Systematic review: thalidomide and thalidomide analogues for treatment of inflammatory bowel disease

Summary Background It has been reported that thalidomide may be effective in treating inflammatory bowel disease ( IBD ). Aim To review the evidence examining the efficacy and safety of thalidomide for inducing and maintaining remission in Crohn's disease ( CD ) and ulcerative colitis ( UC ). Methods The Cochrane Central Register of Controlled Trials ( CENTRAL ), MEDLINE , PubMed (1950–August 2014), EMBASE (1984–August 2014), Scopus, and Web of knowledge were searched for randomised controlled trials ( RCT s), observational studies and case series. The primary outcomes were induction of remission or response for active IBD or relapse rate for patients in remission and subsequently on thalidomide/analogues for at least 3 months. Results Twelve studies (2 RCT s and 10 case series) met the inclusion criteria for inducing remission and included 248 patients (10 with UC , 238 with CD ). Only one RCT of paediatric CD achieved high quality scores (remission rate thalidomide: 46%, placebo: 12%; p=0.01). The crude pooled remission rate for thalidomide was 49% and 25% in luminal and perianal CD respectively. For UC , 50% achieved remission and 10% had partial response. One case series reported 21 patients (17 CD , four UC ) who maintained remission for 6 months. Many adverse events were reported including sedation (32%) and peripheral neuropathy (20%). Conclusions One high quality RCT showed that thalidomide is effective for inducing remission in paediatric CD . The current evidence is insufficient to support using thalidomide to induce remission in UC or adult CD , or to maintain remission in IBD . Significant adverse events may occur, necessitating discontinuation of thalidomide.