Rituxan Decision: Serving Humanity or Taking Care of the Patient (Me)
This is one of those rare posts about my personal medical journey, a Professional patient post. That’s kind of a warning in case I use the word “I” too many times to be polite.
It’s crunch time. No one can decide but me.
About a year ago I hit the end of the line with my rheumatology care. Dr. Smart, who we greatly appreciated had stopped my Actemra and told me to wait for a new drug to be approved. I was to stay on methotrexate “in case it helps somehow” and wait. I’d begun to investigate clinical trials to see whether I might be able to get another treatment that way, but Dr. Smart warned that trials would not accept my almost always “normal” CRP. The more I learned from research and other patients, the more I wanted to get a nuclear bone scan added to my chart – some evidence of inflammation to offset the normal CRP.
I didn’t want to accept that nothing else could be tried to try to stop the rheum monster. It’s hard to accept every day just a little bit worse year in and year out. I can stay positive mentally, but what good does that do my body as the slide continues? And damage of some kind continues unchecked.
Last summer I found a way to try Rituxan! I found a clinical trial for a faster administration of Rituxan, already approved to treat RA. That meant that CRP would not be required – no RA examinations are required at all – only a negative pregnancy test. And THAT I can readily produce.
Speaking of peeing in a cup… within a couple weeks of my first round of Rituxan last September, my Dr. Good GP ran a urine culture with a bunch of blood tests in a regular physical (one reason I call him good). It showed two types of infection. And by the time Nancy and I got back from Philadelphia and the nurse reached me, I’d developed symptoms.
In clinical trial lingo “serious adverse event” equals “really bad.”
Since then, I’ve been through several rounds of antibiotics without success. Eventually, Dr. GP suggested hospitalization for IV antibiotics. The clinical trial nurse responded when I mentioned hospitalization for an IV antibiotic: “THAT would be a serious adverse event for us.” This week, I was ready to choose the hospital anyway. Since October, I’d failed test after test, even after antibiotics. Finally, yesterday, I had my first clear culture. So I’m finally infection-free.
(Aside: if you’re reading and you don’t have RA or it hasn’t gotten to your hands yet, it’s REALLY hard to pee in a cup. It’s more like peeing all over your hand and hoping enough gets into the cup for the lab.)
Meanwhile, whenever I’ve mentioned the six-month infection, with bladder pain and fevers, no one seemed very worried. Do lots of people have infections that last months and it’s no big deal? I just never did before, so I didn’t know. The idea of an infection with an immune-system disease and the Rituxan kind of worried me a bit. I took every precaution I knew of – taking only one five-minute tub bath in the past six months, drinking extra fluids, taking cranberry capsules…
Maybe you are guessing what’s next: my decision. The Rheumatoid disease has been indifferent to the Rituxan. My joints are just as bad and my fever is persistent. So it was inevitable that I’d begin to think about what’s next. My thoughts:
Do I take the second round of Rituxan this week, completing the whole year, risking the long-term infection? Along with the other risks of the infusion? Even though it would postpone my ability to try another treatment if one is approved?
I posed this question to two doctors, Dr. GP and Dr. Tylenol –the rheumatologist we met with last month trying to find a replacement for Dr. Smart. (I am not treated by a rheumatologist in the clinical trial. There are no exams or prescriptions given – only the pregnancy test and Rituxan.) Both doctors gave the same answer.
They both said that I should take the 2nd round of Rituxan, completing the year of treatment even though the drug does not help me, because clinical trials are important to research. I was even told that I should think about what is best for humanity since I “usually want to help others.”
Yes, I do – want to help others. Excuse my being frying-pan blunt, but how could I continue to help others if I succumb to infection? FINALLY, does no one recognize that this unrestrained Rheumatoid disease makes me more disabled all the time? That I continue to do less and need more help as my health is slowly eroded away? I am not sure what percentage of people respond to Rituxan after this long, but that will be how I decide today.
Recommended reading
- The Beginning of an RA Clinical Trial Journey
- Living with (RA) Rheum Disease Is Already Multitasking
- Using CRP in Criteria for Rheumatoid Arthritis Clinical Trials
- Keeper or Loser: I’m Not Giving Up, But What Do You Think?
In my opinion, if you were fully informed of the risks when you began – you should stick it out to the end. Believe me, I understand how it feels to be on a drug that isn’t working (a year and a half on Humira, completely unsuccessful, and now Remicade with no indication that it’s working so far). It sucks. But you signed up for a clinical trial, and as a nurse I also fully appreciate how important these are. Besides, you never know – it might take that second dose before it starts to work.
I did choose to continue as I mentioned above, based upon the odds of it helping me. I signed many pages of docs and nowhere did I commit to being in the trial 1 second longer than I believe it benefitted me. Nowhere did I commit to stay to the conclusion. That is not done most likely because no one would ever join a trial. I have copies of what I signed & I’m certain of this.
As someone who took a double dose of Humira for 2.5 yrs while it was ineffective, I now know much better and use that example in speeches of a complete failure of care. Many doctors are now switching or changing treatment regimens at 3 month increments. 6 months is the accepted norm however around the world for giving up on a biologic. The odds of a biologic working after 6 months are extremely remote with the possible exception of rituxan which is a completely different type of treatment.
