Extended follow-up results through 60 weeks have shown positive outcomes from the phase 3 CHAMPION-MG trial open-label extension trial of ravulizumab-cwvz, according to a press release by AstraZeneca.
The study results demonstrated improved activities of daily life, strength, and quality of life in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis (MG).
“[Generalized MG] is a complex, devastating disease, disrupting many aspects of daily living, and helping patients improve muscle strength and function should be essential to any treatment plan,” said James F. Howard, Jr, MD, lead primary investigator, from the Department of Neurology at the University of North Carolina School of Medicine in Chapel Hill.
“These results reinforce that C5 inhibition with predictable dosing is an important treatment option which provides sustained improvement of functional activities.”
Read more about MG experimental therapies
A total of 161 patients entered the extended follow-up phase after completing the randomized control period of the CHAMPION-MG trial and all were administered ravulizumab-cwvz. At 60 weeks, 113 patients had completed the study and were included in the analysis.
The research team observed significant improvements in quality of life, functional activity, and muscle strength from baseline (the start of ravulizumab-cwvz therapy). Furthermore, the 83 patients who transitioned from placebo responded rapidly and to a similar degree as those who were administered ravulizumab-cwvz during the randomized control period.
The use of ravulizumab-cwvz was found to be generally safe and tolerable for patients, and the most common adverse events were diarrhea (13.6%) and headache (16.6%).
The trial results were presented at the 2022 American Academy of Neurology Annual Meeting on April 5, 2022. Ravulizumab-cwvz is currently under regulatory review for the treatment of generalized MG in the United States, the European Union, and Japan.
ULTOMIRIS® (ravulizumab-cwvz) demonstrated sustained improvements in functional activities and quality of life in adults with generalized myasthenia gravis through 60 weeks. News release. AstraZeneca; April 6, 2022.