Monday, March 3, 2014

Another Rituximab Study Perspective

I wrote an earlier post about a recently released French study on rituximab, and in it I expressed my questions and concerns about the conclusions that the research team reached regarding the use of this drug in the treatment of Sjogren's syndrome.  Here's a bit of what I had to say:

......Immediately after the study release, several stories interpreting the results appeared, and the tone of these discussions were quite pessimistic, like this one: Rituxan Offers Little Help for Sjogren's, found on Medpage today. And this from Medscape Nurses: Rituximab Disappoints in Sjögren Syndrome
Having only read the headlines, my initial reaction was one of disbelief. You may remember that two years ago, I began rituximab infusion cycles separated by six months, and until I had an unusual response (neutropenia) I was very happy with the results.... continue reading here.  
In a nutshell, I didn't agree with the manner in which the study was conducted -- the study participants only received one cycle of rituximab and the study was only of six months duration -- and my opinion regarding the importance of fatigue reduction as a result of this drug's use was different than the investigators'.

I mulled things over for a few days after writing that post. I wondered if I had mis-interpreted any part of the study or it's conclusions, so fired off an email to Dr. Young Guy asking his opinion. Here's what he had to say:
Julia, 
I was able to review this study (thanks for bringing it to my attention).
I would like to add a few points to your blog discussion: 
Among all the symptoms related to Sjogren's syndrome, fatigue is the most difficult to study. There are hundreds of possible causes of fatigue. It may be caused directly by the disease through inflammatory pathways. It also can be caused by depression, lack of sleep secondary of pain or severe dryness, deconditioning or lack of exercise and so on. 
Rituximab would only be expected to directly affect a fraction of the patients suffering from fatigue. Therefore, the numbers would be diluted (decrease the power of the study) for this particular variable. I am surprised the study found the effect on fatigue that it did. 
This study required a fairly large change (improvement in symptoms) to meet the endpoints. This makes the study unable to detect more subtle improvements that may be clinically significant. 
The average patient enrolled had a relatively low total disease activity score. If the group  of patients studied had been sicker, the effects of Rituximab may have been more pronounced.
The authors of the study conclude that Rituximab carries too much expense and risk to justify treatment for temporary relief of fatigue. This is a matter of opinion.
"A matter of opinion". Well said. I'm so glad that my physician's opinion is such that he feels comfortable in prescribing rituximab for me in my fight against Sjogren's syndrome.

6 comments:

Heda said...

I can swallow the mouse medicine but not sure about the prednisone. Please think carefully before going down that path. Steroids are scary. I'm an odd ball I've chosen to go the path of long term low dose antibiotics. I know not everyone believes in their efficacy but for me they work. Not a cure but they keep the worst of the disease at bay. BTW plaquinel is a low dose antibiotic. I also know that so folk have stopped taking low dose antibiotics because of their reaction to them. How sad because they were the ones who were most responsive to this therapy. I don't care what anyone else does because this works for me and has kept me in the workforce for far longer than I expected. I'm officially retiring at the end of this year.

mcspires said...

I sure wish I had Dr. Young Guy for my Doc! Best wishes for your next mouse infusion!!

annie said...

Follow the protocol that best works for you, Julia. I wish you the very best for tomorrow, hope everything goes well. I hope you saved some pralines for yourself!

Shara Bingham Mills said...

As I recall, you wanted to be out there in the front of the pack, taking this drug on - not just for the energy rush - you wanted to make yourself a guinea pig for the advancement of Sjogrens research. Eventually we won't have to risk our remaining health over an experiment, we will know how to treat it. Somebody has to take some risks. I'm glad it makes you feel like a winner. You deserve to get something out of this.

Nicole said...

Good luck, Julia!

Kelly said...

He's a keeper, that Dr. Young Guy. Sending infusion support vibes. Here's a fun mousie theme song for your upcoming adventure: http://www.youtube.com/watch?v=_mktyzXU_ug

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