Session Information
Date: Monday, November 11, 2019
Session Title: RA – Diagnosis, Manifestations, & Outcomes Poster II: Treatments, Outcomes, & Measures
Session Type: Poster Session (Monday)
Session Time: 9:00AM-11:00AM
Background/Purpose: Treatment with upadacitinib (UPA), a selective Janus kinase-1 (JAK-1) inhibitor, resulted in significant and clinically meaningful improvements in patient-reported outcomes (PROs) at Week 12 in patients with RA with inadequate responses to csDMARDs (csDMARD-IR) or bDMARDs (bDMARD-IR).1,2 The current analysis evaluated the potential long-term benefits of UPA on PROs in these patients.
Methods: SELECT-NEXT (NCT02675426) and SELECT-BEYOND (NCT02706847) are ongoing Phase 3, randomized controlled trials (RCTs) which randomized patients with active RA on a stable dose of csDMARDs to receive UPA 15 mg or 30 mg once daily (QD) for 24 weeks or placebo for 12 weeks then UPA 15 mg or 30 mg. In this analysis, we report on PROs in patients treated with UPA from the start of study for 24 weeks, including: Patient Global Assessment of Disease Activity (PtGA), pain by visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F; SELECT-NEXT only), and duration and severity of morning (AM) stiffness. Mean changes from baseline and 95% confidence intervals (CIs) were calculated for each PRO at Week 24. The percentages of patients who continued to report improvements ≥ minimum clinically important differences (MCIDs) at Week 24 were calculated among patients who reported clinically meaningful responses for a given PRO at Week 12.
Results: Overall, 622 and 434 patients completed the double-blind phase of SELECT-NEXT and SELECT-BEYOND, respectively. At Week 24, patients reported improvements from baseline across all PROs: PtGA, pain VAS, HAQ-DI, FACIT-F, duration and severity of AM stiffness in SELECT-NEXT (Table 1) and SELECT-BEYOND (Table 2). In SELECT-NEXT, 85% to 93% of patients treated with UPA 15 mg and 77% to 90% with UPA 30 mg maintained responses ≥ MCIDs from Week 12 to Week 24. Similarly, in SELECT-BEYOND, 66% to 88% of patients treated with UPA 15 mg and 70% to 86% with UPA 30 mg maintained clinically meaningful responses from Week 12 to Week 24.
Conclusion: Substantial and clinically meaningful improvements in disease activity, physical function, pain, fatigue, and AM stiffness were consistently reported over 24 weeks in csDMARD-IR and difficult-to-treat bDMARD-IR patients with active RA who continued to receive UPA 15 mg or 30 mg QD.
References: 1. Strand V, et al. Ann Rheum Dis. 2018;77(Suppl 2):A989; 2. Strand V et al. Ann Rheum Dis. 2018;77(Suppl 2):A990.
Medical writing services provided by Emily Mercadante of JK Associates, Inc. (a member of the Fishawack Group of companies; Conshohocken, PA) and funded by AbbVie.
To cite this abstract in AMA style:
Bergman M, Tundia N, Camp H, Meerwein S, Schlacher C, Goldschmidt D, Song Y, Strand V. Effects of Upadacitinib on Patient-Reported Outcomes After 24 Weeks in Patients with Active Rheumatoid Arthritis and an Inadequate Response to Conventional Synthetic or Biologic Disease-Modifying Anti-Rheumatic Drugs: Results from SELECT-NEXT and SELECT-BEYOND Phase 3 Studies [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/effects-of-upadacitinib-on-patient-reported-outcomes-after-24-weeks-in-patients-with-active-rheumatoid-arthritis-and-an-inadequate-response-to-conventional-synthetic-or-biologic-disease-modifying-anti/. Accessed January 18, 2021.« Back to 2019 ACR/ARP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/effects-of-upadacitinib-on-patient-reported-outcomes-after-24-weeks-in-patients-with-active-rheumatoid-arthritis-and-an-inadequate-response-to-conventional-synthetic-or-biologic-disease-modifying-anti/