I realize you may not be aware because they do not identify themselves but numerous other commenters are nurses or health care providers, including some of those above.
I believe it is very sad that healthcare workers would endanger a persons health in order to try to sell more rituxan. The only purpose of this trial for already approved rituxan is to increase rituxan sales by proving that it is just as safe to administer quickly as slowly. Too many people do not choose rituxan in their opinion because it takes so long. So they have every right to try to reduce the infusion time (increase the rate) if they can find people willing to take that big risk that I did. But they do not have a right to expect people to also endanger their lives against their will.
Hi Kelly,
Thank you for your website & posts. They have really helped me deal with my RA & I am very grateful.
I think asking you to do a study for “humanity” is not only a terrible idea – but it seems immoral. No doctor should try to guilt their patient into doing a scientific study (that benefits their reserach) – especially if it could increase or complicate your health problems.
Please make your choices based on what is best for you and your health.
Two years ago I suffered a terrible fungal infection, called disseminated histoplasmosis, that almost ended my life (while on Enbril/Methotrexate/Plaquenil). Fungal infections are now included on the warning disclaimers of many medications …but I do not think most people understand the seriousness of this warning.
Maybe this could be a future topic for your site.
Thank you for all you do,
Robin Trafton
Hi Kelly, I have worked in research for 10 years – and had a chance to participate in a clinical trial for subcutaneous orencia. I carefully considered, also wanting to help my fellow future RA-ers – but ended up not enrolling. Here’s a few things to consider:
1. YOU are #1. The patient always comes first, before research. Studies have to be approved so that they have your best interest in mind. But Drug companies that want studies completed ASAP sometimes can muddy the waters. So go ahead, be selfish, and think of YOU. (Oh, and if you want to see someone Serving Humanity in a big way, go to rawarrior.com.)
2. Any investigator who wants to publish their research in a major peer-reviewed journal (like Journal of Rheumatology) has to make their research plan public on http://clinicaltrials.gov. You can see their primary and secondary outcome measures (like x ray results and pain scales) and some info in more detail than the consent form. The one I was recruited for had Number of Adverse Events and Serious Adverse Events as an outcome measure. Red flag to me if they’re counting (but, I had other treatment options).
3. Sometimes you can go to PubMed.gov and see what’s already been published by this group. In my case, they had already completed a similar trial and were trying to get more data. And, the numbers of AEs and serious AEs were really high, in my subjective opinion. Red flag #2.
4. If you have an AE, the researcher is required to report it. A nurse on the floor can’t skip a round of meds because they don’t want to do it – it’s their job. Likewise, study nurses or investigators can’t fail to report an AE (or advise you against a treatment that would qualify as an AE.) There are very good research groups out there, but just as many that are under tremendous pressure to recruit and retain patients. If a study site is not wanting to report an AE, that’s a huge red flag.
Bottom line, researchers all go to days of training on abuses or misuses of resarch. We learn history of reseach studies gone amok (like the neuremberg trials or the infamous syphylis study) and how to protect patient rights as research participants. If you do a research study, you and your medical safety come first. Even if there isn’t another treatment. Your doctor and medical center still have to take care of you if you drop out. You don’t have any requirement to stay in if it’s not in your best interest.
That being said, research studies ARE the reason we have biologics, methotrexate, and even NSAIDS. Drug companies do need people to participate… but never at the expense of any one patient’s well-being. If I found a good study, I would participate – especially if it offers an option for a treatment not yet approved. I hope you decide what is best for you – only you will know what you should do.
Peace,
Mary
PS – just re-read your post (I read it this morning and replied based on my thoughts througout the day). Drug studies need to keep count of the number of people who dropped out due to the drug not working or being unsafe for them. That in itself is data. No need to continue treatment that isn’t safe or has serious drawbacks to see what happens. In fact, if a high enough percentage of people dropped out (or had serious AEs) due to infection or otherwise, that would be reason to revise the drug – or shut down the study and not push the drug through FDA approval as is.
You have no obligations as a research participant – ever. I do hope that, soon, you find treatment that works for you, Kelly! Maybe this is it, maybe another study or another drug to come?
THANKS again for everything you do for the RA community!
Peace,
Mary
Dear Mary, thank you for the thoughtful replies & to save my fingers I’ll ask you to look over my specific comments above – teh one I posted last evening (24 hrs ago) witht eh 2 links and the one I just typed to Kathryn. My hands are bad and so exhasuted from 2 days on the road & in the chair. It’s a long ride & I stay overnight w/ a freind. This is such an imp discussion we patients need to have as we want more research & more of us participate. Your bottom line should alsways be so I agfreee. Let us remember the oath to do no harm is above the desire to find out whether we may be able to sell a bit more rituxan than the current level. And I hope that the folks at roche / genetech would agree. every one I ever met from the company would.
Kelly,
I really want to thank you for posting those links to the studies about re-treatment for Rituxan non-responders. I am entering month 3 after my first course of Rituxan. I think it might be starting to work, but not sure yet — I just fractured my sacrum (from prednisone) and so it’s hard to tell what’s going on.
