Amgen Says Dazodalibep Met Primary Endpoint At Week 48

In the randomized, double-blind, placebo-controlled OASIZ-301 study, patients had a mean baseline score of 10.2 on the European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI), which measures systemic disease activity. Both dazodalibep dosing regimens (1,500 mg every four weeks and 3,000 mg every 12 weeks) met the primary endpoint at Week 48, demonstrating statistically significant reductions in systemic disease activity compared with placebo, as measured by the ESSDAI score. The 1,500 mg every four weeks regimen (n=217) showed a least-squares mean reduction of 5.6 points from baseline in ESSDAI score, compared with 3.8 points for placebo (difference of 1.8 points; adjusted p<0.001). The 3,000 mg every 12 weeks regimen (n=217) showed a reduction of 5.2 points, compared with 3.8 points for placebo (difference of 1.4 points; adjusted p=0.010). A treatment effect with dazodalibep was observed as early as Week 4 and sustained through Week 48.