Efficacy of ravulizumab in generalized myasthenia gravis according to time from diagnosis: A post hoc subgroup analysis of the CHAMPION MG study

Topic:

Clinical Trials

Poster Number: 147

Author(s):

Hani Kushlaf, University of Cincinnati, Cincinnati, OH, USA, James Howard, MD, FAAN, The University of North Carolina at Chapel Hill, Tuan Vu, MD, University of South Florida, Renato Mantegazza, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta, Shigeaki Suzuki, Keio University School of Medicine, Tokyo, Japan, Heinz Wiendl, University Hospital Münster, Münster, Germany, Kathleen N Beasley, Alexion, AstraZeneca Rare Disease, Boston, MA, USA, Serena Liao, Alexion, AstraZeneca Rare Disease, Boston, MA, USA, Andreas Meisel, MD, NeuroCure Clinical Research Center, Charité Universitätsmedizin Berlin

“Background: _x000D_
The 26-week, phase 3, double-blind, randomized, placebo-controlled CHAMPION MG study (NCT03920293) demonstrated the efficacy and tolerability of the terminal complement C5 inhibitor ravulizumab, administered every 8 weeks, in patients with anti-acetylcholine receptor antibody-positive (AChR Ab+) generalized myasthenia gravis (gMG)._x000D_
Objective: _x000D_
A post hoc analysis was performed to determine responses to treatment according to time from MG diagnosis._x000D_
Methods: _x000D_
Enrolled patients with Myasthenia Gravis-Activities of Daily Living (MG-ADL) or Quantitative Myasthenia Gravis (QMG) assessments at baseline and Week 26 were included in the analyses. Least-squares mean changes from baseline to Week 26 in MG-ADL and QMG total scores were assessed in ravulizumab- and placebo-treated patient subgroups according to time from MG diagnosis (≤2 years and >2 years) to study start. Within each subgroup, least-squares mean changes for ravulizumab and placebo were compared statistically using mixed models for repeated measures._x000D_
Results: _x000D_
A total of 175 patients (ravulizumab, 86; placebo, 89) were included in the analysis. In ravulizumab-treated patients, least-squares mean (standard error of the mean) changes from baseline to Week 26 were numerically greater in the ≤2-years subgroup (n=19) versus >2-years subgroup (n=67) for both MG-ADL total score (-4.3 [0.70] vs -2.9 [0.37]) and QMG total score (-4.3 [0.94] vs -2.5 [0.50]). No clear trends were observed in the placebo group. Least-squares mean changes from baseline were significantly greater for ravulizumab versus placebo irrespective of whether treatment was initiated within 2 years since diagnosis or later (p=0.0046 and p=0.0035, respectively, for MG-ADL scores; p=0.0238 and p=0.0183, respectively, for QMG scores)._x000D_
Conclusions: _x000D_
Ravulizumab was significantly more effective than placebo, irrespective of whether it was started within 2 years from diagnosis of MG or later. However, ravulizumab treatment earlier in the disease course may result in greater therapeutic benefits. Further studies are required to confirm these observations.”