But I’ve been so worried… what if the Rituxan doesn’t work? So far, it’s the only drug that hasn’t caused a really severe side effect, besides Humira. I cannot take Methotrexate, Enbrel, Orencia — and now prednisone has caused a bone fracture & they are pulling me off it. So as you know there aren’t a lot of options left. I did extensive research on Rituxan side effects and also whether I was a good candidate. It was a hard decision to make, and I’m sure it’s even harder to make the 2nd time around. But those studies you posted do indicate (more than previously thought) that non-responders can eventually respond.
I have not had any infections with any of the DMARDs or Biologics, after 1 1/2 years of trying different ones, aside from a couple of yeast infections with Orencia. I hope you can get the infection really under control.
My “only” side effect with Rituxan is flu-like symptoms and increased joint pain for 3 days after the Rituxan infusion — but compared to other things I’ve been through with side effects, that actually seems manageable.
Let’s keep our hope alive that Rituxan will work for both of us, and spare us any side effects!
Kelly, I know you’ve made your decision to continue with the trial, but I just wanted to give you my $0.02 as a researcher (not medical) and the “obligation to humanity” and adverse event. First, adverse events can be just about anything that happens to a subject during research (it doesn’t even have to be as a direct result of the research) and usually means that the researchers have to report it to their Institutional Review Board to make sure that others aren’t in danger of the same event, that proper precautions have been put in place to prevent it, and that it is appropriately documented. It might not “look good” for whatever the research is trying to prove (e.g. that this method of delivering medication is effective), but the reality is that dropping out of a clinical trial because of an adverse event DOES contribute to the research. Disproving hypotheses contributes to humanity as much as proving them–your experience coupled with others’ adverse events might show that this method of delivery isn’t effective, or isn’t safe enough to use clinically. That’s why we do research and experiments, not just to prove we’re right, but to find out if we’re wrong.
I agree completely. Thanks for adding your perspective. I’ve reported every little event for that reason. I know that a slight “event” for me could be a trend when they look at all in the trial – maybe 200 eventually I think. I’ve taken it very seriously & not swallowed any meds w/out calling the trial nurse. I know that the 6-month-long infection has already been recorded as an AE but I was warned as I wrote “serious AE” whatever the diff is. BTW, I inquired numerous times about whether they’d postpone or cancel the infusion w/ the continuation of the infection and they did not call me back. So, I wrote this post last week and then I got the good news on Tues am that the infection was finally gone. So that was the first 1/2 of my decision. I would have refused to continue if it was not gone. Then I had to decide whether there was a poss it would help since I am not a lab rat. The second stage of my decision. They still never called. I went. I got it. Afterwards, she said, btw, “We don’t cancel infusions for just a uti.”
I did not argue about how foolish that may be since it was NOT just a routine uti – it was 6 months long and resistant to 5 anti-biotics. In a person w/ a sick immune system, yada yada. And a disease which has a 6 times increased risk of dying of infection.
I just said, “Well if it had not been gone, I was prepared to withdraw.”
Food for thought for them because they hadn’t even called me back about it.
Perhaps as I think I wrote last night its good we have this discussion. Patients need to support trials & I have been supportive of research. But patients’ are concern numero uno in all things & that must be pushed and demonstrated to those who are not embracing that fully.
Kelly-
I just wanted to wish you good luck with continuing on the Rituxan. I hope it helps you immensely and there are no more infections.
That being said, I am appalled at what the two doctors said to you. No one should be pressured like that.
BTW – You DO do what is best for humanity right here with your blog. I am so inspired by you, and so very blessed to have found this great resource.
Thank you-
Karen
Kelly,
While I am all for helping your fellow patients, and feel clinical trials are great ways of helping, think of it in light of ALL of the other things you do to help your fellow patients. If you continue to get these infections, you’re gonna have more trouble. Then where will you be? Will you be able to help then? Likely less so.
A bit of a cautionary tale on bladder infections/UTIs. Please bear with me as it is a bit LONG. I have been prone to them most of my life with JRA. When I got married, they got worse. Many docs say avoid caffeine and esp avoid during an infection episode. But one doc said with my history and the fact that the symptoms are not worsened by the caffeine and the fact I get massive migraines when I cut back on caffeine, not to be too concerned about it. The infections had gotten to where I seldom had them after having my son. I began Remicaid in 2007. Shortly after, I ended up with what I thought was the stomach flu. Nausea, vomiting, diarrhea. I couldn’t take meds, which is dangerous when on 20mg of pred. Got dehydrated. Ended up in ER. Doc said tested positive for salmonella. Oh you also have a UTI/bladder inf. (I’m not sure which one exactly on any of these times). I had NONE of the normal UTI symptoms of burning, constantly feeling I needed to go to the bathroom and then not hardly going etc. It was only after beginning the antibiotics that I started to feel symptoms. A few months later, stomach flu was going around. I got sick. Nausea/vomiting/diarrhea. Not able to take meds. Dehydration. End up in ER. Not the stomach flu. Another asymptomatic UTI/bladder inf. Same thing. After starting abx, then I got the symptoms. This cycle happened I’d say 4 or 5 times between 2007 and late 2008. Dec 12, 2008. I felt sick. By then I knew what the N/V/D meant. I figured this time, since I knew, I could handle it. Except I couldn’t. Got dehydrated, probably got into a bit of an adrenal crisis due to not taking the pred. Went to ER. Admitted. Took care of infection, got me to keeping food down, was seen at hosp where rheumy and pain doc have privileges rather than the hosp I usually went to. Rheumy told em to run IV corticosteroids. First time for me having them. I don’t know that they contributed to my weakness. I know I ALWAYS had weakness when I’d been through the 4-5 days of sickness, 3-5 days in hosp. etc. I know it may have added to the weakness. But in NO way do I blame the doc or the IV corticosteroids for my fall. Neither do I blame my hubby, who says HE dropped me. I say I FELL! When I was discharged, I was getting in my car and couldn’t do it on my own. So hubby went to lift me into the seat. I figured I’d help him by shifting my weight. Except I shifted the wrong way and fell. Hit the ground fairly hard. I was at the height of a late 90s Jeep Grand Cherokee seat. Little bit higher than waist high on me and I’m 5’3″. I sat where I fell for a moment. Then began moving body parts cautiously. Nothing hurt any more than before. I could move everything. I decided I was fine. Didn’t even go back in to be checked. I just wanted out of there. Because it was Dec 21 and I’d been sick since Dec 12 and in hosp since the 17th, we’d not done ANY Christmas shopping for our son, had very little in the house in the way of groceries. So rather than going home, we did some shopping. I went in one store, used my wheelchair as I always did at that time. Did fine, but was tired. So I decided to stay in the car the rest of the shopping trip. It was a VERY mild winter here in Myrtle Beach. I had my blankie so I was nice and warm.
