6/29/23, 12:43 AM RAIHA Pathway Feedback Search Clinical Topics Home Studies RAIHA RAIHA Disease Autoimmune hemolytic anemia Trial question What is the role of rituximab in patients with warm autoimmune-hemolytic anemia? Study design Multi-center Double blinded RCT Population Characteristics of study participants 53.0% female N = 32 47.0% male 32 patients (17 female, 15 male) Inclusion criteria: adult patients with warm autoimmune hemolytic anemia who received corticosteroids for < 6 weeks Key exclusion criteria: prior treatment with rituximab; warm autoimmune hemolytic anemia treated for > 6 weeks with corticosteroids; ongoing or recent treatment with immunosuppressants other than corticosteroids; any other associated cause of hereditary or acquired hemolytic anemia Interventions N=16 rituximab (1,000 mg at day 1 and day 15) N=16 placebo (1,000 mg of matching placebo at day 1 and day 15) Primary outcome https://web.pathway.md/studies/recYsRANNKDQLG1Kn 1/2 6/29/23, 12:43 AM RAIHA Pathway Complete or partial response at 1 year 75.0 % 75 56.3 % 37.5 % 31 Significant increase 18.8 % NNT = 2 0.0 % Rituximab Placebo Significant increase in complete or partial response at 1 year (75% vs. 31%; AD 44%, 95% CI 3.72 to 84.28) Secondary outcomes Significant increase in complete response at 2 years (63% vs. 19%; AD 44%, 95% CI 4.44 to 83.56) No significant difference in duration of hospital stay (13 days vs. 28 days; AD -15 days, 95% CI -31.59 to 1.59) Significant decrease in death at 2 years (ARD -38, 95% CI -69.24 to -6.76) Safety outcomes No significant difference in severe infections. Conclusion In adult patients with warm autoimmune hemolytic anemia who received corticosteroids for < 6 weeks, rituximab was superior to placebo with respect to complete or partial response at 1 year. Reference Marc Michel, Louis Terriou, Francoise Roudot-Thoraval et al. A randomized and double-blind controlled trial evaluating the safety and efficacy of rituximab for warm auto-immune hemolytic anemia in adults (the RAIHA study). Am J Hematol. 2017 Jan;92(1):23-27. Open reference URL https://web.pathway.md/studies/recYsRANNKDQLG1Kn 2/2