Effectiveness of anti-TNFα for Crohn disease

Research in a pediatric learning health system

Christopher B. Forrest, Wallace V. Crandall, L. Charles Bailey, Peixin Zhang, Marshall M. Joffe, Richard B. Colletti, Jeremy Adler, Howard I. Baron, James Berman, Fernando Del Rosario, Andrew B. Grossman, Edward J. Hoffenberg, Esther J. Israel, Sandra C. Kim, Jenifer R. Lightdale, Peter A. Margolis, Keith Marsolo, Devendra I. Mehta, David E. Milov, Ashish S. Patel & 2 others Jeanne Tung, Michael D. Kappelman

Research output: Contribution to journalArticle

15 Citations (Scopus)

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 corticosteroidfree 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.

Original languageEnglish (US)
Pages (from-to)37-44
Number of pages8
JournalPediatrics
Volume134
Issue number1
DOIs
StatePublished - 2014

Fingerprint

Crohn Disease
Tumor Necrosis Factor-alpha
Learning
Pediatrics
Confidence Intervals
Health
Adrenal Cortex Hormones
Research
Gastroenterology
Numbers Needed To Treat
Therapeutics
Quality Improvement
Proportional Hazards Models
Randomized Controlled Trials
Remission
Crohn's Disease
Confidence Interval
Therapy
Pediatric Crohn's disease

Keywords

  • Anti-tumor necrosis factor-α, child
  • Comparative effectiveness research
  • Crohn disease

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Arts and Humanities (miscellaneous)

Cite this

Forrest, C. B., Crandall, W. V., Bailey, L. C., Zhang, P., Joffe, M. M., Colletti, R. B., ... Kappelman, M. D. (2014). Effectiveness of anti-TNFα for Crohn disease: Research in a pediatric learning health system. Pediatrics, 134(1), 37-44. https://doi.org/10.1542/peds.2013-4103

Effectiveness of anti-TNFα for Crohn disease : Research in a pediatric learning health system. / Forrest, Christopher B.; Crandall, Wallace V.; Bailey, L. Charles; Zhang, Peixin; Joffe, Marshall M.; Colletti, Richard B.; Adler, Jeremy; Baron, Howard I.; Berman, James; Del Rosario, Fernando; Grossman, Andrew B.; Hoffenberg, Edward J.; Israel, Esther J.; Kim, Sandra C.; Lightdale, Jenifer R.; Margolis, Peter A.; Marsolo, Keith; Mehta, Devendra I.; Milov, David E.; Patel, Ashish S.; Tung, Jeanne; Kappelman, Michael D.

In: Pediatrics, Vol. 134, No. 1, 2014, p. 37-44.

Research output: Contribution to journalArticle

Forrest, CB, Crandall, WV, Bailey, LC, Zhang, P, Joffe, MM, Colletti, RB, Adler, J, Baron, HI, Berman, J, Del Rosario, F, Grossman, AB, Hoffenberg, EJ, Israel, EJ, Kim, SC, Lightdale, JR, Margolis, PA, Marsolo, K, Mehta, DI, Milov, DE, Patel, AS, Tung, J & Kappelman, MD 2014, 'Effectiveness of anti-TNFα for Crohn disease: Research in a pediatric learning health system', Pediatrics, vol. 134, no. 1, pp. 37-44. https://doi.org/10.1542/peds.2013-4103
Forrest CB, Crandall WV, Bailey LC, Zhang P, Joffe MM, Colletti RB et al. Effectiveness of anti-TNFα for Crohn disease: Research in a pediatric learning health system. Pediatrics. 2014;134(1):37-44. https://doi.org/10.1542/peds.2013-4103
Forrest, Christopher B. ; Crandall, Wallace V. ; Bailey, L. Charles ; Zhang, Peixin ; Joffe, Marshall M. ; Colletti, Richard B. ; Adler, Jeremy ; Baron, Howard I. ; Berman, James ; Del Rosario, Fernando ; Grossman, Andrew B. ; Hoffenberg, Edward J. ; Israel, Esther J. ; Kim, Sandra C. ; Lightdale, Jenifer R. ; Margolis, Peter A. ; Marsolo, Keith ; Mehta, Devendra I. ; Milov, David E. ; Patel, Ashish S. ; Tung, Jeanne ; Kappelman, Michael D. / Effectiveness of anti-TNFα for Crohn disease : Research in a pediatric learning health system. In: Pediatrics. 2014 ; Vol. 134, No. 1. pp. 37-44.
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AU - Forrest, Christopher B.

AU - Crandall, Wallace V.

AU - Bailey, L. Charles

AU - Zhang, Peixin

AU - Joffe, Marshall M.

AU - Colletti, Richard B.

AU - Adler, Jeremy

AU - Baron, Howard I.

AU - Berman, James

AU - Del Rosario, Fernando

AU - Grossman, Andrew B.

AU - Hoffenberg, Edward J.

AU - Israel, Esther J.

AU - Kim, Sandra C.

AU - Lightdale, Jenifer R.

AU - Margolis, Peter A.

AU - Marsolo, Keith

AU - Mehta, Devendra I.

AU - Milov, David E.

AU - Patel, Ashish S.

AU - Tung, Jeanne

AU - Kappelman, Michael D.

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