We get home, hubby has to help me into the house. I wheeled my w/c to the restroom and he stood by while I stood up and used the bathroom. This should have been the first clue something was more seriously wrong than I thought. I found out I’d had a bit of diarrhea that I’d NOT felt. So I get cleaned up, start to use my w/c to hold on to and walk to my desk. I was so stiff I needed to move a bit. I should have just wheeled over. Hubby followed me so close I could almost feel him behind me. But halfway to my desk, I just dropped. I hit the floor like a ton of bricks. It was so fast, I couldn’t even get the words “I’m falling” out. Hubby slowed my fall somewhat, but couldn’t catch me. I twisted my left leg so that it was bent at the knee and under me. I thought I’d screwed up my knee but thankfully I didn’t. He got me up, I sat down at my desk a bit then tried to stand again, with him literally holding on to me. When it was clear my legs were basically jelly-like or felt jelly-like, he insisted I go back to the ER. Worst decision EVER. We should have went to a different hosp. But anyway, go to the ER. The nurse I had was pretty nice. The nurse who helped her help me to the restroom was EVIL! She decided to scream at me, while I am trying to use the restroom mind you. She accused me of faking it, saying I could stand and I just wanted attention. I’ve never been the type to want to hit anyone! EVER. And she almost got hit! It is probably only that I had NO energy that kept me from hitting her. They did x-rays, an MRI, labs etc. Admitted me. Later did dopplar imaging, Nothing conclusive. Spent from Dec 21 to Dec 29 in hosp. They discharged me. I was still unable to stand let alone walk. Saw my pain doc. He had no real answers…first time for that. Basically he said it could be a soft tissue injury and to give it a bit and re-evaluate. In the meantime, he planned on getting hosp records.
By Jan 2, 2009, I was having more N/V/D, unable to take meds. In horrendous pain. Couldn’t hardly stand or put one foot in front of the other. Called NP at pain doc and she said “ER NOW!” and advised me to go to a different ER. Knowing me well, she asked to speak to hubby and told him take me. She knew I’d probably dawdle. We get there and they run all kinds of labs, UA, and I can’t remember what else. I think that’s where they first put in a PICC line. I know they had a hard time with getting an IV. They began running plasma as well as fluids. The doc came in and I remember him clearly. He reminded me of a younger version of my oldest brother in a slight way. He felt that given I had: the original infection, dehydration, cellulitis in both legs below the knee with the left one having a large area that was bubbled up (it looked kinda like a thick skinned blister), the blood pressure being sky high, VERY elevated heart rate, all on top of the mysterious inability to stand or walk on top of my “normal” health problems that they couldn’t get me under control there. So he wanted me to go to MUSC in Charleston. Well respected teaching hosp. so I was all for it. I’ve had excellent care at teaching hosp in the past so I was fine with the transfer. So midnight or so we rolled out of the hosp in the ambulance. I spent 2 wks at MUSC. In and out of ICU, had blood and plasma. They did nerve conduction tests. I can’t remember what else. They basically sent me home with NO answers. My family feels they sent me home to die basically. By Jan 22, I was not responding to verbal commands. Prior to that, if someone said to do this or that, I’d comply. They were helping me to the bathroom, and with everything. But that dwindled. So to the ER again. Apparently, had they waited 24-48 hrs, I probably would have died.
