that Rituximab is not going to be discontinued next year. Patent expires and companies don’t think that doing research with it can be profitable because, i guess, they expect Rituximab prizes to drop because generics may appear. But there are hundreds of thousands of patients treated with rituximab now and they’re not going to be discontinued.
Moreover, the fact that drug companies don’t invest doesn’t mean that public institutions or patient’s associations can not. In fact, a lot of research is being made in myasthenia gravis or in neuropathies with rituximab and it’s not paid by drug companies.
Regarding the study in Norway… all drugs have to follow mandatory steps in order to be approved for a specific disease. That means that you first try it in animals (phase 0), then in healthy volunteers to check the safe dose (phase I), then you assess safety in patients (phase II) and finally effectiveness in patients (III). Besides, studies that are performed in one single center usually need a confirmation in another. That does not happen with studies involving many different centers (what we call multicentric studies).

Hope this answer is what you were looking for.

Thank you for the reply.
Is it possible, do you think, that an ME/CFS patient can participate in an *MS* Rituximab trial? My only inclination is that I would want the exact protocol that the patients in Norway are receiving.

Because ME/CFS is still under-represented, I am willing to align myself with the MS community to utilize what has already been set in place for MS patients.

I am 44, and would like (to take the risk) to be treated. Waiting until I’m 60 (FDA approval, etc.) is a depressing prospect.

Well, i wouldn’t say that ME and MS are very similar… from the clinical point of view both are distinct diseases with no overlapping symptoms except fatigue, which, in MS is just an associated symptom and is not a core feature of the disease.
Both may be autoimmune, but there are many autoimmune diseases and that does not necessarily mean similarity between them. Moreover, the evidence favouring autoimmune pathogenesis is overwhelming in MS and, so far, scarce in ME. Although the trial you refer to defend the use of Rituximab in ME is too small to draw any definitive conclusion. So, despite some data point to a possible autoimmune pathogenesis of ME, the evidence, as i say, is scarce and needs to be completed.

Starlit Sky,

I don’t think you could get into an MS study since you don’t have MS and they would want to see what the effects are in MS patients only.

Dr. Kogelnik is prescribing rituxin off-label for ME currently, perhaps another ME specialist might be willing if you were under their care. Don’t know if you’ve tried Hepapressin, GcMAF or Ampligen which are also effective for many pwME. (I am currently trying GcMAF). Good luck in your healing!

Some of my MS patients are insisting to be treated with Rituximab because they have met patients who have benefited with this drug. I have used Methotrexate as an off-label for MS with good results and I will consider using Rituximab as an off label drug for MS. I would like to collect more data from other treating physicians/ Neurologists. Our patient management must not be dependent on the decisions of pharmaceutical companies or government agencies. Thanks for exposing the pharmaceutical greed over patient care.

Hello Ilyas,

Thanks for your comment. The fact is that, despite i think Rituximab may be a very good therapy for MS, i haven’t used it in MS. I’ve used in NMO, CIDP and myasthenia, but in Spain is very difficul for an off-label treatment to get approval if there are other therapies that clearly have proven effective and are approved by authorities, such as Natalizumab. However, it’s true that we can not rely only in pharma trials, but if we know now that Rituximab is effective is thanks to a pharma company that did a phase II trial in a drug nobody thought could be effective for MS. The shameful thing here is that, despite knowing that the drug is very effective in a phase II trial, something that it’s not easy to see in a neurological disease, they push for the use of another drug, ocrelizumab, similar but, to date, more harmful than the original one.
What i have clear is that, if finally, ocrelizumab gets approved, i will push for the use of it’s analog, rituximab.
Thanks again for the comment.

