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
Authors: P. J. Mease, D. D. Gladman, J. F. Merola, A. Deodhar, A. Ogdie, D. Collier, E. Karis, L. Liu, A. Kavanaugh
Journal: Annals of the Rheumatic Diseases (2020)

Background: In psoriatic arthritis (PsA), contextual factors such as sex and body mass index (BMI) may affect response to therapy. Objectives: To examine if sex and BMI influenced 24-week (wk) outcomes in a 48-wk PsA trial of methotrexate (MTX) and etanercept (ETN) as monotherapy (mono) or combined. 1 Methods: MTX- and biologic-naïve adult patients with active PsA were randomized to weekly: MTX 20mg (n=284), ETN 50mg (n=284), or MTX 20mg+ETN 50mg (n=283). Wk-24 outcomes included ACR 20, MDA, VLDA, PASDAS, DAPSA, LDI, SPARCC, BSA, sPGA, and mNAPSI. Descriptive statistics examined outcomes in each treatment arm by sex (male vs female) or BMI (≤30kg/m 2 vs &gt;30kg/m 2 ). Modeling analyses also examined sex or BMI effect on outcomes when comparing MTX mono to the ETN-containing arms (analyses were adjusted for any prior use of a nonbiologic disease-modifying antirheumatic drug; the model for the influence of sex also adjusted for baseline BMI status). Nominal P-values are provided. Results: Baseline disease activity was slightly higher in women, especially with MTX+ETN. Descriptive statistics showed men and women had similar results at wk 24 in the MTX mono and ETN mono arms; with MTX+ETN, men had better outcomes for ACR20, MDA, VLDA, and PASDAS. In treatment-interaction analyses, men had more favorable responses at wk 24 with MTX+ETN vs MTX mono for PASDAS, MDA, and LDI (Table). Baseline disease activity was similar in both BMI categories. Descriptive statistics in each treatment arm showed no consistent differences in results at wk 24 between BMI categories. In treatment-interaction analyses, BMI ≤30kg/m 2 had a more favorable response at wk 24 with MTX+ETN vs MTX mono for sPGA (Table). Conclusion: Results suggest contextual factors may affect response to therapy in PsA. The treatment-interaction analyses suggest disparate responses to MTX+ETN by sex; BMI only affected skin response. References: [1]Mease et al. Arthritis Rheumatol . 2019;71:1112-24 Disclosure of Interests: Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau, Dafna D Gladman Grant/research support from: AbbVie, Amgen Inc., BMS, Celgene Corporation, Janssen, Novartis, Pfizer, UCB – grant/research support, Consultant of: AbbVie, Amgen Inc., BMS, Celgene Corporation, Janssen, Novartis, Pfizer, UCB – consultant, Joseph F. Merola Consultant of: Merck, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB Pharma, Celgene, Sanofi, Regeneron, Arena, Sun Pharma, Biogen, Pfizer, EMD Sorono, Avotres and LEO Pharma, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Alexis Ogdie Grant/research support from: Novartis, Pfizer – grant/research support, Consultant of: AbbVie, BMS, Eli Lilly, Novartis, Pfizer, Takeda – consultant, David Collier Shareholder of: Amgen Inc., Employee of: Amgen Inc., Elaine Karis Shareholder of: Amgen Inc., Employee of: Amgen Inc., Lyrica Liu Shareholder of: Amgen Inc., Employee of: Amgen Inc., Arthur Kavanaugh Grant/research support from: AbbVie, Amgen, Eli Lilly, Novartis, Janssen, Pfizer, Gilead, UCB, Consultant of: AbbVie, Amgen, Eli Lilly, Novartis, Janssen, Pfizer, Gilead, UCB