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Abstract Number: 2026

Efficacy and Safety of Upadacitinib versus Placebo and Adalimumab in Patients with Active Psoriatic Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Anti-Rheumatic Drugs: A Double-Blind, Randomized Controlled Phase 3 Trial

Iain McInnes1, Jaclyn K Anderson2, Marina Magrey3, Joseph Merola4, Yi Liu5, Mitsumasa Kishimoto6, Slawomir Jeka7, Cesar Pacheco Tena8, Xin Wang2, Liang Chen2, Patrick Zueger2, Aileen Pangan9 and Frank Behrens10, 1Institute of Infection, Immunity, and Inflammation, University of Glasgow, Glasgow, United Kingdom, 2AbbVie Inc., North Chicago, IL, 3Case Western Reserve University School of Medicine, Cleveland, OH, 4Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, 5West China Hospital of Sichuan University, Sichuan, China (People's Republic), 6Department Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan, 72nd Univ Hospital, CM UMK, Bydgoszcz, Poland, 8Universidad Autonoma de Chihuahua, Chihuahua, Chihuahua, Mexico, 9Abbvie Inc., La Grange, IL, 10CIRI/Rheumatology & Fraunhofer IME, Research Division Translational Medicine and Pharmacology, Goethe University Hospital, Frankfurt, Hessen, Germany

Meeting: ACR Convergence 2020

Keywords: clinical trial, Psoriatic arthritis

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Session Information

Date: Monday, November 9, 2020

Session Title: Spondyloarthritis Including Psoriatic Arthritis – Treatment II: Emerging Therapies (2023–2027)

Session Type: Abstract Session

Session Time: 11:00AM-11:50AM

Background/Purpose: Upadacitinib (UPA), an oral, reversible, JAK inhibitor approved to treat rheumatoid arthritis (RA), is under evaluation for psoriatic arthritis (PsA). We assess efficacy and safety of UPA vs placebo (PBO) and adalimumab (ADA) in patients (pts) with PsA and prior IR or intolerance to ≥1 non-biologic DMARD (non-bDMARD).

Methods: Pts with active PsA (≥3 swollen and ≥3 tender joints), active or historical psoriasis, and on ≤2 non-bDMARDs were randomized 1:1:1:1 to once daily UPA 15 mg (UPA15), UPA 30 mg (UPA30), ADA 40 mg every other week, or PBO. Primary endpoint was proportion of pts achieving ACR20 for UPA vs PBO at Wk 12. Multiplicity controlled secondary endpoints for each dose of UPA vs PBO included change in HAQ-DI, FACIT-F, and SF-36 PCS (Wk 12); static Investigator Global Assessment of Psoriasis of 0 or 1, PASI75, and change in Self-Assessment of Psoriasis Symptoms (Wk 16); change in modified Sharp/van der Heijde Score (mTSS), proportion of pts achieving MDA, and resolution of enthesitis (LEI=0) and dactylitis (LDI=0) (Wk 24). For each dose of UPA, the multiplicity-controlled analysis also included non-inferiority and superiority vs ADA for ACR20 and superiority for HAQ-DI and pt’s assessment of pain NRS (Wk 12). ACR50/70 at Wk 12 and ACR20 at Wk 2 were additional secondary endpoints. Adverse events (AEs) through 24 wks are reported for pts who received ≥1 dose of study drug.

Results: 1705 pts were randomized; 1704 received study drug (53.2% female, mean age 50.8 yrs, mean duration of PsA diagnosis 6.1 yrs). 82% were on ≥1 concomitant non-bDMARD, of whom 84% received MTX +/- another non-bDMARD.

At Wk 12, ACR20 rates were 70.6% with UPA15 and 78.5% with UPA30 vs 36.2% with PBO (p < .001 for UPA15/30 vs PBO) and 65.0% with ADA (non-inferiority, p < .001 for UPA15/30 vs ADA; superiority, p < .001 for UPA30 vs ADA). A greater proportion of pts achieved ACR50/70 with UPA15/30 vs PBO and UPA30 vs ADA. Improvements were observed with UPA15/30 vs PBO for all multiplicity controlled secondary endpoints and for UPA 15/30 vs ADA for HAQ-DI and UPA 30 vs ADA for improvement in pain (Figure 1A and 1B). At Wk 24, change in mTSS was 0.25 for PBO, -0.04 for UPA15, 0.03 for UPA30, and 0.01 for ADA (p < 0.001 for UPA15/30 vs PBO). AE/SAE rates, including serious infections, were similar in PBO, UPA15, and ADA arms and higher with UPA30 (Figure 2). Herpes zoster rates were similar for PBO and UPA15/30. No MACE was reported with UPA. One malignancy occurred in each PBO and UPA15 arms, and 3 malignancies occurred in each UPA30 and ADA arms. VTE were reported in 1 pt on PBO, 1 pt on UPA30, and 2 pts on ADA. One death occurred in the PBO arm.

