Crohn's disease is a chronic inflammatory disorder of the bowel. Thalidomide may help to reduce inflammation in the gut and might be effective for the treatment of Crohn's disease. One randomised controlled trial on the use of thalidomide for the treatment of active Crohn's disease (and ulcerative colitis) in children is in progress and should be completed in 2011. One randomised controlled trial using lenalidomide, a drug similar to thalidomide, was identified. This relatively small but well designed study did not demonstrate benefit for lenalidomide treatment of active Crohn's disease. Patients treated with high dose lenalidomide (25 mg/day) were more likely than patients receiving placebo (fake drug) to experience side effects. Side effects in the study included headache, rash and nausea. Known side effects of thalidomide include severe birth defects. The use of thalidomide or lenalidomide for the treatment of active Crohn's disease is not recommended.
The results of one well designed study using lenalidomide did not show any statistically significant benefit over placebo. The use of thalidomide or lenalidomide for induction of remission in Crohn's disease is not recommended until data from a definitive study are available.
Crohn's disease is a chronic relapsing condition of the alimentary tract with a high morbidity secondary to bowel inflammation. High levels of tumour necrosis factor-alpha (TNF-α) have been associated with the development of intestinal inflammation in Crohn's disease.Thalidomide, has been demonstrated to have anti TNF-α properties in experimental and clinical studies.
To evaluate the efficacy and safety of thalidomide and its analogue lenalidomide for induction of remission in Crohn's disease.
The Cochrane Central Register of Controlled Trials (CENTRAL) Issue 3, 2008, PUBMED (1966 to August 2008), EMBASE (1984 to August 2008) and the Cochrane IBD/FBD Specialised Trial Register were searched. Manufacturers of thalidomide and leaders in the field were also contacted to identify any unpublished trials. Study references were also searched for additional trials.
Randomised controlled trials (RCTs) that compared thalidomide or lenalidomide against placebo or any other intervention for induction of remission in Crohn's disease were eligible for inclusion.
Data extraction and assessment of methodological quality of included studies were independently performed by two authors. The main outcome measure was clinical remission. Odds ratios and 95% confidence intervals were calculated for dichotomous outcomes.
No published RCTs on thalidomide for induction of remission in Crohn's disease were found. One RCT in paediatric patients is in progress. One RCT using lenalidomide (n = 89) met the inclusion criteria and was included in the review. Three parallel groups of patients on 25 mg of lenalidomide daily (n = 23) , 5 mg of lenalidomide daily (n = 33) or placebo (n = 28) were studied. The clinical remission rate in both treatment groups was not significantly different from that in the placebo group; 25 mg lenalidomide versus placebo (OR 0.29; 95% CI 0.05 to 1.54), 5 mg lenalidomide versus placebo (OR 1.30; 95% CI 0.42 to 4.05). There were no statistically significant differences in clinical response.