A Cochrane review [Abstract] 1 included 1 study with 89 subjects. No published RCTs on thalidomide for induction of remission in Crohn's disease were found; 1 RCT in paediatric patients is in progress. One study using lenalidomide (n = 89), a drug similar to thalidomide, met the inclusion criteria and was included in the review; 3 parallel groups of adult patients on 25 mg of lenalidomide daily (n = 23), 5 mg of lenalidomide daily (n = 33) or placebo (n = 28) were studied for 12 weeks. Subjects could continue their current medication, but doses had to remain unchanged for specified periods prior to randomisation and doses could be decreased but not increased during the study. Lenalidomide demonstrated no statistically significant differences in remission rates between lenalidomide and placebo treated patients regardless of the dose used: lenalidomide 25 mg versus placebo (OR 0.29, 95% CI 0.05 to 1.54), lenalidomide 5 mg versus placebo (OR 1.30, 95% CI 0.42 to 4.05). There were no statistically significant differences in clinical response.
Comment: The quality of evidence is downgraded by imprecise results (few patients and wide confidence intervals).
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