Safety and efficacy of chronic weekly rozanolixizumab in generalized myasthenia gravis: the randomized open-label extension MG0004 study DOI Creative Commons
Vera Bril,

Artur Drużdż,

Julian Großkreutz

et al.

Journal of Neurology, Journal Year: 2025, Volume and Issue: 272(4)

Published: March 19, 2025

In the Phase 3 MycarinG study (NCT03971422), six once-weekly subcutaneous infusions of rozanolixizumab significantly improved myasthenia gravis (MG)-specific outcomes versus placebo in patients with acetylcholine receptor or muscle-specific tyrosine kinase autoantibody-positive generalized MG (gMG). Following completion MycarinG, could enroll open-label extension MG0004 (NCT04124965) to receive chronic weekly rozanolixizumab. Patients were re-randomized 1:1 7 10 mg/kg for up 52 infusions. The primary endpoints occurrence treatment-emergent adverse events (TEAEs) and TEAEs leading discontinuation. After ≥6 visits/infusions switch MG0007 (NCT04650854) cyclic treatment. MG0004, 70 received (n = 35) 35). Mean treatment duration was 22.9 23.7 weeks, respectively, due rollover into MG0007. reported 60/70 (85.7%) patients; most mild/moderate. frequently headache (25/70 [35.7%]), diarrhea (13/70 [18.6%]) decreased blood immunoglobulin G (11/70 [15.7%]). There no opportunistic, serious severe infections, hypersensitivity injection-site reactions, any anaphylactic reactions albumin lipid abnormalities. Maximum mean reduction from baseline Activities Daily Living score 3.1 group 4.1 group. Chronic generally well tolerated, clinically relevant improvements across MG-specific maintained, supporting long-term use gMG. NCT04124965 (registered October 11, 2019).

Language: Английский

Safety and efficacy of chronic weekly rozanolixizumab in generalized myasthenia gravis: the randomized open-label extension MG0004 study DOI Creative Commons
Vera Bril,

Artur Drużdż,

Julian Großkreutz

et al.

Journal of Neurology, Journal Year: 2025, Volume and Issue: 272(4)

Published: March 19, 2025

In the Phase 3 MycarinG study (NCT03971422), six once-weekly subcutaneous infusions of rozanolixizumab significantly improved myasthenia gravis (MG)-specific outcomes versus placebo in patients with acetylcholine receptor or muscle-specific tyrosine kinase autoantibody-positive generalized MG (gMG). Following completion MycarinG, could enroll open-label extension MG0004 (NCT04124965) to receive chronic weekly rozanolixizumab. Patients were re-randomized 1:1 7 10 mg/kg for up 52 infusions. The primary endpoints occurrence treatment-emergent adverse events (TEAEs) and TEAEs leading discontinuation. After ≥6 visits/infusions switch MG0007 (NCT04650854) cyclic treatment. MG0004, 70 received (n = 35) 35). Mean treatment duration was 22.9 23.7 weeks, respectively, due rollover into MG0007. reported 60/70 (85.7%) patients; most mild/moderate. frequently headache (25/70 [35.7%]), diarrhea (13/70 [18.6%]) decreased blood immunoglobulin G (11/70 [15.7%]). There no opportunistic, serious severe infections, hypersensitivity injection-site reactions, any anaphylactic reactions albumin lipid abnormalities. Maximum mean reduction from baseline Activities Daily Living score 3.1 group 4.1 group. Chronic generally well tolerated, clinically relevant improvements across MG-specific maintained, supporting long-term use gMG. NCT04124965 (registered October 11, 2019).

Language: Английский

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