Introduction:
The MycarinG (MG0003/NCT03971422) Phase 3 study demonstrated efficacy and safety of one 6-week cycle of rozanolixizumab in adults with generalized myasthenia gravis (gMG). Patients were enrolled in open-label extension MG0007 to evaluate long-term safety of repeated treatment cycles.
Objective:
To evaluate consistency of safety of repeated rozanolixizumab treatment cycles.
Methods:
Interim safety data were pooled for patients receiving ≥1 rozanolixizumab treatment cycle across MycarinG and MG0007.
Results:
188 patients received ≥1 cycle of rozanolixizumab 7mg/kg (cycle 1, n=94) or 10mg/kg (cycle 1, n=94). Treatment-emergent adverse events (TEAEs; most mild-to-moderate) occurred in 89.9% (169/188) overall, and 77.4% (103/133) and 91.6% (120/131) receiving rozanolixizumab 7mg/kg or 10mg/kg. TEAEs occurred in 78.2% (147/188), 69.9% (100/143), 59.3% (67/113), 57.6% (53/92), 73.0% (46/63) and 65.1% (28/43) of patients in Cycles 1–6, respectively. Incidence of common, severe and serious TEAEs and TEAEs leading to discontinuation did not increase with additional treatment cycles. The most common TEAEs across all cycles were headache (46.3%), diarrhea (28.7%), pyrexia (18.1%) and nausea (14.9%). Infection (45.2%) and headache incidence did not increase across cycles. Overall, 22.3% (42/188) patients reported serious TEAEs. Serious TEAEs occurring in >1 patient were MG (6.4%), MG crisis (2.1%) and COVID-19 (1.6%). At data cut-off, four deaths had occurred during MG0007, all deemed unrelated to rozanolixizumab by investigators. With repeated cycles no clinically meaningful reductions in albumin or lipid levels from baseline were observed.
Conclusions:
Rozanolixizumab was well tolerated in patients with gMG and had an acceptable safety profile that was consistent across repeated treatment cycles.
Funding: UCB Pharma. These data were previously presented at AANEM, November 1–4, 2023.