Session Information
Date: Monday, October 27, 2025
Title: (1434–1466) Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster II
Session Type: Poster Session B
Session Time: 10:30AM-12:30PM
Background/Purpose: We evaluated safety and efficacy of upadacitinib (UPA) versus adalimumab (ADA) at week 260 (5-years) from the long-term extension of SELECT-PsA 1.
Methods: Randomized patients with PsA received UPA 15mg once daily, UPA 30mg once daily, ADA 40mg every other week, or placebo for 24 weeks. At week 24, placebo groups switched to UPA15 or UPA30. Following approval of UPA15, patients on UPA30 switched to UPA15; earliest switch at week 104; data not presented). TEAEs were summarized for patients who received ≥1 dose of the drug using all 5-year data. Safety data are presented as exposure-adjusted event rates (EAERs; events per 100 patient-years) and exposure-adjusted incidence rates (EAIRs; patients per 100 patient-years). Efficacy endpoints were analyzed using nonresponder imputation (NRI) and as observed (AO) (binary endpoints), or mixed-effect model repeated measures and AO (continuous endpoints; P values are nominal).
Results: 1704 patients received ≥1 dose and 983 (57.7%) completed 260 weeks. Most common reasons for discontinuation were AEs (8.4%), withdrawal of consent (6.2%), and lack of efficacy (4.7%). UPA’s safety profile through week 260 (5-years) was comparable to ADA and consistent with week 104 and 152 data. Rates of malignancy excluding nonmelanoma skin cancer (NMSC), VTE, and MACE were low compared to historical comparators and generally similar across treatments. Serious infection, herpes zoster, anemia, lymphopenia, creatine phosphokinase (CPK) elevation, and NMSC rates were higher with UPA versus ADA; serious infection, herpes zoster, anemia, neutropenia, and CPK elevation were higher with UPA30 versus UPA15. Death rates (EAERs) were the same across UPA treatment groups and similar (< 1.0 difference) with ADA; COVID-19/COVID-19 pneumonia was the most common cause. UPA15 achieved ≥20%/50%/70% improvement in ACR response criteria (ACR20/50/70) and minimal disease activity (MDA) comparable to ADA at week 260 (AO). PASI (PASI75/90/100) improvements were also comparable between UPA15 and ADA at week 260 (AO). Using the more conservative NRI, responses were comparable for UPA15 versus ADA at week 260. HAQ-DI and patient assessment of pain changes were consistent through week 260 and comparable between UPA15 versus ADA (AO). Mean change in modified total Sharp/van der Heijde Score (mTSS) at week 260 was similar across treatments.
Conclusion: In patients with PsA and inadequate response/intolerance to ≥1 non-biologic DMARD, no new safety risks were identified with UPA up to 5 years; its safety profile remained consistent with ADA. Efficacy responses were generally maintained over time and comparable to ADA at 5 years.1. McInnes I, et al. N Engl J Med. 2021;384:1227-39.2. McInnes I, et al. Rheumatol Ther. 2023;10:275-92.3. McInnes I, et al. Ann Rheum Dis. 2023 [Abstract].4. Burmester G, et al. RMD Open. 2023;9:e002735.
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To cite this abstract in AMA style:
McInnes I, Kato K, Magrey M, Merola J, kishimoto m, Haaland D, Lagunes I, Coates L, Liu Y, Mancl E, Parikh B, Phillips C. Long-Term Safety and Efficacy of Upadacitinib in Patients With Psoriatic Arthritis: 5-Year Results From the Phase 3 SELECT-PsA 1 Study [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/long-term-safety-and-efficacy-of-upadacitinib-in-patients-with-psoriatic-arthritis-5-year-results-from-the-phase-3-select-psa-1-study/. Accessed .« Back to ACR Convergence 2025
ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-safety-and-efficacy-of-upadacitinib-in-patients-with-psoriatic-arthritis-5-year-results-from-the-phase-3-select-psa-1-study/