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P.096 Final pooled analysis of efficacy and safety of rozanolixizumab cycles in patients with generalised myasthenia gravis: MycarinG and open-label extension studies

Published online by Cambridge University Press:  10 July 2025

V Bril
Affiliation:
(Toronto)*
C Antozzi
Affiliation:
(Milan)
A Drużdż
Affiliation:
(Poznań)
J Grosskreutz
Affiliation:
(Lübeck)
AA Habib
Affiliation:
(Orange)
S Sacconi
Affiliation:
(Nice)
K Utsugisawa
Affiliation:
(Hanamaki)
J Vissing
Affiliation:
(Copenhagen)
T Vu
Affiliation:
(Tampa)
F Grimson
Affiliation:
(Slough)
B McDonough
Affiliation:
(Slough)
I Pulido-Valdeolivas
Affiliation:
(Madrid)
T Tarancón
Affiliation:
(Madrid)
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Abstract

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Background: In the Phase 3 MycarinG study (MG0003/NCT03971422), one 6-week cycle of rozanolixizumab significantly improved myasthenia gravis (MG)-specific outcomes versus placebo. After MycarinG, patients could enrol in open-label extension studies (MG0004 then MG0007, or MG0007 directly). Methods: In MG0004 (NCT04124965), patients received once-weekly rozanolixizumab 7mg/kg or 10mg/kg for ≤52 weeks. In MG0007 (NCT04650854), after a cycle of rozanolixizumab 7mg/kg or 10mg/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 (efficacy; ≤13 cycles) or ≥1 cycle (safety). Results: 196 patients received ≥1 rozanolixizumab dose of whom 129 received ≥2 symptom-driven cycles (7mg/kg: n=70; 10mg/kg: n=59). Treatment response was maintained from Cycles 1–13: mean change from baseline to Day 43 in MG-Activities of Daily Living score ranged from -3.2 to -4.9 (7mg/kg) and -3.2 to -6.7 (10mg/kg). Quantitative MG and MG Composite scores also improved. Treatment-emergent adverse events (TEAEs) did not increase with repeated cyclic treatment, and most were mild/moderate; the most common event was headache. Conclusions: Rozanolixizumab showed consistent improvements across MG-specific outcomes up to 13 cycles and repeated cyclic treatment was generally well tolerated. Funding: UCB.

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Abstracts
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of Canadian Neurological Sciences Federation