title: Thalidomide for inflammatory bowel disease: Systematic review.
abstract: BACKGROUND
  Thalidomide is an immunomodulatory drug used in the experimental treatment of refractory Crohn disease and ulcerative colitis. We aimed to review the existing evidence on the efficacy and safety of thalidomide in the treatment of inflammatory bowel diseases.
  
  
  METHODS
  CENTRAL, MEDLINE, LILACS, POPLINE, CINHAL, and Web of Science were searched in March 2016. Manual search included conference and reference lists. All types of studies, except single case reports, were included. Outcomes evaluated were: induction of remission; maintenance of remission; steroid reduction; effect on penetrating Crohn disease; endoscopic remission; adverse events.
  
  
  RESULTS
  The research strategies retrieved 722 papers. Two randomized controlled trials and 29 uncontrolled studies for a total of 489 patients matched the inclusion criteria. Thalidomide induced a clinical response in 296/427 (69.3%) patients. Clinical remission was achieved in 220/427 (51.5%) cases. Maintenance of remission was reported in 128/160 (80.0%) patients at 6 months and in 96/133 (72.2%) at 12 months. Reduction in steroid dosage was reported in 109/152 (71.7%) patients. Fistulas improved in 49/81 (60.5%) cases and closed in 28/81 (34.6%). Endoscopic improvement was observed in 46/66 (69.7%) and complete mucosal healing in 35/66 (53.0%) patients. Cumulative incidence of total adverse events and of those leading to drug suspension was 75.6 and 19.7/1000 patient-months, respectively. Neurological disturbances accounted for 341/530 (64.3%) adverse events and were the most frequent cause of drug withdrawal.
  
  
  CONCLUSIONS
  Existing evidence suggests that thalidomide may be a valid treatment option for patients with inflammatory bowel diseases refractory to other first- and second-line treatments.
authors.affiliation: Pediatric Department, Institute for Maternal and Child Health IRCCS "Burlo Garofolo" Department of Medical Sciences, University of Trieste WHO Collaborating Centre for Maternal and Child Health, Institute for Maternal and Child Health IRCCS "Burlo Garofolo," via dell'Istria, Trieste, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Bramuzzo
authors.forename: Alessandro
authors.initials: A
authors.lastname: Ventura
authors.forename: Stefano
authors.initials: S
authors.lastname: Martelossi
authors.forename: Marzia
authors.initials: M
authors.lastname: Lazzerini
mesh_terms: D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D060828:Induction Chemotherapy; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D060046:Maintenance Chemotherapy; D012074:Remission Induction; D013792:Thalidomide / Q000627:therapeutic use*
chemical_list: D007166:Immunosuppressive Agents; D013792:Thalidomide