Characterization of Remission in Patients with Psoriatic Arthritis Treated with Upadacitinib: Post-hoc Analysis from Two Phase 3 Trials
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Kavanaugh, Arthur
FitzGerald, Oliver
Soriano, Enrique
Nash, Peter
Feng, Dai
Lertratanakul, Apinya
Douglas, Kevin
Lippe, Ralph
Gossec, Laure
Mease, Philip
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Abstract
Objectives: To assess the rates of patients achieving remission or low disease activity (LDA) based on very low/minimal disease activity (VLDA/MDA) measures, DAPSA and PASDAS scores at Weeks 12 and 24 using data from the SELECT-PsA 1 and SELECT-PsA 2 Phase 3 studies. Individual MDA components among patients who did or did not achieve MDA criteria at Week 24 were also assessed. Methods: This is a post-hoc analysis of 2 randomized controlled trials. In SELECT-PsA 1, patients with PsA and prior inadequate response (IR) or intolerance to ≥ 1 non-biologic DMARD (N = 1705) were randomized to once daily upadacitinib (UPA) 15mg (UPA15), UPA 30mg (UPA30), adalimumab (ADA) 40mg every other week, or placebo (PBO). In SELECT-PsA 2, patients with prior IR or intolerance to ≥ 1 biologic DMARD (N = 642) were randomized to UPA15, UPA30, or PBO. Remission and LDA were assessed using VLDA/MDA, DAPSA scores of ≤ 4/≤ 14, and PASDAS scores of ≤ 1.9/≤ 3.2, at Weeks 12 and 24. Results: Overall, 2345 patients were analyzed. In both studies, higher rates of remission and LDA were observed with both UPA doses vs PBO at Weeks 12 and 24 (nominal P-values < 0.05). Generally, higher rates of remission and LDA were also observed with UPA30 vs ADA in non-biologic DMARD-IR patients (nominal P-values < 0.05). Greater rates of MDA/ VLDA were observed at Weeks 12 and 24 with UPA15 and UPA30 vs PBO in both studies and with UPA30 vs ADA in non-biologic DMARD-IR pts (nominal P-values < 0.05 for all comparisons). The proportion of responder or non-responder patients receiving UPA15 or UPA30 was similar for each of the MDA components in both studies. At Week 24, more responder and non-responder patients in both studies achieved SJC 66 ≤ 1, PASI ≤ 1 or BSA-Psoriasis ≤ 3%, and Leeds Enthesitis Index (LEI) ≤ 1. Conversely, the proportion of patients Achieving TJC 68 ≤ 1 and Patient’s Global Assessment of Pain ≤ 1.5 tended to be lower. Conclusion: Regardless of previous biologic DMARD failure, patients treated with UPA15 or UPA30 achieved a higher rate of remission or LDA measured by various disease activity measures vs PBO at Weeks 12 and 24; higher rates of response were observed in most of the remission and LDA measures with UPA30 vs ADA in non-biologic DMARD-IR patients. Among patients who did or did not achieve MDA criteria at Week 24, a greater proportion of UPA-treated patients achieved physician derived measures such as SJC ≤ 1, PASI ≤ 1 or BSA-Ps ≤ 3%, and LEI ≤ 1.
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The Journal of Rheumatology
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Canadian Rheumatology Association Meeting Virtual Congress February 24 – 26, 2021
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48
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7
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Clinical sciences
Immunology
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Life Sciences & Biomedicine
Rheumatology
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Gladman, D; Kavanaugh, A; FitzGerald, O; Soriano, E; Nash, P; Feng, D; Lertratanakul, A; Douglas, K; Lippe, R; Gossec, L; Mease, P, Characterization of Remission in Patients with Psoriatic Arthritis Treated with Upadacitinib: Post-hoc Analysis from Two Phase 3 Trials, The Journal of Rheumatology, 2021, 48 (7), pp. 1115-1115