Studies and patients
RA
Safety data were pooled from the upadacitinib global phase 3 development program for RA, which comprises SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-CHOICE, SELECT-MONOTHERAPY, and SELECT-BEYOND (Supplementary Table Of the six SELECT phase 3 trials in RA, LATAM patients were enrolled in every study except SELECT-BEYOND. In this analysis, raw safety data for all patients from six LATAM countries (Chile, Argentina, Brazil, Mexico, Guatemala, and Colombia) who received at least one dose of upadacitinib 15 mg QD were pooled and analyzed. This population was compared with the RoW population (with LATAM patients excluded), which included patients from North America, Eastern and Western Europe, and Asia who received at least one dose of upadacitinib 15 mg QD during any of the six SELECT phase 3 trials in RA. Patients who switched to upadacitinib from placebo (PBO), adalimumab (ADA), MTX, or abatacept (ABA) were included in the upadacitinib analysis set from the start of upadacitinib treatment. Data from patients receiving PBO, ADA, MTX, and ABA were not included in this analysis due to the small sample size in the LATAM population. Each phase 3 study had its own LTE period, where patients were followed up for a period of up to 10 years. The data cut-off date was June 30, 2020.All studies were conducted according to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use guidelines, applicable regulations and guidelines governing clinical study conduct, and the Declaration of Helsinki. Study-related documents were reviewed and approved by independent ethics committees and institutional review boards. All patients provided written informed consent before participation in the study.