Efficacy and Safety of Rozanolixizumab Treatment Cycles in Patients With Generalized Myasthenia Gravis: Final Pooled Analysis of Phase 3 Studies

Topic:

Clinical Trials

Poster Number: 227 M

Author(s):

Ali Habib, MD, ALS & Neuromuscular Center, University of California, Irvine, Orange, CA, USA, Carlo Antozzi, MD, Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale Neurologico Carlo Besta, Artur Drużdż, MD, Department of Neurology, Municipal Hospital, Poznań, Poland, Julian Grosskreutz, MD, University of Lübeck, Sabrina Sacconi, MD, PhD, Peripheral Nervous System and Muscle Department, University Côte d’Azur, Kimiaki Utsugisawa, Hanamaki General Hospital, John Vissing, MD, Neurology at the University of Copenhagen, Tuan Vu, MD, University of South Florida, Fiona Grimson, PhD, UCB, Slough, UK, Belinda McDonough, MB, BCh, BAO, UCB, Slough, UK, Irene Pulido-Valdeolivas, MD, PhD, UCB, Madrid, Spain, Thaïs Tarancón, MD, UCB, Vera Bril, MD, PhD, University Health Network, Toronto, ON, Canada

Introduction

In the Phase 3 MycarinG study (MG0003/NCT03971422), one 6-week cycle of subcutaneous rozanolixizumab significantly improved MG-specific outcomes versus placebo. After MycarinG, patients could enroll in open-label extension studies (MG0004 then MG0007, or MG0007 directly) which are now complete.

Objective

To assess the efficacy and safety of rozanolixizumab over multiple symptom-driven cycles in patients with generalised MG.

Methods

In MG0004 (NCT04124965), patients received chronic, once-weekly rozanolixizumab 7 mg/kg or 10 mg/kg for ≤52 weeks. In MG0007 (NCT04650854), after an initial cycle of rozanolixizumab 7 mg/kg or 10 mg/kg, subsequent cycles were based on symptom worsening at the investigator’s discretion. Pooled data are reported across MycarinG, MG0004 (first 6 weeks) and MG0007 (final data) for patients receiving ≥2 symptom-driven cycles for efficacy outcomes (up to 13 cycles) or ≥1 cycle for safety.

Results

Overall, 196 patients received ≥1 dose of rozanolixizumab, of whom 129 received ≥2 symptom-driven cycles of rozanolixizumab (7 mg/kg: n=70; 10 mg/kg: n=59). Treatment response was maintained from Cycles 1 to 13; mean change from baseline to Day 43 in MG-ADL score ranged from −3.2 (in Cycle 3) to −4.9 (in Cycle 12) with 7 mg/kg and −3.2 (in Cycle 3) to −6.7 (in Cycle 12) with 10 mg/kg. Similar improvements from baseline were observed for QMG and MGC scores. The incidence of treatment-emergent adverse events (TEAEs) did not increase with repeated cyclic treatment. The most common TEAE was headache, reported in 94/188 (50%) patients who received ≥1 symptom-driven cycle of rozanolixizumab, and most events were mild or moderate.

Summary/conclusion

Rozanolixizumab showed consistent improvements across multiple MG-specific outcomes up to 13 cycles and was generally well tolerated following repeated cyclic treatment.