AB0529 CHARACTERIZATION OF REMISSION IN PATIENTS WITH PSORIATIC ARTHRITIS TREATED WITH UPADACITINIB: POST-HOC ANALYSIS FROM TWO PHASE 3 TRIALS
Authors: P. J. Mease, A. Kavanaugh, D. D. Gladman, O. Fitzgerald, E. Soriano, P. Nash, D. Feng, A. Lertratanakul, K. Douglas, R. Lippe, L. Gossec
Journal: Annals of the Rheumatic Diseases (2021)

Background: For patients (pts) with PsA, several disease activity measures are available including very low/minimal disease activity (VLDA/MDA), cutoffs based on the Disease Activity in PsA (DAPSA) score, and on the Psoriatic Arthritis Disease Activity Score (PASDAS) score. Objectives: To assess the rates of pts achieving these remission or low disease activity (LDA) criteria at Wk 24 using data from the SELECT-PsA 1 and SELECT-PsA 2 phase 3 studies; 1,2 Additionally, we assessed the distribution of individual MDA components among pts who did or did not achieve MDA criteria at Wk 24. Methods: In SELECT-PsA 1 and SELECT-PsA 2, pts with PsA and prior inadequate response (IR) or intolerance to ≥1 non-biologic DMARD (N=1705) or ≥1 biologic DMARD (N=642), respectively, were randomized to once daily upadacitinib (UPA) 15mg, UPA 30mg, adalimumab (ADA) 40mg every other week (SELECT-PsA 1 only), or placebo (PBO). Remission and LDA were assessed using VLDA/MDA, DAPSA scores of ≤4/≤14, and PASDAS scores of ≤1.9/≤3.2, at Wk 24 (Table 1). Non-responder imputation (NRI) was used for handling missing data; pts rescued at Wk 16 were considered non-responders. Pairwise comparisons between UPA doses and PBO or ADA were conducted using the Cochran-Mantel-Haenszel test. Results: Overall, 2345 pts were analyzed; mean age 51 years, 53% female. In both studies, higher rates of remission and LDA were observed with both UPA doses vs PBO at Wk 24 (nominal P-values &lt;0.05 for both time points; Table 1). Generally, higher rates of remission and LDA were also observed with UPA30 vs ADA in non-biologic DMARD-IR pts (nominal P-values &lt;0.05). Greater rates of MDA/VLDA were observed at Wk 24 with UPA15 and UPA30 vs PBO in both studies and with UPA30 vs ADA in non-biologic DMARD-IR pts (nominal P-values &lt;0.05 for all comparisons). The proportion of responder or non-responder pts receiving UPA15 or UPA30 was similar for each of the MDA components in both studies. At Wk 24, more responder and non-responder pts in both studies achieved Swollen Joint Count (SJC) 66 ≤1, Psoriasis Area and Severity Index (PASI) ≤1 or Body Surface Area-Psoriasis (BSA-Ps) ≤3%, and Leeds Enthesitis Index (LEI) ≤1 (Figure 1). Conversely, the proportion of pts Achieving Tender Joint Count (TJC) 68 ≤1 and Pt’s Global Assessment of Pain ≤1.5 tended to be lower. Conclusion: Regardless of previous biologic DMARD failure, pts treated with UPA15 or UPA30 achieved a higher rate of remission or LDA measured by various disease activity measures vs PBO at Wk 24; higher rates of response were observed in most of the remission and LDA measures with UPA30 vs ADA in non-biologic DMARD-IR pts. Among pts who did or did not achieve MDA criteria at Wk 24, a greater proportion of UPA-treated pts achieved physician derived measures such as SJC ≤1, PASI ≤1 or BSA-Ps ≤3%, and LEI ≤1. References: [1]McInnes IB, et al. Ann Rheum Dis, 2020; 79:12. [2]Genovese MC, et al. Ann Rheum Dis, 2020; 79:139. Table 1. Proportion of Patients Achieving Remission and LDA Measures at Week 24 Endpoint, n (%) SELECT-PsA 1 SELECT-PsA 2 PBO N=423 ADA 40mg EOW N=429 UPA 15mg QD N=429 UPA 30mg QD N=423 PBO N=212 UPA 15mg QD N=211 UPA 30mg QD N=218 MDA 52 (12.3) 143 (33.3) 157 (36.6) * , # 192(45.4) * , †, # 6 (2.8) 53 (25.1) * , # 63 (28.9) * , # ≥6 VLDA components 25 (5.9) 90 (21.0) 105 (24.5) * 134 (31.7) * , † 3 (1.4) 26 (12.3) * 44 (20.2) * VLDA 11 (2.6) 62 (14.5) 55 (12.8) * 72 (17.0) * 3 (1.4) 16 (7.6) * 21(9.6) * DAPSA REM 9 (2.1) 43 (10.0) 47 (11.0) * 79 (18.7) * , † 1 (0.5) 15 (7.1) * 28 (12.8) * DAPSA LDA 70 (16.5) 198 (46.2) 204 (47.6) * 235(55.6) * , † 14 (6.6) 73 (34.6) * 91 (41.7) * PASDAS REM 12 (2.8) 51 (11.9) 60 (14.0) * 91 (21.5) * , † 4 (1.9) 20 (9.5) * 31 (14.2) * PASDAS LDA 63 (14.9) 168 (39.2) 195 (45.5) * 211 (49.9) * , † 9 (4.2) 69 (32.7) * 82 (37.6) * *P ≤ 0.05 for UPA15 and UPA30 vs PBO; †P ≤ 0.05 for UPA30 vs ADA; # Statistically significant in the multiplicity-controlled analysis. MDA (5/7) and VLDA (7/7): TJC ≤ 1; SJC ≤ 1; PASI ≤ 1 or BSA-Psoriasis ≤ 3%; Patient’s Assessment of Pain NRS ≤ 1.5; PtGA-Disease Activity NRS ≤ 2.0; HAQ-DI score ≤ 0.5; and tender entheseal points ≤ 1. DAPSA REM ≤ 4; DAPSA LDA ≤ 14. PASDAS REM ≤ 1.9; PASDAS LDA ≤ 3.2. Figure 1 Acknowledgements: AbbVie and the authors thank the patients, study sites, and investigators who participated in this clinical trial. AbbVie, Inc was the study sponsor, contributed to study design, data collection, analysis &amp; interpretation, and to writing, reviewing, and approval of final version. No honoraria or payments were made for authorship. Medical writing support was provided by Ramona Vladea, PhD of AbbVie Inc. Disclosure of Interests: Philip J Mease Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers, Celgene, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer, Sun Pharma, and UCB., Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers, Celgene, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer, Sun Pharma, and UCB., Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers, Celgene, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer, Sun Pharma, and UCB., Arthur Kavanaugh Consultant of: AbbVie Inc., Amgen, Astra-Zeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB, Grant/research support from: AbbVie Inc., Amgen, Astra-Zeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB, Dafna D Gladman Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer Inc, and UCB, Oliver FitzGerald Speakers bureau: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB, Consultant of: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB, Grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB, Enrique Soriano Speakers bureau: AbbVie, Amgen, Bristol Myers, Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, and UCB, Consultant of: AbbVie, Amgen, Bristol Myers, Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, and UCB, Grant/research support from: AbbVie, Amgen, Bristol Myers, Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, and UCB, Peter Nash Speakers bureau: AbbVie, BMS, Roche, Pfizer, Janssen, Amgen, Sanofi-Aventis, UCB, Eli Lilly, Novartis, and Celgene, Consultant of: AbbVie, BMS, Roche, Pfizer, Janssen, Amgen, Sanofi-Aventis, UCB, Eli Lilly, Novartis, and Celgene, Grant/research support from: AbbVie, BMS, Roche, Pfizer, Janssen, Amgen, Sanofi-Aventis, UCB, Eli Lilly, Novartis, and Celgene, Dai Feng Shareholder of: AbbVie, Employee of: AbbVie, Apinya Lertratanakul Shareholder of: AbbVie, Employee of: AbbVie, Kevin Douglas Shareholder of: AbbVie, Employee of: AbbVie, Ralph Lippe Shareholder of: AbbVie, Employee of: AbbVie, Laure Gossec Consultant of: AbbVie,Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Samsung, Sanofi, UCB, Grant/research support from: Lilly, Pfizer, and Sandoz.