VERY surprised by this article

The benefit of adding rituximab to standard treatment in non-splenectomized patients with primary immune thrombocytopenia (ITP) is uncertain. We performed a pilot randomized trial to determine the feasibility of recruitment, protocol adherence and blinding of a larger trial of rituximab versus placebo; and to evaluate the potential efficacy of adjuvant rituximab in ITP. Non-splenectomized adults with newly-diagnosed or relapsed ITP who were receiving standard ITP therapy for a platelet count below 30 x109/L were randomly allocated to receive four weekly infusions of 375 mg/m2 rituximab or saline placebo. Sixty patients were recruited over 46 months, which was slower than anticipated. Protocol adherence and follow-up targets were achieved and blinding was successful for research staff but not for patients. After 6 months, there was no difference between rituximab and placebo groups for the composite outcome of any platelet count below 50 x109/L, significant bleeding or rescue treatment once standard treatment was stopped [21/32 (65.6%) vs. 21/26 (80.8%); relative risk=0.81, 95% confidence intervals 0.59, 1.11]. Timely accrual poses a challenge to the conduct of a large randomized trial of rituximab for pre-splenectomy ITP. No difference in the frequency of the composite outcome was observed in this pilot trial (registered at www.clinicaltrials.gov NCT00372892).

bloodjournal.hematologylibrary.org/content/early/2012/01/05/blood-2011-08-374777.abstract?ct

I can't believe the trial ended up with this result. Rituxan made a huge difference in my counts and I know of many others. I would go so far as to say it saved my spleen.

They evaluated the wrong people. :whistle:

Sure made a difference with my ITP and still have a Spleen!!! One Dr. suggested a Spleenectomy the first time he seen me. This was inbetween the two Rituxan treatments. Glad I chose not to!

I tried to get into this study, but I was rejected because I tested positive for Hepatitis B antibodies. However, my GP has never been able to replicate that finding and I think the antibodies came from an IVIG treatment that I had. So clearly they were quite picky about who they took. I also think that I rememver that there was someone else from Canada who did get into the trial and the it worked for her. If she got the rituxan.

It is a surprising article. It would be nice to be able to read the whole article as it's not really clear to me what they're measuring.

Elizabeth