Background: Maintenance of remission is a major issue in the management of Crohn's disease. Thalidomide, a tumour necrosis factor-alpha (TNF-alpha) inhibitor and its analogue, lenalidomide, may have a role in the management of Crohn's disease, but it is not clear whether it is an effective maintenance therapy.
Objectives: To conduct a systematic review to evaluate the efficacy and safety of thalidomide and lenalidomide for the maintenance of remission in Crohn's disease.
Search strategy: MEDLINE (1966 to September 2008), EMBASE (1984 to September 2008), the Cochrane Central Register of Controlled Trials from the Cochrane Library (Issue 3, 2008) and the IBD/FBD Review Group Specialized Trials Register were searched to identify relevant studies.
Selection criteria: Randomised controlled trials which compared thalidomide with either placebo or an active comparator were considered for inclusion.
Data collection and analysis: No trials met the inclusion criteria.
Main results: No studies that satisfied the inclusion criteria were found. In the absence of any suitable randomised controlled trial in this area, no analysis was performed.
Authors' conclusions: There is no evidence to support or refute the use of thalidomide or its analogue, lenalidomide, as maintenance therapy for patients with Crohn's disease. Given the teratogenic nature of thalidomide its use for maintenance therapy is difficult to justify. Well designed clinical trials are needed to evaluate the efficacy and safety of lenalidomide in Crohn's disease and its use is not recommended until these data are available.