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Improvements in Workplace and Household Productivity Following 52 Weeks of Treatment with Certolizumab Pegol in Combination with Methotrexate in Dmard-Naive Patients with Severe, Active and Progressive Rheumatoid Arthritis: Results from the C-Early Randomized, Double-Blind, Controlled Phase 3 Study

      Objectives

      To assess effects of CZP+MTX vs PBO+MTX on workplace and household productivity and need for help with daily activities in DMARD-naïve patients with severe, active, progressive RA.1

      Methods

      Patients in this double-blind randomized study (NCT01519791) were DMARD-naïve with active RA <1yr diagnosis at baseline, fulfilling 2010 ACR/EULAR criteria; ≥4 swollen and ≥4 tender joints; DAS28[ESR]≥3.2; CRP≥10mg/L and/or ESR≥28mm/hr, RF/ACPA positive. Patients were randomized 3:1 to CZP (400mg Wks 0,2,4 then 200mg Q2W to Wk52)+MTX or PBO+MTX (MTX initiated at 10mg/wk, increased to 25mg/wk by Wk8, maximum tolerated dose maintained to Wk52). Workplace and household productivity (Work Productivity Survey [WPS]) were assessed; responses (LOCF imputation) compared using a non-parametric bootstrap-t method. Need for assistance was summarized descriptively.

      Results

      660 (CZP+MTX) and 219 (PBO+MTX) patients were randomized; 655 vs 213 in the full analysis set (pts with baseline and post-baseline DAS28[ESR]). Baseline characteristics were balanced between study arms; 52% employed. CZP+MTX patients reported greater improvements vs PBO+MTX in household productivity (household work days missed per month BL vs Wk52: PBO+MTX=10.4 vs 3.0, CZP+MTX=8.8 vs 1.9; household work days with productivity reduced by ≥50%/month: PBO+MTX=10.6 vs 3.0, CZP+MTX=9.4 vs 2.1; level of arthritis interference with household work productivity/month: PBO+MTX=6.4 vs 2.5, CZP+MTX=6.0 vs 1.9). CZP+MTX patients also reported lower need for assistance in usual activities from a relative/friend. Employed CZP+MTX patients reported reductions in absenteeism and presenteeism vs PBO+MTX (work days missed/month BL vs Wk52: PBO+MTX=4.0 vs 0.9, CZP+MTX=4.4 vs 0.6; days with work productivity reduced by ≥50%/month: PBO+MTX=8.8 vs 1.8, CZP+MTX=6.4 vs 1.0; level of arthritis interference with work productivity/month: PBO+MTX=5.8 vs 1.9, CZP+MTX=5.5 vs 1.4).

      Conclusions

      In DMARD-naïve patients with severe, active, progressive RA, CZP+MTX showed greater improvements at 1-year in workplace and household productivity and reduced need for assistance with regular activities vs PBO+MTX. 1. Emery. Ann Rheum Dis 2015;74(S2):712