As it is, I almost didn’t make it a number of times. I do not remember anything after being discharged from MUSC until March 2009! I don’t remember most of March and Apr. I remember more of May and on through the end of July. I wasn’t able to eat so I had an NG tube most of Jan-Jun 2009. Throughout this time, I battled multiple infections. The area on my leg that was like a thick skinned blister? It burst open and was basically black inside. SO I had a wound vac on that leg. I had countless bladder infections, UTIs and kidney infections. It ended up I had VRE, aka Vancomycin-Resistant Enterococci. It is NOT the most fun thing to have, mainly because it meant that EVERYONE entering my room had to put on gloves and a gown. My son had to avoid being on my bed. I was almost afraid to hug and kiss him. But they said as long as he was gowned there was little reason to worry. Here’s a link to info on VRE. http://www.medicinenet.com/vancomycin-resistant_enterococci_vre/article.htm And just because it’s bladder related, here’s a quote. “VRE can exist in the body without causing infection, in which case a patient is said to be colonized with VRE. Colonization usually occurs in the bowel. If the number of VRE bacteria increases, they can invade the bloodstream or spread locally to cause an abdominal abscess or urinary infection.” I also had C-Diff. I was unable to eat because my esophagus, stomach and first few inches of my small intestines were basically raw. That’s why they ended up putting a GJ-Tube in. When it came out less than 2 mo later, they decided to do a PEG tube. I lost the ability to move my legs. I lost movement in my arms and my elbows, wrists and fingers of both arms contracted so that my hands were closed into a loose fist, my wrists bent so that my hands were drawn down to the underside of my forearms. and then my elbows were bent so that I could rest my hands almost on my shoulders. I couldn’t do ANYTHING for myself. Once we got the stomach stuff under control and I was able to keep food down, I couldn’t feed myself. I couldn’t blow my own nose. NOTHING! I had such horrible neuropathy that it was as if I were wearing VERY tight gloves that went to about 2 in below my shoulders. I was pretty much numb from the waist down. I couldn’t tell when I’d went to the bathroom. Well, until I had such bad skin breakdown despite the staff checking me hourly and doing their best to keep me clean. Then I’d almost scream anytime I went to the bathroom.
Apparently during the time I was out of it, I’d almost scream when the staff would barely touch me. My Mom said the staff would leave in tears. Finally in Nov 2009, I was able to be transferred to a nursing home. One of the aides actually told me later on that when she saw me that first day, she honestly thought I’d not be with them very long because I would not make it much longer. I’d gotten rid of the VRE, the C-Diff, my esophagus etc healed up, the feeding tube did it’s job. I’d been 198lbs when I first got sick in Dec 2008 (thank you pred!), WAY too big for a 5’3″ small boned frame. By Apr 2009 I was down to between 90 and 95 lbs. Way too small. Once the feeding tube was in, my digestive sys had healed a bit, I was slowly gaining an appetite back. I was 112 when I got to the nursing home. Over the next 2 yrs I got back up to about 150lb which I’ve held steady at. A bit more than I should weigh. But given my lack of physical activity and my refusal to limit my eating (it’s limited enough due to no appetite from the RA so when I am hungry, I WILL eat what sounds good in moderation, my big downfall is Coca Cola and I have no desire to change that) I put up with the extra 30lbs. I could barely turn over with 2 people helping me when I got to the nursing home.
Slowly I healed. I eventually started PT in Jan 2011. I spent the time bet Nov 2009 and early summer 2010 in bed most of the time. I got in my wheelchair on when my family took me out. Since getting the bladder/kidney/UTIs cleared up and getting the VRE cleared up, I have had ONE infection. I believe it was a UTI. Well, one affecting the urinary system. I have had shingles. A total of 6 times. All in the same area. 4 times in the hosp and twice at the nursing home. Believe me, anytime that area begins to itch, I am having someone look at it before I begin to scratch to make sure it’s not shingles. Although I had them, I didn’t have the typical complaints because I was already on pain meds and neurontin which treat some of the symptoms. I mainly get the itching.
Between all the times I had some sort of urinary infection and all the times I was catheterized, I lost all bladder control. As I slowly got better, I regained the ability to feel when I was wet, then slowly regained the ability to feel I needed to go. Even more slowly did I regain the ability to feel when I needed to go soon enough to be able to get to the bathroom before I went. I am still not 100% continent. But they feel the infections (stemming from 2006/7 on through being in the hosp) were a major contributing factor to the incontinence as well as the catheter being in off and on for well over 6 mo. It has been a long slow road to get to where I am even. So PLEASE be careful with those infections that don’t go away and the repeated infections! Briefs are NOT fun! Nor are the comfortable. Eventually I am sure I will get to the point I don’t need them but in the meantime, I deal with them because the alternatives are even worse! I also was given the dx of over active bladder to go with the mixed incontinence. Mine is a mix of stress and urge incontinence. What’s worse…I have to be VERY careful what briefs I wear because my normally not sensitive skin is VERY VERY sensitive to something in certain briefs. Just 2 hrs of contact with certain brands of briefs is enough to cause larger than a half dollar welts that are raised about 1/4 in. To deal with the OAB, which also helps with the urge incontinence, I take Vesi-Care. I am on 5mg/day. I have good results with it. I pretty much know now how much I can drink and not cause myself problems getting to the bathroom quick enough. And then if I am flaring, that’s blown out of the water. It is unpredictable. I certainly don’t tell my story to influence your decision to stay on or stop the Rituxan. Just a cautionary tale about being as careful as possible with multiple infections that don’t seem to want to go away.
I know that you went for your infusion already, and I hope that it went well. Just wanted to throw in my two cents!
