LUMINESCE, a Phase 3 Study of Satralizumab in Generalized Myasthenia Gravis (gMG): Baseline Characteristics
Ali A. Habib1, Chongbo Zhao2, Inmaculada Aban3, Marcondes Cavalcante França Jr.4, Jorge Gustavo José5, Gerd Meyer zu Hörste6, Elżbieta Klimiec-Moskal7, Michael T. Pulley8, Darío Tavolini9, Petranka Krumova10, Siân Lennon-Chrimes11, Jillian Smith11, Gian-Andrea Thanei10, Ivana Vodopivec10, Gil I. Wolfe12, Hiroyuki Murai13
1Department of Neurology, University of California, Irvine, California, USA, 2Department of Neurology and Rare Disease Center, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China, 3Department of Biostatistics, The University of Alabama at Birmingham, Birmingham, Alabama, USA, 4Department of Neurology, Universidade Estadual de Campinas (UNICAMP), Campinas, Brazil, 5Unit of Demyelinating Diseases, CIMT Tucuman Medical Research Center, Hospital Ángel C. Padilla, Tucumán, Argentina, 6Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany, 7Department of Neurology, Jagiellonian University Medical College, Krakow, Poland, 8Department of Neurology, University of Florida College of Medicine, Jacksonville, Florida, USA, 9INECO Neurociencias Oroño, Rosario, Argentina, 10F. Hoffmann-La Roche Ltd, Basel, Switzerland, 11Roche Products Ltd, Welwyn Garden City, UK, 12Department of Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo/SUNY, Buffalo, New York, USA, 13Department of Neurology, International University of Health and Welfare, Narita, Japan
Objective:

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.

Background:

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.

Design/Methods:

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.

Results:

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.

Conclusions:

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.

10.1212/WNL.0000000000205247