Statistical analysis
MAY, EVENT, EVENTS
Efficacy analyses were performed at 52 weeks on all randomized patients who received ≥ 1 dose of study drug. No statistical comparisons were performed between the treatment groups (continuous upadacitinib versus placebo to upadacitinib).For binary efficacy endpoints, non-responder imputation with multiple imputation (NRI-MI) and as observed (AO) analyses are presented. In the NRI-MI analysis, patients who prematurely discontinued study drug (including those who did not enter open-label extension) or were rescued were considered non-responders; MI was used to handle missing data due to COVID-19.For continuous efficacy endpoints, estimated change from baseline from mixed-effects model repeated measures (MMRM) and AO data are reported. MMRM included the categorical fixed effects of treatment, visit, and treatment-by-visit interaction as fixed factors and baseline value as covariate, and stratification factor of screening high-sensitivity C-reactive protein level (≤ upper limit of normal [ULN] vs > ULN).To better understand the efficacy of upadacitinib in clinically relevant subgroups, post hoc analyses for efficacy endpoints at week 52 were performed in subgroups of patients who had discontinued a prior bDMARD due to lack of efficacy versus intolerance, and patients with prior TNFi exposure versus prior IL-17i exposure, respectively.The safety analysis set included all patients who received ≥ 1 dose of upadacitinib 15 mg QD at any point in the study. Safety outcomes were assessed up to the cut-off date of May 19, 2022. Exposure-adjusted event rates (events per 100 patient-years [E/100 PY]) are reported.