FRI0440 THE EFFECT OF GUSELKUMAB ON PASDAS, GRACE INDEX, MCPDAI, AND DAPSA: RESULTS FROM A PHASE 2 STUDY IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Abstract

Background Psoriatic ArthritiS Disease Activity Score (PASDAS), GRAppa Composite scorE (GRACE) Index, modified Composite Psoriatic Disease Activity Index (mCPDAI), and Disease Activity Index for PSoriatic Arthritis (DAPSA) are composite indices recently developed to assess disease activity in psoriatic arthritis (PsA).1,2 Objectives The effect of guselkumab (GUS) on these indices was evaluated in a phase 2 study in patients with active PsA. Methods Patients with ≥3 tender and ≥3 swollen joints, C-reactive protein ≥3 mg/L, and ≥3% body surface area (BSA) of plaque psoriasis despite treatment were randomized 2:1 to receive GUS 100 mg subcutaneously (N=100) or placebo (PBO, N=49) at Weeks 0, 4, and every 8 weeks thereafter through Week44. At Week16, patients with Results Baseline PASDAS, GRACE, mCPDAI, and DAPSA showed moderate to high disease activity (mean (SD): 6.53 (1.079), 6.08 (1.208), 7.6 (2.15), and 46.65 (20.391), respectively), and were generally comparable between PBO and GUS. At Week24, GUS significantly decreased PASDAS, GRACE, mCPDAI, and DAPSA scores (mean (SD) change from baseline: -2.50 (1.59), -2.73 (1.76), -3.8 (2.72), -23.08 (20.21), respectively) vs PBO (mean (SD) change from baseline: -0.49 (1.33), -0.35 (1.39), -0.8 (2.16), -4.97 (20.11), respectively, all p Conclusion GUS demonstrated consistent improvements based on all PsA composite indices evaluated, and efficacy was maintained through Week44.