Statistical analysis
PsA, TEAEs
EVENTS, EVENT
For this post-hoc analysis, efficacy endpoints were summarized for randomized patients who received at least one dose of trial drug. Data from patients treated with placebo, upadacitinib 15 mg, and adalimumab 40 mg (SELECT-PsA 1 only) at weeks 12 and 24 are presented, as well as placebo switched to upadacitinib 15 mg, continuous upadacitinib 15 mg, and adalimumab 40 mg (SELECT-PsA 1 only) at week 56. As upadacitinib 15 mg is the approved dose for patients with active PsA, [Continuous efficacy endpoints (change from baseline in overall BASDAI, modified BASDAI, individual BASDAI components, and ASDAS) were assessed using mixed-effect model for repeated measures (MMRM) analysis with unstructured variance–covariance matrix, including treatment, visit, treatment-by-visit interaction, and the stratification factor current DMARD use (yes/no) as fixed factors, and the continuous fixed covariate of baseline measurement. Least squares means with 95% confidence intervals (CIs) are provided for the continuous efficacy endpoints. The MMRM analysis for week 24 excluded data collected after premature discontinuation of the study drug. Binary efficacy endpoints (proportions of patients achieving BASDAI50, ASDAS ID, ASDAS LDA, ASDAS MI, and ASDAS CII) were analyzed using Cochran-Mantel–Haenszel tests adjusted for the main stratification factor of current DMARD use (yes/no). Binary efficacy endpoints are summarized as response rates with 95% CIs. Non-responder imputation (NRI) was used for missing data handling of binary endpoints. Differences between upadacitinib 15 mg and placebo at weeks 12 and 24 (SELECT-PsA 1 and SELECT-PsA 2), as well as upadacitinib 15 mg and adalimumab at weeks 12, 24, and 56 (SELECT-PsA 1 only), were based on nominal Exposure-adjusted event rates (EAERs; events per 100 patient-years) of TEAEs (with 95% CIs) are summarized for patients who received ≥ 1 dose of study drug through week 56 in SELECT-PsA 1 and SELECT-PsA 2. Data for upadacitinib 15 mg (including patients who were assigned to placebo at baseline and switched to upadacitinib 15 mg treatment at week 24) and adalimumab (SELECT-PsA 1 only) are shown across all sub-groups (ie, without axial involvement, with axial involvement defined by investigator judgement alone, or with axial involvement defined by investigator judgement and PRO-based criteria).