Details

Autor(en) / Beteiligte

• Khellaf, Mehdi
• Charles-Nelson, Anaïs
• Fain, Olivier
• Terriou, Louis
• Viallard, Jean-François
• Cheze, Stéphane
• Graveleau, Julie
• Slama, Borhane
• Audia, Sylvain
• Ebbo, Mikael
• Le Guenno, Guillaume
• Cliquennois, Manuel
• Salles, Gilles
• Bonmati, Caroline
• Teillet, France
• Galicier, Lionel
• Hot, Arnaud
• Lambotte, Olivier
• Lefrère, François
• Sacko, Salimatou
• Kengue, Dieudonné Kilendo
• Bierling, Philippe
• Roudot-Thoraval, Françoise
• Michel, Marc
• Godeau, Bertrand

Titel

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

Ist Teil von

• Blood, 2014-11, Vol.124 (22), p.3228-3236

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2014

Quelle

EZB-FREE-00999 freely available EZB journals

Beschreibungen/Notizen

• 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/m2 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 × 109/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. •Tolerance of rituximab is acceptable in ITP, and with its benefit/risk ratio may remain a valid option for treating ITP in adults.