Authors' objectives:

This study aims to summarise the currently available evidence on adalimumab (Humira) for moderate to severely active Crohn's disease

Authors' recommendations: Adalimumab (Humira) is a fully human anti-tumour necrosis factor (TNF)-alpha monoclonal antibody in phase III trials for the induction and maintenance of clinical remission and response in patients with moderate to severely active Crohn's disease (Crohn's Disease Activity Index - CDAI score 220 - 450). It is administered by subcutaneous injection. Results from one phase III placebo-controlled, randomised trial, published in abstract, show a significant increase in clinical remission at 4 weeks versus placebo (from 12% to 24-36%). A randomised extension trial in patients who responded is assessing maintenance of remission. A 24-week open-label extension trial in patients who did not respond by 4 weeks, found a remission rate of 33.2% and a response rate of 78.2%. A one-year ongoing phase III trial in 830 patients is due to complete in Q3 2006.

Authors' methods: Overview

Project Status: Completed

Year Published: 2005

URL for published report: http://www.hsric.nihr.ac.uk/search

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Horizon Scanning Centre

Contact Address: The NIHR Horizon Scanning Centre, Department of Public Health, Epidemiology, and Biostatistics, School of Health and Population Sciences, University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP. United Kingdom. Tel: +44 121 414 7831, Fax: +44 121 2269

Contact Name: c.packer@bham.ac.uk

Contact Email: c.packer@bham.ac.uk

Copyright: National Horizon Scanning Centre (NHSC)