Rituxan Maintenance Dose

My wife is an ITP patient and received the standard 4 weeking infusions of Rituxan this summer. So far it seems to be working with her counts staying in the mid 200k range. She is still tapering off prednisone (now at 5 mg every other day). Is there such a thing as providing a maintenance dose of Rituxan - such as a single infusion every few months if her platelet count starts to fall? It seems this would be preferable to going back on prednisone with all the undesirable side effects.

On a related subject, the PDSA information about Rituxan mentions a clinic trial of a pill form of Rituxan. I have not been able to locate any further information about this. Does anyone have further information about this?

My thoughts on the Rituxan maintenance:

This has come up before. All I can do is tell you my story. I have been in remission since 2004 when I last had Rituxan (I also had it 13 months earlier in 2003). Two times, my counts fell into the 60's and rebounded both times on their own. If I had gone with Rituxan maintenance as a preventative, I'd have had about 21 unnecessary infusions to this point (assuming I would have had 3 per year). I may have thought the preventative infusions were keeping my counts up and continued having them. It would have been for nothing.

Quite a few people have had a few years of remission after Rituxan. Those who have had platelet drops when remission ended opted to do a second series of Rituxan. It's not really necessary to prevent platelet drops, only to deal with them as they occur. It's also not necessary to have a normal platelet count, only a safe one. Since ITP can be an ongoing disorder, less may be better as far as treatments go. Rituxan is a heavy duty treatment and it does have it's place, but it can also have some scary side effects that could be worse than ITP.

Sorry, I have not read about a pill form of Rituxan. I'll have to check that out.

Thanks for sharing your experience, Sandi. You made an excellent observation about potential over-use of such a toxic drug. The only reference I have seen for the clinical trial of a pill form of Rituxan comes from the first sentence in this PDSA page: www.pdsa.org/itp-treatments/rituxan.html

"B-cell Depletion (anti-CD20)
Rituximab (Rituxan, Mab Thera) is the most commonly used preparation in this category, although others including a pill version are in clinical trials."

Oh, okay. They were referencing other drugs that deplete B cells, not specifically a pill form of Rituxan. You'd think I'd be more up on the pipeline drugs and I probably should be. New goal.

There have been some articles lately about Rituxan maintenance and it is done sporatically. I can't though for the life of me see why that would be necessary (due to reasons stated above). Time, expense, side effects, all possibly for nothing when counts might just stay up for a while on their own. This is just my opinion and my perspective; anyone can choose to do what they want to do.

Sounds like your wife is doing well so far!

Thanks, Sandi. Yes, she it doing well. She was diagnosed a year ago and has been through two rounds of high prednisone. IVIG and the prednisone got her platelets up to 250k. However, when she tapered down to under 10 mg per day, her platelets went right back down. The last time it happened, she got the 4 infusions of Rituxan (July of this year). She is now down to 5 mg pred. every other day. As toxic as Rituxan is, it seems preferable to staying on prednisone due to the long term side effects.

My doctor started doing a Rituxan maintenance dose (1 treatment) every four months. It worked well and we stretched it out a bit further. He was reluctant at first however the longest I got was one year before platelets started dropping and then we did the maintenance/booster again. I was not on prednisone too. However currently am on a low dose of prednisone for my rheumatoid arthritis, but tapering off. Anita

Anita,
That's interesting that your Dr put you on a maintenance dose. Did you have an initial normal, 4 doses of Rituxan previously? If so how long did that one last for you? Was that what put you in remission for a year?

Jaing50: I am one of those who had a long remission on Rituxan. It lasted 4.5 years. I went back to my Dr in Aug and had another "normal" 4 infusions. My platelets are again in the normal range and my Dr is expecting my remission to again last for several years.

Ananta - Your experience is just what we are hoping for. Have you been on any steroids with your ITP - or just the Rituxan?

Jim

When I was first diagnosed in 2006, my first treatment was prednisone. My platelets went up as long as the dose was high, and fell as the dose was lowered. I was reluctant to try Rituxan at first. But I'm glad I did! This time after my long remission my Dr again tried prednisone again. I knew it wouldn't work, but he was about to go on vacation, and it kept me safe for the 2 weeks he was gone. I told him that we should just do the Rituxan again so I could go back into remission and forget about ITP for a few years again!

My whole story is a little further down on this "Treatment - General" area. It's called "Repeating Rituxan after remission" Of course there is a little more to my story at the Natural Treatment Methods under My journey with Acupuncture.

