Session Type: Poster Session A
Session Time: 8:30AM-10:30AM
Background/Purpose: Pain is a dominant feature of PsA and has been identified by the GRAPPA-OMERACT working group as a core disease domain. Its control is a largely unmet need, especially in patients failing non-biologic DMARDs. The purpose of this study was to evaluate if clinically meaningful improvement in pain, particularly at earlier timepoints after treatment initiation, is associated with greater improvements in other patient reported outcomes (PROs).
Methods: The phase 3 SELECT-PsA1 trial randomized patients with inadequate responses to ≥1 non-biologic DMARDs to receive upadacitinib (UPA) 15 mg once daily (QD), UPA 30 mg QD, adalimumab (ADA) 40 mg every other week, or placebo (PBO) for 24 weeks. Patients with baseline patient global assessment (PGA) of pain numeric rating scale (NRS) score >2 were evaluated. Outcomes assessed included the proportion of patients achieving meaningful pain improvement (defined as achievement of a score of < 4 and ≥2-point decrease from baseline in PGA of pain NRS) through Week 24 and, for those achieving meaningful pain improvement at Weeks 4 (UPA/ADA arms only) or 24, the percentage of patients achieving minimum clinically important differences (MCID) at Week 24 on Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), 36-Item Short-Form Health Survey (SF-36), EuroQoL-5 Dimension, 5 level (EQ-5D-5L), and Work Productivity and Activity Impairment (WPAI). Analyses were performed using the Cochran-Mantel-Haenszel test, adjusting for DMARD use, with non-responder imputation for comparison between treatments, and Chi Square test, with as observed analysis for comparison between responders/nonresponders. P-values < 0.05 were nominal.
Results: A significantly greater proportion of patients with PsA had meaningful pain improvement with UPA 15 mg (N=418), UPA 30 mg (N=413), and ADA (N=420) compared with PBO (N=409) starting as early as Week 2 (P< 0.0001, Figure 1A). Compared with ADA, a significantly greater proportion of patients achieved meaningful pain improvement with UPA 15 mg starting at Week 20 (P< 0.05), and UPA 30 mg starting at Week 4 (P≤0.01). Meaningful pain improvement was maintained at Week 24 by over 80% of patients on UPA and ADA who had achieved improvement at Week 4 (Figure 1B). For patients who attained meaningful pain improvement at Week 24 vs those who did not, a significantly greater proportion reported values ≥ MCID in all PROs (P< 0.0001, Figure 2A). Similarly, for all UPA/ADA patients who did vs did not attain meaningful pain improvement at Week 4, a significantly greater proportion achieved MCID in EQ-5D-5L, HAQ-DI, SF-36 physical component summary, and WPAI activity impairment at Week 24 (P< 0.01, Figure 2B).
Conclusion: A greater proportion of patients achieved meaningful pain improvement with UPA and ADA vs PBO throughout the 24-week treatment period, and with UPA 15 mg vs ADA by Week 20. Meaningful pain improvement by Week 4 was associated with more patients reporting improvements ≥ MCID in several PROs at Week 24. Overall, meaningful pain improvement is closely linked with meaningful improvements in other important outcomes for PsA patients.
To cite this abstract in AMA style:Bessette L, Joven-Ibáñez B, Selmi C, Chen N, Kato K, Lippe R, Zueger P, Patel J, Merola J. Impact of Early Pain Improvement on Patient-reported Outcomes in Patients with Psoriatic Arthritis: Results from a Phase 3 Trial [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/impact-of-early-pain-improvement-on-patient-reported-outcomes-in-patients-with-psoriatic-arthritis-results-from-a-phase-3-trial/. Accessed January 30, 2023.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/impact-of-early-pain-improvement-on-patient-reported-outcomes-in-patients-with-psoriatic-arthritis-results-from-a-phase-3-trial/