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A post hoc subgroup analysis compared TNFi-IR patients receiving upadacitinib 15 mg once daily in 3 Phase 3 clinical trials: SELECT-BEOYND, SELECT-CHOICE, and SELECT-COMPARE.
Patients with rheumatoid arthritis (RA) and an inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR) treated with upadacitinib (UPA) 15 mg attained clinically meaningful efficacy responses by week 24, according to the study “Efficacy and Safety of Upadacitinib in TNFi-IR Patients with Rheumatoid Arthritis from Three Phase 3 Clinical Trials,” presented at the American College of Rheumatology Convergence 2022. Safety was comparable with patients who had inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs-IR) in the Phase 3 program.
“For patients with RA who are refractory to bDMARDs, such as TNFis, optimal disease control is less likely to be achieved with subsequent therapy,” Roy Fleischmann, MD, and colleagues, stated. “In line with recommendations from European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology (ACR), switching to a treatment with a different mechanism of action is appropriate for these patients.”
A post hoc subgroup analysis compared TNFi-IR patients receiving UPA 15 mg once daily in 3 Phase 3 clinical trials: SELECT-BEOYND, SELECT-CHOICE, and SELECT-COMPARE. In the COMPARE cohort, only patients who were originally treated with adalimumab and subsequently switched to UPA as rescue therapy were included in the analysis.
Efficacy was evaluated using improvements in ACR criteria (ACR ≥20/50/70%), Clinical Disease Activity Index (CDAI), Simple Disease Activity Index (SDAI), and Disease Activity Score-28 for RA with C-reactive protein (DAS28-CRP). Changes in baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) and patient-reported outcomes (PROs) were recorded through week 24 and safety measures, presented as exposure-adjusted event rates (EAERs), were accounted for.
In total, 568 TNFi-IR patients were included in the analysis (263 from CHOICE, 159 from COMPARE, and 146 from BEYOND). The mean duration since diagnosis was longer for both BEYOND and CHOICE when compared with the COMPARE group.
ACR20/50/70 and disease activity outcomes in the TNFi-IR cohort were similar to the BEYOND and CHOICE bDMARD-IR groups, as well as across all 3 studies regarding the TNFi-IR subgroups. Improvements in PROs, such as fatigue, pain, morning stiffness, and HAQ-DI were also observed over the 24-week period.
Pooled safety results of 1574.8 patient years (PY) of exposure in the TNFi-IR subgroup were comparable with the bDMARD-IR patients in the BEYOND and CHOICE studies. EAERs reported 3.1 events per 100 PY for herpes zoster and 0.8 events per 100 PY regarding adjudicated major adverse cardiovascular events and venous thromboembolism. AEs that led to death were 1.4 events per 100 PY.