Safety and efficacy of recombinant human interleukin 10 in chronic active Crohn's disease. Crohn's Disease IL-10 Cooperative Study Group

Gastroenterology. 2000 Dec;119(6):1461-72. doi: 10.1053/gast.2000.20196.


Background & aims: Interleukin (IL)-10 is a cytokine with potent anti-inflammatory properties. We investigated the safety and efficacy of different doses of human recombinant (rhu)IL-10 in patients with Crohn's disease (CD).

Methods: A prospective, multicenter, double-blind, placebo-controlled study was conducted in 329 therapy-refractory patients with CD. Clinical improvement was defined by a reduction of the Crohn's Disease Activity Index (CDAI) by 100 points or more and clinical remission by a decrease of the CDAI to <150 points. At selected centers, patients underwent ileocolonoscopies and activation of the nuclear factor-kappa B (NF-kappa B) system was assessed in biopsy specimens.

Results: Subcutaneous treatment with rhuIL-10 over 28 days induced a fully reversible, dose-dependent decrease in hemoglobin and thrombocyte counts but no clinically significant side effects. No differences in the induction of remission were observed between rhuIL-10 groups (1 microg, 18% [9.6-29.2]; 4 microg, 20% [11.3-32.2]; 8 microg, 20% [11.1-31.8]; 20 microg, 28% [18-40.7]; and placebo, 18% [9.6-29.6]). Clinical improvement was observed in 46% (33.7-59) in the 8-microg/kg rhuIL-10 group in comparison with 27% (17-39.6) in patients taking placebo. Responders to rhuIL-10 showed inhibition of NF-kappaB p65 activation in contrast to nonresponders.

Conclusions: Up to 8 microg/kg of rhuIL-10 was well tolerated. A tendency toward clinical improvement but not remission was observed in the 8-microg/kg dose group. Further studies should delineate which subgroups of patients with CD benefit from rhuIL-10 therapy.

Publication types

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

MeSH terms

  • Adult
  • Chronic Disease
  • Crohn Disease / blood
  • Crohn Disease / drug therapy*
  • Crohn Disease / pathology
  • Crohn Disease / physiopathology
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Resistance
  • Endoscopy, Digestive System
  • Female
  • Humans
  • I-kappa B Proteins / physiology
  • Interleukin-10 / administration & dosage*
  • Interleukin-10 / adverse effects
  • Interleukin-10 / therapeutic use
  • Male
  • Patient Dropouts
  • Prospective Studies
  • Quality of Life
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / therapeutic use
  • Remission Induction
  • Retreatment
  • Safety
  • Severity of Illness Index
  • Steroids / therapeutic use
  • Treatment Outcome


  • I-kappa B Proteins
  • Recombinant Proteins
  • Steroids
  • Interleukin-10