Patient-Reported Outcomes of Upadacitinib Versus Abatacept in Patients with Rheumatoid Arthritis and an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: 12-Week Results of a Phase 3 Trial

Abstract Background In previous clinical trials, patients with active rheumatoid arthritis (RA) treated with upadacitinib (UPA) have improved patient-reported outcomes (PROs). This post hoc analysis of SELECT-CHOICE, a phase 3, double-blind, randomized clinical trial evaluated the impact of UPA vs abatacept (ABA) with background conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) on PROs in patients with RA who have inadequate response or intolerance to biologic DMARDs (bDMARD-IR).Methods: Patients in SELECT-CHOICE received UPA (oral 15 mg once daily) or ABA (intravenous). PROs evaluated included Patient Global Assessment of Disease Activity (PtGA) by visual analog scale (VAS), patient’s assessment of pain by VAS, Health Assessment Questionnaire Disability Index (HAQ-DI), duration and severity of morning stiffness, 36-Item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Impairment (WPAI), and EQ-5D 5-Level (EQ-5D-5L) index score. Least squares mean (LSM) changes from baseline to week 12 were based on an analysis of covariance model. Proportions of patients reporting improvements ≥ minimal clinically important differences (MCID) were compared using chi-square tests.Results: Data from 612 patients were analyzed (UPA, n=303; ABA, n=309). Mean age was 56 years and mean disease duration was 12 years. Thirty-two percent received >1 bDMARD and 72% received concomitant methotrexate at baseline. At week 12, UPA treatment showed significantly greater improvements than ABA treatment in PtGA, pain, HAQ-DI, morning stiffness severity, EQ-5D-5L, WPAI activity impairment domain, and 3/8 SF-36 domains and physical component summary (PCS) scores (P<0.05). Significantly more UPA- vs ABA-treated patients reported improvements ≥ MCID in HAQ-DI (74% vs 64%) and SF-36 PCS (79% vs 66%) and 4/8 domain scores (P<0.05). The proportions of patients achieving MCID in the remaining PROs were similar between groups.Conclusions: In this study, treatment with UPA or ABA resulted in clinically meaningful improvements in PROs at week 12 in patients with active RA. UPA treatment elicited greater improvements in key domains of physical functioning, pain, and general health, and earlier improvements in HAQ-DI compared with ABA.Trial registration: NCT03086343, March 22, 2017