Quality of life in patients with generalized myasthenia gravis receiving rozanolixizumab: Post hoc analysis of MycarinG

Topic:

Clinical Trials

Poster Number: 207 M

Author(s):

Sabrina Sacconi, MD, PhD, Peripheral Nervous System and Muscle Department, University Côte d’Azur, Carlo Antozzi, MD, Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale Neurologico Carlo Besta, Elena Cortés-Vicente, MD, PhD, Neuromuscular Diseases Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, Robert Pascuzzi, MD, Neurology Department, Indiana University School of Medicine, Indiana University Health, IN, USA, Kimiaki Utsugisawa, Hanamaki General Hospital, John Vissing, MD, Neurology at the University of Copenhagen, Tuan Vu, MD, University of South Florida, Jos Bloemers, PhD, UCB, Brussels, Belgium, Fiona Grimson, PhD, UCB, Slough, UK, Thaïs Tarancón, MD, UCB, Vera Bril, MD, PhD, University Health Network, Toronto, ON, Canada

Introduction

Generalized myasthenia gravis (gMG) is a chronic autoimmune disease that can significantly impact many aspects of patients’ quality of life (QoL). In the MycarinG study (NCT03971422), rozanolixizumab significantly improved myasthenia gravis (MG)-specific outcomes versus placebo in patients with gMG. In this post hoc analysis, we identified three themes of the MG-QoL 15-items revised (MG-QoL 15r) tool to evaluate the impact of rozanolixizumab on QoL.

Methods

Patients received six weekly infusions of rozanolixizumab 7mg/kg, 10mg/kg or placebo to Day 43. We grouped the 15 items of MG-QoL 15r (total score 0–30; higher scores reflect worse QoL) into three themes: physical (e.g., eating, walking; 0–14), social (e.g., hobbies, family; 0–8) and emotional (e.g., frustration, depression; 0–8). Descriptive analyses of the change from baseline (CFB) in scores at Day 43 for each theme were conducted.

Results

Overall, 200 patients received rozanolixizumab 7mg/kg (n=66), 10mg/kg (n=67) or placebo (n=67). Least squares mean (standard error) CFB in MG-QoL 15r total score at Day 43 was greater for both rozanolixizumab groups than placebo – 7mg/kg: −4.35 (0.93), p=0.018; 10mg/kg: −5.80 (0.97), p<0.001; placebo: −2.11 (0.95). Mean scores CFB were greater for rozanolixizumab than placebo patients for all three themes – physical: −1.6, −2.4 and −0.6; social: −1.3, −1.5 and −0.3; emotional: −1.0, −1.4 and −0.4 for 7mg/kg, 10mg/kg and placebo, respectively. Conclusion Rozanolixizumab led to greater improvements in scores for the physical, social and emotional themes of the MG-QoL 15r versus placebo, demonstrating the benefit of treatment across the spectrum of MG symptoms that affect patients’ QoL.