Dear Ilyas
My husband (aged 39) is about to start treatment with rituximab off- license for his highly active RRMS which has not responded effectively to natalizumab. He is under the care of Prof Gavin Giovannoni at The Royal London Hospital, East London ( his contact details are easily found if you search his name on internet) I think he mentioned that he has at least one other patient on rituximab for similar indications so it may be worth you contacting him for further information.
Best wishes

Sara, how is your husband doing on the rituximab? My daughter, age 36, is starting this next month (Feb. 2013) for her RRMS. She has taken everything else available and has had one of her worse relapses since the onset of her MS in 1997. Looking forward to hearing from you. Liza

Starlit sky….the answer to your question about rituximab generic coming to market is yes. There is a biosimilar drug being made by a company called viropro. They have a contract with spectrum pharmicutical. Their company website is

Thank you Phillip — that leaves a shimmer of light at the end of the tunnel for many people who are hopeful about this drug. Appreciate the feedback!

And the silver lining of rituxin going off-patent is that a generic will hopefully be much cheaper. If i remember correctly, Rituxin currently costs about $1,200 per treatment and the patients in the Norwegian study were given two treatments (more treatments than this are reported more effective anecdotally).

In Spain Rituximab costs about 1400 euros the 500mg vial. It’s not expensive (at least not for a biologic standard) considering that the effect is long-lasting. For example, in Musk myasthenia, a standard regimen includes 4 doses of 1000mg aprox (it’s calculated by body surface) and one more a month after and that’s all they need to be almost perfect. If we consider costs of repeated visits for relapses, disability, interferon costs… it turns out that it can be a much cheaper alternative than what we have now.
What i wouldn’t expect is a dramatic drop of prices when the patent expires. A biologic treatment has a manufacturation cost that probably precludes dramatic price drops. It happens with intererons… their patent has expired long ago, but there are no generic, cheaper alternatives because manufacture costs and required technology are a barrier for small drug companies.

Well, this article is shocking for me.

I am a ms patient, spms and waiting desperately for an effective treatment.
All other drugs are non effective and in a few years from now it will all be to late.

Money is more important than my life and the lifes of so many other patients.
I will write to hospitals to see if I can get this medication anyway!

Shame on them!

My life is a constant struggle. I am 46 and Dutch. Hope to get to 50 years but I am not sure that will happen.

Hi Marjet,

Thanks for sharing with us your thoughts. Money is too important for too may things. In this case it is too. Mostly because a potentially effective treatment may be left aside because of commercial interests, not strictly medical interests. However, the population in which this treatment was tested was relapsing remitting MS, not SPMS, so we don’t know if it could be effective too for those patients, like you, that have progressive MS already and that makes it more difficult that a doctor can prescribe it.
In fact, Rituximab was tested for primary progressive MS, in the Olympus trial, and did not show benefit (younger patients with higher inflammatory activity seemed to respond, but was not clear).
Progressive (either primary or secondary) MS is the great challenge that has to be addressed. How to improve the disease when a degenerative phase has started.

The Open Medicine Institute in Mountain View, California (Dr. Kogelnik) is treating ME/CFS patients with Rituximab off label. One has to pay out of pocket. However, if financial need is demonstrated, one can get Rituximab free.
Otherwise, everything else is also out of pocket…. and expensive. At least 7,000 – 14,000 US$.
I don’t know if they will treat MS patients. Let me know if you want their email address.

Hi Querolus and Starlit Sky,

Thanks for your reply, this is very nice of you both.

Having SPMS is a problem in treatment, I know. Because I have no active inflamations anymore, there is nothing available for me. Prednison helped me a few years but that is also a passed station.

Getting a treatment payed is not the problem here, the problem is getting the hospital to expiriment with me. I had an email back from my hospital and they do not want to try this.

I will investigate all results that I can find for any positive sparkle about SPMS.

The good news is, there is a new MS treatment centre nearby that will start a study on stemcells. They also want to study the progressive ms types. I hope I can be a patient in one of the studies. It is all over the local news here today.

Time is running out for me and that has the positive point of nothing more to loose. Expirimenting is dangerous but doing nothing is a sure way down.

