Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia.

Abstract

Previous observational studies suggest that rituximab may be useful in the treatment of primary immune thrombocytopenia (ITP). This randomized trial investigated rituximab efficacy in previously untreated adult ITP patients with a platelet count of 20 x 10(9)/L or less. One hundred three patients were randomly assigned to receive 40 mg/d dexamethasone for 4 days with or without 375 mg/m(2) rituximab weekly for 4 weeks. Patients who were refractory to dexamethasone alone received salvage therapy with dexamethasone plus rituximab. Sustained response (ie, platelet count > or = 50 x 10(9)/L at month 6 after treatment initiation), evaluable in 101 patients, was greater in patients treated with dexamethasone plus rituximab (n = 49) than in those treated with dexamethasone alone (n = 52; 63% vs 36%, P = .004, 95% confidence interval [95% CI], 0.079-0.455). Patients in the experimental arm showed increased incidences of grade 3 to 4 adverse events (10% vs 2%, P = .082, 95% CI, -0.010 to 0.175), but incidences of serious adverse events were similar in both arms (6% vs 2%, P = .284, 95% CI, -0.035 to 0.119). Dexamethasone plus rituximab was an effective salvage therapy in 56% of patients refractory to dexamethasone. The combination of dexamethasone and rituximab improved platelet counts compared with dexamethasone alone. Thus, combination therapy may represent an effective treatment option before splenectomy. This study is registered at http://clinicaltrials.gov as NCT00770562.

• Authors: Francesco Zaja, Michele Baccarani, Patrizio Mazza, Monica Bocchia, Luigi Gugliotta, Alfonso Zaccaria, Nicola Vianelli, Marzia Defina, Alessia Tieghi, Sergio Amadori, Selenia Campagna, Felicetto Ferrara, Emanuele Angelucci, Emilio Usala, Silvia Cantoni, Giuseppe Visani, Antonella Fornaro, Rita Rizzi, Valerio De Stefano, Francesco Casulli, Marta Lisa Battista, Miriam Isola, Franca Soldano, Enrica Gamba, Renato Fanin
• Journal: Blood (Blood) Vol. 115 Issue 14 Pg. 2755-62 (Apr 08 2010) ISSN: 1528-0020 [Electronic] United States
• PMID: 20130241 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Murine-Derived
• Rituximab
• Dexamethasone

Topics

• Adult
• Aged
• Antibodies, Monoclonal (administration & dosage, adverse effects)
• Antibodies, Monoclonal, Murine-Derived
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Dexamethasone (administration & dosage, adverse effects)
• Female
• Humans
• Male
• Middle Aged
• Platelet Count
• Purpura, Thrombocytopenic, Idiopathic (blood, drug therapy)
• Rituximab
• Salvage Therapy (methods)
• Time Factors