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Abstract Details

Ravulizumab in Adults with Generalized Myasthenia Gravis: A Sub-Analysis of the Phase 3 CHAMPION MG Study According to Chronic IVIg Use at Study Entry
Autoimmune Neurology
P1 - Poster Session 1 (8:00 AM-9:00 AM)
6-013
The long-acting terminal complement C5 inhibitor, ravulizumab, demonstrated sustained efficacy and was well tolerated in the phase 3 CHAMPION MG study in adults with AChR Ab+ gMG. While IVIg treatment was only allowed as rescue therapy during the CHAMPION MG study, many patients had a history of IVIg use prior to entering the study.
To assess differences in response to ravulizumab in adults with anti-acetylcholine receptor antibody-positive (AChR Ab+) generalized myasthenia gravis (gMG), according to previous intravenous immunoglobulin (IVIg) treatment.
Subgroup analysis of all patients enrolled in a double-blind, placebo-controlled, phase 3 study (CHAMPION MG; NCT03920293) that assessed response to ravulizumab (administered every 8 weeks) in adults with AChR Ab+ gMG. Changes from baseline to Weeks 26 in Myasthenia Gravis-Activities of Daily Living (MG-ADL; primary endpoint) and Quantitative Myasthenia Gravis (QMG) total scores were analyzed according to IVIg use between MG diagnosis and study entry.

Of 175 patients enrolled in the study, 79 had no previous IVIg use (38 placebo; 41 ravulizumab) and 96 had received any (acute or chronic) IVIg (51 placebo; 45 ravulizumab). Forty-six patients (22 placebo; 24 ravulizumab) had received chronic IVIg therapy. There were no notable differences in baseline characteristics/demographics between the IVIg subgroups.

Least squares (LS) mean changes (95% confidence intervals [CI]) from baseline for ravulizumab vs placebo at Week 26 in MG-ADL total score were -2.1 (-3.6, -0.5), -1.3 (-2.8, -0.6), and -1.1 (-2.6, -0.0) in patients with history of no, any or chronic IVIg use, respectively. LS mean change (CI) from baseline vs placebo at Week 26 in QMG total scores were -2.4 (-4.2, -0.7), -1.6 (-3.2, -0.0), and -2.3 (-4.6, 0.1), respectively.
There were no differences in response to ravulizumab with respect to improvements in functional ability and muscle strength, in patients with AChR Ab+ gMG according to previous IVIg treatment.
Authors/Disclosures
Glen Frick, MD, PhD
PRESENTER
Dr. Frick has received personal compensation for serving as an employee of AstraZeneca/Alexion Rare Disease. Dr. Frick has stock in AstraZeneca/Alexion Rare Disease.
Vera Bril, MD (Toronto General Hospital) Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CSL. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alnylam. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Grifols. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Octapharma. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Powell Mansfield. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Akcea. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ionis. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Momenta (now J&J). Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NovoNordisk. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunovant. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Bril has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Akcea. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alnylam. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CSL. Dr. Bril has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. The institution of Dr. Bril has received research support from UCB. The institution of Dr. Bril has received research support from Argenx. The institution of Dr. Bril has received research support from Momenta (now J&J). The institution of Dr. Bril has received research support from Immunovant. The institution of Dr. Bril has received research support from Alexion. The institution of Dr. Bril has received research support from Takeda. The institution of Dr. Bril has received research support from Grifols. The institution of Dr. Bril has received research support from CSL. The institution of Dr. Bril has received research support from Octapharma. The institution of Dr. Bril has received research support from Akcea. The institution of Dr. Bril has received research support from Ionis. The institution of Dr. Bril has received research support from Viela Bio (now Horizon). Dr. Bril has received intellectual property interests from a discovery or technology relating to health care.
Jin-Hong Shin No disclosure on file
Nicholas J. Silvestri, MD, FAAN (UBMD Neurology) Dr. Silvestri has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for argenx. Dr. Silvestri has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sarepta. Dr. Silvestri has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Regeneron. Dr. Silvestri has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Strongbridge. Dr. Silvestri has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Silvestri has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. Dr. Silvestri has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunovant. Dr. Silvestri has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for argenx. Dr. Silvestri has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Silvestri has received publishing royalties from a publication relating to health care.
James M. Winkley, MD Dr. Winkley has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Biogen. Dr. Winkley has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Winkley has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Sanofi. Dr. Winkley has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Novartis. Dr. Winkley has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Serrono. Dr. Winkley has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Teva. Dr. Winkley has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Winkley has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Biogen. Dr. Winkley has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Sanofi. Dr. Winkley has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Serrono. Dr. Winkley has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Novartis. Dr. Winkley has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Roche. Dr. Winkley has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Teva. Dr. Winkley has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Winkley has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Allergan. Dr. Winkley has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for lilly. Dr. Winkley has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Pfizer. The institution of Dr. Winkley has received research support from Noveratis. The institution of Dr. Winkley has received research support from Merck. The institution of Dr. Winkley has received research support from Sanofi. The institution of Dr. Winkley has received research support from Biogen. The institution of Dr. Winkley has received research support from Alexion.
Andrew J. Gordon, MD (Northwest Neurology) Dr. Gordon has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Catalyst. Dr. Gordon has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Gordon has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion . Dr. Gordon has received personal compensation in the range of $0-$499 for serving as a Consultant for Vertex. Dr. Gordon has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Gordon has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. Dr. Gordon has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Gordon has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Cassiday.
Yasushi Suzuki, MD, PhD (National Hospital Organization Sendai Medical Center) Yasushi Suzuki, MD, PhD has nothing to disclose.
Rasha Aguzzi (Alexion) No disclosure on file