Results from the CHAMPION-NMOSD clinical trial suggest that ravulizumab-cwvz (Ultomiris®) could decrease relapses in patients with neuromyelitis optica spectrum disorder (NMOSD), according to a recent press release.
Ravulizumab is a long-acting drug that inhibits C5 in the terminal complement cascade involved in the physiopathology of NMOSD. The intravenous drug is initially administered as a loading dose and is later injected every 8 weeks. It has previously received approval for the treatment of other complement-mediated pathologies, such as myasthenia gravis and paroxysmal nocturnal hemoglobinuria.
The phase 3, open-label, multicenter trial included 58 patients in multiple centers in America, Europe, and Asia. The trial had a median duration of 73 weeks.
All patients had a history of at least 1 relapse 12 months prior to the beginning of the study. Concomitant use of other immunosuppressive therapies were not among the exclusion criteria.
Read more about NMOSD therapies
The primary endpoint of the study was relapsing during the trial. Until week 50, which comprised the primary treatment period of the trial, no patients had reported any relapse. All patients that completed the 50-week treatment could opt to participate in a long-term extension period.
Furthermore, results showed ravulizumab to be superior to placebo in patients receiving other forms of immunosuppressive therapy, such as rituximab.
The most significant adverse effect associated with ravuluzimab was the increased risk of meningococcal meningitis. All unvaccinated patients were recommended to receive 2 doses of meningococcal vaccines before the beginning of treatment. Among patients included in the second trial, 2 suffered from meningococcal infections during the trial.
“The CHAMPION-NMOSD trial showed zero relapses with a median treatment duration of 73 weeks, providing evidence that ravulizumab-cwvz may offer patients sustained reduction in the risk of relapse with dosing every eight weeks and underscoring the efficacy of C5 inhibition in managing NMOSD,” said Sean J. Pittock, MD, director of Mayo Clinic’s Center for Multiple Sclerosis and Autoimmune Neurology and of Mayo’s Neuroimmunology Laboratory and lead primary investigator in the CHAMPION-NMOSD trial.
ULTOMIRIS® (ravulizumab-cwvz) showed zero relapses in adults with neuromyelitis optica spectrum disorder (NMOSD) with median treatment duration of 73 weeks. News release. Alexion; October 12, 2022.