Divozilimab reduces the risk of exacerbations in patients with neuromyelitis optica spectrum disorders

Objective : the aim of the AQUARELLE trial was to evaluate the efficacy of divozilimab compared with a historical control (placebo) and to characterise its safety in patients with neuromyelitis optica spectrum disorder (NMOSD). Material and methods . The AQUARELLE clinical trial population included patients aged 18 years and older with a diagnosis of NMOSD established in accordance with the international consensus diagnostic criteria for NMOSD (2015). The primary efficacy endpoint was the mean annual rate of confirmed exacerbations (MAR) over 6 months of treatment with divozilimab compared with a historical control, which was the placebo from the N-MOmentum study. Results. A total of 105 patients received treatment with the investigational drug divozilimab. At the time of analysis, the proportion of patients without confirmed exacerbations was 94.3% (99/105); the ARR was 0.124 (95% CI 0.056–0.276). The ARR ratio for divozilimab /historical placebo was 0.172 (90% CI 0,083–0,359), indicating the superiority of divozilimab compared to historical placebo over 6 months of therapy. During divozilimab therapy, a therapy-related decrease in lymphocyte count was reported in 16 (15.2%) patients, and infusion reactions were reported in 6 (5.7%) patients. The overall incidence of therapy-related infectious events was 6 cases (5.7%). Conclusion. Within patients with NMOSD, the use of divozilimab reduces the risk of exacerbations. The good tolerability of the drug allows divozilimab to be recommended as a new therapeutic option for patients with NMOSD.