POS0934 EFFICACY OF UPADACITINIB ON PSORIATIC ARTHRITIS WITH AXIAL INVOLVEMENT DEFINED BY INVESTIGATOR ASSESSMENT AND PRO-BASED CRITERIA: RESULTS FROM TWO PHASE 3 STUDIES

Abstract

BackgroundPatients with PsA and axial involvement have higher disease activity and greater reductions in quality of life;1 however, there are no accepted criteria for identifying axial involvement in PsA.ObjectivesThe objective of this post-hoc analysis is to assess the efficacy of upadacitinib (UPA), a Janus kinase inhibitor, on axial symptoms in patients with active PsA and axial involvement defined by investigator assessment and PRO-based criteria from two phase 3 SELECT trials.2,3MethodsPatients with active PsA (≥3 swollen joints and ≥3 tender joints) and prior inadequate response or intolerance to ≥1 non-biologic (SELECT-PsA 1) or ≥1 biologic (SELECT-PsA 2) DMARD were randomly assigned to once daily oral UPA 15 mg or 30 mg, placebo (PBO), or every other week subcutaneous adalimumab (ADA) 40 mg (SELECT-PsA 1 only).2,3 At baseline, axial involvement in PsA was determined by investigator assessment based on the totality of clinical information, such as duration and character of back pain, age of onset, and previous imaging. In addition to investigator assessment, PRO-based criteria for axial involvement (BASDAI ≥4 and BASDAI Question 2 ≥4 at baseline) were applied for this analysis to identify patients with active disease. Efficacy in the sub-group of patients defined using both investigator assessment and PRO-based criteria was evaluated at week 24 for UPA 15 mg vs PBO and ADA (SELECT-PsA 1 only). Data were analyzed using mixed-effect model repeated measures (MMRM) or non-responder imputation (NRI), with nominal P-values shown.ResultsBased on investigator assessment alone, 31.3% (n=534/1704) of patients in SELECT-PsA 1 and 34.2% (n=219/641) in SELECT-PsA 2 were defined as having axial involvement. When both investigator assessment and PRO-based criteria were applied, 23.1% (n=393/1704) of patients in SELECT-PsA 1, or 73.6% (n=393/534) of those defined using investigator assessment alone, and 27.5% (n=176/641) in SELECT-PsA 2, or 80.4% (n=176/219) using investigator assessment alone, met the combined criteria for axial involvement. In both studies, UPA 15 mg showed significantly greater clinical responses vs PBO at week 24 across all endpoints assessed (Figure 1). In SELECT-PsA 1, UPA showed numerically greater responses than ADA at week 24 across all BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS) endpoints. The proportion of patients achieving ASDAS clinically important improvement (CII) at week 24 was significantly greater with UPA vs ADA based on nominal P-value.ConclusionPatients with active PsA and axial involvement defined by both investigator assessment and PRO-based criteria demonstrated statistically greater clinical responses related to their axial involvement with UPA 15 mg compared to PBO, and consistently numerically higher responses compared to ADA, at week 24 in the SELECT-PsA trials. Findings from this post-hoc analysis are consistent with previous data based on investigator assessment alone.4References[1]Mease PJ et al. J Rheumatol. 2018; 45(10):1389-96[2]McInnes IB et al. N Engl J Med. 2021; 384(13):1227-39[3]Mease PJ et al. Ann Rheum Dis. 2020; 80(3):312-20[4]Deodhar A et al. Arthritis Rheumatol. 2020; 72(Suppl 10)AcknowledgementsAbbVie funded these studies and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. No honoraria or payments were made for authorship. Medical writing support was provided by Monica R.P. Elmore, PhD of AbbVie.Disclosure of InterestsXenofon 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, R Ranza Speakers bureau: AbbVie, Janssen, Novartis, and Pfizer, Consultant of: AbbVie, Janssen, Novartis, and Pfizer, 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, francesco ciccia Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, MSD, Novartis, Pfizer, Janssen, Sanofi, Sandoz, Galapagos, Sobi, and UCB, Grant/research support from: AbbVie, Celgene, Pfizer, Roche, and UCB, Laura Coates Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, MSD, Novartis, Pfizer, Janssen, Sanofi, Sandoz, Galapagos, Sobi, and UCB, Grant/research support from: AbbVie, Celgene, Pfizer, Roche, and UCB, Simona Rednic Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, and Pfizer, Grant/research support from: AbbVie, Boehringer Ingelheim, Eli Lilly, MSD, Novartis, Pfizer, and UCB, Jessica A. Walsh Consultant of: AbbVie, Amgen, Eli Lilly, Merck, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Eli Lilly, Merck, Novartis, Pfizer, and UCB, Tianming Gao Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Apinya Lertratanakul Shareholder of: Formerly of AbbVie, Employee of: Former employee of AbbVie, In-Ho Song Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Fabiana Ganz Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Kevin Douglas Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Atul Deodhar Consultant of: AbbVie, Amgen, Aurinia, BMS, Boehringer Ingelheim, GSK, Janssen, Lilly, MoonLake, Novartis, Pfizer and UCB, Grant/research support from: AbbVie, GSK, Lilly, Novartis, Pfizer and UCB