Rituxan...anyone on it?

[Vig16]

I'm looking to take a new medication and it comes down to either Tysabri or Rituxan. Would anyone recommend one over the other? I'm leaning more towards Rituxan. As from what I've found, I couldn't find anyone who got PML if they were being treated for MS. Does anyone have any information on Rituxan as far as side effects and/ or results?

I'm just very weary of the PML side effect, so I was wondering what are the chances of getting it if my JCV test comes back negative or positive? Does anyone know if there's information on that?

Any help would be greatly appreciated!!

[Redwings]

Hi Vig16:
I just replied to your questions under your other thread about needing to change medications, so check out that thread for more details.

Rituxan hasn't proved to be great in treating MS (you can google the studies). For that reason, there probably haven't been enough people with MS on it for long enough periods of time for there to be sufficient exposure for PML to have developed in that specific population. Assuming that no reports of it happening means that it hasn't occurred yet, it still doesn't mean that it won't.

PML has been reported with Rituxan, but the exact incidence may not be known. In spite of its lower risk of PML, Rituxan doesn't offer the benefits that Tysabri does. And those reduced benefits come with increased risk of other problems.

As far as what the chances are of developing PML for negative or positive JCV antibody results, the odds aren't known yet. Because the test is so new, the data are still being analyzed and studies are in progress. In fact, there isn't even a reliable JCV antibody test commercially available yet. Even though they're currently pushing to have the antibody test added to the prescribing information for Tysabri, Biogen has stressed that results obtained by any tests being used shouldn't be relied on for making treatment decisions.

Though the preliminary data suggest that the risk of PML is lower in the absence of the JCV antibody (which is what you'd think anyway), researchers are reluctant to say that without more proof.

But there is enough data on risk of PML vs. length of treatment with Tysabri, and the data show that the risk is quite low in the first year, increasing with increasing exposure. So the odds of you developing PML in your first year of treatment are pretty low. Based on that, the benefits of Tysabri and the low risk of PML in the first year seem to outweigh the less-beneficial Rituxan, at least for a year. That year could buy you enough stability to hold you over until other medications (like Cladribine) are approved.

[Vig16]

Hi Vig16:
I just replied to your questions under your other thread about needing to change medications, so check out that thread for more details.

Rituxan hasn't proved to be great in treating MS (you can google the studies). For that reason, there probably haven't been enough people with MS on it for long enough periods of time for there to be sufficient exposure for PML to have developed in that specific population. Assuming that no reports of it happening means that it hasn't occurred yet, it still doesn't mean that it won't.

PML has been reported with Rituxan, but the exact incidence may not be known. In spite of its lower risk of PML, Rituxan doesn't offer the benefits that Tysabri does. And those reduced benefits come with increased risk of other problems.

As far as what the chances are of developing PML for negative or positive JCV antibody results, the odds aren't known yet. Because the test is so new, the data are still being analyzed and studies are in progress. In fact, there isn't even a reliable JCV antibody test commercially available yet. Even though they're currently pushing to have the antibody test added to the prescribing information for Tysabri, Biogen has stressed that results obtained by any tests being used shouldn't be relied on for making treatment decisions.

Though the preliminary data suggest that the risk of PML is lower in the absence of the JCV antibody (which is what you'd think anyway), researchers are reluctant to say that without more proof.

But there is enough data on risk of PML vs. length of treatment with Tysabri, and the data show that the risk is quite low in the first year, increasing with increasing exposure. So the odds of you developing PML in your first year of treatment are pretty low. Based on that, the benefits of Tysabri and the low risk of PML in the first year seem to outweigh the less-beneficial Rituxan, at least for a year. That year could buy you enough stability to hold you over until other medications (like Cladribine) are approved.

Thanks for the replies on both of my threads, they were VERY detailed with tons of information! This sort of leaves the only thing for me to do at this point is get tested for the JC virus, so hopefully my results come back negative to give me more peace of mind.

Thanks again!

[MSLazarus]

I've been on rituxan for over a year

This is a post I made on another MS board:

"I just finished my third round of Rituxan.
I do a round of 2 infusions (2 weeks apart) every 6 months. So far I have done it for one year and have just started treatment again.

The year on rituxan gave me back a lot of functioning. I was able to stand better, to work longer hours (crawling the rows of my farm to pick veggies) and to think/organize/plan.

