Adalimumab (Humira) for moderate to severely active Crohn's disease - horizon scanning review
This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.
NHSC. Adalimumab (Humira) for moderate to severely active Crohn's disease - horizon scanning review. Birmingham: National Horizon Scanning Centre (NHSC). 2005
This study aims to summarise the currently available evidence on adalimumab (Humira) for moderate to severely active Crohn's disease
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.