Hani Kushlaf (Cincinnati, OH / US), James F Howard Jr (Chapel Hill, NC / US), Tuan Vu (Tampa, FL / US), Renato Mantegazza (Milan / IT), Shigeaki Suzuki (Tokyo / JP), Prof. Dr. Heinz Wiendl (Münster / DE), Kathleen N Beasley (Boston, MA / US), Serena Liao (Boston, MA / US), Prof. Dr. Andreas Meisel (Berlin / DE)
Abstract-Text (inkl. Referenzen)
and the CHAMPION MG Study Group
Background
26-week, phase 3, double-blind, randomized, placebo-controlled CHAMPION MG study demonstrated the efficacy and tolerability of the terminal complement C5 inhibitor ravulizumab, administered q8w, in patients with AChR Ab+ generalized myasthenia gravis (gMG).
Objective
A post hoc analysis was performed to determine responses to treatment according to time from MG diagnosis.
Methods
Enrolled patients with MG-ADL or QMG assessments at baseline and post-baseline 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.
Results
A total of 175 patients were included in the analysis. In ravulizumab-treated patients, least‑squares mean changes from baseline to Week 26 were numerically greater in the ≤2-years subgroup versus >2-years subgroup for both MG-ADL and QMG total score. 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.
Conclusions
Ravulizumab was significantly more effective than placebo, irrespective of whether it was started within 2 years from diagnosis of MG or later. Ravulizumab treatment earlier in the disease course may result in greater therapeutic benefits.