Why interleukin-10 supplementation does not work in Crohn's disease patients

World J Gastroenterol. 2013 Jul 7;19(25):3931-41. doi: 10.3748/wjg.v19.i25.3931.


Inflammatory bowel diseases (IBD) such as Crohn's disease (CD) or ulcerative colitis are chronic intestinal disorders, which are on the increase in "Westernised" countries. IBD can be caused by both genetic and environmental factors. Interleukin-10 (IL-10) is an immunoregulatory cytokine that has been identified as being involved in several diseases including IBD. Studies have shown that polymorphisms in the promoter region reduce serum levels of IL-10 and this reduction has been associated with some forms of IBD. Mouse models have shown promising results with IL-10 supplementation, as such IL-10 supplementation has been touted as being a possible alternative treatment for CD in humans. Clinical trials have shown that recombinant human IL-10 is safe and well tolerated up to a dose of 8 μg/kg. However, to date, the results of the clinical trials have been disappointing. Although CD activity was reduced as measured by the CD activity index, IL-10 supplementation did not result in significantly reduced remission rates or clinical improvements when compared to placebo. This review discusses why IL-10 supplementation is not effective in CD patients currently and what can be addressed to potentially make IL-10 supplementation a more viable treatment option in the future. Based on the current research we conclude that IL-10 supplementation is not a one size fits all treatment and if the correct population of patients is chosen then IL-10 supplementation could be of benefit.

Keywords: Crohn’s disease; Inflammatory bowel disease; Interleukin-10; Recombinant human interleukin-10.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Crohn Disease / drug therapy*
  • Crohn Disease / physiopathology
  • Dose-Response Relationship, Drug
  • Humans
  • Interleukin-10 / physiology
  • Interleukin-10 / therapeutic use*
  • Recombinant Proteins / therapeutic use
  • Treatment Outcome


  • Recombinant Proteins
  • Interleukin-10