The European Alliance of Associations for Rheumatology (EULAR) Annual Congress 2025, held in Barcelona, showcased groundbreaking advances in autoimmune disease research and therapy. From novel biologics and dual-pathway inhibitors to precision medicine and Artificial Intelligence (AI)-driven diagnostics, the meeting underscored a shift toward more personalized, effective, and safer treatment strategies. Below are the most impactful developments presented at the congress.
1. Dapirolizumab Pegol in SLE
The PHOENYCS GO phase 3 trial, sponsored by UCB and Biogen, demonstrated that dapirolizumab pegol (DZP), when added to standard care, significantly improved disease activity and fatigue in patients with moderate-to-severe systemic lupus erythematosus (SLE). Notably, more patients achieved low disease activity and remission compared to standard care alone. The safety profile was favorable, with fewer serious adverse events in the DZP group, reinforcing its potential as a promising therapeutic option in SLE management.
2. Efgartigimod in Myositis and Sjögren’s Disease
Efgartigimod showed encouraging results in phase 2 trials for both idiopathic inflammatory myopathies (ALKIVIA study) and Sjögren’s disease (RHO study), both funded by Argenx. In myositis, it significantly improved muscle strength and function, with a rapid onset of action. In Sjögren’s, nearly half of the treated patients met the composite efficacy endpoint, with sustained reductions in IgG and autoantibodies. These findings support continued development in phase 3 trials.
3. CPL’116 in Rheumatoid Arthritis
CPL’116, a dual JAK/ROCK inhibitor, demonstrated dose-dependent efficacy in reducing disease activity and joint counts in patients with rheumatoid arthritis (RA) who had inadequate response to methotrexate. The 240 mg dose was particularly effective, with over 45% achieving remission. Importantly, the treatment did not adversely affect lipid or creatine kinase levels, suggesting a potentially safer profile compared to traditional JAK inhibitors.
4. Sonelokimab in Psoriatic Arthritis
The ARGO phase 2 trial, sponsored by MoonLake Immunotherapeutics, highlighted the multidomain efficacy of sonelokimab, a Nanobody targeting IL-17A and IL-17F, in psoriatic arthritis. A majority of patients achieved minimal disease activity, with strong joint and skin responses, including high rates of ACR70 and PASI 100. The drug was well tolerated, with no major safety concerns, supporting its continued evaluation in phase 3 studies.
5. Precision Medicine and Biomarkers
EULAR 2025 emphasized the role of biomarkers in personalizing autoimmune disease treatment. Synovial fluid analysis in RA, AI-driven spatial mapping in lupus nephritis, and new risk stratification criteria for pre-RA and pediatric CNO are paving the way for targeted interventions. Additionally, identification of “rituximab super-responders” in SLE suggests that biomarker-guided therapy could optimize outcomes and reduce treatment burden.
6. AI and Digital Tools in Autoimmune Research
AI emerged as powerful tools reshaping autoimmune clinical trials. In imaging, AI-assisted HRCT analysis in systemic sclerosis (SSc) and deep learning models for MRI in axial spondyloarthritis demonstrated superior diagnostic precision, while AI-driven ultrasound improved lesion classification in giant cell arteritis. Remote monitoring also advanced, with the Mefisto study validating smartphone-based motion capture as a digital biomarker for RA. Machine learning models predicted cancer risk in SSc, and large language models showed promise in osteoporosis triage. Additionally, a pilot study introduced a social robot to support patient communication. Collectively, these innovations support more decentralized, efficient, and personalized trial models, signaling a new era in autoimmune research.
7. CAR-T and Next-Generation Cell Therapies
Cell therapies, particularly CAR-T, are emerging as transformative options in autoimmune diseases. The RESET program showed that CD19 CAR-T therapy induced drug-free remission in conditions like SLE, myositis, and SSc. New platforms, including iPSC-derived and in vivo CAR-T technologies (which was not presented at EULAR 2025), are advancing rapidly, offering scalable and potentially safer alternatives. These therapies may redefine long-term disease control by resetting immune tolerance.
EULAR 2025 highlighted a transformative era in autoimmune disease management, driven by biologic innovation, dual-pathway targeting, precision diagnostics, and digital integration. These advances promise not only improved outcomes but also more personalized and accessible care for patients worldwide.
About the Author
Dr. Juan Ovalles, M.D., Ph.D.
Dr. Ovalles is the Senior Director of Rheumatology at Indero, providing medical leadership and strategic guidance in rheumatology research. He collaborates with business development, supports operational and regulatory teams, and builds relationships with key stakeholders. With over 12 years of clinical development experience, he began his career as an investigator in 2012 and transitioned to the CRO industry in 2021. A board-certified rheumatologist with a PhD in biomedical sciences, he specializes in innovative therapies for immune-mediated inflammatory diseases.
