Ravulizumab reduced relapse risk and Hauser Ambulation Index score worsening versus placebo in participants with anti-aquaporin-4 antibody-positive NMOSD.
Ravulizumab binds the same complement component 5 epitope as eculizumab. However, because of its longer half-life, it can be dosed more conveniently at every 8 weeks instead of every 2 weeks. The safety and efficacy of ravulizumab were evaluated in the global, open-label phase 3 study CHAMPION-NMOSD, and the results were presented at the AAN 2023 meeting by lead author Sean Pittock, MD.
CHAMPION-NMOSD included 58 adult participants with anti-AQP4 NMOSD who had at least one attack or relapse in the 12 months before the screening visit. They were allowed to stay on stable supportive immunosuppressive therapy for the duration of the trial. All participants were given two meningococcal vaccines at least 2 weeks before starting ravulizumab treatment.
The placebo arm of the PREVENT study served as an external comparator. The primary endpoints were time to first on-trial relapse and relapse risk reduction (RRR). The median follow-up was 73.5 weeks for 58 ravulizumab-treated participants and 36.0 weeks for 47 participants receiving a placebo in the PREVENT study.
In the ravulizumab group, no participants had a relapse compared with 20 participants in the control group (RRR, 98.6%; P<0.0001). Also, significantly fewer participants in the ravulizumab group had clinically important worsening of healthcare-associated infection scores compared with placebo: 2/58 (3.4%) versus 11/47 (23.4%; P=0.023). In the ravulizumab group, 93.1% reported treatment-emergent adverse events (AEs). Serious AEs were seen in 13.8%, including two cases of meningococcal infection (2.4/100 patient years), which recovered with no sequelae. Despite a longer follow-up period in the experimental group, efficacy and safety remained consistent with the primary treatment period. After a median of 91 weeks, no relapses were observed.
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