REG-argenx to Present Phase 3 ALKIVIA Results in Autoimmune Myositis as a Late-Breaking Oral Presentation at ACR Convergence 2026
argenx announced that Phase 3 ALKIVIA data for VYVGART Hytrulo in autoimmune myositis will be presented as a late-breaking oral at ACR Convergence 2026 on November 11. The study met its primary endpoint: a 15.4-point greater mean Total Improvement Score versus placebo at Week 52 in the combined IMNM and DM population (47.95 vs 32.56; p=0.0011), with improvements visible by Week 4 and sustained through 52 weeks. The result gives argenx the first Phase 3 evidence of an FcRn blocker in myositis, where IMNM patients currently have no approved treatment options, and roughly 100,000 U.S. patients are affected.
Key figures
- Drug Name
- VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
- Phase Of Trial
- Phase 3
- P value
- 0.0011
- Tis placebo
- 32.56
- Tis treatment
- 47.95
- Patients randomized
- 265
- Us myositis patients
- 100000
- Tis difference vs placebo
- 15.4 points
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