To assess successful self-administration, efficacy and safety of rozanolixizumab using manual push (MP) and syringe driver (SD) methods in patients with generalized myasthenia gravis (gMG).

Rozanolixizumab, indicated for the treatment of adults with gMG, is currently administered by healthcare professionals (HCPs) using programmable SDs. Options for patients to self-administer rozanolixizumab are of clinical interest; MP and SD are potential self-administration methods.

In the Phase 3, open-label, randomized, crossover MG0020 study (NCT05681715), adults with gMG received once-weekly rozanolixizumab (weight-tiered dosing or 7 mg/kg) for 18 weeks, comprising a 6-week training period and two 6-week self-administration periods where patients were randomized 1:1 to Sequence 1 (SD then MP) or Sequence 2 (MP then SD) to self-administer at clinic and at home. Primary endpoint: successful self-administration of rozanolixizumab (choosing correct infusion site, administering subcutaneously and delivering intended dose) evaluated by an HCP at Weeks 12 and 18. Secondary endpoints included occurrence of treatment-emergent adverse events (TEAEs). Additional endpoints included change from baseline in total IgG and MG Activities of Daily Living (MG-ADL) score.

62 patients received treatment; 55 were randomized to Sequence 1 (n=28) or Sequence 2 (n=27). The rozanolixizumab self-administration success rate was 100%; all patients successfully self-administered with MP or SD at clinic and at home. Decreases from baseline in median total IgG and mean MG-ADL score were observed at Week 7 and maintained during self-administration. TEAEs occurred in 75.8% (47/62) of patients; the most common TEAE was headache (21.0% [n=13]). Incidence of TEAEs was comparable for both self-administration methods (31.5% [n=17; SD] and 34.0% [n=18; MP]). Most TEAEs (97.6% [161/165 events]) were mild/moderate.