Multiple doses of intravenous interleukin 10 in steroid-refractory Crohn's disease. Crohn's Disease Study Group

Gastroenterology. 1997 Aug;113(2):383-9. doi: 10.1053/gast.1997.v113.pm9247454.


Background & aims: Interleukin 10 (IL-10) is a cytokine with immunosuppressive and anti-inflammatory activities. Gene-targeted IL-10-deficient mice develop a chronic intestinal inflammatory disease that is reminiscent of Crohn's disease. The present double-blind randomized multicenter trial was designed to evaluate the safety, tolerance, and pharmacokinetics of IL-10 in Crohn's disease.

Methods: Forty-six patients with active steroid-resistant Crohn's disease were treated with one of five doses of recombinant human IL-10 (0.5, 1, 5, 10, or 25 micrograms/kg) or placebo administered once daily by intravenous bolus injection over 7 consecutive days.

Results: Treatment was safe and well tolerated, and no evidence for IL-10 accumulation was observed at the end of the treatment period. At the end of the study, Crohn's disease activity scores were 179 in IL-10-treated patients and 226 in patients receiving placebo. The proportion of patients that experienced a complete remission at any time in the 3-week follow-up period was 50% in the IL-10 group and 23% in placebo-treated patients.

Conclusions: These results indicate that IL-10 administered as a daily bolus injection over 1 week is safe and well tolerated and may be clinically efficacious.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Crohn Disease / drug therapy*
  • Crohn Disease / metabolism
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Injections, Intravenous
  • Interleukin-10 / administration & dosage
  • Interleukin-10 / adverse effects
  • Interleukin-10 / pharmacokinetics
  • Interleukin-10 / therapeutic use*
  • Male
  • Middle Aged
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / pharmacokinetics
  • Recombinant Proteins / therapeutic use


  • Recombinant Proteins
  • Interleukin-10