Thanks to a member of one of my newsgroups for a link to this recent study: Rituximab therapy for primary Sjögren's syndrome: An open-label clinical trial and mechanistic analysis
"In primary Sjögren's syndrome, a single treatment course of rituximab was not associated with any unexpected toxicities and led to only modest clinical benefits despite effective depletion of blood B cells."and a discussion of the the same study on Medscape: Reuters Health Information: Rituximab Only Modestly Beneficial in Primary Sjögren's Syndrome Feb 01, 2013
"Improvements in tongue dryness, thirst, oral discomfort, and overall fatigue were statistically significant, albeit modest, but there were no significant improvements in joint pain, stimulated and unstimulated whole salivary flow, tear production, or ocular surface dryness."Only modest clinical benefits....hm......
Let's review my mousie energy chart, shall we? And, um, disregard the highlighted mousie ears, tails, and enlarged eye because I want to minimize the goofy elements in this post.
If we examine the graph, specifically the Y axis, near the top of the graph is a mark which indicates estimated energy levels before the onset of Sjogren's syndrome. Note also the distance from this point, to the intersection of the X axis.
THEN note the height of the curve of energy response, which occurs somewhere between one and a half and four months post infusion. I approximated that at the peak of my response to rituximab, that I had regained about half the energy reserves that I had pre-autoimmune disease.
Half.
To some, that amount may seem "moderate", but to me regaining half of my previous energy levels is vitally important. That half made it possible for me to attend my kids' weddings with enough energy to truly be present and cherish the day. It means that Christmas cards were sent, presents purchased and wrapped, and that I was able to spend quality time with my family and friends over the holidays. It meant months without daily naps. And months without experiencing that awful physical sensation of reaching the absolute bottom of my energy reserves which results in cold sweats, shaking, feeling profoundly sad and frustrated, and hours in bed replenishing those reserves.
That "moderate" response gave me back a good chunk of my life. Not all of it -- but a big piece. I consider the importance of that chunk of energy far more valuable than "modest" or "moderate" worth. I guess it's just a matter of looking at a glass and deciding if it's half full, or half empty, don't you think? For me, the rituximab glass is definitely half FULL.
I wonder if this sentence is a reflection of the outdated assumption that Sjogren's syndrome's biggest physical problem is dry eyes and dry mouth?
"...improvements in tongue dryness, thirst, oral discomfort, and overall fatigue were statistically significant, albeit modest, but there were no significant improvements in joint pain, stimulated and unstimulated whole salivary flow, tear production, or ocular surface dryness."Of course, this is an important observation. Yes, dry eyes and dry mouth are an integral part of this disease. But for me, these things are a major annoyance, not a life changer. The symptom that robbed me of my job, my hobbies, several of my friends, and changed my life forever is FATIGUE.
What good is a moist mouth or not having to use eyedrops if I'm still unable to do anything except eat and sleep and bathe? Don't these researchers get it? While I'm glad that the authors of the study recommend continued research, their conclusion leads me to believe that the research world isn't seeing the forest for the trees:
"Despite the limited benefits in this small study, the authors argue against abandoning research on rituximab for these patients. "Larger randomized, placebo-controlled clinical trials...are needed to further evaluate the clinical efficacy and safety of rituximab therapy for primary Sjögren's syndrome," they conclude."If this were a political campaign, I'd recommend that the bumper stickers for candidate rituximab would read: IT'S THE FATIGUE, STUPID!"
10 comments:
I know you know this, but it is of course possible that you are an outlier with an atypical response. (And if you in fact are, YAY for that atypical response in this case....)
However, the fact that they never MENTIONED whether any fatigue gains were made is telling and suggests they ignored it, perhaps because it is even harder to quantify or test than the other symptoms are. It's also possible they observed none and just didn't say so, but...I somehow doubt it. :|
Hi Laura - the thing is, they DID find "......improvements in.....overall fatigue were stastically significant" , and in my opinion, gave this less significance than the dry mouth/dry eye symptoms.
Your post rings quite true for me as well. My first Rituxan dose is on the wane and while I was not a normal person at peak performance, on Rituxan, for once, I could actually do some normal things. Normal things like go to the grocery store and have enough energy to cook a meal that very same day. Like attending a party in the evening without collapsing in pain afterwards. And most importantly, being at my mother's side when she was in ICU for almost 2 weeks. If her crisis had occurred 3 months earlier, I wouldn't have been able to be there for her. So moderate improvements can make a huge difference for people who are quite debilitated by pain and fatigue. Rituxan has been the only drug to make such a difference for me in the last 5 years of trying just about every treatment modality. Obviously, I am a big fan! Bring on more trials.
I remember reading somewhere (and it may well have been on your blog Julia) that fatigue is at the top of the list for patients in terms of the symptom they most want relief from - but is generally not considered as an important parameter in the study of ANY new drug treatment for autoimmune disease. How do we bridge this gap between what researchers believe is important and what we know really is important?
I have only been diagnosed for a year, but already I am so sick of people, even my doctor, that think Sjs is nothing more than dry eyes and mouth :( While my fatigue is not as severe as other commenters, that and joint pain are my biggest problems! Wish I knew of a good rheumy that truly understood in the Cheyenne, WY/Denver, CO area!
Does insurance pay for this? I thought it was hideously expensive.
Anonymous: my insurance covers rituximab. Thank goodness because without insurance, I couldn't afford it.
I just wish I could find a doctor who would offer it to me...my dryness is a life change unfortunately...it has totally messed up my digestive system - so I would give anything to slow it down...Still looking for a doctor who will partner with me here...contemplating even purchasing plane tickets if I could connect with the right doctor - any suggestions?
Anyhoo - good update! Thanks Julia!
You're right - the lack of comprehension that it's the symptoms like fatigue that are most disabling is very frustrating. I am doing daily naps now, each several hours long. I would love to be doing what most 46 year olds are doing now - turning in a full productive day.
I hope some day I get a good doctor and the insurance/income to afford the rituxumab. Your response sounds so promising. Thanks for sharing it with us!
Jane
I think the reason that researchers don't focus on the fatigue is because it is so subjective. They have no way to measure it. It's hard to judge the efficacy of a drug based on a patient's own fatigue evaluation.
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