TY - JOUR
T1 - Effectiveness of anti-TNFα for Crohn disease
T2 - Research in a pediatric learning health system
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.
PY - 2014/7
Y1 - 2014/7
N2 - 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.
AB - 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.
KW - Anti-tumor necrosis factor-α, child
KW - Comparative effectiveness research
KW - Crohn disease
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UR - http://www.scopus.com/inward/citedby.url?scp=84904185134&partnerID=8YFLogxK
U2 - 10.1542/peds.2013-4103
DO - 10.1542/peds.2013-4103
M3 - Article
C2 - 24935993
AN - SCOPUS:84904185134
SN - 0031-4005
VL - 134
SP - 37
EP - 44
JO - Pediatrics
JF - Pediatrics
IS - 1
ER -