Amgen announces positive Phase 3 results for dazodalibep in Sjögren's disease
AMGN•Amgen said dazodalibep met the primary endpoint at week 48 in a global Phase 3 trial. The 1,500 mg regimen reduced ESSDAI scores by 5.6 points versus 3.8 for placebo, with adjusted p<0.001.
1. Trial results
Dazodalibep regimens met the primary endpoint at week 48, reducing disease activity in patients with Sjögren's disease. The 1,500 mg regimen showed a 5.6-point ESSDAI reduction versus 3.8 points for placebo, with adjusted p<0.001.
2. Safety and other findings
Serious adverse events and discontinuations were balanced across treatment groups. Amgen reported greater increases in stimulated salivary flow versus placebo, no imbalance in thromboembolic events or infections, and low, comparable malignancy rates.
