Measuring the effect of rozanolixizumab using the Myasthenia Gravis Impairment Index: analyses from the randomized phase 3 MycarinG study
Por:
Barnett-Tapia, C, Vicente, EC, Pascuzzi, RM, Utsugisawa, K, Bloemers, J, Grimson, F, Tarancon, T, Bril, V
Publicada:
8 nov 2025
Resumen:
Background Generalized myasthenia gravis (gMG) is an autoimmune disease characterized by fluctuating muscle weakness. The MG Impairment Index (MGII) incorporates patients' perspectives (22 items) and physician evaluation (6 items) of impairment. We evaluated the effect of rozanolixizumab using the MGII in the randomized, double-blind, placebo-controlled, Phase 3 MycarinG study. Methods Adult patients with gMG were randomized 1:1:1 to once-weekly rozanolixizumab 7 mg/kg, 10 mg/kg or placebo for 6 weeks. MGII assessment was optional. Exploratory MGII analyses included change from baseline (CFB) to Day 43 in total score and ocular/generalized subscores; higher scores reflect greater impairment. Post hoc analyses included responder rates (>= 5.5-point improvement) and achievement of patient-acceptable symptom state (PASS; <= 10 points, patient-reported items only). Results Overall, 200 patients received rozanolixizumab 7 mg/kg (n = 66), 10 mg/kg (n = 67) or placebo (n = 67). The MGII was completed by 144/200 (72.0%) patients. Mean CFB in MGII total score was greater in the rozanolixizumab groups versus placebo; mean CFB in ocular and generalized subscores was consistent with the total score. At Day 43, 57.1%, 83.3% and 40.4% of patients, respectively, were responders, and 30.8%, 39.2% and 7.7%, respectively, achieved MGII PASS. Responsiveness correlations between MGII total score CFB and MG-ADL anchor at Day 43 demonstrated a Spearman's correlation coefficient of 0.5991 (p < 0.0001). Conclusion These findings further support efficacy analyses from MycarinG to highlight the benefit of rozanolixizumab in patients with gMG and demonstrate the utility of the MGII in evaluating patient-relevant symptoms following treatment.
Filiaciones:
Barnett-Tapia, C:
Univ Toronto, Toronto Gen Hosp, Ellen & Martin Prosserman Ctr Neuromuscular Dis, Toronto, ON, Canada
Univ Toronto, Inst Hlth Policy Management & Evaluat, Toronto, ON, Canada
Vicente, EC:
Hosp La Santa Creu I Sant Pau, Neuromuscular Dis Unit, Barcelona, Spain
Pascuzzi, RM:
Indiana Univ Sch Med, Indiana Univ Hlth, Dept Neurol, Indianapolis, IN 46202 USA
Utsugisawa, K:
Hanamaki Gen Hosp, Dept Neurol, Hanamaki, Japan
Bloemers, J:
UCB, Brussels, Belgium
Grimson, F:
UCB, Slough, England
Tarancon, T:
UCB, Madrid, Spain
Bril, V:
Univ Toronto, Toronto Gen Hosp, Ellen & Martin Prosserman Ctr Neuromuscular Dis, Toronto, ON, Canada
Green Submitted, hybrid
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