Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study
Publication highlights from Bril V, et al. Lancet Neurol. 2023;22:383–394
Rozanolixizumab is a humanised IgG4 monoclonal antibody targeting the IgG binding region of FcRn, reversibly inhibiting IgG salvage and recycling
The commercially available dose of rozanolixizumab is 140mg/mL, which equates to a weight-based dose of 7mg/kg. The 10mg/kg dose of rozanolixizumab is included for completeness of the study design and results.
Improvements from baseline in MG-ADL and MGC scores were seen as early as Day 8 with rozanolixizumab†
Conclusion
In the Phase 3 MycarinG study:
Rozanolixizumab showed consistent and clinically meaningful efficacy across patient-reported and clinician-reported outcomes for both 7 mg/kg and 10 mg/kg doses
Both doses of rozanolixizumab were generally well tolerated
Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study
Bril V, et al. Lancet Neurol. 2023;22:383–394
Footnotes
†Not represented in the bar chart.
‡Observed values; this outcome was not included in the hierarchical testing procedure.
Abbreviations
AChR Ab+, positive for autoantibodies against acetylcholine receptors; CFB, change from baseline; D, day; FcRn, neonatal Fc receptor; (g)MG, (generalised) myasthenia gravis; IgG, immunoglobulin G; IST, immunosuppressant; IVIg, intravenous immunoglobulin; LS, least squares; MG-ADL, Myasthenia Gravis Activities of Daily Living; MGC, Myasthenia Gravis Composite; MGFA, Myasthenia Gravis Foundation of America; MuSK Ab+, positive for autoantibodies against muscle-specific kinase; OLE, open-label extension; PD, pharmacodynamic; PK, pharmacokinetic; PLEX, plasma exchange; PRO, patient-reported outcome; QMG, Quantitative Myasthenia Gravis; RLZ, rozanolixizumab; TEAE, treatment-emergent adverse event; Wk, week.
References
1. Bril V, et al. Lancet Neurol. 2023;22:383–394.
This document summarises highlights from the MycarinG study publication and does not include the entirety of the results. For reactive use only to support discussions with healthcare professionals.
PBS information: Not listed on the PBS for the treatment of generalised myasthenia gravis
Please review the full Product Information before prescribing RYSTIGGO®. The full Product Information is available from UCB Australia here.
▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
AU-RZ-2400002
Date of preparation: December 2025