argenx Reports Topline P-III (ALKIVIA) Trial Data on Vyvgart Hytrulo in Autoimmune Myositis
Shots:
- The P-II/III (ALKIVIA) trial assessed Vyvgart Hytrulo (SC, QW) vs PBO PH20 (SC) for the treatment of pts (n=264) with autoimmune myositis across immune-mediated necrotizing myopathy (IMNM), dermatomyositis (DM) & PM
- The study met its 1EP, with Vyvgart Hytrulo delivering a 15.4-point greater improvement in mean TIS at Wk. 52 in IMNM & DM pts (47.95 vs 32.56). Benefits emerged by Wk. 4 & remained significant through the full year despite steroid tapering
- In IMNM, TIS improved by 14.8 points (45.05 vs 30.24), while DM showed a 14.5-point improvement (51.51 vs 36.96). All six TIS measures favored Vyvgart, incl. muscle strength, physical function & disease activity, with skin improvement also seen in DM
Ref: Globenewswire | Image: argenx | Press Release
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