Primary and Secondary Results of LUMINESCE, a Phase 3 Study of Interleukin-6 Signalling Inhibition by Satralizumab in Generalized Myasthenia Gravis

Elenco Abstract

Carlo Antozzi

Primary and Secondary Results of LUMINESCE, a Phase 3 Study of Interleukin-6 Signalling Inhibition by Satralizumab in Generalized Myasthenia Gravis

Autori

CARLO ANTOZZI (NEUROIMMUNOLOGY AND MUSCLE PATHOLOGY UNIT, MULTIPLE SCLEROSIS CENTER, FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA, MILAN, ITALY – NEUROLOGIST)
LORENZO MAGGI (NEUROIMMUNOLOGY AND NEUROMUSCULAR DISEASES UNIT, FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA, MILAN, ITALY – NEUROLOGIST)
RENATO MANTEGAZZA (DEPARTMENT OF NEUROIMMUNOLOGY AND NEUROMUSCULAR DISEASES, FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA, MILAN, ITALY – NEUROLOGIST)
ALI HABIB (DEPARTMENT OF NEUROLOGY, UNIVERSITY OF CALIFORNIA, IRVINE, CALIFORNIA, USA – NEUROLOGIST)
CHONGBO ZHAO (DEPARTMENT OF NEUROLOGY AND RARE DISEASE CENTER, HUASHAN HOSPITAL, SHANGHAI MEDICAL COLLEGE, FUDAN UNIVERSITY, SHANGHAI, CHINA – NEUROLOGIST)
IMMACULADA ABAN (DEPARTMENT OF BIOSTATISTICS, THE UNIVERSITY OF ALABAMA AT BIRMINGHAM, BIRMINGHAM AL – BIOSTATISTICIAN)
MARCONDES CAVALCANTE FRANCA (DEPARTMENT OF NEUROLOGY, UNIVERSIDADE ESTADUAL DE CAMPINAS (UNICAMP), CAMPINAS, BRAZIL – NEUROLOGIST)
JORGE GUSTAVO JOSE (UNIT OF DEMYELINATING DISEASES, CIMT TUCUMAN MEDICAL RESEARCH CENTER, HOSPITAL ÁNGEL C. PADILLA, TUCUMÁN, ARGENTINA – NEUROLOGIST)
GERD MEYER ZU HORSTE (DEPARTMENT OF NEUROLOGY WITH INSTITUTE OF TRANSLATIONAL NEUROLOGY, UNIVERSITY OF MÜNSTER, MÜNSTER, GERMANY – NEUROLOGIST)
ELZBIETA KLIMIEC-MOSKAL (DEPARTMENT OF NEUROLOGY, JAGIELLONIAN UNIVERSITY MEDICAL COLLEGE, KRAKOW, POLAND – NEUROLOGIST)
MICHAEL PULLEY (DEPARTMENT OF NEUROLOGY, UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE, JACKSONVILLE, FL, USA – NEUROLOGIST)
DARIO TAVOLINI (INECO NEUROCIENCIAS OROÑO, ROSARIO, ARGENTINA – NEUROLOGIST)
KATHLEEN BLONDEAU (F. HOFFMANN-LA ROCHE LTD, BASEL, SWITZERLAND – BIOMEDICAL SCIENTIST)
PETRANKA KRUMOVA (ROCHE PRODUCTS LTD, WELWYN GARDEN CITY, UK – BIOCHEMISTRY AND MOLECULAR BIOLOGY)
SIAN LENNON-CHRIMES (ROCHE PRODUCTS LTD, WELWYN GARDEN CITY, UK – CLINICAL PHARMACOLOGIST)
GIAN ANDREA THANEI (F. HOFFMANN-LA ROCHE LTD, BASEL, SWITZERLAND – STATISTICIAN AND MATHEMATICIAN)
IVANA VODOPIVEC (F. HOFFMANN-LA ROCHE LTD, BASEL, SWITZERLAND – NEUROLOGIST)
GIL WOLFE (DEPARTMENT OF NEUROLOGY, JACOBS SCHOOL OF MEDICINE AND BIOMEDICAL SCIENCES, UNIVERSITY AT BUFFALO/SUNY, BUFFALO, NY, USA – NEUROLOGIST)
HIROYUKI MURAI (DEPARTMENT OF NEUROLOGY, INTERNATIONAL UNIVERSITY OF HEALTH AND WELFARE, NARITA, JAPAN – NEUROLOGIST)

Presentatore

CARLO ANTOZZI

Modalità

Poster Session

Abstract

“OBJECTIVE
To report efficacy and safety results of LUMINESCE (NCT04963270), a Phase 3 study investigating satralizumab in patients ≥12 years with generalized myasthenia gravis (gMG).
BACKGROUND
gMG results in fatigable skeletal muscle weakness; pre-clinical and clinical data implicate IL-6 in the pathology of MG. 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 neuromyelitis optica spectrum disorder, with long-term (~9 years) experience regarding safety and efficacy.
METHODS
Eligibility criteria included gMG seropositivity (AChR-IgG+, MuSK-IgG+, or LRP4-IgG+), MGFA severity class II–IV, MG-ADL score ≥5 (non-ocular contribution >50%), 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 included, among others, mean change from baseline in QMG score, percentage of patients with ≥2 points reduction in total MG-ADL score, percentage of patients with ≥3 points reduction in QMG score, at Week 24 (AChR-IgG+); durability of efficacy of satralizumab. Safety analyses included incidence and severity of adverse events.
RESULTS
To date, 186 participants were randomized. Baseline demographics, primary and 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.”