Self-administration of rozanolixizumab via manual push and infusion pump methods in patients with generalised myasthenia gravis: a randomised, phase 3, open-label, crossover study.
Bril V., Antozzi C., Berkowicz T., Drużdż A., Gandhi Mehta RK., Mahuwala ZK., Zschüntzsch J., Boehnlein M., Kerbusch V., Lavrov A., Morris M., Singh P., Leite MI.
BACKGROUND: The phase 3, open-label, randomised, crossover MG0020 study investigated rozanolixizumab self-administration, efficacy, and safety in patients with generalised myasthenia gravis (gMG) using infusion pump and manual push methods. METHODS: Adults with gMG received once-weekly rozanolixizumab for 18 weeks, comprising a 6-week Training Period and two 6-week Self-Administration Periods where patients were randomised 1:1 to Sequence 1 (infusion pump then manual push) or Sequence 2 (manual push then infusion pump). The primary endpoint was successful rozanolixizumab self-administration (choosing correct infusion site, administering subcutaneously, delivering intended dose), evaluated by a healthcare professional (HCP) at weeks 12 and 18. Secondary endpoints included treatment-emergent adverse events (TEAEs). Additional endpoints included change from baseline in total immunoglobulin G (IgG) and Myasthenia Gravis Activities of Daily Living (MG-ADL) score, and patients' administration method preference. RESULTS: Sixty-two patients received treatment; 55 were randomised (Sequence 1: n = 28; Sequence 2: n = 27). The self-administration success rate was 100% with both methods. Decreases from baseline in IgG and MG-ADL score were maintained during self-administration with both methods. TEAEs occurred in 47/62 (75.8%) patients; most events (161/165 [97.6%]) were mild or moderate. Incidence was comparable for both methods. Most patients (35/55 [63.6%]) preferred self-administration to HCP administration (5/55 [9.1%]); more preferred manual push (25/55 [45.5%]) to infusion pump (17/55 [30.9%]). CONCLUSIONS: All patients successfully self-administered rozanolixizumab; more patients preferred manual push. Efficacy and safety were consistent with the known HCP-administered profile. These results support rozanolixizumab self-administration and manual push administration in patients with gMG. TRIAL REGISTRATION: NCT05681715 (registered 4 January 2023).