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Clinical trial: the effects of certolizumab pegol therapy on work productivity in patients with moderate-to-severe Crohn's disease in the PRECiSE 2 study.

Author(s): Feagan BG, Reilly MC, Gerlier L, Brabant Y, Brown M, Schreiber S

Affiliation(s): Robarts Research Institute, The University of Western Ontario, London, ON, Canada. bfeagan@robarts.ca

Publication date & source: 2010-06, Aliment Pharmacol Ther., 31(12):1276-85. Epub 2010 Mar 18.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: The effect of certolizumab pegol on employment status and work productivity has not been previously assessed. AIM: To assess the impact of treatment with certolizumab pegol, the only PEGylated, Fab' TNF antagonist, on work productivity in patients with active Crohn's disease (CD) from the PRECiSE 2 study. METHODS: Patients (n = 668) with active disease [CD activity index (CDAI) score of 220-450] were treated with open-label subcutaneous certolizumab pegol 400 mg (week 0, 2, 4). Responders (n = 425) (> or = 100-point decrease in CDAI from baseline) were randomized to receive certolizumab pegol 400 mg or placebo every 4 weeks until week 24, with final evaluation at week 26. Patients completed the Work Productivity and Activity Impairment for CD questionnaire (WPAI:CD) and the Inflammatory Bowel Disease Questionnaire (IBDQ) at weeks 0, 6, 16 and 26 and at the withdrawal visit. RESULTS: Work productivity improved following induction with certolizumab pegol. Between week 6 and 26, certolizumab pegol-treated patients experienced significant improvement in work productivity compared with placebo recipients (11% and 10% overall improvement in work and activity impairment, respectively). During the maintenance phase, impairments in productivity and activities due to CD were significantly less in the certolizumab pegol group than in the placebo group. CONCLUSION: Induction and maintenance therapy with certolizumab pegol significantly improved the work productivity of patients with active CD compared with those in the placebo group.

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