Analyzing Phase 2/3 ALKIVIA Study of Efgartigimod to Treat Inflammatory Myopathies: Nicholas Streicher, MD, MPH

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“For inflammatory myopathy, we traditionally treated patients with steroids, IVIG, oral immune suppression, and sometimes B-cell depleters. Now, this study demonstrates potential efficacy based on the phase 2/3 data of efgartigimod in inflammatory myopathy. The important takeaway is that there is another mechanistic way to treat these diseases—using IVIG depletion through efgartigimod, which targets the FcRn."

Idiopathic inflammatory myopathy (IIM) is a rare, systemic autoimmune rheumatic disease characterized by muscle weakness and potential extramuscular involvement across several clinical subtypes. Currently, there are no therapies specifically approved for the treatment of different IIM subtypes. The ALKIVIA trial (NCT05523167), a phase 2/3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study, tests the efficacy and safety of efgartigimod (Vyvgart; argenx) in adults with IIM.¹

In the phase 2 portion of the trial, 89 participants were randomly assigned in a 1:1 ratio to receive weekly subcutaneous efgartigimod PH20 or placebo, in addition to standard-of-care treatment. The primary end point was the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology Total Improvement Score at 24 weeks, Manual Muscle Testing-8, the Health Assessment Questionnaire Disability Index, muscle enzyme levels, and extramuscular global disease activity. Neurologist Nicholas Streicher, MD, MPH, recently presented the findings from ALKIVIA at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, held March 9-11, in Orlando, Florida.

To learn more about the study results, Streicher, an assistant professor in neurology at Georgetown University, MedStar Health, spoke with NeurologyLive^®. In the conversation, he noted how while historically IIMs have been managed with steroids, IVIG, oral immunosuppressants, and B cell depleters, these conditions may now benefit from FcRn-mediated IgG depletion. The discussion also touched on the broader challenge of optimizing the treatment landscape across neuromuscular diseases, including coordinating care between neurology and rheumatology. Furthermore, he talked about ensuring that the right patients receive the right treatments in a clinically responsible manner.

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REFERENCES
1. Aggarwal R, Siluk T, Rodriguez-Garcia SC, et al. Efficacy and Safety of Efgartigimod Ph20 Sc in Adult Participants with Active Idiopathic Inflammatory Myopathy: Phase 2 Results from the ALKIVIA Study. Presented at: MDA Clinical & Scientific Conference; March 8-11, 2026; Orlando, Florida. Abstract 408 O.