Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFalpha, improves health-related quality of life in patients with moderate to severe Crohn's disease

Paul Rutgeerts, Stefan Schreiber, Brian Feagan, Dorothy L Keininger, Liz O'Neil, Richard N Fedorak, CDP870 Crohn's Disease Study Group, Paul Rutgeerts, Stefan Schreiber, Brian Feagan, Dorothy L Keininger, Liz O'Neil, Richard N Fedorak, CDP870 Crohn's Disease Study Group

Abstract

Background and aims: Certolizumab pegol, a polyethylene glycolated Fc-free Fab' was efficacious and well tolerated in patients with moderate-to-severe Crohn's disease in a previously reported randomized, placebo-controlled study. In this paper, we report the effect of certolizumab pegol on health-related quality of life (HRQoL).

Materials and methods: Patients with moderate-to-severe active Crohn's disease (n = 292) received subcutaneous certolizumab pegol 100, 200, or 400 mg or placebo at weeks 0, 4, and 8. A post hoc analysis of the intent-to-treat population (290 patients with HRQoL data) assessed HRQoL by evaluating patients' responses to the self-administered inflammatory bowel disease questionnaire (IBDQ) at baseline and weeks 2, 4, 6, 8, 10, and 12.

Results: Patients receiving certolizumab pegol 400 mg at weeks 0, 4, and 8 demonstrated, via their IBDQ total score, significantly (P <or= 0.05) greater improvement in HRQoL from baseline to week 12 and at all other time points compared with placebo. Moreover, HRQoL improved over time in all certolizumab pegol groups, irrespective of baseline C-reactive protein levels. Emotional well-being (IBDQ Emotional Function domain) improved throughout the study for patients receiving certolizumab pegol 400 mg. This improvement was significantly (P <or= 0.05) greater than for patients receiving placebo at all time points. In addition, systemic symptoms (IBDQ Systemic Symptoms domain) improved significantly more in patients receiving certolizumab pegol 400 mg than in those receiving placebo at weeks 4, 8, 10, and 12 (P <or= 0.05) and approached statistical significance at week 2 (P = 0.054).

Conclusion: This analysis suggests that certolizumab pegol 400 mg improves HRQoL in patients with moderate-to-severe Crohn's disease.

Figures

Fig. 1
Fig. 1
Study design (showing the total numbers of patients recruited into each treatment group)
Fig. 2
Fig. 2
Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score during 12 weeks’ subcutaneous treatment with either certolizumab pegol or placebo in patients with moderate-to-severe Crohn’s disease (intent-to-treat population); least-squares means (adjusted for stratum, pooled country, and baseline score)
Fig. 3
Fig. 3
Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores during 12 weeks subcutaneous treatment with either certolizumab pegol or placebo in patients with moderate-to-severe Crohn’s disease (intent-to-treat population); least-squares means (adjusted for stratum, pooled country, and baseline score): a Bowel Symptoms domain, b Systemic Symptoms domain, c Emotional Function domain, and d Social Function domain

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