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Abstract Details

LUMINESCE, a Phase 3 Study of Satralizumab in Generalized Myasthenia Gravis (gMG): Baseline Characteristics
Neuromuscular and Clinical Neurophysiology (EMG)
P10 - Poster Session 10 (11:45 AM-12:45 PM)
11-015

gMG, a rare, autoimmune disease of the neuromuscular junction, results in fatigable skeletal muscle weakness. Satralizumab, a humanized anti-IL-6 receptor monoclonal recycling antibody that inhibits IL-6 signalling, has the potential to modulate upstream immunopathogenic mechanisms in gMG.

To describe the baseline characteristics of patients enrolled in LUMINESCE (NCT04963270), a Phase 3 study investigating the efficacy and safety of satralizumab in patients aged ≥12 years with gMG.

Eligible participants had a confirmed diagnosis of seropositive gMG (AChR-IgG+, MuSK-IgG+, or LRP4-IgG+), an MGFA severity class II–IV, an MG-ADL score ≥5 with non-ocular contribution >50%, and were receiving stable background therapy. Randomization stratification factors included: autoantibody-type, healthcare geographical region, and background therapy (acetylcholinesterase inhibitor and/or an oral corticosteroid; steroid-sparing immunosuppressive therapy [IST], or steroid-sparing IST with other treatments). Participants were randomized 1:1 to receive subcutaneous satralizumab or placebo at Weeks 0, 2, 4, and Q4W thereafter until Week 24.

As of September 20, 2023, 186 participants have been randomized 1:1 to satralizumab or placebo. Participant autoantibody seropositivity was as follows: AChR-IgG+ (n=165/184, 89.7%), MuSK-IgG+ (n=15/184, 8.2%), and LRP4-IgG+ (n=4/184, 2.2%). The mean age (range) of participants was 46.8 years (15–76) and the majority were female (n=117, 62.9%). The mean (SD) age at diagnosis was 37.7 (17.5) years old, and mean time (SD) since diagnosis was 9.2 (8.5) years. At screening, distribution (n=184, %) across MGFA classes were: 58.2%, 39.1%, and 2.7%, for classes II–IV. Mean (SD) baseline MG-ADL and QMG scores were 8.0 (2.9) and 14.4 (5.3), respectively. 63 participants had a history of thymectomy. Data presented are preliminary and are subject to revision following final analyses.

LUMINESCE, the first study of IL-6R antagonism with satralizumab in gMG, has enrolled 186 participants who are representative of a broad gMG population. LUMINESCE will evaluate the efficacy, safety, and PK/PD profiles of satralizumab in gMG.

Authors/Disclosures
Ivana Vodopivec, MD (F Hoffmann-La Roche AG)
PRESENTER
Dr. Vodopivec has received personal compensation for serving as an employee of Roche. An immediate family member of Dr. Vodopivec has received personal compensation for serving as an employee of Novartis. Dr. Vodopivec has stock in Roche.
Ali A. Habib, MD (University of California, Irvine) Dr. Habib has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Habib has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for argenx. Dr. Habib has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunovant. Dr. Habib has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Habib has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech/Roche. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NMD Pharma. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alpine Immune Sciences. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NIH/NINDS. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunis Biomedical. Dr. Habib has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hoffman-La Roche. Dr. Habib has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Habib has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for argenx. Dr. Habib has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UCB. The institution of Dr. Habib has received research support from Alexion. The institution of Dr. Habib has received research support from VielaBio. The institution of Dr. Habib has received research support from Immunovant. The institution of Dr. Habib has received research support from UCB. The institution of Dr. Habib has received research support from argenx. The institution of Dr. Habib has received research support from CabalettaBio. The institution of Dr. Habib has received research support from Genentech. The institution of Dr. Habib has received research support from Regeneron.
Chongbo Zhao (Chongbo Zhao, Neurologist, Department of Neurology, Huashan Hospital, Fudan Uni) No disclosure on file
Immaculada Aban No disclosure on file
Marcondes C. Franca, Jr., MD Dr. Franca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Franca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PTC. Dr. Franca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Franca has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. The institution of Dr. Franca has received research support from FARA.
Jorge Gustavo Jose Jorge Gustavo Jose has received personal compensation for serving as an employee of hospital padilla. Jorge Gustavo Jose has received personal compensation in the range of $0-$499 for serving as a Consultant for Novartis, . Jorge Gustavo Jose has received personal compensation in the range of $0-$499 for serving as a Consultant for RAFFO. Jorge Gustavo Jose has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NOVARTIS. Jorge Gustavo Jose has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for roche. Jorge Gustavo Jose has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for SANOFI. Jorge Gustavo Jose has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for MERCK. Jorge Gustavo Jose has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for ROCHE. The institution of Jorge Gustavo Jose has received research support from NOVARTIS. Jorge Gustavo Jose has received research support from ROCHE. Jorge Gustavo Jose has received research support from SANOFI.
Gerd Meyer Zu Horste, MD (University Hospital Muenster) Dr. Meyer Zu Horste has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for LFB. The institution of Dr. Meyer Zu Horste has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Meyer Zu Horste has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. The institution of Dr. Meyer Zu Horste has received research support from Merck KGaA. The institution of Dr. Meyer Zu Horste has received research support from Roche. Dr. Meyer Zu Horste has received intellectual property interests from a discovery or technology relating to health care.
Elzbieta Klimiec Ms. Klimiec has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Medison Pharma.
Michael T. Pulley, MD, PhD (University of Florida Jacksonville) Dr. Pulley has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion`. Dr. Pulley has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MT Pharma. Dr. Pulley has received personal compensation in the range of $500-$4,999 for serving as a Consultant for amylyx. Dr. Pulley has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Pulley has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Argenx. Dr. Pulley has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Pulley has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Multiple law firms.
Dario Raul Tavolini Dario Raul Tavolini has nothing to disclose.
Petranka Krumova No disclosure on file
Sian Lennon-Chrimes No disclosure on file
Jillian Smith Jillian Smith has received personal compensation for serving as an employee of Roche Products Ltd. Jillian Smith has stock in Roche Holdings. Jillian Smith has received intellectual property interests from a discovery or technology relating to health care.
Gian-Andrea Thanei No disclosure on file
Gil I. Wolfe, MD, FAAN (Univ. At Buffalo, SUNY) Dr. Wolfe has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Grifols. Dr. Wolfe has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Wolfe has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ArgenX. Dr. Wolfe has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Dr. Wolfe has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB/Ra. Dr. Wolfe has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Wolfe has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Wolfe has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Grifols. The institution of Dr. Wolfe has received research support from UCB/Ra. The institution of Dr. Wolfe has received research support from ArgenX. Dr. Wolfe has received personal compensation in the range of $0-$499 for serving as a Advisor with FDA Advisory Panel for Cellular, Tissue and Genetic Therapies.
Hiroyuki Murai, MD (International University of Health and Welfare) Dr. Murai has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion Pharmaceuticals. Dr. Murai has received personal compensation in the range of $500-$4,999 for serving as a Consultant for argenx. Dr. Murai has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Murai has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Chugai Pharmaceutical. The institution of Dr. Murai has received research support from Japan Blood Products Organization.