POS0235 COMPARISON OF AXIAL AND PERIPHERAL MANIFESTATIONS IN PATIENTS WITH PSORIATIC ARTHRITIS AND ANKYLOSING SPONDYLITIS IN UPADACITINIB CLINICAL TRIALS
Authors: X. Baraliakos, A. Deodhar, R. Ranza, S. Rednic, F. Ciccia, F. Ganz, T. Gao, A. Lertratanakul, I. H. Song, A. Ostor, L. C. Coates
Journal: Annals of the Rheumatic Diseases (2021)

Background: 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. Objectives: 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-AXIS 3 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 &gt;0 or SJC66 &gt;0), or presence of enthesitis at baseline (Maastricht Ankylosing Spondylitis Enthesitis Score &gt;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&lt;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&lt;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 1). 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 1). Table 1. Baseline demographics, medical history, and disease characteristics Mean (SD), unless otherwise specified PsA with axial involvement n=626 PsA without axial involvement n=1289 AS with peripheral involvement n=135 AS without peripheral involvement n=52 p-value (PsA with axial involvement versus AS with peripheral involvement) Male, n (%) 300 (47.9) 583 (45.2) 88 (65.2) 44 (84.6) 0.0003 Age, years 50.7 (12.6) 52.0 (12.0) 46.6 (12.7) 42.2 (11.4) 0.0008 Body mass index, kg/m 2 30.3 (7.1) 30.7 (6.8) a 26.7 (4.9) 26.8 (5.2) * Duration of disease symptoms, years 11.2 (9.3) b 10.4 (9.5) a 14.6 (10.9) 14.0 (10.6) 0.0009 Duration of disease since diagnosis, years 7.7 (8.0) 7.3 (8.0) 7.0 (9.2) 6.8 (8.4) 0.3738 TJC68 23.6 (16.4) 20.6 (14.6) 5.3 (8.2) 0 * SJC66 11.9 (9.0) 11.2 (8.2) 1.5 (3.2) 0 * Psoriasis, n (%) 616 (98.4) 1269 (98.4) 7 (5.2) 0 * Uveitis, n (%) 1 (0.2) 5 (0.4) 3 (2.2) 1 (1.9) 0.0191 Inflammatory bowel disease, n (%) 10 (1.6) 13 (1.0) 2 (1.5) 2 (3.8) 1.0000 PhGA 6.7 (1.7) 6.5 (1.7) 6.7 (1.5) c 6.9 (1.7) b 0.6960 Pain, VAS 0–10 6.3 (2.0) b 6.1 (2.2) d 6.9 (1.6) a 6.8 (1.7) a 0.0002 ASDAS(CRP) 3.4 (1.0) e 3.1 (1.0) f 3.5 (0.7) a 3.7 (0.8) a 0.0351 BASDAI (Total score) 6.0 (2.1) e 5.5 (2.2) f 6.4 (1.6) 6.3 (1.8) a 0.0076 BASDAI Q2 (Back pain) 6.1 (2.7) e 4.8 (3.2) f 7.2 (1.7) 7.2 (1.6) a * BASDAI Q3 (Peripheral pain/ swelling) 6.3 (2.4) e 6.0 (2.6) f 5.9 (2.4) 5.5 (2.4) a 0.0747 BASDAI Q4 (Tenderness) 5.8 (2.6) e 5.6 (2.7) f 6.1 (2.5) 5.7 (2.4) a 0.3196 *p&lt;0.0001 Data missing for a n=1, b n=3, c n=6, d n=11, e n=4, f n=14 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. Acknowledgements: AbbVie funded this study; contributed to its design; participated in data collection, analysis, and interpretation of the data; and participated in the writing, review, and approval of the abstract. No honoraria or payments were made for authorship. Medical writing support was provided by Grant Thomas Kirkpatrick, MSc, of 2 the Nth (Cheshire, UK), and was funded by AbbVie. Disclosure of Interests: Xenofon Baraliakos Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB, Atul Deodhar Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GSK, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GSK, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB, R Ranza Speakers bureau: AbbVie, Janssen, Novartis, and Pfizer, Consultant of: AbbVie, Janssen, Novartis, and Pfizer, Simona Rednic: None declared, francesco ciccia Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Novartis, Pfizer, UCB, and Werfen, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, MSD, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Celgene, Chugai, Pfizer, and UCB, Fabiana Ganz Shareholder of: May own stock or options in AbbVie, Employee of: AbbVie, Tianming Gao Shareholder of: May own stock or options in AbbVie, Employee of: AbbVie, Apinya Lertratanakul Shareholder of: May own stock or options in AbbVie, Employee of: AbbVie, In-Ho Song Shareholder of: May own stock or options in AbbVie, Employee of: AbbVie, Andrew Ostor Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, Gilead, MSD, Novartis, Pfizer, and Roche, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Gilead, MSD, Novartis, Pfizer, and Roche, Laura C Coates: None declared.