Long-term Efficacy and Safety of Ravulizumab, a Long-acting Terminal Complement Inhibitor, in Adults with Anti-acetylcholine Receptor Antibody-positive Generalized Myasthenia Gravis: Final Results from the Phase 3 CHAMPION MG Open-label Extension

Elenco Abstract

Silvia Bonanno

Long-term Efficacy and Safety of Ravulizumab, a Long-acting Terminal Complement Inhibitor, in Adults with Anti-acetylcholine Receptor Antibody-positive Generalized Myasthenia Gravis: Final Results from the Phase 3 CHAMPION MG Open-label Extension

Autori

TUAN VU (UNIVERSITY OF SOUTH FLORIDA MORSANI COLLEGE OF MEDICINE, TAMPA, FL, USA – NEUROLOGIA)
RENATO MANTEGAZZA (FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA, MILAN, ITALY – NEUROLOGIA)
DJILLALI ANNANE (HÔPITAL RAYMOND POINCARÉ, GARCHES, FRANCE – NEUROLOGIA)
MASAHISA KATSUNO (NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE, NAGOYA, JAPAN – NEUROLOGIA)
ANDREAS MEISEL (CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN, BERLIN, GERMANY; – NEUROLOGIA)
MICHAEL NICOLLE (LONDON HEALTH SCIENCES CENTRE, LONDON, ON, CANADA – NEUROLOGIA)
VERA BRIL (ELLEN & MARTIN PROSSERMAN CENTRE FOR NEUROMUSCULAR DISEASES, UNIVERSITY HEALTH NETWORK, UNIVERSITY OF TORONTO, TORONTO, ON, CANADA – NEUROLOGIA)
RASHA AGUZZI (ALEXION, ASTRAZENECA RARE DISEASE, BOSTON, MA, USA – NEUROLOGIA)
GLEN FRICK (ALEXION, ASTRAZENECA RARE DISEASE, BOSTON, MA, USA – NEUROLOGIA)
JAMES HOWARD JR (THE UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL, NC, USA – NEUROLOGIA)
CHAMPION MG STUDY GROUP (N/A – NEUROLOGIA)

Presentatore

SILVIA BONANNO (FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA, MILAN, ITALY)

Modalità

Poster Session

Abstract

“Objective: To evaluate the long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive (AChRAb+) generalized myasthenia gravis (gMG).
Background: The 26-week, double-blind, randomized, placebo-controlled period (RCP) of the CHAMPION MG study demonstrated the efficacy and favorable safety profile of ravulizumab in adults with AChRAb+ gMG. Participants who completed the RCP could receive ravulizumab in the open-label extension (OLE; NCT03920293).
Methods: In the OLE, patients could receive intravenous ravulizumab for up to 4 years at database lock. Assessments included Myasthenia Gravis-Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) total scores, and safety evaluations.
Results: A total of 161 patients (78 ravulizumab, 83 placebo in the RCP) entered the OLE and received ravulizumab for up to 164 weeks. Mean duration of ravulizumab treatment was ~2 years. Improvements in MG-ADL and QMG total score seen in ravulizumab-treated patients in the RCP were maintained. MG-ADL least-squares mean change from RCP baseline at Week 164 was -4.0 (95% confidence interval [CI] -5.3, -2.8; p<0.0001). Patients who switched from placebo in RCP to ravulizumab in OLE showed rapid improvements in MG-ADL score, which were maintained through 138 weeks (least-squares mean change from OLE baseline at Week 164: -2.1 [95% CI -3.3, -0.9]; p<0.0005); a significant improvement was also seen in QMG score. Ravulizumab was well tolerated; no meningococcal infections were reported.
Conclusions: Ravulizumab, administered every 8 weeks, demonstrated clinically meaningful sustained improvements in MG symptoms and was well tolerated for up to 164 weeks in adults with AChRAb+ gMG.”