P.040 Long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis

Abstract

Background: The 26-week double-blind, randomized, placebo-controlled period (RCP) of the CHAMPION MG study (NCT03920293) demonstrated ravulizumab’s efficacy and tolerability in anti-acetylcholine receptor antibody-positive (AChR Ab+) generalized myasthenia gravis (gMG). Methods: In the ongoing open-label extension (OLE), patients receive intravenous ravulizumab (blind loading dose in placebo-treated patients or bridging dose in ravulizumab-treated patients, then 3000–3600 mg according to body weight every 8 weeks) for ≤4 years. Data from RCP baseline up to Week 60 were analyzed. Results: Ravulizumab’s long-term efficacy (n=161) and safety (n=169) were assessed. Patients who switched from placebo in the RCP to ravulizumab in the OLE (n=83) showed rapid improvement (least squares mean, 95%CI) in Myasthenia Gravis-Activity of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) total scores, which were maintained through 34 weeks (MG-ADL: −1.7, −2.7 to −0.8; QMG: −3.1, −4.2 to −1.9). Improvements achieved by ravulizumab-treated patients (n=78) in the RCP were sustained through 60 weeks (MG-ADL: −4.0, −4.8 to −3.1; QMG: −4.1, −5.4 to −2.9). Ravulizumab was well tolerated; no meningococcal infections were reported. Four deaths unrelated to study treatment occurred. Conclusions: Ravulizumab demonstrated sustained improvements in MG symptoms and was well tolerated for up to 60 weeks in adults with AChR Ab+ gMG.