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A multicenter randomized study comparing cyclosporin-A alone and antithymocyte globulin with prednisone for treatment of severe aplastic anemia

par Gluckman, Éliane E.;Esperou-Bourdeau, Hélène;Baruchel, André;Boogaerts, Michel;Briere, Jean;Leverger, Guy;Donadio, Daniel;Leporrier, Michel;Reiffers, Josy;Janvier, Maud;Michallet, Mauricette;Stryckmans, Pierre
Référence Journal of autoimmunity, 5, SUPPL. A, page (271-275)
Publication Publié, 1992

Article révisé par les pairs

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Résumé :

This article reports the results of a randomized multicentric study comparing the efficacy of antithymocyte globulin (ATG) with cyclosporin-A (CsA) as first line therapy for severe aplastic anemia (SAA). Patients were randomized to receive ATG and prednisone (PDN) or CsA; hematological response and toxicity were compared. At 3 months, patients who had no or minimal response received the alternative therapy in order to assess the value of a sequential immunosuppressive therapy for treatment of severe aplastic anemia. One hundred and sixteen patients were analysed, 60 received CsA and 56 received ATG PDN. The actuarial survival was 55% with a median follow-up time of 19 months. There was no significant difference in survival between the two groups. The main prognostic factor was the absolute neutrophil count (ANC) at entry: patients with ANC <0.2 × 109/L had a significantly lower survival when compared with patients with an ANC greater than 0.2 × 109/L (P = 0.0001). At 3 months, 16% of patients had a complete or partial response and a cross-over treatment was given to 68 patients. At 12 months, 77 patients were alive, with a complete or partial response in 47 patients. Patients who had responded to the first treatment. © 1992.