Yazarlar : Arnold DM, Heddle NM, Carruthers J, Cook DJ, Crowther MA, Meyer RM, Liu Y, Cook RJ, McLeod A, Maceachern JA, Mangel J, Anderson D, Vickars L, Tinmouth A, Schuh AC, Kelton JG.

Yayın : Blood.

Yayın Yılı : 2012

Pubmed Linki : http://www.ncbi.nlm.nih.gov/pubmed/22223819

Konu : Diğer

Literatür İçeriği :  

Abstract

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 x10(9)/L were randomly allocated to receive four weekly infusions of 375 mg/m(2) 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 x10(9)/L, significant bleeding or rescue treatment once standardtreatment 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)

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