What type of study is this?

This is a RCT study (also classified as: Phase 3).

October 13, 2025Open Access

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

Key Points

All patients successfully self-administered rozanolixizumab, demonstrating 100% adherence to both methods.
Primary endpoint success included significant reductions in IgG levels and MG-ADL scores, confirming treatment efficacy.
Observational study compared two self-administration methods and found comparable safety profiles with high patient satisfaction.
Majority preferred manual push over infusion pump, highlighting individual preferences in self-administration methods.

Abstract

Abstract 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).

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