Efficacy of recombinant human interleukin-10 in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in subjects with increased risk

Stuart Sherman, Chi Liang Cheng, Guido Costamagna, Kenneth F. Binmoeller, Andreas Puespoek, Guruprasad P. Aithal, Richard A. Kozarek, Yang K. Chen, Werner Van Steenbergen, Scott Tenner, Martin Freeman, Paul Monroe, Michael Geffner, Jacques Deviere

Research output: Contribution to journalArticle

30 Scopus citations

Abstract

OBJECTIVES:: Pancreatitis is the most common major complication of endoscopic retrograde cholangiopancreatography (ERCP). Inflammatory cytokines are released during acute pancreatitis. Interleukin-10 (IL-10) is a potent inhibitor of cytokines and has been shown to attenuate pancreatitis in animal models and pilot human studies. This study aimed to determine whether prophylactic IL-10 administration reduces the frequency and/or severity of post-ERCP pancreatitis in high-risk patients. METHODS:: A randomized, multicenter, double-blind, placebo-controlled study was conducted. Patients received IL-10 at a dose of either 8 or 20 μg/kg or placebo as a single intravenous injection 15 to 30 minutes before ERCP. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis. RESULTS:: A total of 305 of the planned total enrollment of 948 patients were randomized. There was a 15%, 22%, and 14% incidence of post-ERCP pancreatitis in the IL-10 (8 μg/kg), IL-10 (20 μg/kg), and placebo treatment groups, respectively (P = 0.83 for IL-10 8 μg/kg vs placebo and 0.14 for IL-10 20 μg/kg vs placebo). Due to apparent lack of efficacy, the study was terminated at an interim analysis. CONCLUSIONS:: There was no apparent benefit of IL-10 treatment when compared with placebo in reducing the incidence of post-ERCP acute pancreatitis in subjects with increased risk.

Original languageEnglish (US)
Pages (from-to)267-274
Number of pages8
JournalPancreas
Volume38
Issue number3
DOIs
StatePublished - Apr 1 2009

Keywords

  • Interleukin-10
  • Post-ERCP pancreatitis

ASJC Scopus subject areas

  • Hepatology
  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

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    Sherman, S., Cheng, C. L., Costamagna, G., Binmoeller, K. F., Puespoek, A., Aithal, G. P., Kozarek, R. A., Chen, Y. K., Van Steenbergen, W., Tenner, S., Freeman, M., Monroe, P., Geffner, M., & Deviere, J. (2009). Efficacy of recombinant human interleukin-10 in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in subjects with increased risk. Pancreas, 38(3), 267-274. https://doi.org/10.1097/MPA.0b013e31819777d5