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

29 Citations (Scopus)

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

Fingerprint

Endoscopic Retrograde Cholangiopancreatography
Pancreatitis
Interleukin-10
Placebos
Interleukin-8
Cytokines
Incidence
Intravenous Injections
Animal Models
Therapeutics

Keywords

  • Interleukin-10
  • Post-ERCP pancreatitis

ASJC Scopus subject areas

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

Cite this

Efficacy of recombinant human interleukin-10 in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in subjects with increased risk. / Sherman, Stuart; Cheng, Chi Liang; Costamagna, Guido; Binmoeller, Kenneth F.; Puespoek, Andreas; Aithal, Guruprasad P.; Kozarek, Richard A.; Chen, Yang K.; Van Steenbergen, Werner; Tenner, Scott; Freeman, Martin; Monroe, Paul; Geffner, Michael; Deviere, Jacques.

In: Pancreas, Vol. 38, No. 3, 04.2009, p. 267-274.

Research output: Contribution to journalArticle

Sherman, S, Cheng, CL, Costamagna, G, Binmoeller, KF, Puespoek, A, Aithal, GP, Kozarek, RA, Chen, YK, 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, vol. 38, no. 3, pp. 267-274. https://doi.org/10.1097/MPA.0b013e31819777d5
Sherman, Stuart ; Cheng, Chi Liang ; Costamagna, Guido ; Binmoeller, Kenneth F. ; Puespoek, Andreas ; Aithal, Guruprasad P. ; Kozarek, Richard A. ; Chen, Yang K. ; Van Steenbergen, Werner ; Tenner, Scott ; Freeman, Martin ; Monroe, Paul ; Geffner, Michael ; Deviere, Jacques. / Efficacy of recombinant human interleukin-10 in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in subjects with increased risk. In: Pancreas. 2009 ; Vol. 38, No. 3. pp. 267-274.
@article{06ae9c592d0447c19b95cae382b7c72f,
title = "Efficacy of recombinant human interleukin-10 in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in subjects with increased risk",
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.",
keywords = "Interleukin-10, Post-ERCP pancreatitis",
author = "Stuart Sherman and Cheng, {Chi Liang} and Guido Costamagna and Binmoeller, {Kenneth F.} and Andreas Puespoek and Aithal, {Guruprasad P.} and Kozarek, {Richard A.} and Chen, {Yang K.} and {Van Steenbergen}, Werner and Scott Tenner and Martin Freeman and Paul Monroe and Michael Geffner and Jacques Deviere",
year = "2009",
month = "4",
doi = "10.1097/MPA.0b013e31819777d5",
language = "English",
volume = "38",
pages = "267--274",
journal = "Pancreas",
issn = "0885-3177",
publisher = "Lippincott Williams and Wilkins",
number = "3",

}

TY - JOUR

T1 - Efficacy of recombinant human interleukin-10 in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in subjects with increased risk

AU - Sherman, Stuart

AU - Cheng, Chi Liang

AU - Costamagna, Guido

AU - Binmoeller, Kenneth F.

AU - Puespoek, Andreas

AU - Aithal, Guruprasad P.

AU - Kozarek, Richard A.

AU - Chen, Yang K.

AU - Van Steenbergen, Werner

AU - Tenner, Scott

AU - Freeman, Martin

AU - Monroe, Paul

AU - Geffner, Michael

AU - Deviere, Jacques

PY - 2009/4

Y1 - 2009/4

N2 - 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.

AB - 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.

KW - Interleukin-10

KW - Post-ERCP pancreatitis

UR - http://www.scopus.com/inward/record.url?scp=65549121589&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=65549121589&partnerID=8YFLogxK

U2 - 10.1097/MPA.0b013e31819777d5

DO - 10.1097/MPA.0b013e31819777d5

M3 - Article

VL - 38

SP - 267

EP - 274

JO - Pancreas

JF - Pancreas

SN - 0885-3177

IS - 3

ER -