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argenx Presents Phase 3 ALKIVIA Data at ACR Convergence 2026 Showing Rapid and Sustained Improvement with Efgartigimod in Autoimmune Myositis

ARGX
  • argenx announced that the Phase 3 ALKIVIA study met its primary & key secondary endpoints in patients with immune-mediated necrotizing myopathy (IMNM) & dermatomyositis (DM).
  • The study demonstrated a statistically significant 15.4-point greater improvement in mean Total Improvement Score (TIS) at Week 52 for the combined IMNM & DM population treated with efgartigimod versus placebo.
  • IMNM patients showed a clinically meaningful 14.8-point greater TIS improvement versus placebo, representing potential first approved treatment for this subtype which currently has no therapies.
  • IMNM patients treated with efgartigimod had twice the likelihood of maintaining a TIS of 40 or more through Week 52 compared to placebo.
  • Muscle strength improvements in the IMNM cohort were measured by a 5.4-point greater gain in Manual Muscle Testing-8 (MMT-8) versus placebo.
  • Creatine kinase (CK) levels decreased rapidly in IMNM patients, showing a 43.5 percentage-point greater reduction from baseline versus placebo as a biomarker of muscle injury.
  • In the DM population, efgartigimod showed a 14.5-point greater TIS improvement versus placebo, though statistical significance was not reached due to the smaller cohort size.
  • DM patients experienced a 5.6-point greater improvement in skin disease severity measured by the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) versus placebo.
  • argenx plans to submit a Supplemental Biologics License Application (sBLA) to the U.S. FDA for efgartigimod in IMNM by the end of 2026, supported by Breakthrough Therapy Designation.
  • Data from the study will be presented as a late-breaking oral presentation at the American College of Rheumatology (ACR) Convergence 2026 on November 11, 2026.
  • Efgartigimod was generally well tolerated, with a safety profile consistent with prior studies & the known profile of the drug.
  • The ALKIVIA trial was a global, randomized, double-blind, placebo-controlled study involving 265 patients with active autoimmune myositis on background treatment.
Company
argenx SE
Keywords
Brussels Stock Exchange:ARGX, argenx SE