OA38 Efficacy and safety of upadacitinib in patients with psoriatic arthritis and axial involvement

Abstract Background/Aims Patients (pts) with psoriatic arthritis (PsA) and axial involvement exhibit greater disease activity and quality of life impairments compared with those without axial involvement. Here the aim was to characterize PsA pts with and without axial involvement and compare efficacy of UPA vs placebo (PBO) in PsA pts with axial involvement. Methods In SELECT-PsA 1 (NCT03104400; N = 1705, non-biologic DMARD IR) and SELECT-PsA 2 (NCT03104374; N = 642, biologic DMARD IR), pts with active PsA (≥3 swollen and ≥3 tender joints), active or historical psoriasis, and on ≤ 2 non-biologic DMARDs were randomized to once daily UPA 15 mg, UPA 30 mg, adalimumab 40 mg every other week (SELECT-PsA 1 only), or PBO. Efficacy was assessed in pts with axial involvement (diagnosed by investigators based on totality of information) pooled from the two studies. Assessments included change from BL in BASDAI, BASDAI Q2 (neck/back/hip pain) and Q3 (joint swelling/pain), and the AS Disease Activity Score (ASDAS-CRP), and percentage with BASDAI 50 response, ASDAS inactive disease (ID), ASDAS low disease activity (LDA), ASDAS major improvement (MI), and ASDAS clinically important improvement (CII). Uveitis and inflammatory bowel disease (IBD) adverse events were reviewed. Data on 24-week PBO-controlled period are presented. Results Prevalence of axial involvement was 31.3% in SELECT-PsA 1 and 34.2% in SELECT-PsA 2 (Table). Treatment with UPA 15 mg and 30 mg resulted in significantly greater improvements from BL in the BASDAI, BASDAI Q2 (neck/back/hip pain) and Q3 (joint swelling/pain) and ASDAS-CRP at weeks 12 and 24 vs PBO. Similarly, significantly higher percentages of pts on UPA 15 mg and 30 mg achieved BASDAI 50, ASDAS ID, LDA, MI, and CII at weeks 12 and 24 vs PBO. One pt on UPA 30 mg had incident uveitis, and no IBD was reported on UPA. Conclusion PsA pts with axial involvement had higher BL disease burden compared with those without axial involvement. UPA was efficacious in treating axial symptoms in pts with psoriatic spondylitis. Disclosure A. Deodhar: Consultancies; A.D. has received consultancy fees from Novartis, Pfizer, AbbVie, Eli-Lilly, UBC Pharma, GlaxoSmithKline, Galapagos, Janssen, Boehringer Ingelheim, Celgene. Member of speakers’ bureau; A.D. is a member of the speakers' bureau of Novartis and Pfizer. Grants/research support; A.D. has received research grants from Novartis, Pfizer, AbbVie, Eli-Lilly, UBC Pharma, GlaxoSmithKline. R. Ranza: Consultancies; R.R. has acted as a consultant to AbbVie, Janssen, Lilly, Novartis, Pfizer. Member of speakers’ bureau; R.R. is a member of the speakers' bureau of AbbVie, Janssen, Lilly, Novartis, Pfizer. Grants/research support; R.R. has received grant/research support from AbbVie, Janssen. F. Ganz: Shareholder/stock ownership; F.G. is an employee of AbbVie and may hold stock or options. T. Gao: Shareholder/stock ownership; T.G. is an employee of AbbVie and may hold stock and options. J. Anderson: Shareholder/stock ownership; J.A. is an employee of AbbVie and may hold stock and options. A. Ostor: Consultancies; A.O. has acted as a consultant for AbbVie, BMS, Roche, Janssen, Lilly, Novartis, UBC, Pfizer, Gilead, Paradigm.