Argenx presents new efgartigimod data at EULAR 2025

Rheumatology studies show promising results for Sjogren’s disease

Argenx has presented positive phase 2 results for efgartigimod in myositis and Sjogren’s disease at EULAR 2025. The company also announced the US FDA has granted Fast Track designation for efgartigimod in primary Sjogren’s disease.

Data from the ALKIVIA study showed significant improvements in muscle strength and physical function in myositis patients treated with efgartigimod. The treatment led to a significantly higher Total Improvement Score compared to placebo, with 79% of patients achieving moderate improvement and 34% achieving major improvement.

Patients receiving efgartigimod improved significantly faster than placebo-treated patients, reaching minimal improvement within 30 days and moderate improvement within 16 weeks. The drug was well-tolerated, with a comparable rate of treatment-emergent adverse events in both arms of the study.

Dr Hector Chinoy, ALKIVIA study investigator and Professor of Rheumatology and Neuromuscular Disease at The University of Manchester said: “Results from this study, the first of an FcRn inhibitor in myositis, demonstrate the potential of a transformative targeted treatment approach.”

In Sjogren’s disease, findings from the phase 2 RHO study showed efgartigimod achieved sustained autoantibody reductions and improved functional outcomes. 45.5% of treated patients showed improvement across key measures, compared to 11.1% of placebo-treated patients.

Efgartigimod demonstrated a favourable safety profile, with no new safety signals observed. The phase 3 UNITY trial is ongoing to further assess its efficacy and safety in moderate to severe Sjogren’s disease.

Argenx remains committed to advancing efgartigimod in rheumatology, with ongoing phase 3 studies in both conditions and further clinical developments expected.