Safety and efficacy of recombinant human interleukin 10 in chronic active Crohn's disease

Stefan Schreiber, Richard N. Fedorak, Ole Haagen Nielsen, Gary Wild, C. Noel Williams, Susanna Nikolaus, Meron Jacyna, Bret A. Lashner, Alfred Gangl, Paul Rutgeerts, Kim Isaacs, Sander J H Van Deventer, Jacob C. Koningsberger, Marielle Cohard, Alesandre LeBeaut, Stephen B. Hanauer

Research output: Contribution to journalArticlepeer-review

437 Scopus citations


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-κB (NF-κB) 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 μg, 18% [9.6-29.2]; 4 μg, 20% [11.3-32.2]; 8 μg, 20% [11.1-31.8]; 20 μg, 28% [18-40.7]; and placebo, 18% [9.6-29.6]). Clinical improvement was observed in 46% (33.7-59) in the 8-μg/kg rhuIL-10 group in comparison with 27% (17-39.6) in patients taking placebo. Responders to rhuIL-10 showed inhibition of NF-κB p65 activation in contrast to nonresponders. Conclusions: Up to 8 μg/kg of rhuIL-10 was well tolerated. A tendency toward clinical improvement but not remission was observed in the 8-μg/kg dose group. Further studies should delineate which subgroups of patients with CD benefit from rhuIL-10 therapy.

Original languageEnglish (US)
Pages (from-to)1461-1472
Number of pages12
Issue number6
StatePublished - 2000

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology


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