OP0233 EFFICACY AND SAFETY OF UPADACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS AND AXIAL INVOLVEMENT

Abstract

Background:Patients (pts) with psoriatic arthritis (PsA) and axial involvment exhibit greater disease activity and quality of life impairments compared with those without axial involvment.Objectives: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 2 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 involvment 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 (Figure). 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 (Figure). One pt on UPA 30 mg had incident uveitis, and no IBD was reported on UPA.Table 1.Demographics and Baseline CharacteristicsSELECT-PsA 1SELECT-PsA 2Parameter, mean (SD)With Psoriatic Spondylitis(n=534)Without Psoriatic Spondylitis(n=1170)Pvalue*With Psoriatic Spondylitis(n=219)Without Psoriatic Spondylitis(n=421)Pvalue*BMI (kg/m2)29.9 (6.5)30.5 (6.9).081031.6 (8.0)31.3 (6.9).6226TJC6821.6 (15.1)19.2 (13.5).002227.5 (18.0)23.3 (16.2).0027SJC6611.7 (9.4)11.0 (7.9).118412.9 (9.2)11.7 (8.7).0804Physician’s Global Assessment (NRS 0–10)6.7 (1.6)6.5 (1.7).04376.6 (1.8)6.5 (1.7).1897HAQ-DI1.2 (0.6)1.1 (0.6).01701.2 (0.6)1.2 (0.7).2049n=531n=1164n=218n=416Presence of dactylitis, n (%)†188 (35.2)328 (28.0).002869 (31.5)100 (23.8).0348Presence of enthesitis, n(%)‡432 (80.9)884 (75.6).0147189 (86.3)337 (80.0).0125ASDAS–CRP3.4 (0.9)3.1 (1.0)<.00013.3 (1.0)3.2 (1.1).1032n=530n=1161n=217n=416BASDAI5.8 (2.0)5.3 (2.2)<.00016.2 (2.2)5.8 (2.2).0673n=530n=1161n=217n=416Morning Stiffness Duration (NRS 0–10; BASDAI Q6)5.0 (3.0)4.7 (3.0).03685.6 (3.2)5.1 (3.0).0454n=530n=1161n=217n=416Patient’s Assessment of Inflammatory Neck, Back, or Hip Pain (NRS 0–10; BASDAI Q2)5.8 (2.7)4.6 (3.2)<.00016.4 (2.8)5.4 (3.1).0001n=530n=1161n=217n=416*Calculated by t-test for continuous variables and chi-square test for categorical values. Bolded if <0.05.Defined as †LDI>0 and ‡total enthesitis count >0Conclusion: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 spondylits.