Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Primary and Secondary Results of LUMINESCE, a Phase 3 Study of Interleukin-6 Signaling Inhibition by Satralizumab in Generalized Myasthenia Gravis
Autoimmune Neurology
ES1 - Emerging Science 1 (11:21 AM-11:27 AM)
002

gMG, a rare autoimmune disease affecting the neuromuscular junction, results in fatigable skeletal muscle weakness. Pre-clinical and clinical data implicate IL-6 in the pathology of MG, suggesting its therapeutic target viability. Satralizumab, a humanized IL-6 receptor monoclonal recycling antibody, provides durable inhibition of IL-6 signaling, which has the potential to modulate upstream immunopathogenic mechanisms in gMG. Satralizumab is approved for the treatment of anti-aquaporin-4-seropositive neuromyelitis optica spectrum disorder, with long-term (~9 years) experience regarding its benefit:risk profile. This is the first report of data assessing IL-6 signaling inhibition with satralizumab in gMG, and will inform on the benefit:risk profile of satralizumab in gMG.

To report primary and notable secondary efficacy and safety results of LUMINESCE (NCT04963270), a Phase 3 study investigating satralizumab in patients aged ≥12 years with generalized myasthenia gravis (gMG).

Eligibility criteria included gMG seropositivity (AChR-IgG+, MuSK-IgG+, or LRP4-IgG+), an MGFA severity class II–IV, an MG-ADL score ≥5 (non-ocular contribution >50%), and use of stable background therapy. Participants were randomized 1:1 to receive subcutaneous satralizumab or placebo at Weeks 0, 2, 4, and Q4W thereafter until Week 24. The primary efficacy endpoint was mean change from baseline in total MG-ADL score at Week 24 (AChR-IgG+). Secondary efficacy endpoints include, but are not limited to, mean change from baseline in QMG score, percentage of patients with ≥2 points reduction in total MG-ADL score, and percentage of patients with ≥3 points reduction in QMG score, at Week 24 (AChR-IgG+); and durability of efficacy of satralizumab. Safety analyses included incidence and severity of adverse events.

To date, 186 participants were randomized. Baseline demographics, and primary and notable secondary efficacy and safety results will be presented.

LUMINESCE, the first study of IL-6 signaling inhibition with satralizumab in gMG, will generate important data to evaluate satralizumab’s efficacy and safety in gMG.

Authors/Disclosures
Ali Habib (University of California, Irvine)
PRESENTER
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.
No disclosure on file
No disclosure on file
Marcondes Franca 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 (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 Pulley (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.
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
Ivana Vodopivec (F Hoffmann-La Roche AG) 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.
Gil Wolfe (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 (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.