The following article is part of conference coverage from the 2022 American Academy of Neurology (AAN) Annual Meeting. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from the 2022 AAN Annual Meeting.
For adults with anti-acetylcholine receptor antibody-positive (AChR Ab+) generalized myasthenia gravis (gMG), use of ravulizumab may provide sustained improvements for up to 1 year, according to interim analysis findings presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, held from April 2 to April 7 in Seattle, Washington, and virtually from April 24-26, 2022.
Ravulizumab is a long-acting terminal complement inhibitor that allows extending maintenance dosing every 8 weeks. The current study is an ongoing open-label extension (OLE) of a 26-week, double-blind, randomized, placebo-controlled phase (RCP) as part of the CHAMPION MG study (ClinicalTrials.gov Identifier: NCT03920293) to evaluate the long-term safety and efficacy of ravulizumab in adults with AChR Ab+ gMG.
Researchers randomly assigned 79 patients to receive ravulizumab (n=39), a terminal complement C5 inhibitor, or placebo (n=41) at a dose of 3000 to 3600 mg according to body weight every 8 weeks for up to 4 years. Patients were either blindly inducted or were provided a bridging dose depending on whether they received ravulizumab or placebo during the RCP phase of the study. The Myasthenia Gravis-Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis assessments were given to all patients.
Patients treated with ravulizumab in the RCP and the OLE experienced and maintained improvement in the MG-ADL score from baseline to Week 52 (least squares mean change, -4.2; 95% CI, -5.7 to -2.7; P <.0001). Patients who received placebo in the RCP and later received ravulizumab in the OLE experienced and maintained significant improvement in their MG-ADL score from baseline to Week 26 (least squares mean change, -2.4; 95% CI, -3.8 to -0.9; P <.01).
There were no cases of meningococcal infection reported in the interim analysis and ravulizumab was well-tolerated in patients.
Overall, the study investigators concluded that ravulizumab “demonstrated sustained improvements in symptoms and was well tolerated for up to 1 year in adults with AChR Ab+ gMG” when administered every 8 weeks.
Howard JF, Vu T, Mantegazza R, et al. Long-term efficacy and safety of ravulizumab, a long-acting terminal complement inhibitor, in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis: results from the phase 3 CHAMPION MG open-label extension. Presented at: the 2022 AAN Annual Meeting; April 2-7, 2022; Seattle, Washington; April 24-26, 2022; Virtual Meeting. Abstract S25.005.