I hope Rituxan helps your wife a lot and she can forget about ITP for a while. After obsessing about it all summer, I have again practically forgotten about it, which is a good place to be in my book!

PS If that wasn't clear, my hema puts me on prednisone, but tapers me off as soon as the Rituxan is working. I was on it only 6 weeks this time. I tapered quicker than my Dr suggested. But then I can do that, since I get very little reaction from tapering and I was on it a very short time.

With counts over 200K and the prednisone at a less-than-therapeudic dose, I would not consider a "maintenance" rixutan treatment. Your wife may never need treatment again, but if you do not test it, you will not know. As Sandi said, Rituxan is a heavy duty treatment with its own side effects.

I'm glad the Rituxan worked--enjoy!

On the second attempt with IVIG and prednisone to put my wife's ITP into remission, when her taper got under 10 mg/day pred, her platelets dropped from the 240k range down to 90k. That's when her hema talked her into the 4 weekly infusions of Rituxan.
1st infusion 89,000
2nd 119,000
3rd 138,000
4th 159,000
2 weeks after 4th 185,000
All this time she was kept at 10 mg/day pred. Her hema has been very slow in her prednisone taper as she is down to 5 mg every other day and we are now 3 1/2 months after her 4th infusion. Her counts have remained over 200k throughout the taper from 10mg/day tonow. From this data, it seems apparent the Rituxan is doing what it's supposed to and the predisone isn't doing anything.

Having said all this, we are not considering any sort of maint dose of Rituxan. I was just curious in what cases a doctor might recommend it.

Jaing - just so you know, your wife had a very good response to whatever she was responding to. When I had Rituxan, my counts were something like this: First infusion - 8k, Second infusion - 11k, Third Infusion - 3k, Fourth Infusion - 150k. Rituxan isn't known to work quickly and most people don't have a real response until after the fourth infusion and some not until 8 or 12 weeks after. There are a few who have had responses early, but it could also have been because they had another treatment around the same time that helped the counts along.

I just thought I'd let you know that her response was above average based on what I have seen on the Forum over the past nine years.

If you have some extra time and are interested, below is a discussion about Rituxan that began in 2002. I can't believe it's been that long! This was around the time that Rituxan was first being used for ITP. The man who started the thread, Ron, had a wife with ITP. She was the very first of any of us on the Forum to try it.

discuss.pdsa.org/topic.asp?TOPIC_ID=11396

I just noticed that a lot of the threads have missing sentences. That's weird!

Thanks for the response, Sandi. That's a lot of information on that message thread! A lot of positive testimony to Rituxan. Our hema is convinced my wife's rise in platelet count is due solely to the Rituxan. My only reservation is the fact that she has remained on a lose dose of prednisone throughout this period. We really want to be totally off the prednisone and have her platelets stay up. I guess we'll know more next week when we go for a CBC. If her platelets have stayed up, then we'll stop the prednisone altogether and see what happens. Thanks again for all you do on these message boards. It helps to have someone who has "been there, done that" to offer support. I appreciate your support!

Jim

I'm more inclined to think that the combination shot her up that fast, but Rituxan is holding her there. There have been studies that show that steroids in combination with Rituxan give a better response. The studies actually quote Decadron, not Prednisone, but I don't see why Prednisone wouldn't help as well.

In any case, she's up and that's the goal! Yes, we've been there, done that! Thanks!

I just want to add that a drop to 90K isn't in and of itself time to consider another or a different treatment. Maybe a drop to 30K or 20K, unless your wife has symptoms at 90K.

I might have read the backstory wrong, but I think you said that rituxan was given when your wife's platelet count dropped to 90K while still on low-dose prednisone. That could be considered an over-reaction, again depending on what other factors are present.

I'm happy as a clam at 90K, even though my count seems to hover closer to 120-130K these days. I had a very low dose of rituxuan that may or may not have contributed to my rise to over 100K a few years ago.

Tamar -
You may be right that the Rituxan was a bit of an over-reaction. Yes, we opted for the Rituxan an 90k - but she had dropped from 240k down to 90 in a two week period. In her first round with IVIG followed by high doses of prednisone, she had dropped from 240k to under 50k while still at 50mg/day pred. The hema had set up the Rituxan at that time, but then her platelets shot back up to 220k the day she was supposed to start the Rituxan. I feel her chances are much greater of at least a one year remission with Rituxan - plus the benefit of being off prednisone. Thanks for your observations. It helps to hear others' opinions.

