Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Although treatment with csDMARDs and bDMARDs can lead to remission in patients with RA, many patients still experience pain and morning (AM) stiffness, which have a meaningful negative impact on quality of life. We assessed the effect of upadacitinib (UPA), a selective JAK-1 inhibitor, alone or in combination with csDMARDs vs background therapy on pain and AM stiffness in patients with active RA who had an inadequate response (IR) to csDMARDs or bDMARDs.
Methods: Data from the SELECT-NEXT (NCT02675426), SELECT-BEYOND (NCT02706847), and SELECT-MONO (NCT02706951) randomized controlled trials were analyzed. Patients in NEXT (csDMARD-IR) and BEYOND (bDMARD-IR) received UPA (15 mg or 30 mg daily) or PBO with csDMARDs for 12 weeks (wks), and those in the MONO trial (csDMARD-IR) received UPA monotherapy (15 mg or 30 mg daily) or MTX (mean dose: 17 mg/wk) for 14 wks. Pain and duration of AM stiffness were assessed through 12/14 wks. Least squares mean (LSM) percent changes from baseline (BL) to wk 12/14 were based on mixed effect repeated measures models. Percentages of patients reporting ≥50% improvement in pain, those reporting no pain or mild pain (absolute pain score <20), and those reporting AM stiffness <15 minutes were determined at each timepoint for UPA (both doses), PBO, or MTX; comparisons between groups used Cochran-Mantel-Haenszel tests with prior bDMARDs use as stratification factor.
Results: Across all 3 trials, statistically significant LSM percent changes from BL to wks 12/14 in pain and duration of AM stiffness were reported in both UPA dose groups (except AM stiffness duration in BEYOND) compared with PBO or MTX groups (Figures 1 and 2). Across trials, significantly (p<0.05) more UPA-treated patients (15 mg: 41–51%, 30 mg: 42–56%) reported ≥50% improvement in pain at wks 12/14 compared with PBO or MTX (19–25%). Significantly (p<0.05) more UPA-treated patients (15 mg: 30-36%, 30 mg: 36-44%) reported no pain or mild pain at wks 12/14 compared with PBO or MTX (14–15%). The percentage of UPA-treated patients (15 mg: 26–42%, 30 mg: 29–43%) reporting AM stiffness duration <15 minutes at wks 12/14 was approximately twice that in PBO or MTX (15–23%) groups. Across all measures, improvements in UPA-treated patients were evident as early as wk 2.
Conclusion: Treatment with UPA in combination with csDMARDs vs PBO resulted in significant and rapid improvements in pain and AM stiffness across different RA patient populations including csDMARD-IR and bDMARD-IR. Similar improvements vs MTX were reported when UPA was administered as monotherapy.
Medical writing services provided by Joann Hettasch (Fishawack Group, US) and funded by AbbVie.
To cite this abstract in AMA style:Wells AF, Lee YC, Tundia N, Suboticki J, Chen K, Friedman A, Strand V. Effect of Upadacitinib on Pain and Morning Stiffness in Patients with Rheumatoid Arthritis and Inadequate Response to Conventional Synthetic or Biologic Disease-Modifying Anti-Rheumatic Drugs [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/effect-of-upadacitinib-on-pain-and-morning-stiffness-in-patients-with-rheumatoid-arthritis-and-inadequate-response-to-conventional-synthetic-or-biologic-disease-modifying-anti-rheumatic-drugs/. Accessed January 17, 2021.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/effect-of-upadacitinib-on-pain-and-morning-stiffness-in-patients-with-rheumatoid-arthritis-and-inadequate-response-to-conventional-synthetic-or-biologic-disease-modifying-anti-rheumatic-drugs/