The Effect of Guselkumab on PASDAS, GRACE Index, mCPDAI and DAPSA: Results from a Phase 2 Study in Patients with Active Psoriatic Arthritis

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. References [1] Helliwell PS, FitzGerald O, and Fransen J. JRheumatol2014;41:1212-1217. [2] Scholes MM, Aletaha D, Alasti F, Smolen JS. AnnRheumDis2016;75:811-818. Disclosure of Interests Dafna D Gladman Grant/research support from: AbbVie, Amgen, Celgene, Lilly, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB, Philip Helliwell Grant/research support from: Paid to charity: from AbbVie, Janssen and Novartis, Consultant for: Paid to charity: from AbbVie, Amgen, Pfizer, and UCB and Celgene. Paid to self: from Celgene and Galapagos, Atul Deodhar Grant/research support from: AbbVie, Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Amgen, BMS, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Alice B Gottlieb Grant/research support from: PI: Incyte Corporation, Janssen-Ortho Inc., Lilly ICOS LLC, Novartis, UCB, XBiotech, Consultant for: AbbVie, Dermira, Incyte Corporation, Lilly ICOS LLC, Novartis, Sun Pharmaceutical Industries Ltd., Avotres (unpaid), XBiotech (unpaid), Speakers bureau: AbbVie, Eli Lilly and Company, Janssen Biotech; advisory board: Bristol-Myers Squibb, Celgene Corporation, Janssen Biotech, Janssen-Ortho Inc., LEO Pharma, Novartis, UCB, Wolf-Henning Boehncke Consultant for: Pfizer Inc, Speakers bureau: Pfizer Inc, Xie L Xu Employee of: Employee of Janssen Research & Development, LLC, Stephen Xu Employee of: Employee of Janssen Research & Development, LLC, Yuhua Wang Employee of: Employee of Janssen Research & Development, LLC, Elizabeth C Hsia Employee of: Employee of Janssen Research & Development, LLC, Christopher T. Ritchlin Grant/research support from: AbbVie, Amgen, UCB Pharma, Consultant for: AbbVie, Amgen, Lilly, Novartis, Pfizer, UCB Pharma