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Pediatrics. 2014 Jul;134(1):37-44. doi: 10.1542/peds.2013-4103. Epub 2014 Jun 16.

Effectiveness of anti-TNFα for Crohn disease: research in a pediatric learning health system.

Author information

  • 1Department of Pediatrics, andLeonard Davis Institute of Health Economics, and forrestc@email.chop.edu.
  • 2Department of Pediatrics, The Ohio State University College of Medicine, Nationwide Children's Hospital, Columbus, Ohio;
  • 3Department of Pediatrics, andCenter for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;
  • 4Department of Pediatrics, and.
  • 5Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;
  • 6Department of Pediatrics, The University of Vermont College of Medicine, Burlington, Vermont;
  • 7Department of Pediatrics and Communicable Diseases, Division of Pediatric Gastroenterology, University of Michigan, Ann Arbor, Michigan;
  • 8Department of Pediatrics, University of Nevada School of Medicine, Pediatric Gastroenterology and Nutrition Associates, Las Vegas, Nevada;
  • 9Advocate Children's Hospital, UIC College of Medicine, Loyola University School of Medicine, Chicago, Illinois;
  • 10Department of Pediatrics, Division of Pediatric Gastroenterology Nemours/Alfred I. duPont Hospital for Children, Wilmington, Delaware;
  • 11Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania;
  • 12Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado;
  • 13Department of Pediatrics, Massachusetts General Hospital for Children, Harvard Medical School, Boston, Massachusetts;
  • 14Department of Medicine, Boston Children's Hospital, Boston, Massachusetts;
  • 15Department of Pediatrics, James M. Anderson Center for Health Systems Excellence, and.
  • 16Division of Biomedical Informatics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio;Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio;
  • 17Department of Pediatrics, Arnold Palmer Hospital for Children, Florida State University, Orlando, Florida;
  • 18Department of Pediatrics, Nemour's Children's Hospital, Orlando, Florida;
  • 19Department of Pediatrics, The University of Texas Southwestern Medical Center, Dallas, Texas;Department of Pediatrics, Children's Medical Center, Dallas, Texas;
  • 20Department of Pediatric and Adolescent Medicine, Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota; and.
  • 21Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

Abstract

OBJECTIVES:

ImproveCareNow (ICN) is the largest pediatric learning health system in the nation and started as a quality improvement collaborative. To test the feasibility and validity of using ICN data for clinical research, we evaluated the effectiveness of anti-tumor necrosis factor-α (anti-TNFα) agents in the management of pediatric Crohn disease (CD).

METHODS:

Data were collected in 35 pediatric gastroenterology practices (April 2007 to March 2012) and analyzed as a sequence of nonrandomized trials. Patients who had moderate to severe CD were classified as initiators or non-initiators of anti-TNFα therapy. Among 4130 patients who had pediatric CD, 603 were new users and 1211 were receiving anti-TNFα therapy on entry into ICN.

RESULTS:

During a 26-week follow-up period, rate ratios obtained from Cox proportional hazards models, adjusting for patient and disease characteristics and concurrent medications, were 1.53 (95% confidence interval [CI], 1.20-1.96) for clinical remission and 1.74 (95% CI, 1.33-2.29) for corticosteroid-free remission. The rate ratio for corticosteroid-free remission was comparable to the estimate produced by the adult SONIC study, which was a randomized controlled trial on the efficacy of anti-TNFα therapy. The number needed to treat was 5.2 (95% CI, 3.4-11.1) for clinical remission and 5.0 (95% CI, 3.4-10.0) for corticosteroid-free remission.

CONCLUSIONS:

In routine pediatric gastroenterology practice settings, anti-TNFα therapy was effective at achieving clinical and corticosteroid-free remission for patients who had Crohn disease. Using data from the ICN learning health system for the purpose of observational research is feasible and produces valuable new knowledge.

Copyright © 2014 by the American Academy of Pediatrics.

KEYWORDS:

Crohn disease; anti-tumor necrosis factor-α; child; comparative effectiveness research

PMID:
24935993
[PubMed - indexed for MEDLINE]
PMCID:
PMC4531278
Free PMC Article
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