Ravulizumab in adults with generalized myasthenia gravis: A post-hoc analysis of the phase 3 CHAMPION MG study by muscle domain

Topic:

Clinical Trials

Poster Number: 137

Author(s):

Tahseen Mozaffar, MD, University of California Irvine, Renato Mantegazza, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta, Shahram Attarian, MD, Referral Centre for Neuromuscular Diseases and ALS, Hôpital La Timone, Marseille, France, John Vissing, MD, DMSci, Copenhagen Neuromuscular Center, Rigshospitalet, University of Copenhagen, Shunsuke Yoshimura, Nagasaki University Hospital, Nagasaki, Japan, Kathleen N Beasley, Alexion, AstraZeneca Rare Disease, Boston, MA, USA, Serena Liao, Alexion, AstraZeneca Rare Disease, Boston, MA, USA, Shirali Pandya, Alexion, AstraZeneca Rare Disease, Boston, MA, USA, James Howard, MD, FAAN, The University of North Carolina at Chapel Hill

“Introduction: _x000D_
Ravulizumab, a long-acting terminal complement C5 inhibitor, is efficacious in adults with anti-acetylcholine receptor antibody-positive (AChR Ab+) generalized myasthenia gravis (gMG), across a range of disease-specific assessment scales. A post-hoc analysis of the CHAMPION MG study was performed to determine response to ravulizumab across four muscle domains._x000D_
Methods: _x000D_
The double-blind, randomized, phase 3 CHAMPION MG study (NCT03920293) compared changes from baseline to Week 26 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) total scores in adults with AChR Ab+ gMG receiving ravulizumab or placebo. A post-hoc analysis based on a mixed model for repeated measures was undertaken to calculate least-squares mean changes from baseline to Week 26 in MG-ADL and QMG scores in four separate muscle domains (ocular, bulbar, limb, and respiratory) as a percentage of the respective maximum domain scores._x000D_
Results: _x000D_
In 175 enrolled patients, least-squares mean MG-ADL score changes from baseline to Week 26, expressed as a percentage of the maximum domain score, showed greater improvements for ravulizumab vs placebo in ocular (-14.6% vs -3.2%, p=0.0028) and respiratory domains (-10.3% vs -4.2%, p=0.0484). Similar trends were seen for bulbar (-12.7% vs -8.0%, p=0.0603) and limb domains (-13.5% vs -7.9%, p=0.0639). For QMG, greater improvements for ravulizumab vs placebo were seen in ocular (-13.0% vs -3.1%, p=0.0020) and limb (-5.9% vs -1.5%, p=0.0134) domains. There was no difference in the bulbar (-8.6% vs -5.3%, p=0.2171), and respiratory domains (+6.2% vs +3.0%, p=0.3415)._x000D_
Conclusions: _x000D_
Ravulizumab treatment resulted in greater improvements compared with placebo in ocular and respiratory muscle domains on the MG-ADL scale and in ocular and limb domains on the QMG scale.”