Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia
| Autor: | Renato Fanin, Rita Rizzi, Michele Baccarani, Patrizio Mazza, Emanuele Angelucci, Selenia Campagna, Silvia Cantoni, Enrica Gamba, Valerio De Stefano, Felicetto Ferrara, Giuseppe Visani, Marzia Defina, Franca Soldano, Sergio Amadori, Emilio Usala, Alfonso Zaccaria, Francesco Casulli, Alessia Tieghi, Antonella Fornaro, Miriam Isola, Luigi Gugliotta, Monica Bocchia, Marta Lisa Battista, Francesco Zaja, Nicola Vianelli |
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| Přispěvatelé: | Zaja F, Baccarani M, Mazza P, Bocchia M, Gugliotta L, Zaccaria A, Vianelli N, Defina M, Tieghi A, Amadori S, Campagna S, FerraraF, Angelucci E, Usala E, Cantoni S, Visani G, Fornaro A, Rizzi R, Zaja, Francesco, Baccarani, M, Mazza, P, Bocchia, M, Gugliotta, L, Zaccaria, A, Vianelli, N, Defina, M, Tieghi, A, Amadori, S, Campagna, S, Ferrara, F, Angelucci, E, Usala, E, Cantoni, S, Visani, G, Fornaro, A, Rizzi, R, DE STEFANO, V, Casulli, F, Battista, Ml, Isola, Miriam, Soldano, F, Gamba, E, Fanin, Renato |
| Jazyk: | angličtina |
| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Combination therapy medicine.drug_class medicine.medical_treatment Immunology Splenectomy Salvage therapy Biochemistry Gastroenterology Dexamethasone Antibodies Monoclonal Murine-Derived Refractory dexamethasone purpura thrombocytopenic idiopathic rituximab salvage therapy platelet count measurement arm Internal medicine hemic and lymphatic diseases Antineoplastic Combined Chemotherapy Protocols medicine Humans Adverse effect Aged Salvage Therapy Purpura Thrombocytopenic Idiopathic Platelet Count business.industry Antibodies Monoclonal Cell Biology Hematology Middle Aged Surgery Corticosteroid Female Rituximab business Settore MED/15 - Malattie del Sangue medicine.drug |
| Popis: | 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 × 109/L or less. One hundred three patients were randomly assigned to receive 40 mg/d dexamethasone for 4 days with or without 375 mg/m2 rituximab weekly for 4 weeks. Patients who were refractory to dexamethasone alone received salvage therapy with dexamethasone plus rituximab. Sustained response (ie, platelet count ≥ 50 × 109/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. |
| Databáze: | OpenAIRE |
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