This prospective study investigated the efficacy, safety, and response duration of low-dose rituximab (100 mg fixed dose for 4 weekly infusions) together with a short course of steroids as first- or second-line therapy in 23 patients with primary autoimmune hemolytic anemia (AIHA). The overall response was 82.6% at month +2, and subsequently stabilized to ∼ 90% at months +6 and +12; the response was better in warm autoimmune hemolytic anemia (WAIHA; overall response, 100% at all time points) than in cold hemagglutinin disease (CHD; average, 60%); the relapse-free survival was 100% for WAIHA at +6 and +12 months versus 89% and 59% in CHD, respectively, and the estimated relapse-free survival at 2 years was 81% and 40% for the warm and cold forms, respectively.
The risk of relapse was higher in CHD and in patients with a longer interval between diagnosis and enrollment.
Steroid administration was reduced both as cumulative dose (∼ 50%) and duration compared with the patient's past history.
Treatment was well tolerated and no adverse events or infections were recorded; retreatment was also effective.
The clinical response was correlated with amelioration biologic markers such as cytokine production (IFN-γ, IL-12, TNF-α, and IL-17), suggesting that low-dose rituximab exerts an immunomodulating activity.
This study is registered at www.clinicaltrials.gov as NCT01345708.
2012-04-20
Eng.
Blood
Unità Operativa Ematologia, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. wbarcel [at] policlinico.mi.it
Blood. 2012 Apr;119(16):3691-7
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