Looking for info from the brainy folks on here!

Looking for information from the great minds on here. I usually just lurk but my doctor really wants me to consider going on Rituximab for my MS. Is anyone on here on it or have been on it? What were your experiences, good, bad and indifferent?

I can not do Ocrevous because of the increased breast cancer risk. I am positive on the breast cancer genes and I have 5 family members who have had breast cancer so it is too big a risk for me.



22 Replies

  • @bygonelines /Jacqui,

    Hi there! Not-so-brainy here, but Rituximab or Rituxan is an anti-CD20 monoclonal antibody (attacks B cells which express CD20) which was first approved many years ago for NHLymphoma. I recall working on a Phase IV trial in ~ 1998.

    Anyway, why is this relevant, you ask? It has since been used in MS, and, fast forward to 2017, Ocrevus is basically the new and improved version of Rituxan. By that, it is basically supposed to have fewer side-effects.

    With regard to breast cancer, I am not familiar with Rituxan's safety profile. It must be that your doctor believes Rituximab would be safer for you, than Ocrevus, all other things being equal. That is my take on this.

    I recall severe hypotension to be a significant risk with this drug and we had to interrupt one patient's IV because of this. I believe Rituxan still has a black box warning for this.

    The therapeutic approach of attacking B cells (as opposed to T cells) is considered novel in MS treatment.

    I hope this sheds some light on the topic! Best wishes!!

  • Bygonelines

    Also not sure about the brainy qualifications but my neuro speaks highly of Rituxan. It's interesting that with similar mechanisms of action to Ocrevus, breast cancer isn't mentioned on a Rituxan Google search (and its def. been around long enuf to demo this).

    Best wishes!

  • Hi Jacqui,

    I have been on Rituximab for the last three years and have had no side effects. My Neuro felt that I should stick with it other than changing to Ocrevus due to the breast cancer issues. Hope this helps.

  • @bygonelines I have been doing Rituxan infusions for a few years. I'm scheduled to have one next Tuesday and then the second two weeks later. I had 2 in February. The first time I did the infusion I had some mild effects that passed within 30-45 minutes. There have been no issues at all after that. The nice part is that I am given some Benedril as a premed and that let's me sleep through part of the time. I drive approximately 90 minutes home after the infusion. The MRIs have shown no new lesions and my MS hasn't really progressed which was the goal for me. If you choose to do the Rituxan, I hope you have good results and no issues with the infusion!

  • Kitsey mrsmike Bygonelines

    Is insurance covering the Rituxan? I heard that because it was off label for MS and because Ocrevus was now available and because genetech makes both drugs, insurance wasn't covering Rituxan any more???

  • Don't know about some insurances. I'm on Medicare and had an infusion two weeks ago. It was approved.

  • My insurance still covers it. In fact, they prefer it because it has a known long-term history where Ocrevous does not. My friend in the PA dept is the one who first suggested it because he has seen it do so much good with no bad effects for MS patients. I spend all day with my job talking to insurance companies and getting authorizations for medications and procedures.

  • erash Genentech has been providing the Rituxan for me. I met their financial criterion so they send the drug directly to the infusion center. In addition, I had to go through the insurance denying coverage as well as the appeals. I have to pay the cost of the infusion center. That is approximately $300-$350 per infusion. So grateful that the $9,000 drug is provided.

  • Kitsey and anyone else who may be interested... I believe the patent for Rituxan has expired or will be soon. Hopefully that means a biosimilar (i.e. generic) will be available soon. 😊Insurers should be more inclined to cover that, I would think. Who knows. They don't always act logically.

    It is interesting that Genentech got approval for Ocrevus just as Rituxan's patent was expiring. It makes me suspicious that they prolonged the development of O while they rode out the patent life for R. Maybe I'm just too cynical. 🙄

    It would be a shame if they found a way to restrict the off-label use of R (or biosimilar) for MS and thereby force pts to use O instead, so they can make a profit. I doubt it, but nothing would surprise me. I'm not savvy enough to sort all those facts out now, but if it turns out to be the case, I'm sure we'll hear about it!