Going to the USA for treatment is no option. The flight will take about 13 hours and that will take to much out of me, but thanks for thinking with me!

But, I am a positive thinking woman, I’ve got a lot to live for and that will keep me going!

There is a trial , phase III , going on with Ocrelizumab for PPMS.
If Ocre is proven to be effective for PPMS , I am pretty sure Rituximab will do the same.
In countries like Germany or UK , they are using it off label for PPMS.
At the moment there is also another trial going on for PPMS , Fingolimod , also pahase III
Let cross the fingers!!!!!

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)- as defined in the International Consensus Criteria 2012 – Canadian Consensus Criteria 2003 patients also have had a great response to rituximab and are in the same boat. This much malingered autoimmune disease has no current treatment protocol – 2/3 of patients on rituximab had a significant recovery!!!!

Can someone explain how it works that a physician is allowed to use a drug off label but they often won’t do it even when something like rituximab has shown so much potential for CFS/ME patients who essentially have no real treatment options. The Valcyte/Valtrex
is in somewhat the same league. I have found a doc who was willing to put me on the Valtrex because she said it was so much less problematic than Valcyte. I’ve been on it for almost a year with some very good results, but I can’t call it a cure. I’ve had CFS/ME since ’86 though and they have said the longer one has had the disease the less likely they are to fully regain their health. I’d really like to try the Valcyte since it seems to do a better job, albeit with more risk. I too would volunteer for the rituximab. The CFS/ME folks are pretty willing to try anything since every day feels like you belong to the walking dead anyway.

I have just read your comments on ME and am wondering how you are now. I have had ME for only 8 years, I am 48, but actively seeking a way forward. Thank you. Sally

I have been on Rituxan to treat my Secondary Progressive MS for a little over a year with terrific success. Before this I spent almost 2 years on Copaxone, 1 year on Rebif, a little over 1 year on Novantrone none of which demonstrated any measurable efficacy in decreasing disease progression or even symptom relief. The Novantrone nearly killed me with the cardiac complications.

I can’t tell you how exciting it was to receive my latest MRI results and to see, for the first time since my diagnosis in 2007, that not only were there no new ring enhancing lesions but the existing lesions were no longer ring enhancing.

My concern now is what’s next? Can I really be on a drug like Rituxan for the rest of my life? I’m only 32 and I assume it’s not advisable to suppress your immune system for 40+ years. What are the long term effects…5 years+…of Rituximab? My disease progression has been fairly rapid and debilitating and I worry about what happens if/when Rituxan stops working or if/when I progress from SPMS to PPMS? Is there anything waiting in the wings for some of the more advanced kinds of MS?

Just came across your blog. It’s dated 2013 and we are now July 27,2015. I hope that you are doing well with Rituxan. I was diagnosed with Follicular Non-Hodgkins Lymphoma in 2009. Have been on Rituxan maintenance every 3 months for 6 years now. No major problems with drug, some night sweats and back pain. It’s been a life saver. Hope it is helps you too. Doctor will continue until relapse. I am an active 75 year old woman. Best to you.


Hello Jazmin,

I’m very glad you were able to get approval for Rituximab and use it. Many people, thanks to the absence of phase III trials, are not able to do the same. I don’t know if Rituximab is effective or not for all patients but the results in phase II trials should force a phase III. But so far, it’s not the case.

When using immuno-suppressive therapies is difficult to know if it’s possible to continue them indefinitely. In myasthenia gravis, for example, there are two types of patients. Patients with Musk antibodies that seem to respond to only one course and don’t need any other (at least in 6 years-time) and patients with AChR antibodies taht usually need re-infussions. In MS, as we don’t have trials, we don’t know.