Obviously our situation is different since Em is also on Remicade, but we were warned right away that Rituxan would lower Emily’s immune system significantly more than just Remicade alone. It is a bit risky to do them both together, but for us it has absolutely been worth it. As you know, she’s been fighting the sinus infection since November. I think we’ve ticked off our ENT by having our rheumy intervene, but I don’t care. We are told that any serious infection requires a 21 day course of antibiotics for anyone that is immune suppressed. Rituxan can significantly lower the IgM and IgG levels in your immune system, which is why the sickness prevails. Hopefully whomever your new rheumy ends up being, whether Dr. Tylenol or someone better, they will also give you IViG to boost those immune levels back to the normal. It’s a balancing act.
Also, I read your post on the robbery the other night but I was packing and just couldn’t reply but OMGosh!!! I’m glad that it happened the way that it did without any physical altercation. Thank the Lord that you’re ok! This, too, shall pass. <3
TY Dee, blessings to all u guys.. Very tired tonight. Give my love to Em – what a champ.
After my initial dose of Methotrexate, I had a near death experience. Later I was asked if I didn’t think I should give it another try. After I stopped laughing, I was able to mutter “no way.” Would I recommend Methotrexate? You bet! It’s done a lot for many, many people. Only you can make the decision. I urge you to think long and hard.
Kelly, I wish you much peace as you make this decision. Just remember that YOU are part of humanity, and any decision should be based upon what your own heart tells you first and foremost. Your contribution to mankind goes beyond a clinical trial.
Good luck, Kelly. Hard decision. I get what they are saying because it is a clinical trial. You did need to show how many people it helped and how many it didn’t. But that doesn’t mean you should do it. Your body.
They are not measuring whether it helped me at all or measuring my RA in any way. I know it might blow your mind, but the only measure is a pregnancy test. They only need to know whether there are adverse events with the extra fast administration rate. So an adverse event is info that is helpful to them too.
Having to make drug decisions is so awful and frightening on so many levels. I’m glad you are on the other side of the decision now. Praying in the wings for great results. Thank you for sharing your experience and thought process with us.
Not calling you back is pretty sloppy for a research trial. Your concerns and health are and should be numero uno to the researchers and I’m so glad to hear that you are pushing that and reporting everything. All research subjects should, but I know it’s hard for many because they feel they are letting down the research if they don’t. But, as researchers, ethically we are supposed to attend to that as well with the understanding that subjects must always have informed consent (in this case meaning they must return phone calls) and be on guard against coercion, which often comes in the form of subjects feeling unduly obligated to participate.
When I’m teaching research methods, I take as much time talking about ethical responsibility with human subjects as I do about everything else combined because unfortunately it’s too easy for researchers to lapse into thinking of subjects as guinea pigs instead of humans and to value proving themselves right over all else. Of course, this happen in clinical practice too, where there is lesser oversight… In any event, I encourage you to take this to their IRB if they continue to behave badly.
Hi fellow Warriors. I’m new to RA Warrior and was diagnosed with the RA monster in July 2011. We know it was lerking for at least a year prior to diagnosis and treatment but I guess I was lucky based on some of your stories.
Kelly, thank you so much for all the great information and priceless wisdom you share thru the site. Ive learned so much in the last few weeks. I start with one post and next thing I know Im surfing for hours.
I wish you peace and serenity as you make your decision on Rituxan. I suppose the weekend has been more mentally and physically taxing than normal. You have a big decision to make.. I understand your anger when your Rituxan decision is treated as ‘no biggie’ (just like many of our other struggles with RA). I’m facing a similar situation as a 1-year breast cancer (bc) survivor making a decision on Rituxan.. I feel so alone. It’s so different compared to my bc battle where I was surrounded with compassion at every turn. Your blog helps me feel part of a community, kinda like my new best friend. Thank you…
PS — if any of you have had breast cancer (or any cancer) and had to make a go/no decision on biologics I’d welcome your input. TNF Blockers and Orencia are ruled out for me due to the link to lymphoma. I’m currently on high doses of Prednisone and Methotrexate subq and it ain’t doing the job, despite the terrible side effects. Thanks…. Jodi
Jodi, wishing you the best with your decisions and outcomes. Something else to consider unless they are contraindicated is adding the other older dmards to your mtx and prednisone. Plaquenil and/or sulfasalazine. That triple combination has produced similar outcomes to biologics plus mtx. Hope you are or can take folic acid to help wiith the mtx side effects some.
Hello and thank you for this post.
I have been on every possible treatment of Meth, steroids, all biologics available and finally my RA Rx Rituxan 6-7 IV infusion. For the first hour I was prepared by steroidal IV and anti histamines. And there Rituxan IV started; for the first 2 hr I was doing great, until this terrible painful itch started in the ear and scalp first and than burning painful itch all over the body – in a matter of seconds.
Nurses at that department very knowledgeable, they called my and other doctors immediately. I was dark purple color with huge blisters and hives all over my body. Burning sensation was so bad, it felt like someone pour gasoline all over my body and put me on fire. When the throat started to close, oxygen tank was hooked, I was off the Rituxan IV and hooked to IV with steroids and anti histamines for another 8 hr. 3 weeks later, I am still on oral form of them, due to itch, skin peeling, very sensitive scalp and face.
I was told that they had never see such severe,life threatening reaction to this drug.
