Ravulizumab Sustains Improvement in Patients With Generalized Myasthenia Gravis

Chen Fang, PharmD, RPh
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Book about Myasthenia gravis and medication, injection, syringe and pills
Researchers reported results from an interim analysis of an ongoing open-label extension to study the safety and efficacy of adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis.

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.

Reference

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.