Considering that Rituximab depletes B cells for, at least, 6 months, is reasonable to think that unless B cells return back to normal or unless there’s any sign of activity again, maybe it’s not necessary to use it continously. But the truth is that we don’t know exactly. However, in Rheumatoid Arthritis, in which they use RTX monthly the rate of complications is pretty low, even with long-term use. I don’t think it’s necessary to use RTX montlhy (B cells, as i say, do not re-appear until 6 months later)

So, in summary, we need to specifically study how to treat patients in the long-term (that uncertainty is not exclusive for RTX, it happens the same for Natalizumab, for example) but, in the meantime, a combination of evidence (the treatment seems to work for you), common sense (it’s not necessary to deplete B cells every month) and tests (MRI can be a good “alarm test”) is the best approach possible. At least is what i would do with my patients, obviously, individualizing care for each one.

[…] I will have my last infusion this October and after that, a 6-week washout for this new drug I’ll be getting. My neurologist is very confident about it and is actually enthusiastically used in Sweden and Europe as a third in line treatment after the Betaferons and Tysabri. It’s called Mabthera (Rituximab), and although the drug has been around for a while to treat lymphoma and rheumatoid arthritis, it has not yet been approved officially for Multiple Sclerosis. Phase 2 trials yielded incredible results; the relapse rate is reduced to 50% and lesion apperance are reduced to 90%, just as effective as Tysabri and even better than the much-touted oral pill Tecfidera. But due to commercial and political issues, we might not see a Phase 3. Apparently because it is a cheaper drug, it is not deemed profitable for Biogen/Roche. Read this article here. […]

[…] I will have my last infusion this October and after that, a 6-week washout for this new drug I’ll be getting. My neurologist is very confident about it and is actually enthusiastically used here in Sweden and Europe as a third in line treatment after the Betaferons and Tysabri. It’s called Mabthera (Rituximab), and although the drug has been around for a while to treat lymphoma and rheumatoid arthritis, it has not yet been approved officially for Multiple Sclerosis. Phase 2 trials yielded incredible results; the relapse rate is reduced to 50% and lesion apperance are reduced to 90%, just as effective as Tysabri and even better than the much-touted oral pill Tecfidera. But due to commercial and political issues, we might not see a Phase 3. Apparently because it is a cheaper drug, it is not deemed profitable for Biogen/Roche. Read this article here. […]

Hi! This is kind of off topic but I need some advice from an established blog.

Is it tough to set up your own blog? I’m not very techincal
but I can figure things out pretty quick. I’m thinking about setting up my
own but I’m not sure where to begin. Do you have any ideas or suggestions?

So, I am confused! Is Ocrelizumab a clone of Rituximab?

I have seen many positive news items around Ocrelizumab but if deaths have been attributed to the use of Ocrelizumab then clearly the risk/reward figure becomes un acceptable.

Big Pharms companies would have you believe they have huge development costs to recoup, thereby justifying exhorbitant drug costs when it is finally approved.

I am sceptical of anything that is seen as profit-driven health care.

Thank you for publishing such useful information.

After publication of PhIII trials data for Ocrelizumab, do you confirm that:
– Rituximab and Ocrelizumab have the same effectiveness in treatment of PPMS and RRMS
– Rituximab is safer than Ocrelizumab

I didn’t find if any case of PML occurred among patients treated with these drugs. Is this information available?

Sorry, I didn’t write cleanly: I referred to MS patients. Your article already stated that some RA patients suffered PML.

I wonder if PML occurred only in RA patients because of higher dose and the combined effect of previous immuno-suppressive treatments.

this really is sad so many people waiting on knew MS drug and Rituxamab has been in 🇨🇦 the whole time

[…] Because Rituxan is authorized for use in cancer diagnosis and a few other autoimmune diseases, though not MS, few Americans with MS have easy entrance to Rituxan. That’s since Roche chose not to pursue FDA capitulation for it for that use (a move, some have alleged, intended to sideline an effective drug that was losing a distinction intensity and reinstate it with…).  […]

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I have MS. Live in the US. And have been on Rituxan for 9 years.
It’s wonderful. I don’t know how it’s still available. But I’m glad it is

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