Conclusion: In this non-bDMARD-IR PsA population, treatment with UPA15/30 demonstrated improvement in musculoskeletal symptoms, psoriasis, physical function, pain, and fatigue and inhibited radiographic progression; improvements were observed by Wk 2. At Wk 12, UPA15/30 were non-inferior to ADA for ACR20, with superiority demonstrated for UPA30. Greater percentages of UPA vs PBO pts achieved stringent measures of disease control (MDA, ACR50/70, sIGA 0/1). No new safety signals were identified compared with the safety profile observed in RA.


Disclosure: I. McInnes, Novartis, 9, AbbVie, 9, Celgene, 9, Janssen, 2, 9, UCB, 2, 9, Bristol Myers Squibb, 2, 9, AstraZeneca, 2, Boehringer Ingelheim, 2, Lilly, 9, LEO, 9; J. Anderson, AbbVie Inc., 1, 3, 4; M. Magrey, Novartis, 5, Eli Lilly, 5, AbbVie, 2, UCB, 2, Amgen, 2, Pfizer, 5, Janssen, 5; J. Merola, AbbVie, 1, Arena, 1, Avotres, 1, Biogen, 1, Celgene, 1, Dermavant, 1, Eli Lilly, 1, EMD Serono, 1, Janssen, 1, LEO Pharma, 5, Merck, 1, Novartis, 1, Pfizer Inc, 5, Sanofi, 1, Regeneron, 1, Sun Pharma, 1, UCB Pharma, 5; Y. Liu, None; M. Kishimoto, AbbVie, 1, 2, Amgen-Astellas BioPharma, 1, 2, Asahi-Kasei Pharma, 1, 2, Astellas, 1, 2, Ayumi Pharma, 1, 2, BMS, 1, 2, Chugai, 1, 2, Daiichi-Sankyo, 1, 2, Eisai, 1, 2, Eli Lilly, 1, 2, Gilead, 1, 2, Janssen, 1, 2, Kyowa Kirin, 1, 2, Novartis, 1, 2, Pfizer, 1, 2, Tanabe-Mitsubishi, 1, 2, Teijin Pharma, 1, 2, UCB Pharma, 1, 2, Celgene, 5, 8; S. Jeka, Pfizer, 2, 8, Novartis, 2, 8, Abbvie, 2, 8, UCB, 2, 8, MSD, 2, 8, Roche, 2, 8, Sandoz, 2, 8, Egis, 2, 8, Lilly, 2, 8, Celgene, 2, 8; C. Pacheco Tena, None; X. Wang, AbbVie Inc., 1; L. Chen, AbbVie, 1, 3; P. Zueger, AbbVie Inc., 1, 3; A. Pangan, AbbVie, 1, 3; F. Behrens, Pfizer, 2, 5, 8, Janssen, 2, 5, 8, Chugai, 2, 5, 8, Celgene, 2, 5, 8, Bionorica, 2, Roche, 2, 5, 8, Abbvie, 5, 8, Sanofi, 5, 8, Lilly, 5, 8, Novartis, 5, 8, Genzyme, 5, 8, Boehringer, 5, 8, MSD, 5, 8, Amgen, 5, 8, UCB, 5, 8, Gilead, 5, 8, Sandoz, 5, 8.

To cite this abstract in AMA style:

McInnes I, Anderson J, Magrey M, Merola J, Liu Y, Kishimoto M, Jeka S, Pacheco Tena C, Wang X, Chen L, Zueger P, Pangan A, Behrens F. Efficacy and Safety of Upadacitinib versus Placebo and Adalimumab in Patients with Active Psoriatic Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Anti-Rheumatic Drugs: A Double-Blind, Randomized Controlled Phase 3 Trial [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-upadacitinib-versus-placebo-and-adalimumab-in-patients-with-active-psoriatic-arthritis-and-inadequate-response-to-non-biologic-disease-modifying-anti-rheumatic-drugs-a-double-b/. Accessed May 26, 2022.
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