FRI0440 THE EFFECT OF GUSELKUMAB ON PASDAS, GRACE INDEX, MCPDAI, AND DAPSA: RESULTS FROM A PHASE 2 STUDY IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
Authors: Dafna D. Gladman, Philip Helliwell, Atul Deodhar, Alice B. Gottlieb, Wolf-Henning Boehncke, Xie L. Xu, Stephen Xu, Yuhua Wang, Elizabeth C. Hsia, Christopher T. Ritchlin
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> 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).<sup>1,2</sup> <h3>Objectives</h3> The effect of guselkumab (GUS) on these indices was evaluated in a phase 2 study in patients with active PsA. <h3>Methods</h3> 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 &lt;5% improvement in both swollen and tender joint counts were eligible for early escape (EE) to open-label ustekinumab. All remaining PBO patients crossed-over to receive GUS 100 mg at Weeks 24, 28, 36, and 44 (PBO→GUS). The PsA composite indices through Week24 were analyzed using last-observation-carried-forward for missing data and data post EE. After Week24, observed data were used. Missing baseline data were excluded in the analyses. <h3>Results</h3> 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&lt;0.001). Significantly more GUS-treated patients achieved a low or very low disease activity state defined by PASDAS, GRACE, and mCPDAI (35.0%, 29.6%, and 45.9%, respectively) vs PBO (4.1%, 2.1%, and 10.4%, respectively, all p&lt;0.001). In addition, 12% of GUS- vs 0% of PBO-treated patients achieved DAPSA remission (p&lt;0.01). Post Week24, improvements in PASDAS, GRACE, mCPDAI, and DAPSA were also observed in PBO→GUS patients (39.3%, 39.3%, 71.4%. and 50.0% achieved disease activity states of low, very low, or remission at Week 44, respectively), and were maintained through Week44 in GUS patients (45.8%, 42.2%, 62.7%, and 51.1% achieved disease activity states of low, very low, or remission, respectively). <h3>Conclusion</h3> GUS demonstrated consistent improvements based on all PsA composite indices evaluated, and efficacy was maintained through Week44. <h3>References</h3> [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. <h3>Disclosure of Interests</h3> 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 &amp; Development, LLC, Stephen Xu Employee of: Employee of Janssen Research &amp; Development, LLC, Yuhua Wang Employee of: Employee of Janssen Research &amp; Development, LLC, Elizabeth C Hsia Employee of: Employee of Janssen Research &amp; Development, LLC, Christopher T. Ritchlin Grant/research support from: AbbVie, Amgen, UCB Pharma, Consultant for: AbbVie, Amgen, Lilly, Novartis, Pfizer, UCB Pharma