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.