For subjects with baseline presence of dactylitis (LDI>0, n=126, 127, and 136, respectively, for placebo, adalimumab, and RINVOQ).
#RINVOQ 15 mg did not meet superiority vs adalimumab for ACR20 response, thus statistical vs placebo regarding proportion of patients achieving resolution of dactylitis could not be tested under the hierarchical analysis plan.
The percentage in brackets show 95% confidence interval.
Subjects rescued at Week 16 were imputed as nonresponders in the resolution of enthesitis and dactylitis at Week 24.
DATA LIMITATIONS: Data not labeled as a ranked primary or secondary endpoint were prespecified nonranked endpoints not controlled for multiplicity with nominal P-values; therefore, treatment differences could represent chance findings. No conclusions regarding these comparisons can be made. Missing data were handled using NRI.
BSA: body surface area; csDMARD: conventional synthetic disease-modifying antirheumatic drug; EOW: every other week; LDI: Leeds Dactylitis Index; LEI: Leeds Enthesitis Index; NRI: nonresponder imputation; PASI 75: Psoriasis Area and Severity Index 75% improvement; QD: once daily.