*p≤0.001 vs placebo, statistically significant in the multiplicity-controlled analysis.
†p≤0.001 vs adalimumab for non-inferiority, statistically significant in the multiplicity-controlled analysis.
‡Nominal p≤0.001 vs placebo.3 #Nominal p≤0.05 vs adalimumab.3 §Not significant (nominal p=0.06) vs adalimumab.3
Nominal p-values denote data not controlled for multiplicity. No clinical inferences can be drawn.
Superiority vs adalimumab in ACR20 at Week 12 could not be demonstrated.1,3 At Week 24, all patients randomised to placebo were switched to RINVOQ 15 mg or 30 mg QD in a blinded manner. The approved dose of RINVOQ is 15 mg once daily. Upadacitinib 30 mg QD is not an approved dose.
ACR20/50/70: American College of Rheumatology 20%/50%/70% improvement in both tender and swollen joint counts plus three of the following patient assessments of pain global disease activity and physical function physician global assessment of disease activity and acute phase reactant (high sensitivity C-reactive protein).
DATA LIMITATIONS: Data not labelled as a primary or ranked secondary endpoint were prespecified but not controlled for multiplicity. Nominal p-values are provided where available. Treatment differences could represent chance findings. No clinical conclusions can be made from these comparisons. Missing data were handled using NRI.