AB0745 ASSESSMENT OF DISEASE ACTIVITY USING RAPID3 AND EVALUATION OF TREATMENT EFFECT OF GUSELKUMAB IN PATIENTS WITH PSA: RESULTS FROM A RANDOMIZED PLACEBO-CONTROLLED PHASE 2 CLINICAL TRIAL

Abstract

Background Objectives To evaluate the effect of guselkumab (GUS) on Routine assessment of Patient index Data 3 (RAPID3) in patients with psoriatic arthritis (PsA). Methods In a phase 2 trial, patients with active PsA and ≥3% body surface area of plaque psoriasis despite current or previous treatment with standard-of-care therapies, including anti-TNFα agents, were randomized 2:1 to receive GUS 100 mg (n=100) or placebo (PBO, n=49) subcutaneously at wks 0, 4, and every 8 wks (q8w) thereafter through wk44. At wk16, patients from either group with Results The mean (SD) RAPID3 score at baseline was 16.9 (5.19). At wk24, patients in the GUS group (n=100) achieved statistically significantly greater decrease from baseline (improvement) in RAPID3 (-5.81 ± 6.0) than the PBO group (n=49) (-0.57 ± 5.1, p Conclusion GUS-treated PsA patients demonstrated significant improvement in RAPID3 compared to PBO. RAPID3 is simple and feasible to use in routine clinical care, and it correlates well with other comprehensive PsA-specific disease activity measures. Disclosure of interests 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, L Bruce Kirkham Grant/research support from: investigator for Janssen Research & Development, LLC, Consultant for: abbvie, Eli Lilly and Company, Janssen, Novartis, Proton Rahman: None declared, 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, 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, Chenglong Han Employee of: Employee of Janssen Research & Development, LLC