I want to tell everyone how important if you develop even little itch or burning sensation, immediately report to your nurse: every second matter to be able to save your life. 80% fatal side effects to this drug happens during first treatment and 24 hr after,
Hope this helps
Best of luck to you
Linda 57
I am sorry you are so sick. You must be, to be gone so long. Hope yjr sun shines on you soon.
Thank you Anna,
I am intelligent enough to know when something is wrong. You have no idea how many “big stars” doctors I visited who did not take any interest in me. They were looking for hands which is deformed already (easy diagnoses) but wouldn’t do any research on me. I missed so much time!
This is why I am big advocate for people who in same position I used to be, I tell them to not stop if your body tells you something is not right.
Not only I was diagnosed with RA, I also was diagnosed within one year with Lupus and MS. All these diagnoses were “awaiting” for a good doctors which I have now. I have great team of doctors, who work with me. They gave me their email addresses, cell phones in case I need them and i can reach them 24/7 and they always answer in a matter of minutes. They are real “stars” and work at excellent institutions in NYC, but they never make you feel that they are superior. They involve me in my treatments, they dont hesitate to ask my opinion…
I learned in a very hard way how important to knock in every door if you need until you get your questions answered.
But unfortunately, they can fix what is done by RA, they just trying to prevent further damages.
I wish you all the best and less pain…
Hugs, Linda
Miss Kelly – I am here to help figure out if I should start Remicade infusions. Reading this discussion has, as always, been very helpful. I am really shocked at what your docs told you. Isn’t it their job to help you determine the best course for you? Could they believe that staying in the trial is the best course?
Do I start Remicade? I am so scared to start it. I am scared of the side effects, I am scared that it won’t work. Then I think, maybe I don’t really need it. My RA is seronegative, with usually low CRP. Doesn’t that mean that it is supposed be be less damaging? Methotrexate has helped control some of the swelling but the pain, fatigue, and stiffness are brutal and constant and full body. The best Rheumy ever says that if I don’t do something else that in two years, I will be in BAD shape. What does that mean? I guess it means that even with methotrexate and steroids (and prayer), I end up needing joint replacements at 46?
Fortunately or unfortunately, no matter what my doctors have said or what my family thinks, I know that the decision to go on Remicade is ultimately between me and God. Arrrgh, why can’t it be simple and easy? God Bless You, I pray that you get some relief!
Oh,, Kelly, what a difficult situation! I am so very sorry.
I hope I am not over-stepping my bounds,, but I have been reading your blog and web posts for the last few years, after I was diagnosed with psoriatic arthritis, and I feel like I know you.
If you were a close friend, I would tell you to stay away from that second trial round, long term serious infection is nothing to mess around with for folks with AI disease! (Then I would bake you some brownies and watch a funny movie with you.)
And if you decided to go through with it, I would support you all the way.
Why do rheumatologists never seem to understand what it is like to be their patient?
{{gentle hug}}
Simone
I may have missed later posts about this, so please excuse if what I am saying is no longer relevant.
Hi – I just to add a little P.S. to my post the other night, where I was simple enough to say “the decision to take remicade is between me and God”. Oops, evidently, the decision is between me and my insurance company. And the insurance company does not think that I should be on Remicade. Well, no more worry about that. Humph!
Dear Leslie,
I read your story and still cant get over it. I am so very sorry you went through this. This is my big question: should I or shouldn’t? I can only imagine your pain, your fear, your family worries… I wish you would go through your future treatments without any problems. You paid plenty already. 😉
One young man at our office had RA as well and he was a big believer that this young immune system will protect him from side effects of treatments.
He went on Rituxan, everything was fine with drug itself, but after 5th infusion he developed pneumonia, than eye infection and died finally at age… 25.
I am still devastated. One thing you die from the disease, another from infection due to treatment.
Gentle hugs to you dear
Linda57
Dear Kelly,
You are so young and so beautiful and have so much to live for. You gave yourself to humanity already, you done everything you could to help research.
Forgive me please if I am to pushy, but your life is important too…
One thing if everything goes fine, and also if drugs work well for you, another if you develop side effects or drug stops working.
You a wonderful person, I know who goes to be a part of the research (I been there myself until got very sick), this is already something we all command you for.
Take care of YOURSELF, be well and happy!!!!
