Long-term use of rozanolixizumab in generalised myasthenia gravis: final pooled analysis of the phase III MycarinG study and two open-label extensions
Abstract
Background: Myasthenia gravis (MG) is a rare autoimmune disease characterised by fluctuating and fatigable muscle weakness. In the randomised, double-blind phase III MycarinG study, one 6-week rozanolixizumab cycle significantly improved MG-specific outcomes versus placebo and was generally well tolerated in patients with generalised MG (gMG).
Objectives: To assess the efficacy and safety of cyclic rozanolixizumab treatment.
Design: A pooled analysis of the MycarinG, MG0004 and MG0007 studies.
Methods: Following MycarinG, eligible patients could enrol in the open-label extension studies MG0004 or MG0007 to receive rozanolixizumab 7 or 10 mg/kg. In MG0004, patients received chronic weekly treatment for ⩽52 weeks. In MG0007, after an initial 6-week treatment cycle, subsequent cycles were based on symptom worsening (investigator's discretion). Final efficacy data were pooled across MycarinG, MG0004 (first 6 weeks) and MG0007 for patients receiving ⩾2 symptom-driven cycles. Efficacy endpoints included change from baseline (CFB) in MG Activities of Daily Living (MG-ADL), MG Composite (MGC) and Quantitative MG (QMG) scores. Safety outcomes were assessed in patients who received ⩾1 cycle with a ⩽8-week follow-up period across MycarinG and MG0007.
Results: Overall, 188 patients received ⩾1 cycle and 129 received ⩾2 symptom-driven cycles. Across Cycles 1-13, mean (standard deviation) CFB to Day 43 in MG-ADL score ranged from -3.2 (3.3 (n = 113; Cycle 3)) to -6.0 (3.9 (n = 24; Cycle…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 188 participants or records.
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