Questions about rituxan

[trc1962]

Dealing with neuropathy and am on prednisone (awful) and was on cellcept but it didn't set with me and I was anxious and awake half the night. I am receiving a referral to a rheumy and neuro at a teaching hospital to really try and get answers. I am in the east side of Washington and they are very slow here, all Summer and I have had an MRI and just Monday a punch biopsy and I need more work, so happy to get an appointment. I know a gal here that has dealt with neuropathy so that she couldn't work anymore and when they got her on rituxan she responded pretty well in time and now works and lives a decent life. Jasper and others who have taken it for neuropathy has it helped you? It is an infusion right and how often must you get infused? What side effects have younoticed? Is it hard to get insurance to cover? Lots of questions for sure, but years ago Imuran did a good job for me but I had to stop it when the dose got too high. Hoping for information.

[warmwaters]

Rituxan has been added to the guidelines for Sjogren's treatment.

I tried rituxan.  The way it works is 2 infusions 2 weeks apart, and your repeat this roughly every 6 months. See a blog by a Sjoggie at http://www.reasonablywell.net. It gives the details of exactly what happens during the infusions. 

The infusions take 4-6 hours, and the first time a bit longer because they go very slowly the first time. You'll be given some antihistamine and steroids to help your body tolerate the rituxan.

I happen to be one of those for whom didn't work.  I got some very modest improvement about 2 weeks after the 2nd infusion, but it was that I didn't feel quite so awful, rather than any actual change.  It faded rather quickly, within a few weeks.  My dr noted improvements in the parotids.

I've tried a lot of different things, and had some real hopes as several people here have or on Sjoggie blogs have had some success. And my rheumy felt it was a good match for my particular situation.

Despite it not working for me, I would suggest trying it if you've already tried other things (sounds like you have), and are comfortable with the risk.

[gurs]

I had it a few times over the last several years. I did not notice any improvement in my dryness or neuropathy, however, Im actually going to try it again in the fall. I did miss the 2nd infusion the last time, and it might have helped.

If you have no other options, and your doc agree's, you might want to give it a try.

Gursie

[Jasper]

"Jasper and others who have taken it for neuropathy has it helped you?"
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Without a doubt, Rituxan has been a miracle for me.

I had 1000 mg Rituxan infusion on Feb. 25th and another 1000 mg infusion on March 10th. Within a month of the first infusion I started to feel better.  Rituxan has been very effective in lifting the fatigue and giving me energy. I am accomplishing things. I can think more clearly, process thoughts more rapidly, concentrate better, remember more. I can figure things out (like how to operate new electrical equipment).  I feel better than I have felt for years and years.  I can plan and do things now, which I could not do before Rituxan. I have a life now.

My peripheral neuropathy pain/burning is much improved, at least 50% improved (even more so at about 3-4 months post infusion). The electric shocks, throbbing, vibrating, crawling sensations almost completely disappeared (90% improved). My joint pain and stiffness is much improved. My urinary symptoms are improved. I feel globally improved.


"It is an infusion right and how often must you get infused?"
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You get the infusions in sets of 2. The first infusion is 1000 mg of Rituxan and then 2 weeks later you get the second infusion of 1000 mg of Rituxan. That set is good for 24 weeks (from the first infusion). Then you get another set of 2 infusions, 2 weeks apart. This regimen is repeated every 24 weeks.


"What side effects have you noticed?"
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About 80-90% of people have some type of transfusion reaction with the infusions.  To help avoid these reactions and to lessen their severity, people receiving Rituxan infusions are premedicated with IV steroids, oral Benadryl, and Tylenol. However, as stated, about 80-90% of people will still have some type of infusion reaction. Unless it is a very severe reaction, additional IV steroids and IV Benadryl are given and these additional drugs generally clear up the reaction and the infusion can be finished.

I had transfusion reactions both times I received the infusions. I received additional IV steroids and IV Benadryl and this kept the reaction under control. After the infusion, at home, I took 50 mg Hydroxyzine for a couple of days for some residual edema and itchy throat and cough. After that, I was fine and had no further reactions of any kind to Rituxan infusions.

I do know that Rituxan, as well as other immune suppressants and biologics, suppress the immune system so they do make us more susceptible to infections. I did get a sore throat, cough, and very bad sinus infection about a month after receiving the first Rituxan infusion. I needed 2 courses of antibiotics to clear up the sinus infection and the dry cough lingered for months, even with additional treatment such as a short course of Prednisone. It is finally mostly gone.

In the past I developed Shingles while on high dose Prednisone.  Last December I developed Shingles  and an abscess (2 separate problems) while on Cellcept, so increased susceptibility to infections will occur with any immune suppressant.



"Is it hard to get insurance to cover?"
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Coverage depends on your age (ie are you on Medicare), your insurance company, and your diagnosis.

