Prevzaté: Efficacy and Safety of Rituximab for Adults with Idiopathic Thrombocytopenic Pur|
Posted on 30.10.2009 17:31
Efficacy and Safety of Rituximab for Adults with Idiopathic Thrombocytopenic Purpura
Donald M. Arnold, MD, MSc; Francesco Dentali, MD; Mark A. Crowther, MD, MSc; Ralph M. Meyer, MD; Richard J. Cook, PhD; Christopher Sigouin, MSc; Graeme A. Fraser, MD; Wendy Lim, MD, MSc; and John G. Kelton, MD
Corresponding Author: Donald M. Arnold, MD, McMaster University Health Sciences Center, Room 3N-43, 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada; e-mail, firstname.lastname@example.org.
Ann Intern Med. 2007;146:25-33. www.annals.org
Background: Rituximab, a monoclonal anti-CD20 antibody, is increasingly used to treat idiopathic thrombocytopenic purpura (ITP).
Purpose: To systematically review the literature on the efficacy and safety of rituximab for the treatment of adults with ITP.
Study Selection: Descriptive and comparative studies in any language that met predefined inclusion criteria were eligible. Efficacy analysis was restricted to studies enrolling 5 or more patients.
Data Extraction: Platelet count response, toxicities, dose, previous treatments, baseline platelet count, duration of ITP, study design, and sources of funding were extracted in duplicate.
Data Synthesis: We identified 19 eligible reports on efficacy (313 patients) and 29 on safety (306 patients). Weighted means for complete response (platelet count >150x10/9 cells/L) and overall
response (platelet count >50x10/9 cells/L) with rituximab were 43.6% (95% CI, 29.5% to 57.7%) and 62.5% (CI, 52.6% to 72.5%), respectively. Responses lasted from 2 to 48 months. Nearly all patients had received corticosteroids, and 53.8% had undergone splenectomy. Nine patients (2.9%) died.
Limitations: There were no controlled studies, and no studies met all criteria for study quality. Reported deaths could not necessarily be attributed to rituximab. Overall, the number of rituximab-treated
patients with ITP reported in the literature is small.
Conclusions: Rituximab resulted in an overall platelet count response in 62.5% of adults with ITP. However, this finding derives from uncontrolled studies that also reported significant toxicities, including death in 2.9% of cases. These data suggest that providers should avoid indiscriminate use of rituximab and that randomized, controlled trials of rituximab for ITP are urgently needed.
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