Low-dose rituximab in adult patients with idiopathic autoimmune hemolytic anemia: Clinical efficacy and biologic studies

Wilma Barcellini, Francesco Zaja, Anna Zaninoni, Francesca Guia Imperiali, Marta Lisa Battista, Eros Di Bona, Bruno Fattizzo, Dario Consonni, Agostino Cortelezzi, Renato Fanin, Alberto Zanella

Research output: Contribution to journalArticlepeer-review


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 immu-nomodulating activity. This study is registered at www.clinicaltrials.gov as NCT01345708.

Original languageEnglish
Pages (from-to)3691-3697
Number of pages7
Issue number16
Publication statusPublished - Apr 19 2012

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology


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