argenx to Present Phase 3 ALKIVIA Results in Autoimmune Myositis as a Late-Breaking Oral Presentation at ACR Convergence 2026
argenx announced Phase 3 ALKIVIA results showing efgartigimod met its primary endpoint in autoimmune myositis, with a 15.4-point greater mean Total Improvement Score versus placebo at Week 52 (47.95 vs 32.56, p=0.0011) in the combined IMNM and DM population. Improvements appeared as early as Week 4 and were sustained through 52 weeks even with corticosteroid tapering, and the safety profile was consistent with prior studies. The data will be presented as a late-breaking oral at ACR Convergence 2026 on November 11.
Key figures
- Drug Name
- VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
- Phase Of Trial
- Phase 3
- Presentation
- Late-breaking oral #LB24 at ACR Convergence 2026, Nov 11
- Patients randomized
- 265
- Us myositis patients
- approximately 100,000
- Phase3 patients treated
- 175
- Primary endpoint result
- 15.4-point greater mean TIS improvement vs placebo at Week 52 (47.95 vs 32.56, p=0.0011)
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