While the newly published Sjogren's treatment guidelines now recommend Rituxan as a treatment for Sjogren's, Rituxan is not on the FDA approved list of treatments for Sjogren's (yet).

If you are not on Medicare and you have your own insurance, some insurance companies may cover Rituxan for Sjogren's.

Medicare will not cover Rituxan if you do not have a diagnosis which Medicare has approved fro treatment with Rituxan. If Medicare won't cover it, most Medicare medi-gap insurance will also not cover it. Sjogren's is NOT on the approved FDA list for Rituxan treatment.

So, your diagnosis for Rituxan infusions needs to be something other than Sjogren's. Rituxan is FDA approved for RA. Therefore Medicare will cover Rituxan to treat RA, either sero positive RA or sero negative RA. There are other diagnoses that are also FDA approved, but I am not sure which ones. A good Rheumatologist will know which diagnoses have FDA approval for Rituxan coverage. Most Sjogren's patients have several systemic manifestations of Sjogren's and co-morbidities along with their Sjogrens'.
Including one of these will suffice as an approved diagnosis. Keep in mind that most biologics are not FDA approved for Lupus either and those people get treated with biologics all of the time, off label, via their other associated diagnoses.

[trc1962]

Thanks for all the good info. So glad you are feeling much better Jasper! I am off the cellcept for now until we get the skin biopsy back for small fiber neuropathy but still on the prednisone and am holding my own. I will file this information to share with my rheumy if the biopsy is positive. I don't currently have a rock solid diagnosis although the rheumy lists it as primary sjogren's but hopefully he could find a way to bill it if it is needed. Lots of good info on this forum - thanks to all. Expect the biopsy back early next week.

[Jasper]

Studies have shown that Rituxan works for Sjogren's neuropathy, although not on everyone. Best results were observed in patients with cryoglobulinemia or vasculitis-related PNS involvement.

"Rituximab, an anti-CD20 antibody, may be useful in systemic complications in pSS patients [95, 96] and in some cases of refractory neuropathy. Recently, Mekinian et al. [97] reported 17 patients with pSS and PNS involvement treated with rituximab. Neurological improvement was observed in 11/17 patients (65%) at three months. Best results were observed in patients with cryoglobulinemia or vasculitis-related PNS involvement (9/10 patients improved)."

http://www.hindawi.com/journals/ad/2012/645967/

(Scroll way down to the treatment section for this quote.)


There are plenty of us patients who have had good results with Rituxan.

Here are a few links to Julia's blog on her (very good) experiences with Rituxan:

http://www.reasonablywell.net/2013/02/rituximab-therapy-in-sjogrens-syndrome.html

http://www.reasonablywell.net/2012/11/rituximab-and-julia.html

Also, don't believe it when people say that the studies on Sjogren's and Rituxan do not show any benefit. Those people may have read the study conclusions (ie whether the studies met their endpoints) but they obviously have not read the actual breakdowns of the studies, all of the facts, methodology, actual findings, etc. If a person reads  each entire study, not just some article in a newspaper or the conclusion, but each entire study, one will see that all of the studies show significant improvement in various factors, especially fatigue, but also other factors. The longest study, 120 weeks, showed significant improvement in fatigue and other factors. One has to keep in mind that most of the studies (except the 120 week study) were poorly designed and the endpoints were poorly designed. If the studies are poorly designed, then the study will not meet it endpoints. If the study does not meet it endpoints, then the study is considered a failure, even if the improvements were significant.

Serious Sjogren's researchers are currently doing studies that are much better designed and have a much better selection of study participants. These newer studies will hopefully be well enough designed that they show the improvement these drugs have for us so that they will be approved by the FDA for use in treating Sjogren's.

[gurs]

I know the biggest thing for me with the infusions was to have them done super slow. I was there 8-10 hours and let it drip, drip, drip.
I noticed a huge difference when they would speed it up. I had more reactions after too. Your doc can note this on the order.
I think alot of us have RA, even though some labs done always indicate this either, and if your on alot of medications, especially prednisone, can alter them anyways. Your doc might be able to add this for insurance purposes to get you covered?

I just had sinus surgery yesterday, but looking forward to giving it another try in the fall.

Great info Jasper..thanks

Gursie

[Anastasia]

Hi all!

I had my first Rituxan infusion last Tuesday, and the second will be on the 24th.  I will let you know if I see benefits.
The first infusion was done super slowly - I was at the infusion center for 8 hours!  I had a mild reaction early on - itching in my ears, so they stopped and restarted and I had no further problems.  I have felt wiped out in the days since the infusion - I'm hoping this is temporary. 

Interestingly, the infusion center I went to is for rheumatology patients only - and they are incredibly busy.  Perhaps the biologics are being used more commonly now.

Regards, Anastasia.