Amgen (NASDAQ: AMGN) will showcase new data on its portfolio of treatments for rare and serious autoimmune diseases at the American College of Rheumatology (ACR) Convergence 2026. The company will present late-breaking results from the Phase 3 OASIZ-301 study of dazodalibep, a potential first-in-class CD40L antagonist, in patients with Sjögren's disease. The study showed statistically significant and clinically meaningful improvements in systemic disease activity and patient-reported dryness compared to placebo.
Patients in the OASIZ-301 study had an average European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of 10.2 at baseline. After 48 weeks, both dosing regimens of dazodalibep (1,500 mg every four weeks and 3,000 mg every 12 weeks) demonstrated reductions in disease activity scores. The least-squares mean change from baseline was -5.6 points for the every-four-weeks group (difference vs placebo, −1.8; adjusted p<0.001) and -5.2 points for the every-12-weeks group (difference vs placebo, −1.4; adjusted p=0.010), compared with -3.8 points for placebo.
Dazodalibep also showed improvements in patient-reported dryness, as measured by the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) dryness score and the Diary for Assessing Sjögren's Patient Reported Index (DASPRI) dryness score. Treatment emergent adverse events, serious adverse events, and TEAEs leading to discontinuation were observed at similar rates across treatment groups. Dr. Teresa K. Tarrant, MD, Associate Professor of Medicine at Duke University, highlighted the significance of these findings for managing Sjögren's disease.
In addition to dazodalibep, Amgen will present data on the long-term safety and efficacy of UPLIZNA in IgG4-related disease, as well as real-world evidence for KRYSTEXXA and TAVNEOS in uncontrolled gout and ANCA-associated vasculitis, respectively. Paul Burton, M.D., Ph.D., senior vice president and chief medical officer at Amgen, emphasized the company's commitment to addressing unmet needs in rare and serious autoimmune diseases.