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Abstract Number: 1802

Comparison of Axial and Peripheral Manifestations in Patients with Psoriatic Arthritis and Ankylosing Spondylitis in Upadacitinib Clinical Trials

Xenofon Baraliakos1, Atul Deodhar2, Roberto Ranza3, Simona Rednic4, Francesco Ciccia5, Fabiana Ganz6, Tianming Gao6, Apinya Lertratanakul6, In-Ho Song6, Andrew Ostor7 and Laura Coates8, 1Rheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Herne, Germany, 2Oregon Health & Science University, Portland, OR, 3Hospital de Clinicas, Universidade Federal de Uberlândia, Uberlandia, MG, Brazil, 4Emergency Clinical County Hospital, Rheumatology and Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania, 5University of Campania “Luigi Vanvitelli", Naples, Italy, 6Abbvie Inc., North Chicago, IL, 7Monash University, Cabrini Hospital, and Emertius Research, Malvern, Australia, 8Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom

Meeting: ACR Convergence 2021

Keywords: Ankylosing spondylitis (AS), clinical trial, Randomized Trial, spondyloarthritis

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Session Information

Date: Tuesday, November 9, 2021

Session Title: Spondyloarthritis Including PsA – Treatment Poster III: Psoriatic Arthritis II (1801–1835)

Session Type: Poster Session D

Session Time: 8:30AM-10:30AM

Background/Purpose: Axial, peripheral, and other disease manifestations often overlap between psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Upadacitinib (UPA) is an oral Janus kinase inhibitor under evaluation for the treatment of PsA and AS. The objective of this analysis was to describe and compare baseline characteristics and UPA efficacy across 4 subgroups of patients (pts) from clinical trials: active PsA (with/without axial involvement) and active AS (with/without peripheral involvement).

Methods: Baseline characteristics and efficacy of UPA in reducing axial and peripheral signs and symptoms were assessed via an integrated analysis across the 4 pt subgroups from the SELECT-PsA 1,1 SELECT-PsA 2,2 and SELECT-AXIS3 studies. Analyses of baseline characteristics included pts in the UPA 15 mg once daily (QD), UPA 30 mg QD, and placebo (PBO) groups; efficacy analyses included pts in the UPA 15 mg QD group only. Axial involvement in PsA (axial PsA) was determined by investigator assessment. Peripheral involvement in AS was defined based on presence of tender or swollen joints (TJC68 >0 or SJC66 >0), or presence of enthesitis at baseline (Maastricht Ankylosing Spondylitis Enthesitis Score >0).

Results: 2102 pts (UPA 15 mg; UPA 30 mg; PBO) were evaluated across the 4 subgroups (PsA [with/without axial involvement]: 626/1289; AS [with/without peripheral involvement]: 135/52). 33% of pts with PsA had axial PsA; 72% of pts with AS had peripheral symptoms. Pts with axial PsA had higher peripheral joint (TJC68 and SJC66) and skin (psoriasis) burden than pts with AS with peripheral involvement (p< 0.0001). Pts with AS with peripheral involvement had significantly greater overall pain (pt’s assessment of pain; p=0.0002) and back pain (BASDAI Q2; p< 0.0001) scores, and higher total BASDAI (p=0.0076) and ASDAS (p=0.0351) scores than pts with axial PsA; physician’s global assessment of disease activity, and peripheral pain and tenderness (BASDAI Q3 and Q4) were numerically similar for these 2 subgroups (Table). The efficacy of UPA 15 mg (measured using ASDAS and BASDAI) was generally consistent across the 4 pt subgroups regardless of peripheral or axial involvement (Figure).

Conclusion: Pts with PsA with axial involvement and pts with active AS showed some differences in baseline characteristics but similar improvements versus placebo with UPA 15 mg QD.

References: 1. McInnes I, et al. Ann Rheum Dis 2020;79(Suppl 1):16–17; 2. Genovese MC, et al. Ann Rheum Dis 2020;79(Suppl 1):139; 3. van der Heijde D, et al. Lancet 2019;394:2108–17.


Disclosures: X. Baraliakos, AbbVie, 2, 5, 6, Chugai, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, UCB, 2, 5, 6, Bristol-Myers Squibb, 2, 5, 6, Celegene, 2, 5, 6, Merck, 2, 6, Werfen, 2; A. Deodhar, Amgen, 2, Celgene, 2, Boehringer Ingelheim, 2, 12, Paid Instructor, AbbVie, 2, 5, Eli Lilly, 2, 5, Glaxo Smith & Kline, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, 6, 12, Paid Instructor, UCB, 2, 5, Janssen, 2, 6, Bristol-Myers Squibb, 2; R. Ranza, AbbVie, 2, 6, Janssen, 2, 6, Novartis, 2, 6, Pfizer, 2, 6; S. Rednic, AbbVie, 2, 5, Boehringer Ingelheim, 2, 5, Eli Lilly, 2, 5, MSD, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, UCB, 5; F. Ciccia, Eli Lilly and Company, 1, 2, 6, AbbVie, 1, 2, 6, Celgene, 1, 2, 6, Amgen, 1, 2, 6, Novartis, 1, 2, 6, Janssen, 1, 2, 6, UCB, 1, 2, 6, Roche, 1, 2, 6, Pfizer, 1, 2, 6, Galapagos, 1, 2, 6, Glaxo, 1, 2, 6; F. Ganz, AbbVie, 3, 11; T. Gao, AbbVie, 3, 11; A. Lertratanakul, AbbVie, 3, 11; I. Song, AbbVie, 3, 11; A. Ostor, AbbVie, 2, 6, Bristol-Myers Squibb, 2, 6, Eli Lilly, 2, 6, Gilead, 2, 6, MSD, 2, 6, Novartis, 2, 6, Pfizer, 2, 6, Roche, 2, 6, Janssen, 1, 2, UCB, 1, 2, Paradigm, 1, 2; L. Coates, Abbvie, 5, 6, Amgen, 5, 6, Biogen, 6, Celgene, 5, 6, Gilead, 6, Janssen, 6, Eli Lilly, 5, 6, Medac, 6, Novartis, 5, 6, Pfizer, 5, 6, UCB Pharma, 6, Galapagos, 6, GSK, 6, Boehringer Ingelheim, 6, Domain, 2.

To cite this abstract in AMA style:

Baraliakos X, Deodhar A, Ranza R, Rednic S, Ciccia F, Ganz F, Gao T, Lertratanakul A, Song I, Ostor A, Coates L. Comparison of Axial and Peripheral Manifestations in Patients with Psoriatic Arthritis and Ankylosing Spondylitis in Upadacitinib Clinical Trials [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/comparison-of-axial-and-peripheral-manifestations-in-patients-with-psoriatic-arthritis-and-ankylosing-spondylitis-in-upadacitinib-clinical-trials/. Accessed January 27, 2023.
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