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. 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

Christopher B Forrest  1 , Wallace V Crandall  2 , L Charles Bailey  3 , Peixin Zhang  4 , Marshall M Joffe  5 , Richard B Colletti  6 , Jeremy Adler  7 , Howard I Baron  8 , James Berman  9 , Fernando del Rosario  10 , Andrew B Grossman  11 , Edward J Hoffenberg  12 , Esther J Israel  13 , Sandra C Kim  2 , Jenifer R Lightdale  14 , Peter A Margolis  15 , Keith Marsolo  16 , Devendra I Mehta  17 , David E Milov  18 , Ashish S Patel  19 , Jeanne Tung  20 , Michael D Kappelman  21
Affiliations

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

Christopher B Forrest et al. Pediatrics. 2014 Jul.

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.

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

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Figures

FIGURE 1
FIGURE 1
Cumulative probability of remission and corticosteroid-free remission for initiator and non-initiator trials during a 26-week follow-up period.
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