Ocular symptoms in patients with generalized myasthenia gravis receiving rozanolixizumab: Post hoc analysis of MycarinG

Topic:

Clinical Trials

Poster Number: P353

Author(s):

Ali Habib, MD, ALS & Neuromuscular Center, University of California, Irvine, Orange, CA, USA, Robert Pascuzzi, MD, Neurology Department, Indiana Univ. School of Medicine, Indiana Univ. Health, Indianapolis, IN, USA, John Vissing, MD, University of Copenhagen, Tuan Vu, MD, Department of Neurology, University of South Florida, Tampa, FL, USA, Thaïs Tarancón, MD, UCB, Madrid, Spain, Francesca Pannullo, PhD, UCB, Slough, UK, Asha Hareendran, MA, PhD, UCB, Slough, UK, Vera Bril, MD, University Health Network, Toronto, ON, Canada

Introduction

The Phase 3 MycarinG study (NCT03971422) demonstrated the efficacy and safety of rozanolixizumab in patients with acetylcholine receptor or muscle-specific tyrosine kinase autoantibody-positive generalized myasthenia gravis (gMG). This post hoc analysis assessed ocular subdomains of the Myasthenia Gravis Symptoms Patient-Reported Outcomes (MGSPRO), Myasthenia Gravis Impairment Index (MGII) and Myasthenia Gravis Activities of Daily Living (MG-ADL) instruments.

Methods

Ocular Muscle Weakness scores for MGSPRO covered a 7-day recall period for five items rated by the patient on a 4-point verbal rating scale (“none” to “severe”) and a total score of 0–100. The MGII ocular subdomain (optional) assessed eight items (two clinician-reported for current signs, six patient-reported with a 14-day recall period; total score 0–24). The MG-ADL ocular subdomain assessed two patient-reported items (current signs; total score 0–6). Descriptive analyses of change from baseline (CFB) scores during treatment were conducted (randomized set). Safety was also assessed.

Results

In MycarinG, 200 participants were randomized to receive rozanolixizumab 7 mg/kg (n=66), rozanolixizumab 10 mg/kg (n=67) or placebo (n=67) weekly for 6 weeks, followed by an 8-week observation period. Improvements in MGSPRO Ocular Muscle Weakness scores versus placebo were observed from Day 15 until end of treatment. At Day 43, mean (standard deviation [SD]) CFB in MGSPRO Ocular Muscle Weakness score was −9.6 (16.8), −11.9 (14.0) and −3.4 (18.2) for rozanolixizumab 7 mg/kg, 10 mg/kg, and placebo, respectively. Mean (SD) CFB in the MGII ocular score was −2.9 (5.4), −5.2 (4.9) and −1.0 (4.3), respectively. Mean (SD) CFB in the MG-ADL ocular subdomain score was −0.8 (1.3), −1.0 (1.2) and −0.1 (0.9), respectively. Rozanolixizumab was generally well tolerated and most treatment-emergent adverse events were mild or moderate.

Conclusion

Greater improvements in the MGSPRO Ocular Muscle Weakness score, and MGII and MG-ADL ocular subdomain scores were observed with rozanolixizumab than with placebo.

These data were previously presented at ICNMD, October 25–29, 2024.