RAIHA
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
47.0% male
N = 32
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
Complete or partial response at 1 year
75%
31%
75.0 %
56.3 %
37.5 %
18.8 %
0.0 %
Rituximab
Placebo
Significant
increase ▲
NNT = 2
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 (0% vs. 38%; 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.
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