Clinical TrialJun 3, 2026, 01:01 AM
Argenx efgartigimod shows sustained improvement in myositis, Sjogren's
AI Summary
Argenx announced new data at EULAR 2026 for efgartigimod in autoimmune rheumatic diseases, including myositis and Sjogren's disease. The ALKIVIA+ open-label extension study in myositis showed sustained, clinically meaningful improvements and a consistent safety profile through 52 weeks. The RHO+ open-label extension study in Sjogren's disease indicated maintenance of response following a switch to biweekly dosing. A cross-indication analysis reinforced efgartigimod's consistent safety profile across a large patient population.
Key Highlights
- ALKIVIA+ (myositis) showed 37.5% of continuous efgartigimod patients maintained major TIS improvement at 52 weeks.
- 33.3% of myositis patients switching from placebo to efgartigimod achieved major TIS improvement at 52 weeks.
- Mean TIS was 52.19 for continuous efgartigimod and 49.62 for switch patients in myositis at 52 weeks.
- RHO+ (Sjogren's disease) showed maintenance of response with biweekly dosing and improvements for switch patients.
- Median ClinESSDAI scores were low (2.5 and 2.0) at Week 72 in Sjogren's disease patients.
- Efgartigimod demonstrated a consistent and well-tolerated safety profile across 834 patients and >1,300 patient-years.
- Topline results for Phase 3 ALKIVIA (myositis) are expected in Q3 2026.
- Topline results for Phase 3 UNITY (Sjogren's disease) are expected in H2 2027.
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