I was in no way living my former life but I did recognize myself again.

My neuro is cautious about linking changes in my condition to the med I am taking but, it does seem to be the case. I was not functioning at all well as my last infusion slowly wore off and I have popped up again after last week's infusion. Sort of a 'Jack in the Box' life.

There are cases of PML with rituxan so there is a risk. Ionete at Umass Medical in Worcester is doing a lot of research with rituxan and SPMS and PPMS.
Well, that's my FYI post."

{I was one of the first people on Betaseron when it became available (over 20 years ago). I did 4 years of monthly solumedrol pulses during these years. After years I switched to IVIg infusions for 7 years that were 7 hour infusions two days a month. Spectacular results. It stopped working. Took copaxone at this time also. Flirted with methotrexate and then did novantrone. novantrone was great also. Now am on rituxan.}

__________________

[Vig16]

This is a post I made on another MS board:

"I just finished my third round of Rituxan.
I do a round of 2 infusions (2 weeks apart) every 6 months. So far I have done it for one year and have just started treatment again.

The year on rituxan gave me back a lot of functioning. I was able to stand better, to work longer hours (crawling the rows of my farm to pick veggies) and to think/organize/plan.

I was in no way living my former life but I did recognize myself again.

My neuro is cautious about linking changes in my condition to the med I am taking but, it does seem to be the case. I was not functioning at all well as my last infusion slowly wore off and I have popped up again after last week's infusion. Sort of a 'Jack in the Box' life.

There are cases of PML with rituxan so there is a risk. Ionete at Umass Medical in Worcester is doing a lot of research with rituxan and SPMS and PPMS.
Well, that's my FYI post."

{I was one of the first people on Betaseron when it became available (over 20 years ago). I did 4 years of monthly solumedrol pulses during these years. After years I switched to IVIg infusions for 7 years that were 7 hour infusions two days a month. Spectacular results. It stopped working. Took copaxone at this time also. Flirted with methotrexate and then did novantrone. novantrone was great also. Now am on rituxan.}

__________________

Thanks for the reply! I'll definitely put some more thought into that for an avenue now!

[Redwings]

Hi Vig:
Of the so-so response shown by people with MS in the Rituxan studies, there were people who did very well. You could be one of them. But in playing this "medication chess game" of trying to anticipate several moves in advance, there has to be consideration of what your options are if you choose Rituxan first and it isn't effective for you.

Rituxan may knock you out of eligibility to take Tysabri later. An analysis of the Tysabri PML cases showed that a large number of those patients had been on immunosupressants or other immune-modifying drugs before -- sometimes years before (although I think the 7-year gap for one patient may have been a fluke because immunosuppresants don't stay active for 7 years). Rituxan would put you into that category, making Tysabri even more risky for you, regardless of your JC virus status.

One thing that could be helpful in your decision is to disregard cases of PML that appeared in people who were actively taking Tysabri and find out how long PML took to appear in people who had stopped Tysabri. That might give you a clue about what meds might be less risky to start taking -- and when -- after stopping Ty. For example, is the risk acceptable to have Rituxan 6 or 9 months later? And if not Rituxan, what else?

That kind of backup plan is important because it looks like a good bet that you wouldn't be starting Tysabri 6 months after Rituxan because of the high risk.

[GooGooGirl]

I have another question. The needle has been in my arm since Thursday, Is is normally for it to remain there the whole 5 days of my treatment? I guess I just thought the nurse would come and chanhe the needle every day, All she said was as the end of the cycle to lull the needle out. Ounch. This has me very nervous!

[MrsBones]

I have another question. The needle has been in my arm since Thursday, Is is normally for it to remain there the whole 5 days of my treatment? I guess I just thought the nurse would come and chanhe the needle every day, All she said was as the end of the cycle to lull the needle out. Ounch. This has me very nervous!

I suspect you meant to ask this on your other thread, but I'll answer. Yes, you can have the IV left in for the duration of a IVSM treatment.

I always chose to do mine outpatient in a hospital infusion center. I was given the option to leave it in or take it out as I would be coming back the next day. I always took it out, just because IVs have a huge ick factor for me. I preferred getting stuck to keeping it in.