Hugs and best wishes,
Linda57
Kelly,
Your experience with Rituxan sounds just like mine except that I felt (subjectively)it did help. I too am sero-neg so we go by physical symptoms to grade my symptoms/disease process. That was May 2011 my 1st 2 doses of Rituxan…we already knew at this time that I had common variable immune deficiency (CVID)..,.I be lieve I have mentioned this in previous posts. So in short my B cells were already low and the aim of Rituxan is to lower B cells. My Rheumy cautioned me that I was at a higher than usual risk for infection but the benefits outweighed the risks. All was fine that summer, felt the best I have in years then in August I wound up with a foot infection. Round after round of antibiotics with no fix. Xray showed bone infection by Sept. so in the hospital I went for IV antibiotics which turned into being long tern antibiotic therapy with a PIC line. By the time Dec. rolled around I had been admitted to the hospital 4 times (2 weeks each) and 3 surgeries resulting in a first ray amputation of my 1st metatarsal and toe, severe sepsis and a pulmonary embolism. I am now getting SCIG to treat my immune deficiency in hopes that I can try the Rituxan again without wiping out my B cells completely. Do I blame you for hesitating to “help humanity” by taking that 2nd dose after the 1st showed no positive results? NO! First of all you have a family with which to care for and you owe it to yourself to be able to experience life. We all take risks with these drugs but we have to avoid the unnecessary ones. We will check my B cell level before I take Rituxan again
Only you can make the decision and whatever you do will be ‘right’ – but to stick my oar in ;), I’m pretty gobsmacked they are encouraging you to stay on it when you are getting infections, no doctor should be using the greater good argument when continuing is causing you harm – what about the Hippocratic Oath? As far as the trial goes, the fact you didn’t complete the full study and the reason why is useful information in itself…
YESTERDAY I WROTE ABOUT MY SITUATION WITH RITUXAN. HOW DO I VIEW WHAT I WROTE AND COMMENTS FROM THAT. PLEASE TELL ME HOW I DO THAT. YOU CAN E MAIL ME AT KSCRUSH@AOL.COM IF YOU WOULD LIKE. I WOULD REALLY APPRECIATE FEEDBACK
THANK YOU
SHERRY
Hey Kelly, It sounds as if those trial docs just want you to continue just to see the results regardless of what is in your best interest. My gut feeling would be that I would absolutely NOT continue with all of those side effects. Maybe if they weren’t life threatening side effects. Scary stuff. Good luck with your decision, I can relate, I am trying to decide whether or not to try my 3rd biologic and I just keep having the doubts, but then my desperation for some relief takes over and I start again the feeling of I would do whatever it takes to feel better. It’s a very difficult decision to make and the unknown is really scary, but I usually rely on my gut feelings. Thanks for the post!! And again, good luck!
Dear Kelly,
I have been following ra warrior for a few months now and have got some wonderful information. It is wonderful to read what other RA patients are feeling. I am glad to not be alone in this battle. I had two infusions of Rituxan. It did not work for me so now I am on Remicade and taking 8 vials. I have infusions every six weeks, it helps but by the 3rd week I am starting to feel awful along with lots of flares. My family says having me feel better for a few weeks is wonderful to see, so it is worth it. I still have to work for the insurance and there is days that it is so hard to go to work. I also teach small children and love it. I will keep you in my prayers and hope that your journey with Rituxan is helpful. God Bless, Wanda
Take care of yourself – there are other ways you can serve humanity (like the way you spread the word about RA, for example). I am on Rituxan as well – just completed the two infusions that will wrap up my first year on therapy. I have been really, really lucky that I have responded so well and have been able to work my way off of Methotrexate. But I’ve also had my fair share of infections – not as much with Rituxan. When I was on Remicade, I developed impetigo inside my nose and on my ear lobes for almost 6 months – it was so awesome when it hurt to just inhale slightly through my nose. And oh yeah, I’ve never had an elevated CRP and have only managed to squeak out a positive RF twice in ten years that I’ve had this disease. Hard to convince a doctor that you’re sick when you can’t see any of it in your lab work. Treat the patient, not the lab value! I am on my third rheumatologist and I love him to death because he listens to me! Please don’t give up your fight – there are patients out there that need to keep hearing your story. Thanks.
Google CH4051 for alternat trials.
They both said that I should take the 2nd round of Rituxan, completing the year of treatment even though the drug does not help me, because clinical trials are important to research. I was even told that I should think about what is best for humanity since I “usually want to help others.”
I admire you for trying helping others; I also was a participant for RA research group. But when I got sick, my RA called and let them know that I wouldn’t be able to be a part of it and she was very strict about it.
I also felt very bad to stop; I also wanted to help others with all my heart. But she told me to think how important my life for my kids and family, this should be my priority.
When I read the above where 2 doctors told you to continue for the sake of others, I wonder if they would say same thing if this would be their wives and daughters….
I would understand if you would do well on this drug, if it would be making you feel better. But when such harsh drug as Rituxan doesnt help and more – gives you side effects which potentially can be dangerous for you – why would you continue? What good a drug can do which didn’t help you in first round except put you in more danger? Just to try on your expense?
I hardly survived during my first Rituxan treatment, 2 hr unto infusion. Only b/c I had so many wonderful doctors and nurses I am here. I realized one thing dear people; as bad as it gets for us, life is still very beautiful thing and very short too.
My best,
Linda
That’s discouraging… I was unable to remain on Orencia, due to infection. Dr. called today and changed the Orencia to Rituxan beginning Aug 5th. I was hoping that I would find positive news since all I read and have experienced is scary. I wish we could chew great tasting bubble gum and it all just go away. Not so for us. It’s one evil to battle another.
Why did they say the antibiotics will hinder the Rituxan? Is that normal with this type of treatment, that you cannot be on antibiotics at all?
Hi Kelly, to be ‘frying plan blunt’ your doctors’ attitude sucks! Your decision needs to be based on YOU – clinical trials are important; it’s also important to know if someone’s having a bad reaction in a trial and has to pull out. You are … and personally I think you should! I don’t see how it helps humanity to pretend everything’s OK when it so clearly isn’t! That just gets something approved that isn’t actually doing what it should be, which helps no one.
Can you tell me – are you a health care professional in Rituximab? I’m looking for info about safety of working in acute care while on Rituximab.
Thanks