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Safety and efficacy of rituximab in adult immune thrombocytopenia: results from a prospective registry including 248 patients.

Abstract
We conducted a prospective multicenter registry of 248 adult patients with immune thrombocytopenia (ITP) treated with rituximab to assess safety. We also assessed response and predictive factors of sustained response. In total, 173 patients received 4 infusions of 375 mg/m(2) and 72 received 2 fixed 1-g infusions 2 weeks apart. The choice of the rituximab regimen was based on the physician's preference and not patient characteristics. Overall, 38 patients showed minor intolerance to rituximab infusions; infusions had to be stopped for only 3 patients. Seven showed infection (n = 11 cases), with an incidence of 2.3 infections/100 patient-years. Three patients died of infection 12 to 14 months after rituximab infusions, but the role of rituximab was questionable. In total, 152 patients (61%) showed an overall initial response (platelet count ≥30 × 10(9)/L and ≥2 baseline value). At a median follow-up of 24 months, 96 patients (39%) showed a lasting response. On multivariate analysis, the probability of sustained response at 1 year was significantly associated with ITP duration <1 year (P = .02) and previous transient complete response to corticosteroids (P = .05). The pattern of response was similar with the 2 rituximab regimens. With its benefit/risk ratio, rituximab used off-label may remain a valid option for treating persistent or chronic ITP in adults. This trial was registered at www.clinicaltrials.gov as #NC1101295.
AuthorsMehdi Khellaf, Anaïs Charles-Nelson, Olivier Fain, Louis Terriou, Jean-François Viallard, Stéphane Cheze, Julie Graveleau, Borhane Slama, Sylvain Audia, Mikael Ebbo, Guillaume Le Guenno, Manuel Cliquennois, Gilles Salles, Caroline Bonmati, France Teillet, Lionel Galicier, Arnaud Hot, Olivier Lambotte, François Lefrère, Salimatou Sacko, Dieudonné Kilendo Kengue, Philippe Bierling, Françoise Roudot-Thoraval, Marc Michel, Bertrand Godeau
JournalBlood (Blood) Vol. 124 Issue 22 Pg. 3228-36 (Nov 20 2014) ISSN: 1528-0020 [Electronic] United States
PMID25293768 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Copyright© 2014 by The American Society of Hematology.
Chemical References
  • Antibodies, Monoclonal, Murine-Derived
  • Rituximab
Topics
  • Adult
  • Aged
  • Antibodies, Monoclonal, Murine-Derived (adverse effects, therapeutic use)
  • Cause of Death
  • Disease-Free Survival
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Purpura, Thrombocytopenic, Idiopathic (drug therapy, epidemiology)
  • Recurrence
  • Registries
  • Rituximab
  • Treatment Outcome

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