Efficacy
tender joints
DISEASE
At week 1 (day 8), 11.1% (3.11%, 26.06%) of subjects achieved ACR20 and 2.8% (0.07%, 14.53%) of subjects achieved ACR50 response rates, while in the placebo group the ACR20 and ACR50 response rates were 22.2% (2.81%, 60.01%) and 0 (0.00, 33.63%), respectively. A gradual increase in ACR20 and ACR50 response rates was observed from week 4 (day 29) in the overall population but no substantial change in the placebo group. At week 24 (day 169), the ACR20 and ACR50 response rates for the overall study population were 38.9% (95% CI: 23.14, 56.54) and 8.3% (95% CI: 1.75, 22.47), respectively, while in the placebo group the rates were 0 (95% CI: 0.00, 33.63) and 0 (95% CI: 0.00, 33.63), respectively (
With WBP216 treatment, the number of subjects with DAS28 scores ≤2.6 increased while the number of subjects with DAS28 scores ≥5.1 decreased, with no substantial change in the placebo group. At week 24 (day 169), 6 subjects (16.7%) had DAS28 scores ≤2.6, 4 subjects (11.1%) had DAS28 scores >2.6 and ≤ 3.2, 15 subjects (41.7%) had DAS28 scores > 3.2 and ≤ 5.1, and 2 subjects (5.6%) had DAS28 scores > 5.1 (Summary of DAS28 disease activity: Efficacy analysis set.Baseline means last non-missing value before first dose.Physician’s global assessment of disease activity scores and number of swollen and tender joints decreased from baseline in the WBP216 groups and slightly decreased from baseline in the placebo group. The subject’s global assessment of disease activity score also decreased from baseline in WBP216 groups, but increased in the placebo group.