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

Research output: Contribution to journalArticle

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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
JournalClinical Gastroenterology and Hepatology
Volume8
Issue number8
DOIs
StatePublished - Aug 1 2010

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Crohn Disease
Certolizumab Pegol
Infliximab
Maintenance
Hypersensitivity
Therapeutics
Carcinoma
Skin

Keywords

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

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

Certolizumab pegol in patients with moderate to severe crohn's disease and secondary failure to infliximab. / Sandborn, William J.; Abreu, Maria T; D'Haens, Geert; Colombel, Jean Frédéric; Vermeire, Severine; Mitchev, Krassimir; Jamoul, Corinne; Fedorak, Richard N.; Spehlmann, Martina E.; Wolf, Douglas C.; Lee, Scott; Rutgeerts, Paul.

In: Clinical Gastroenterology and Hepatology, Vol. 8, No. 8, 01.08.2010.

Research output: Contribution to journalArticle

Sandborn, WJ, Abreu, MT, D'Haens, G, Colombel, JF, Vermeire, S, Mitchev, K, Jamoul, C, Fedorak, RN, Spehlmann, ME, Wolf, DC, 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, vol. 8, no. 8. https://doi.org/10.1016/j.cgh.2010.04.021
Sandborn, William J. ; Abreu, Maria T ; D'Haens, Geert ; Colombel, Jean Frédéric ; Vermeire, Severine ; Mitchev, Krassimir ; Jamoul, Corinne ; Fedorak, Richard N. ; Spehlmann, Martina E. ; Wolf, Douglas C. ; Lee, Scott ; Rutgeerts, Paul. / Certolizumab pegol in patients with moderate to severe crohn's disease and secondary failure to infliximab. In: Clinical Gastroenterology and Hepatology. 2010 ; Vol. 8, No. 8.
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AU - Sandborn, William J.

AU - Abreu, Maria T

AU - D'Haens, Geert

AU - Colombel, Jean Frédéric

AU - Vermeire, Severine

AU - Mitchev, Krassimir

AU - Jamoul, Corinne

AU - Fedorak, Richard N.

AU - Spehlmann, Martina E.

AU - Wolf, Douglas C.

AU - Lee, Scott

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N2 - 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.

AB - 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.

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