FRI0351 DOES SEX OR BODY MASS INDEX IMPACT RESPONSE TO THERAPY IN PSORIATIC ARTHRITIS?: RESULTS FROM A PHASE 3, DOUBLE-BLIND, RANDOMIZED TRIAL EXAMINING METHOTREXATE AND ETANERCEPT AS MONOTHERAPY OR IN COMBINATION FOR TREATING PSORIATIC ARTHRITIS

Background: Psoriatic arthritis (PsA) is a chronic and complex inflammatory disease with both articular and extra-articular symptoms. Pain and fatigue are two of the most common patient-reported symptoms. Improvements in pain and fatigue have been demonstrated with up to 2 years of treatment with ixekizumab (IXE) in patients who had an inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi).1,2 Objectives: To report improvements in pain and fatigue in TNFi-experienced patients with PsA who were treated with IXE for 3 years (156 weeks). Methods: SPIRIT-P2 (NCT02349295) was a 156-week, Phase 3 study that included patients who met the Classification Criteria for Psoriatic Arthritis (CASPAR) and had an inadequate response or intolerance to 1 or 2 TNFi. Although there was a placebo group through Week 24, these data were derived only from patients in the intent-to-treat population randomized to IXE at baseline. After a 160-mg starting dose, patients received 80 mg subcutaneous IXE every 2 or 4 weeks (Q2W or Q4W). Patients self-rated their symptoms using the Joint Pain Visual Analog Scale (Joint Pain VAS; 0 [none] to 100 [worst imaginable]), the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36; with the domains ranging from 0 [worst] to 100 [best]), and the Fatigue Severity Numeric Rating Scale (Fatigue NRS; 0 [none] to 10 [worst imaginable]). Minimum clinically important difference (MCID) cutoffs were ≥10 for Joint Pain VAS, ≥5 for SF-36 domains, and ≥3 for Fatigue NRS. Missing values were imputed by modified baseline observation carried forward for continuous variables and modified non-responder imputation for categorical variables. Results: The proportions of patients who completed Week 156 were 70/122 (57.4%) in the IXE Q4W group and 55/123 (44.7%) in the IXE Q2W group. At Week 156, mean change from baseline for the Joint Pain VAS was -28.9 (IXE Q4W) and -25.3 (IXE Q2W) (Fig. A). In addition, 51.8% of patients on IXE reported clinically meaningful improvement of joint pain (56.1% IXE Q4W, 47.5% IXE Q2W) at Week 156. Patients reported an 18-point mean improvement in the SF-36 bodily pain domain at Week 156 (Fig. B). Patients also reported improvements in fatigue up to Week 156 (Fig. C), with 35.0% of patients achieving the MCID on the Fatigue NRS (39.4% IXE Q4W, 30.6% IXE Q2W). Improvement in fatigue was supported by a14-point mean improvement in the vitality domain of the SF-36 at Week 156 (Fig. D). Conclusion: In patients with PsA who had an inadequate response or intolerance to TNFi, improvements in pain and fatigue were sustained through 3 years of IXE treatment in both the Q2W and Q4W treatment groups. References: [1]Kavanaugh A, Marzo-Ortega H, Vender R, et al. Clin Exp Rheumatol. 2019;37(4):566-574. [2]Turkiewicz A, Gellett A, Kerr L, et al. [abstract] Arthritis Rheumatol. 2018;70(S9):2577. Disclosure of Interests: Ana-Maria Orbai Grant/research support from: Abbvie, Eli Lilly and Company, Celgene, Novartis, Janssen, Horizon, Consultant of: Eli Lilly; Janssen; Novartis; Pfizer; UCB. Ana-Maria Orbai was a private consultant or advisor for Sun Pharmaceutical Industries, Inc, not in her capacity as a Johns Hopkins faculty member and was not compensated for this service., Kurt de Vlam Grant/research support from: Celgene, Consultant of: Celgene, Eli Lilly and Company, UCB, Novartis, and Pfizer, Speakers bureau: Celgene, Eli Lilly and Company, UCB, Novartis, and Pfizer, Peter Nash Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Julie Birt Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Gaia Gallo Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Keri Stenger Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Vladimir Geneus Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB