Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab

Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.


Background: Crohn's disease (CD) is associated with impaired health-related quality of life (HRQoL). Certolizumab pegol, administered either every 2 weeks (q2w) or q4w, maintains efficacy in patients previously failing on the anti-TNF agent infliximab (WELCOME study).

Aim: To investigate the impact of certolizumab pegol administered q2w and q4w on work productivity and HRQoL in the WELCOME study.

Methods: Patients with loss of response to infliximab received open-label certolizumab pegol induction and were randomised to receive double-blind maintenance treatment with certolizumab pegol 400 mg either q4w or q2w through week 24, with a final evaluation at week 26. Work productivity and HRQoL were assessed using the Work Productivity and Activity Impairment:CD questionnaire and Inflammatory Bowel Disease Questionnaire respectively.

Results: Baseline HRQoL burden was representative of moderately to severely active CD. HRQoL, daily activity and work productivity improved in both treatment groups as early as week 6 and were maintained through week 26. Treatment benefits to HRQoL, daily activity and work productivity were similar between the certolizumab pegol q2w vs. q4w groups.

Conclusions: Certolizumab pegol therapy results in meaningful improvements in work productivity, daily activities and HRQoL in patients with active CD who previously responded to but either lost response or could not tolerate infliximab (ClinicalTrials.gov number: NCT00308581).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Certolizumab Pegol
  • Crohn Disease / drug therapy*
  • Double-Blind Method
  • Drug Resistance
  • Female
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Immunoglobulin Fab Fragments / therapeutic use*
  • Immunologic Factors / therapeutic use*
  • Infliximab
  • Male
  • Middle Aged
  • Polyethylene Glycols / therapeutic use*
  • Quality of Life
  • Severity of Illness Index
  • Treatment Outcome


  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Gastrointestinal Agents
  • Immunoglobulin Fab Fragments
  • Immunologic Factors
  • Polyethylene Glycols
  • Infliximab
  • Certolizumab Pegol

Associated data

  • ClinicalTrials.gov/NCT00308581