Effect of Ravulizumab on MG-ADL Item Scores in Adults With Generalized Myasthenia Gravis: Post Hoc Analysis of Data From the Phase 3 CHAMPION MG Study


Clinical Trials

Poster Number: M264


John Vissing, MD, DMSci, Rigshospitalet, University of Copenhagen, Tahseen Mozaffar, MD, FAAN, University of California, Irvine, Renato Mantegazza, MD, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Shahram Attarian, MD, PhD, Assistance Publique Hôpitaux de Marseille, CHU La Timone, Shunsuke Yoshimura, MD, Nagasaki University Hospital, Kathleen N Beasley, Alexion, AstraZeneca Rare Disease, Serena Liao, Alexion, AstraZeneca Rare Disease, Shirali Pandya, Alexion, AstraZeneca Rare Disease, James Howard, MD, University of North Carolina, Chapel Hill

Background: In the 26-week, randomized placebo-controlled period of the phase 3 CHAMPION MG study (NCT03920293) in adults with anti-acetylcholine receptor antibody-positive (AChR Ab+) generalized myasthenia gravis (gMG), ravulizumab was associated with improvement versus placebo in the Myasthenia Gravis–Activities of Daily Living (MG-ADL) total score.
Objectives: This post hoc analysis evaluated changes in impairment severity for the 8 MG-ADL items.
Methods: Patients scored MG-ADL item impairment as 0-3 (higher scores correspond to more severe impairment) at baseline and week 26. Proportions of patients with improved MG-ADL item scores during the randomized placebo-controlled period were calculated.
Results: In patients with data available at baseline and week 26 (ravulizumab, n=160; placebo, n=175), greater proportions of ravulizumab-treated patients than patients receiving placebo achieved improved scores in 7 of the 8 MG-ADL items (ravulizumab/placebo: breathing, 33.3%/24.4%; chewing, 44.9%/28.0%; talking, 42.3%/37.8%; double vision, 37.2%/22.0%; eyelid droop, 50.0%/28.0%; brushing teeth/combing hair, 43.6%/41.5%; rising from chair, 30.8%/24.4%), and achieved complete resolution (score 0) for all 8 items. The ocular items had the highest proportions of patients with severe impairment (score 3) at baseline. Proportions of patients with a score of 3 in the ravulizumab-treated group were reduced from baseline to week 26 for eyelid droop (23.1% to 14.1%) and were similar at baseline and week 26 for double vision (11.5% and 10.3%). With placebo, increases from baseline to week 26 were observed for both eyelid droop (20.7% to 24.4%) and double vision (6.1% to 12.2%).
Conclusions: In patients with AChR Ab+ gMG, ravulizumab provided greater treatment benefit than placebo in reducing symptom severity in 7/8 MG-ADL items, including ocular items, which had the highest proportions of patients with severe impairment at baseline.