argenx SE (ARGX), an immunology company, on Wednesday reported positive data for efgartigimod in autoimmune rheumatic diseases, including myositis and Sjogren's disease, ahead of presentations at the EULAR 2026 Congress in London.
In the ongoing ALKIVIA+ extension study in myositis, patients who continued efgartigimod treatment after the 24-week Phase 2 ALKIVIA trial, maintained functional improvements through 52 weeks. Among patients who had received efgartigimod throughout the study, 37.5% maintained major Total Improvement Score (TIS) improvement from week 24, and 33.3% of those who switched from placebo achieved similar major improvement. Mean TIS scores at week 52 were 52.19 and 49.62, respectively. The safety profile remained consistent, with no increase in adverse events over longer treatment periods.
Topline results from the Phase 3 ALKIVIA study are expected in the third quarter of 2026.
In Sjogren's disease, data from the 48-week RHO+ extension study showed that patients who continued efgartigimod maintained their response after switching to biweekly dosing, while those who transitioned from placebo experienced improvements in disease activity measures. At week 72, median ClinESSDAI scores remained low in both groups, indicating low disease activity. The treatment was well tolerated, with no new safety signals identified.
The Phase 3 UNITY trial evaluating efgartigimod in moderate-to-severe Sjogren's disease is ongoing, with topline results expected in the second half of 2027.
Efgartigimod, marketed as Vyvgart, is approved for Myasthenia Gravis in more than 30 markets worldwide, including the United States, the European Union, China, Canada, and Japan. It is also approved for chronic inflammatory demyelinating polyneuropathy (CIDP) in the United States, the European Union, and Japan.
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