Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFα, improves health-related quality of life in patients with moderate to severe Crohn’s disease
- Paul RutgeertsAffiliated withDivision of gastroenterology, University Hospital LeuvenDivision of Gastroenterology, Universitair Ziekenhuis Gasthuisberg Email author
- , Stefan SchreiberAffiliated withDepartment of General Internal Medicine, University Hospital Kiel
- , Brian FeaganAffiliated withRobarts Research Institute
- , Dorothy L. KeiningerAffiliated withGlobal Health Outcomes Research, UCB
- , Liz O’NeilAffiliated withUCB
- , Richard N. FedorakAffiliated withUniversity of Alberta
- , CDP870 Crohn’s Disease Study Group
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.
Patients receiving certolizumab pegol 400 mg at weeks 0, 4, and 8 demonstrated, via their IBDQ total score, significantly (P ≤ 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 ≤ 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 ≤ 0.05) and approached statistical significance at week 2 (P = 0.054).
This analysis suggests that certolizumab pegol 400 mg improves HRQoL in patients with moderate-to-severe Crohn’s disease.
KeywordsCrohn’s disease Immunotherapy Quality of life Inflammatory bowel disease
- Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFα, improves health-related quality of life in patients with moderate to severe Crohn’s disease
- Open Access
- Available under Open Access This content is freely available online to anyone, anywhere at any time.
International Journal of Colorectal Disease
Volume 23, Issue 3 , pp 289-296
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- Crohn’s disease
- Quality of life
- Inflammatory bowel disease
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- Author Affiliations
- 1. Division of gastroenterology, University Hospital Leuven, Leuven, Belgium
- 7. Division of Gastroenterology, Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde, Herestraat 49, Leuven, 3000, Belgium
- 2. Department of General Internal Medicine, University Hospital Kiel, Kiel, Germany
- 3. Robarts Research Institute, London, Canada
- 4. Global Health Outcomes Research, UCB, Braine-l’Alleud, Belgium
- 5. UCB, Slough, UK
- 6. University of Alberta, Edmonton, Canada