Improvements in Productivity at Paid Work and Within the Household, and Increased Participation in Daily Activities Over 52 Weeks of Certolizumab Pegol Treatment of Rheumatoid Arthritis: Results of A Belgian Observational Non-Interventional Study

Westhovens R,Ravelingien I, Van de Vyvere K, Pansar I,Purcaru O, Kumke T, Gyselbrecht L

VALUE IN HEALTH(2016)

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摘要
To evaluate the effect of certolizumab pegol (CZP) treatment on workplace and household productivity over 52 weeks (wks) in rheumatoid arthritis (RA) patients in real-world clinical practice in Belgium. RA0046 was an observational, non-interventional, prospective study. Eligible patients were ≥18 years with moderate to severe active RA suitable for treatment with CZP according to the SmPC and Belgian local reimbursement criteria (DAS28≥3.7). Disease burden at study baseline on workplace and household productivity over the preceding month was evaluated using the validated, RA-specific Work Productivity Survey. Data are presented for all patients who received ≥1 CZP dose with ≥1 post-baseline assessment of ≥1 primary efficacy variable (full analysis set). Missing data were imputed using last observation carried forward. Of 141 patients enrolled, 93 (66%) completed the study to Wk52. At baseline, patients had active disease: mean (SD) DAS28: 4.8 (0.9), tender joint count: 8.8 (6.1), swollen joint count: 6.4 (4.1), HAQ-DI: 1.5 (0.6), and Pain (0–100mm VAS): 65.5 (19.4). All patients reported a high burden on productivity at baseline. At Wk52, patients missed fewer days of paid and household work ([mean baseline/Wk52] paid: 5.9/2.9; household: 8.9/5.2), suffered fewer days of ≥50% reduced productivity at work and home ([baseline/Wk52] work: 5.1/3.0; home: 7.9/4.7), and reported reduced interference of arthritis in paid and household work ([mean baseline/Wk52, 0–10 scale] paid: 5.4/2.7; household: 5.7/3.2). Improvements in clinical outcomes were also observed; by Wk52, 71% of patients achieved a good EULAR response, and 66% achieved EULAR remission. The safety profile of CZP was comparable to previous reports, with no new safety signals identified. CZP treatment over 52 wks was associated with improvements in workplace and household productivity in real-world clinical practice in Belgium; comparable improvements in clinical outcomes were also observed.
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关键词
certolizumab pegol treatment,rheumatoid arthritis,paid work,daily activities,non-interventional
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