Gastroenterology

Gastroenterology

Volume 113, Issue 2, August 1997, Pages 383-389
Gastroenterology

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

https://doi.org/10.1053/gast.1997.v113.pm9247454Get rights and content

Abstract

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.

(Gastroenterology 1997 Aug;113(2):383-9)

References (0)

Cited by (510)

  • The key role of gut–liver axis in pyrrolizidine alkaloid-induced hepatotoxicity and enterotoxicity

    2021, Acta Pharmaceutica Sinica B
    Citation Excerpt :

    This result suggests that PA-induced intestinal injury may contribute to the development of IBD, of which the etiology is not fully understood. Notably, apart from the DSS model, other animal models of IBD exist, such as the interleukin-10 knockout mouse, which may present additional pathological features as well as etiological factors of human IBD37. Future studies incorporating PA exposure in these animal models are warranted to fully explore the role of PA exposure in IBD pathogenesis.

View all citing articles on Scopus
View full text