Jim

My wife had a visit with her hematologist yesterday. Platelet count holding up nicely at 234k. We are 3 and a half months after last Rituxan infusion. She had been taking 5 mg prednisone every other day. Her hematologist wants to continue a very slow taper. She'll take 5mg three times a week for two weeks, then 5mg twice a week for another two weeks. Not entirely sure why to long, slow taper. The good news is at this level of prednisone, my wife's side effects to taking it are gone.

Excellent news! It sounds like the prognosis is very good. I understand wanting to get totally off prednisone!! If there truly aren't any symptons at the current dose, even though the very slow taper seems overly cautious, it can't hurt. I hope your wife's count remains normal, or if not normal then safe!

Thanks for the good wishes, Tamar. My wife's hematologist admits to being cautious. The previous two times my wife has tapered off prednisone (without Rituxan), her platelets fell rapidly. He's concerned about "memory cells" among the white cells that could trigger another round of ITP if she goes off prednisone too quickly. In my wife's case, we are hoping the Rituxan has knocked out or altered these memory cells.

Well, those memory cells are also beneficial. They are the cells that give us immunities that we've acquired over the years to anything we've been immunized against or illnesses that we've had (chicken pox, measles, etc). Supposedly, they regenerate (long explanation) which you want them to do (but without the ITP). They are specifically B cells and T cells (types of lymphocytes).

Prednisone at that dose isn't doing much, really. It's less cortisol than the body produces naturally, which is approximately 7.5 mg's per day.

I'll see if I can find an article for you, but I'm under the gun with a dead line at the moment.

I too have been on the slooooow taper off Prednisone and its worked for me! I was at 7.5mg in Feb. so finally am off of it in Oct- yay! My hemo and I agreed it was working better to go slow. Worked best for me to take a bit each day even when I was down to 1mg. I tried skipping a day and would get very slight nasal bleeding on those days. So took it slow and steady.

Feels good to be normal again, I'd forgotten what it was like! I had been on Prednisone for 2 years. Started Promacta in Feb and it is keeping my counts in an acceptable range. ~p

Sandi - I knew I had seen the mention of a maintenance dose of Rituxan somewhere. I'm sure you've seen the article I have linked below. About the 3rd paragraph from the end suggests the possibility of a single Rituxan infusion every 6 months.

Jim

www.ncbi.nlm.nih.gov/pmc/articles/PMC2040174/

Yes, I've seen it. My opinion, for what it's worth, is that it can be unnecessary since no one knows how long a remission will last.

Update on my wife's platelet count. She went in for a routine check-up with her regular doctor today. Her platelet count is exactly the same as 3 1/2 weeks ago - 234k. She is now 4 1/2 months since her last Rituxan infusion. She is down to taking 5 mg pred twice a week. Her hema is to review her bloodwork and let her know whether to stop pred altogether or go to 5 mg once a week. We are very happy with these results from the Rituxan. I read somewhere that patients who have a complete response to Rituxan (platelet counts above 150k) usually have a long lasting response (over a year). We are hopeful she is in this category.

Jim

Great news, Jim. Keep the updates coming!

My wife took her last 5 mg tablet of prednisone on Monday, Nov. 28. She had been taking just one 5 mg tablet per week for the last few weeks. For the first time in over a year, she is totally off prednisone. We go to the hemotologist on Dec. 27 for CBC. We are praying to hear the hemotolgist say the word "remission".

If you don't hear it, don't worry. My doctor has never used the word with me, but I've had remission nevertheless.

Mine never said remission but said if I went 5y without low counts we could hope it was controlled. I went 10y before I crashed again, and now 18m later and rituxan I'm around 250 and happy. I learned from this site a lot more about platelet levels and when to get excited about "low" and went to live life with less worry about platelets. I do however do a CBC every several months for monitoring.

I sure remember the day I took my last pred - YAHOO!!!! Hope she does well, doesn't stress, and can live worry free. That last one can be tough but a worthy goal to strive for.

Steve - thanks for your encouragement! Your experience with Rituxan is what we are hoping for. I guess the word "remission" as it applies to ITP can mean different things. Since my wife's numbers have been good for the past 6 months, this can be considered a remission. However, since she has been on low doses of prednisone during that time, it hasn't seemed like a remission. Now that she's off pred and other medications entirely, it feels more like a remission. Even if she needs another round of Rituxan at some point, as long as she stays of prednisone, we're ok with that. She took the infusions with no side effects or problems.

Hope your second "remission" with Rituxan is at least as long as your first one. I thought I read somewhere that subsequent Rituxan treatments yield at least as effective responses as the first time. Best of luck!