Background/Purpose: The efficacy and safety of upadacitinib (UPA), a selective Janus kinase inhibitor, in patients with PsA is under investigation in Phase 3 clinical trials. Patient-reported outcomes (PROs) are an important component in the evaluation of efficacy for a new therapy. This post hoc analysis evaluated the impact of UPA vs placebo (PBO) on PROs in patients with active PsA and an inadequate response to biologic DMARDs (bDMARD-IR).

Methods: Patients in SELECT-PsA 2 (NCT03104374), a Phase 3, randomized, PBO-controlled trial, received UPA 15 mg or UPA 30 mg once daily or PBO for 24 weeks, with the primary endpoint assessment at Week 12. The following PROs were assessed: Patient Global Assessment of Disease Activity (PtGA), Patient’s Assessment of Pain, HAQ-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue, 36-Item Short-Form Health Survey (SF-36), EQ-5D-5L, Self-Assessment of Psoriasis Symptoms (SAPS), Work Productivity and Activity Impairment, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and morning stiffness (items 5 and 6 from the BASDAI). BASDAI was assessed in patients with evidence of psoriatic spondylitis at baseline (BL). Least squares mean changes from BL to Week 12 (Week 16 for SAPS) were assessed. The proportions of patients reporting improvements ≥ minimal clinically important differences (MCID) from BL through Week 24 were compared between both doses of UPA and PBO. The number needed to treat (NNT) to achieve 1 additional MCID response for each PRO of interest with UPA vs PBO were calculated at Weeks 12/24.

Results: Data from 641 patients (UPA 15 mg: 211; UPA 30 mg: 218; PBO: 212) were analyzed. Significant improvements from BL to Week 12 were reported with both doses of UPA vs PBO across all PROs, including all SF-36 domains (Table, Figure 1). Significantly greater proportions of patients receiving either dose of UPA vs PBO reported improvements ≥ MCID as early as Week 2 (the first post-BL visit) in PtGA, pain, and HAQ-DI. Compared with PBO at Week 12, a significantly greater proportion of patients receiving either dose of UPA reported improvements ≥ MCID across all PROs except SF-36 mental component summary (UPA 30 mg) (Figure 2). Improvements were maintained or further improved through Week 24. NNTs with UPA 15 mg and 30 mg ranged from 3–10 across PROs at Week 12.

Conclusion: Among bDMARD-IR patients with active PsA, treatment with UPA 15 mg or 30 mg once daily for 12 weeks resulted in clinically meaningful improvements in PROs, which were maintained or further improved through 24 weeks.

Medical writing services provided by Brandy Menges of JK Associates, Inc. (a member of Fishawack Group of Companies; Conshohocken, PA) and funded by AbbVie.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/improvement-in-patient-reported-outcomes-for-upadacitinib-versus-placebo-among-patients-with-psoriatic-arthritis-and-an-inadequate-response-to-biologic-disease-modifying-anti-rheumatic-drugs/