  • Nom_De_Plume

    I wouldn't doubt that big pharma strategy for a nano second 🙁

  • erash Depressing isn't it?! And I used to work in pharma! It makes me angry that Genentech didn't study the MS indication a long time ago (for Rituxan), including for PPMS. They make this big announcement with the PPMS data as if its a "new" drug (Ocrevus) but, in reality, they were just holding out for bigger profits. UGH. I'd estimate that it could have been available approx. 10 years ago, maybe sooner. :(

    Similarly, Biogen's patent on Avonex was due to expire in 2013, before they were granted an extension for other indications. Along comes Plegridy, approved in 2016, which was just a pegylated version of Avonex (simple tweak). If you've taken Avonex, you know that the IM injection every week is a lot harder than having a SQ injection every *other* week. Again, they were just riding out the patent life (what it was projected to be at the time the studies started). Just the thought of their NOT saving people from having to experience 50% of their flu-like symptoms, makes me pretty angry.

    Thanks for listening. I guess I needed to vent.

  • Nom_De_Plume

    I actually taught a doctoral pharmacology (Doctor of Nursing Practice not pharmacists) class and we spent several weeks discussing this (in general-not necessarily MS drug related--what a wealth of knowledge you have about the MS DMTs!!!) as well as the biases entrenched in the studies that lead to drug approval.

    It's surely dated by now, but The Truth About the Drug Companies (Marcia Angell, 2005) was one of the books we used in the class. Very eye opening.

    But we do need some of these drugs...

    What did you do when working for Pharma?

  • erash You're right. There is a real need for these meds, but it is purely business in the eyes of pharma, biotech, etc. They may have a mission statement that states they want to improve patients' lives, yada, yada, yada, but I haven't found that to be true. Just lip service, IMO.

    The government has done much to crack down on physician pay-outs by drug companies, etc. In that sense, yes, Angell's book is dated, thankfully, but much remains the same.

    My background is in biochemistry, but I've served in many different roles, and seen the various sides of the industry, over a 25-year period. It has left me pretty cynical. I'm sure you and I could chat a long time about that!...

    I've worked with some real gems whose selfless dedication have made scientific advances possible, and I've worked with some real shysters too, whose ethos could be summed up in "how discoverable would this be in an inspection?" As a whole, I'd say I saw more "lacking" in the system than "inspiring."

    I'm not sure how different pharma/biotech is really, in this regard, than other industries. It certainly gets a bad rap, though, and, having seen the underbelly up-close, I can't defend it. (I will say that I don't think the general public grasps the huge outlay in R&D which impacts the cost of marketed drugs. A topic for another time, perhaps.)

    So, I don't know about a "wealth of information," but I certainly do have opinions!! ;) As it relates to MS, I guess I am more passionate because it hits close to home.

    Incidentally, I've worked with a lot of nurses over the years and have tremendous respect for them. They are, for the most part, the unsung heroes of the healthcare system.

  • Nom_De_Plume

    I have to confess I missed the freebies, dinners, spa days etc. when they imposed stricter marketing regs on pharma.

    i was astonished though to find out that drug reps know the exact # of Prescriptions you write for their drug and can target you with enticements!

    Perhaps they should further regulate direct to consumer advertising and TV spots to save additional $

    Ok, I'm climbing down off my soap box 🤐

  • erash 😁

  • I couldn't agree more! Big pharma needs to cut down on the direct to consumer advertising. We get people in all the time who are positive that this drug or that drug they saw on tv will solve all their health problems. When the doctors try to tell them that it is not appropriate for their situation many of them go a bit ballistic. They think that because they saw it on tv it must be right for them. It is so frustrating.

  • Bygonelines

    And there is the placebo and nocebo effect ----it works because they believe it will vs it doesn't work because they expect it won't or expect the laundry list of side effects that are included in the small text at the end of the ad.

    I think we should be informed consumers but serene mountain scenes and smiling gorgeous actors/actresses conveying the information create misperceptions 🙁

  • An interesting situation will be coming if/when oral cladribine (brand name mavenclad) is approved for MS. It's currently available as a generic injectable treatment for cancer and pretty safely depletes B- & T-lymphocytes. It's a small molecule and inexpensive to produce. In the US, the generic version is available from either Mylan (of Epipen fame), or Fresenius Kabi. I don't think that they are big sellers. It's a pulsed-dose treatment, where you take a few subcutaneous injections over 1 month, then another course of treatment a year later. The effects last for years as your immune system reconstitutes.

