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Comparative Effectiveness of Nutritional and Biological Therapy in North American Children with Active Crohn's Disease

Lee, Dale MD, MSCE*,†; Baldassano, Robert N. MD*; Otley, Anthony R. MD; Albenberg, Lindsey DO*; Griffiths, Anne M. MD§; Compher, Charlene RD, PhD||; Chen, Eric Z. MS; Li, Hongzhe PhD; Gilroy, Erin BS; Nessel, Lisa MSS; Grant, Amy PhD; Chehoud, Christel AB**; Bushman, Frederic D. PhD**; Wu, Gary D. MD††; Lewis, James D. MD, MSCE¶,††

doi: 10.1097/MIB.0000000000000426
Original Clinical Articles

Background: Therapeutic targets in pediatric Crohn's disease include symptoms, quality of life (QOL), and mucosal healing. Although partial enteral nutrition (PEN), exclusive enteral nutritional (EEN), and anti-tumor necrosis factor alpha (anti-TNF) therapy all improve symptoms, the comparative effectiveness of these approaches to improve QOL and achieve mucosal healing has not been assessed prospectively.

Methods: In a prospective study of children initiating PEN, EEN, or anti-TNF therapy for Crohn's disease, we compared clinical outcomes using the Pediatric Crohn's Disease Activity Index (PCDAI), QOL (IMPACT score), and mucosal healing as estimated by fecal calprotectin (FCP). PCDAI, IMPACT, FCP, and diet (prompted 24-h recall) were measured at baseline and after 8 weeks of therapy.

Results: We enrolled 90 children with active Crohn's disease (PCDAI, 33.7 ± 13.7; and FCP, 976 ± 754), of whom 52 were treated with anti-TNF, 22 with EEN, and 16 with PEN plus ad lib diet. Clinical response (PCDAI reduction ≥15 or final PCDAI ≤10) was achieved by 64% on PEN, 88% EEN, and 84% anti-TNF (test for trend P = 0.08). FCP ≤250 μg/g was achieved with PEN in 14%, EEN 45%, and anti-TNF 62% (test for trend P = 0.001). Improvement in overall QOL was not statistically significantly different between the 3 groups (P = 0.86). However, QOL improvement was the greatest with EEN in the body image (P = 0.03) domain and with anti-TNF in the emotional domain (P = 0.04).

Conclusions: Although PEN improved clinical symptoms, EEN and anti-TNF were more effective for decreasing mucosal inflammation and improving specific aspects of QOL.

Article first published online 12 May 2015

*Department of Pediatrics, Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania;

Department of Pediatric, Division of Gastroenterology and Nutrition Seattle Children's Hospital, Seattle, Washington; and University of Washington;

Department of Pediatrics, IWK Health Centre, Halifax, NS, Canada;

§Department of Pediatrics, Division of Gastroenterology, Hepatology and Nutrition, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada;

||School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania;

Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;

**Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; and

††Department of Medicine, Division of Gastroenterology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.

Reprints: James D. Lewis, MD, MSCE, 720 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104 (e-mail: lewisjd@upenn.edu).

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.ibdjournal.org).

Supported by NIH Grants: T32-DK007740, UH3-DK083981, K24-DK078228; Penn Digestive Disease Center (P30 DK050306), The Joint Penn-CHOP Center for Digestive, Liver, and Pancreatic Medicine, The Penn-CHOP Microbiome Program.

J. D. Lewis has received research funding from Centocor, Shire, Takeda, and Nestec Ltd., served as a consultant for Prometheus, Shire, Pfizer, Lilly, Janssen, AbbVie, Immune Pharmaceuticals, Takeda, Merck, AstraZeneca, Amgen, Rebiotix, and MedImmune, and received honorarium from Nestle Nutrition Institute for organizing and speaking in a scientific symposium. R. N. Baldassano has served on the pediatric advisory board for Janssen Pharmaceuticals, Takeda Pharmaceuticals, and Abbvie, Inc. A. M. Griffiths has received research funding and clinical program support from Abbvie and Janssen and has served as consultant for Abbvie, Ferring, Janssen, Nestle, and Receptos. A. R. Otley has received research funding from Janssen, Abbvie, Astra Zeneca, Shire, and Optimer and served as a consultant for Medunik Canada, and Nestle. He has served on the pediatric advisory board for Janssen, Abbvie, and Nestle. G. D. Wu is a member of scientific advisory boards for Janssen, Rebiotix, and Chr. Hansen and has received an honorarium from Nestle Nutrition Institute for organizing and speaking in scientific symposia. F. D. Bushman has served as a consultant for Merck. The remaining authors have no conflicts of interest to disclose.

Received January 30, 2015

Accepted March 10, 2015

© Crohn's & Colitis Foundation of America, Inc.
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