Improvements In Patient-Reported Outcomes And Workplace And Household Productivity Following 52 Weeks Of Treatment With Certolizumab Pegol In Combination With Methotrexate In Dmard-Naive Early Rheumatoid Arthritis Patients: Results From The C-Early Randomized, Double-Blind, Controlled Phase 3 Study

Background Rheumatoid arthritis (RA) leads to high burden on patient (pt) physical function, quality of life (QoL) and work disability. Improvements in pt-reported outcomes (PROs) 1 and workplace and household productivity 2 with certolizumab pegol (CZP)+MTX were reported in established RA. Here we report results from C-EARLY, a phase 3 study of CZP+MTX in DMARD-naive pts with early active RA. Objectives To assess the effect of CZP+MTX vs placebo (PBO)+MTX on PROs, workplace and household productivity, and need for help with daily activities in DMARD-naive pts with early active RA. Methods Pts in this multicenter, double-blind, randomized study (NCT01519791) were DMARD-naive, had early, active RA: 3 ) were assessed. At Wk52 changes from BL were analyzed using ANCOVA (LOCF imputation); categorical variables were analyzed using logistic regression (non-responder imputation); WPS responses (LOCF imputation) were compared using a non-parametric bootstrap-t method. Need for regular assistance in usual activities was summarized descriptively. Results 660 (CZP+MTX) and 219 (PBO+MTX) pts were randomized; 655 vs 213 in the full analysis set (pts with BL and post-BL DAS28[ESR]). BL characteristics were balanced between study arms. BL disease severity was high: mean (SD) HAQ-DI 1.6 (0.6), Pain VAS 66.1 (22.4), PtGADA 65.3 (22.0) (Table A), DAS28[ESR] 6.7 (0.9), months since diagnosis 2.9 (4.3). 52% of pts were employed at BL (Table B). At Wk52, greater PRO improvements were observed with CZP+MTX vs PBO+MTX (Table A). CZP+MTX pts reported greater improvements vs PBO+MTX in household productivity, and lower need for assistance in usual activities. Employed CZP+MTX pts reported reductions in absenteeism and presenteeism vs PBO+MTX (Table B). Conclusions In DMARD-naive early RA pts, CZP+MTX showed greater improvements at 1yr in physical function, pain, disease activity, fatigue and health-related QoL, improved workplace and household productivity, and reduced need for assistance with regular activities compared to PBO+MTX. References Strand V. Arthritis Res Ther 2009;11:R170; Kavanaugh A. Arthritis Care Res 2009;61(11):1592–1600; Osterhaus J. Arthritis Res Ther 2009;11:R73 Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma. Disclosure of Interest P. Emery Consultant for: Pfizer, MSD, AbbVie, UCB Pharma, Roche and BMS, Speakers bureau: Pfizer, MSD, AbbVie, UCB Pharma, Roche and BMS, C. Bingham: None declared, G.-R. Burmester: None declared, V. Bykerk: None declared, D. Furst Grant/research support from: Abbott, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB Pharma, Consultant for: Abbott, Actelion, Amgen, Bristol-Myers Squibb, BiogenIdec, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB Pharma, Speakers bureau: Abbott, Actelion, UCB Pharma, X. Mariette Grant/research support from: Pfizer, Roche, Consultant for: BMS, GSK, Pfizer, Roche, UCB Pharma, O. Purcaru Employee of: UCB Pharma, G. Coteur Employee of: UCB Pharma, B. VanLunen Employee of: UCB Pharma, M. Weinblatt Grant/research support from: Bristol Myers Squibb, Crescendo Bioscience, UCB Pharma, Consultant for: Amgen, Abbvie, Bristol Myers Squibb, Crescendo Bioscience, UCB Pharma, Roche