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Intravenous CDP870, a PEGylated Fab′ fragment of a humanized antitumour necrosis factor antibody, in patients with moderate-to-severe Crohn's disease: an exploratory study

  1. T. A. Winter1,
  2. J. Wright2,
  3. S. Ghosh3,
  4. J. Jahnsen4,
  5. A. Innes5,
  6. P. Round5

Article first published online: 6 DEC 2004

DOI: 10.1111/j.1365-2036.2004.02285.x

Issue

Alimentary Pharmacology & Therapeutics

Alimentary Pharmacology & Therapeutics

Volume 20, Issue 11-12, pages 1337–1346, December 2004

Additional Information

How to Cite

Winter, T. A., Wright, J., Ghosh, S., Jahnsen, J., Innes, A. and Round, P. (2004), Intravenous CDP870, a PEGylated Fab′ fragment of a humanized antitumour necrosis factor antibody, in patients with moderate-to-severe Crohn's disease: an exploratory study. Alimentary Pharmacology & Therapeutics, 20: 1337–1346. doi: 10.1111/j.1365-2036.2004.02285.x

Author Information

  1. 1

    Department of Internal Medicine, University of Kentucky, KY, USA

  2. 2

    Kingsbury Hospital, Claremont, South Africa

  3. 3

    Gastroenterology Department, Hammersmith Hospital, London, UK

  4. 4

    Medical Department, Aker University Hospital, Oslo, Norway

  5. 5

    Celltech Research and Development, Slough, UK

*Dr T. A. Winter, Department of Internal Medicine, Division of Digestive Diseases and Nutrition, University of Kentucky, 800 Rose Street, MN 649, Lexington, KY 40536-0298, USA. E-mail: winter@uky.edu

Publication History

  1. Issue published online: 6 DEC 2004
  2. Article first published online: 6 DEC 2004
  3. Accepted for publication 8 September 2004

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Summary

Background : CDP870 is a PEGylated Fab′ fragment of a humanized monoclonal antibody that neutralizes tumour necrosis factor-α.

Aim : To evaluate the safety and efficacy of a single intravenous dose of CDP870 or placebo over a 12-week period in patients with moderate-to-severe Crohn's disease.

Methods : Ninety-two adult patients with Crohn's disease (Crohn's Disease Activity Index: 220–450 points) were randomized to receive CDP870 [1.25 (n = 2), 5 (n =26), 10 (n = 17) or 20 mg/kg (n = 23)] or placebo (n = 24). Crohn's Disease Activity Index scores were determined at weeks 0, 2, 4, 8 and 12. The primary end-point was the percentage of patients achieving clinical response [i.e. a decrease in Crohn's Disease Activity Index score ≥ 100 points or remission (Crohn's Disease Activity Index score: ≤150 points)] at week 4 in the intent-to-treat population.

Results : The percentage of patients achieving the primary end-point was comparable across all treatment groups (56.0%, 60.0%, 58.8% and 47.8% for placebo, CDP870 5, 10 and 20 mg/kg, respectively). The remission rate at week 2 was 47.1% with CDP870 10 mg/kg vs. 16.0% for placebo (P = 0.041). All treatments were well-tolerated: adverse events, reported by 43 patients treated with CDP870 and 15 patients treated with placebo, were mainly mild-to-moderate in intensity. There were no infusion reactions.

Conclusions : A single intravenous dose of CDP870 was well-tolerated by patients with Crohn's disease. While no statistically significant difference in clinical response rates between CDP870 and placebo was observed, clinical benefit in terms of remission was demonstrated.

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