Yours would be left in mainly so that a nurse wouldn't have to be compensated (coming out of the insurance co's or your pocket) to return each day and to spare you getting stuck 5 times, which is just kinder to your veins.

Don't worry too much above removing the IV, though a nurse usually (I believe) would be there to do it, JIC. It's not a big deal, just that ick factor. If it's a major concern for you, contact the nurse or your doctor either for advice or to have them remove it.

Good luck!

[Vig16]

Hi Vig:
Of the so-so response shown by people with MS in the Rituxan studies, there were people who did very well. You could be one of them. But in playing this "medication chess game" of trying to anticipate several moves in advance, there has to be consideration of what your options are if you choose Rituxan first and it isn't effective for you.

Rituxan may knock you out of eligibility to take Tysabri later. An analysis of the Tysabri PML cases showed that a large number of those patients had been on immunosupressants or other immune-modifying drugs before -- sometimes years before (although I think the 7-year gap for one patient may have been a fluke because immunosuppresants don't stay active for 7 years). Rituxan would put you into that category, making Tysabri even more risky for you, regardless of your JC virus status.

One thing that could be helpful in your decision is to disregard cases of PML that appeared in people who were actively taking Tysabri and find out how long PML took to appear in people who had stopped Tysabri. That might give you a clue about what meds might be less risky to start taking -- and when -- after stopping Ty. For example, is the risk acceptable to have Rituxan 6 or 9 months later? And if not Rituxan, what else?

That kind of backup plan is important because it looks like a good bet that you wouldn't be starting Tysabri 6 months after Rituxan because of the high risk.

Hi Redwings,

Thanks for your response! I never thought of it that way, but it totally makes sense. I probably am better off going with the Tysabri for now and once I get to the 2 year mark, then decide what I want to take after my 6 month time off. At that point, they'll probably have some new medications available to take as well.

Thanks again!

[MSLazarus]

Lots of good advice on things to think about.....

Vig,
My medicine journey for 25+ years has been been aided by luck and, mostly, by a great neurologist.

The luck was winning the betaseron lottery when it became the first dmd on the market and there was not enough to go around. My MS body seemedto like betaseron and monthly steroid pulses.

When malignant melanoma struck 10 years later I was lucky again. The cancer was fully removed and because Dr. Vollmer thought it dangerous to do novantrone at the time, I was put on copaxone and IVIg. (I did 7 bottles every other week for 7 years). Wow!

Sometimes I would come to infusion day dragging a leg into the infusion center and I would get better by the hour. Eight hours later I could walk out --almost skipping. IVIg is the safest of the meds I have done and I was sorry when it stopped working.
My body also responded very well to novantrone but it was risky. We used much of the allowed lifetime dosage. Rituxan has worked so well that I have been able to live some life separate from the MSlife.

Deciding which med to take is daunting. Redwing was wise to counsel being aware of what is ruled in and what is ruled out by the choices you make.

Quite a chess game we are playing.

By the way, I use a walkaide which is helpful. And my Segway is a neat tool also.

Best of luck.

[Vig16]

Vig,
My medicine journey for 25+ years has been been aided by luck and, mostly, by a great neurologist.

The luck was winning the betaseron lottery when it became the first dmd on the market and there was not enough to go around. My MS body seemedto like betaseron and monthly steroid pulses.

When malignant melanoma struck 10 years later I was lucky again. The cancer was fully removed and because Dr. Vollmer thought it dangerous to do novantrone at the time, I was put on copaxone and IVIg. (I did 7 bottles every other week for 7 years). Wow!

Sometimes I would come to infusion day dragging a leg into the infusion center and I would get better by the hour. Eight hours later I could walk out --almost skipping. IVIg is the safest of the meds I have done and I was sorry when it stopped working.
My body also responded very well to novantrone but it was risky. We used much of the allowed lifetime dosage. Rituxan has worked so well that I have been able to live some life separate from the MSlife.

Deciding which med to take is daunting. Redwing was wise to counsel being aware of what is ruled in and what is ruled out by the choices you make.

Quite a chess game we are playing.

By the way, I use a walkaide which is helpful. And my Segway is a neat tool also.

Best of luck.

Thanks MSLazarus! It's good to just have some medications that I can keep in the back of my mind for what I can do next if this doesn't work!

Thanks again!