Certolizumab pegol in patients with moderate to severe crohn's disease and secondary failure to infliximab

William J. Sandborn, Maria T. Abreu, Geert D'Haens, Jean Frédéric Colombel, Severine Vermeire, Krassimir Mitchev, Corinne Jamoul, Richard N. Fedorak, Martina E. Spehlmann, Douglas C. Wolf, Scott Lee, Paul Rutgeerts

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Abstract

Background & Aims: Patients with moderate to severe Crohn's disease who receive infliximab may experience secondary failure (loss of response and/or hypersensitivity). Data on the utility of switching to certolizumab pegol in these patients are limited. Methods: A total of 539 patients with active Crohn's disease and secondary failure to infliximab were enrolled in a 26-week trial. Patients received open-label induction with subcutaneous certolizumab pegol 400 mg at weeks 0, 2, and 4. Those in clinical response at week 6 were randomized to certolizumab pegol 400 mg every 2 or every 4 weeks through week 24. The primary end point was response at week 6. Secondary end points included remission at week 6 and response and remission at week 26. Results: At week 6, 334 of 539 patients (62.0%) achieved response and 212 of 539 (39.3%) achieved remission. A total of 329 patients were randomized and received maintenance therapy. At week 26, 39.9% (67 of 168) and 36.6% (59 of 161) of patients in the every-4-weeks and every-2-weeks groups were in clinical response, respectively (P = .55). Corresponding remission rates at week 26 were 29.2% and 30.4%, respectively (P = .81). Serious infections occurred in 9 of 539 (1.7%) and 12 of 373 (3.2%) of patients during induction and maintenance, respectively. A single malignancy (skin carcinoma) occurred in a patient receiving every-4-weeks maintenance therapy. Conclusions: Response to open-label induction therapy with certolizumab pegol was achieved by 62% of patients with moderate to severely active Crohn's disease and secondary failure to infliximab. Among these patients, certolizumab pegol 400 mg every 4 weeks showed similar efficacy to every-2-weeks dosing for maintenance of response and remission.

Original languageEnglish (US)
Pages (from-to)688-695.e2
JournalClinical Gastroenterology and Hepatology
Volume8
Issue number8
DOIs
StatePublished - Aug 2010

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Keywords

  • Anti-TNF
  • Certolizumab Pegol
  • Crohn's Disease

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

Sandborn, W. J., Abreu, M. T., D'Haens, G., Colombel, J. F., Vermeire, S., Mitchev, K., Jamoul, C., Fedorak, R. N., Spehlmann, M. E., Wolf, D. C., Lee, S., & Rutgeerts, P. (2010). Certolizumab pegol in patients with moderate to severe crohn's disease and secondary failure to infliximab. Clinical Gastroenterology and Hepatology, 8(8), 688-695.e2. https://doi.org/10.1016/j.cgh.2010.04.021