Therapeutic Potential of Self-Administered Subcutaneous Rozanolixizumab in Myasthenia Gravis: Rachana K. Gandhi Mehta, MBBS

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"If patients would have more self-administration options for rozanolixizumab, they can do infusions on their own, without relying on nurses or going to the infusion center. It’s really, really innovative, and I think it’s really cool."

Rozanolixizumab is a humanized high-affinity, anti-human neonatal Fc receptor (FcRn) monoclonal antibody targeting the immunoglobulin G. In mid-2023, the FDA approved the agent as a treatment for adults with generalized myasthenia gravis (gMG) who are either anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive, the most common subtypes of gMG. With the approval, it became the first marketed treatment to treat both subtypes of the disease.

MG0020, a phase 3, open-label, randomized, crossover study, is a new innovative trial that tests whether patients can safely self-administer rozanolixizumab using a syringe driver and manual push method. To date, 75 patients with gMG have been screened and 55 were randomized. In the study, patients receive once-weekly rozanolixizumab for 18 consecutive weeks consisting of a 6-week self-administration training period followed by two 6-week self-administration periods. After training, patients are randomly assigned 1:1 to the syringe driver or manual push self-administration method, subsequently crossing over to the alternative method.

The design of the trial was presented at the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) meeting, held October 15-18, in Savannah, Georgia, by lead author Rachana K. Gandhi Mehta, MBBS. Mehta, an assistant professor of neurology at the Wake Forest University School of Medicine, sat down with NeurologyLive® during the meeting to discuss the study and its unique build. She provided clinical insight on how the study came to be and the advantages the syringe driver may bring. Furthermore, Mehta commented on how this study speaks to the progress in treating patients with gMG.

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REFERENCES
1. Mehta RG, Bril V, Antozzi C, et al. Self-administration of subcutaneous rozanolixizumab in patients with generalized myasthenia gravis: clinical study design. Presented at: 2024 AANEM Annual Meeting; October 15-18; Savannah, GA. ABSTRACT 164