Clinical Responses and Improvements in Patient-Reported Outcomes are Associated with Increased Productivity in the Workplace and at Home in Rheumatoid Arthritis Patients Treated with Certolizumab Pegol

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OBJETIVES:

To assess associations between certolizumab pegol (CZP)-mediated stringent clinical targets and workplace/household productivity improvements in DMARD-naïve, severe, progressive, early rheumatoid arthritis (RA) patients.

METHODS:

C-EARLY (NCT01519791), a double-blind RCT, enrolled DMARD-naïve patients with active, moderate-to-severe, progressive, early RA (<1year from diagnosis). Patients were randomized 3 CZP+MTX1 placebo (PBO)+MTX MTX was titrated to 15–25mg/wk by Week (Wk)8; maximum tolerated (optimized) dose was maintained to Wk52. Associations between clinical responses and workplace/household productivity outcomes were evaluated at Wk52 in CZP patients. Clinical response criteria included sustained remission (sREM.DAS28[ESR ]<2.6,Wks40&52), sustained low disease activity (sLDA.DAS28[ESR]≤3.2,Wks40&52 ), radiographic non-progression (mean change from baseline [CFB] mTSS≤0.5), and normative physical function (NF:HAQ-DI≤0.5). CFB at Wk52 in workplace/household productivity (Work Productivity Survey [WPS]) were compared in responders/nonresponders (non-parametric bootstrap-t method). Missing data were imputed using LOCF (WPS) and non-responder imputation (clinical).

RESULTS:

655 CZP patients were included. At baseline, burden was similar between groups; 52.3% employed. Responders achieving sREM, sLDA or NF reported greater productivity improvements versus non-responders (workplace days missed month:-4.2 vs -2.5[p<0.05], -4.1 vs -1.9[p<0.01], -3.7 vs -2.3; workplace days with productivity reduced by ≥50%/ month:-6.2 vs -4.3,-6.5 vs -3.3[p<0.01], -5.8 vs -4.0; level of RA interference with work productivity: -4.6 vs -3.6[p<0.01], -4.6 vs -3.2[p<0.001], -4.4 vs -3.4[p<0.01]; household days missed/month:-8.3 vs -6.1[p<0.01], -8.0 vs -5.8[p<0.01], -7.7 vs -5.8[p<0.05]; household days with productivity reduced by ≥50%/month:-8.8 vs -6.3[p<0.01], -9.0 vs -5.5[p<0.001], -8.9 vs -5.3[p<0.001]; level of RA interference with household productivity: -5.1 vs -3.7[p<0.001], -4.9 vs -3.4[p<0.001], -4.9 vs -3.3[p<0.001]; nominal p-values). There were no associations with radiographic non-progression (data not shown).

CONCLUSIONS:

Achieving stringent clinical targets (sREM/sLDA) and NF was associated with numerically greater improvements in workplace/household productivity after 1year in CZP-treated DMARDnaïve patients with early, moderate-to-severe, progressive RA. The ability to return to maximum participation levels, early in the disease course, is an important goal for RA patients