Amgen presents Phase 3 data showing dazodalibep reduces systemic activity in Sjögren's disease
- OASIZ‑301 (n≈621) showed least‑squares mean ESSDAI changes at Week 48 of −5.6 (1,500 mg q4w) and −5.2 (3,000 mg q12w) versus −3.8 for placebo (differences −1.8, p<0.001; −1.4, p=0.010).
- Dazodalibep 1,500 mg q4w produced significant improvements in patient‑reported dryness: ESSPRI dryness −2.50 vs −1.33 (p<0.001) and DASPRI dryness −1.98 vs −1.05 (p<0.001).
- Treatment‑emergent adverse events, serious adverse events and discontinuations occurred at similar rates across dazodalibep and placebo groups.
- Amgen will present long‑term UPLIZNA data in IgG4‑RD and real‑world evidence for KRYSTEXXA and TAVNEOS; OASIZ‑303 is expected to complete in Q4 2026.
OASIZ‑301 Phase 3 results
Late‑breaking results from the randomized, double‑blind, placebo‑controlled OASIZ‑301 trial show dazodalibep reduced systemic disease activity in adults with Sjögren's disease and moderate‑to‑severe activity. At Week 48, least‑squares mean ESSDAI changes were −5.6 for 1,500 mg every four weeks and −5.2 for 3,000 mg every 12 weeks versus −3.8 for placebo; differences versus placebo were −1.8 (adjusted p<0.001) and −1.4 (adjusted p=0.010). Treatment effects were observed as early as four weeks.
Patient‑reported outcomes and safety
Key secondary endpoints showed clinically meaningful improvement in dryness for the 1,500 mg q4w regimen: ESSPRI dryness change −2.50 versus −1.33 for placebo (adjusted p<0.001) and DASPRI dryness change −1.98 versus −1.05 for placebo (adjusted p<0.001). Rates of treatment‑emergent adverse events, serious adverse events and TEAEs leading to discontinuation were reported as similar across treatment arms.
Broader program and conference agenda
Amgen will also present Phase 3 MITIGATE open‑label extension data on long‑term safety and sustained efficacy of UPLIZNA in IgG4‑related disease, and multiple real‑world and clinical analyses for KRYSTEXXA (pegloticase) in uncontrolled gout and TAVNEOS (avacopan) in ANCA‑associated vasculitis. Additional OASIZ studies include OASIZ‑303 (high symptom, low systemic cohort) expected to complete in Q4 2026 and an open‑label long‑term extension (OASIZ‑304).
Source: Amgen