Clinical TrialJun 3, 2026, 07:21 AM
Argenx Efgartigimod Shows Long-Term Benefit in Myositis & Sjogren's
AI Summary
Argenx presented new efgartigimod data at EULAR 2026, demonstrating long-term sustained patient benefit and a consistent safety profile in myositis and Sjogren's disease. The ALKIVIA+ open-label extension study showed sustained clinically meaningful improvements in myositis patients, with 37.5% maintaining major TIS improvement at 52 weeks. The RHO+ study indicated maintenance of response in Sjogren's disease patients following a switch to biweekly dosing, with low median ClinESSDAI scores at Week 72. A cross-indication safety analysis reinforced efgartigimod's well-tolerated profile across multiple autoimmune rheumatic diseases.
Key Highlights
- ALKIVIA+ (myositis): 37.5% of continuous efgartigimod patients maintained major TIS improvement at Week 52.
- ALKIVIA+ (myositis): 33.3% of placebo-to-efgartigimod patients achieved major TIS improvement at Week 52.
- ALKIVIA+ (myositis): Mean TIS of 52.19 (continuous) and 49.62 (switch) at Week 52.
- RHO+ (Sjogren's): Median ClinESSDAI scores of 2.5 (continuous) and 2.0 (switch) at Week 72.
- Efgartigimod safety profile consistent across 834 patients and over 1,300 patient-years.
- Phase 3 ALKIVIA (myositis) topline results expected in Q3 2026.
- Phase 3 UNITY (Sjogren's) topline results expected in H2 2027.
Price Impact
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