    The cost part will be interesting. Currently I was able to get each 10mg/10mL vial for less than $500 each. All together, my treatment cost was less than $4500, 5 vials for year 1, 4 for 2nd year, not counting a few blood tests, antiviral drugs and syringe costs.

    Merck Serono (http://www.medscape.com/viewarticle/882043) has invested hundreds of millions in the development of this drug for MS. Even though the compound is already approved for hairy cell leukemia, Merck Serono had to do a lot of work to get it to near the finish line of approval for treating MS in the US & EU. They had to work out manufacturing and formulation, preclinical pharmacokinetics, toxicology & efficacy. The real $$$$ costs start then with the clinical trials, probably tens of thousands per patient. Regulatory Affairs, statistics, and reporting is a huge effort. This is a partial list. After the phase 1 & 2 trials, they ran 2 phase 3 trials that showed good efficacy. From the Medscape article:

    "Cladribine for MS has had a rocky road. A new drug application was rejected by European regulators in 2010 and by the US Food and Drug Administration in 2011. The agencies cited concerns about a signal of cancer risk in the initial results of the phase 3 CLARITY trial.

    However, recent post hoc analysis of CLARITY and CLARITY Extension showed that with cladribine treatment, depending on cumulative dose, up to 90% of patients were free of new lesions on MRI and up to 81% remained relapse-free after 4 years.

    Especially important for this agent, the analysis raised no long-term safety concerns."

    Without Merck Serono running these trials, we wouldn't have known how safe or effective cladribine is in MS. I'm guessing that the oral treatment will cost maybe $40,000 to $60,000 per year (thousands of $$$ per pill). Will the news be focussed on how much each pill costs? (probably somewhat) Will MS groups then prescribe generic injectable cladribine? (maybe) Will generics manufacturers then raise the price of generic cladribine? (I think so) Will the Marcia Angells of the world think that this is anther example of greedy pharma printing money off the shoulders of other's research? (of course)

    What do you think they should charge for this?

    Keep your eyes open and the popcorn ready.

  • tnolan2006 Thanks so much for this fascinating read. I thought cladribine was dead in the water a long time ago and am happy to see that it is not!

    How did it work for you??

    I vaguely recall it was being tested for SPMS, is that correct?

    It just goes to show the value of long-term follow-up for safety and efficacy data.

  • tnolan2006

    Eyes open. Are we closer to approval of cladribine for MS? Perhaps, yes, in the EU, at least.

    An abstract dated 31-Aug-2017, and titled "An update on cladribine for relapsing-remitting multiple sclerosis," in the Expert Opinion on Pharmacotherapy states:

    "...In June 2017, the European Medical Agency recommended marketing authorization [i.e. approval] for treatment of aggressive relapsing MS..."


  • I took rituximab as part of a trial at the NIH. Was in the treated arm of this double-blind placebo controlled trial, that lasted 3 years. Until they unblinded the study and told me that I was treated, I had no idea that I was. Easy to tolerate! The Kaiser Permanente Health group and Sweden use this drug a lot. Effective, relatively safe and costs much less than inferior drugs. Looking at you Biogen, Teva ... for your price rises on the interferons and glatiramir.

  • tnolan2006 That was brave of you to enroll in a study with that design for 3 years. I'm not understanding why NIH would sponsor this trial instead of Genentech? If you have the time, would you please clarify the study results (high-level), and why it was not used to support (in part) an indication for MS, if it's not otherwise obvious? Thanks!

    One additional tidbit of MS DMT R&D trivia for anyone who is interested: :)

    Tecfidera's API, dimethyl fumarate, has been used in Germany for over *30* years to treat psoriasis. It was licensed and approved there as "Fumaderm" in 1994. Biogen partnered with Fumapharm to study it in MS, and, when the Phase 2 data readout was positive, ...you guessed it... , Biogen promptly acquired Fumapharm. :) The annual cost forTecfidera treatment is approx. $ 55 K. I guess we cannot blame Biogen for recognizing that an effective treatment for one inflammatory autoimmune disease may be good for others as well, and for capitalizing on it, but is this steep of price hike justified? (rhetorical) ;)

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