• Effect of Thalidomide on Clinical Remission in Children and Adolescents With Refractory Crohn Disease A Randomized Clinical Trial

    Thalidomide is a drug not often used in IBD but is known to decrease the function of the immune system and also reduce levels of TNF (a powerful inflammatory molecule). Studies in the 1950’s and 1960’s of thalidomide in pregnancy were associated with a range of birth defects but much more has been learnt about this drug since then.

    Children at hospitals in Italy were involved in this study. 28 children received thalidomide and 28 children received placebo for 8 weeks. Children had active Crohn’s disease despite being on treatment. Nearly one third of children in both groups were already on Infliximab and nearly all were taking azathioprine or 6MP – these medicines were all stopped at entry to this study. In patients given thalidomide it took about 8 weeks to work; nearly half the children entered clinical remission and two thirds of children noticed improvement in symptoms. In the placebo group only 10% of patients entered remission and one third noticed improvement in symptoms. After the 8 week study patients who had responded to thalidomide and those who had placebo continued thalidomide treatment and were followed for one year; nearly 60% achieved disease remission.

    Nearly 30% of children experienced unwanted side effects usually affecting the nervous system.

    This was a well designed study to answer a common clinical problem of how to manage children with active disease despite active medical treatment. A larger study is required to confirm these results and evaluate side effects. Currently thalidomide is not part of agreed standards to treat Crohn’s disease and remains a “trial therapy”.

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