title: Comparative Effectiveness of Nutritional and Biological Therapy in North American Children with Active Crohn's Disease.
abstract: 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.
authors.affiliation: *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.
authors.forename: Dale
authors.initials: D
authors.lastname: Lee
authors.forename: Robert N
authors.initials: RN
authors.lastname: Baldassano
authors.forename: Anthony R
authors.initials: AR
authors.lastname: Otley
authors.forename: Lindsey
authors.initials: L
authors.lastname: Albenberg
authors.forename: Anne M
authors.initials: AM
authors.lastname: Griffiths
authors.forename: Charlene
authors.initials: C
authors.lastname: Compher
authors.forename: Eric Z
authors.initials: EZ
authors.lastname: Chen
authors.forename: Hongzhe
authors.initials: H
authors.lastname: Li
authors.forename: Erin
authors.initials: E
authors.lastname: Gilroy
authors.forename: Lisa
authors.initials: L
authors.lastname: Nessel
authors.forename: Amy
authors.initials: A
authors.lastname: Grant
authors.forename: Christel
authors.initials: C
authors.lastname: Chehoud
authors.forename: Frederic D
authors.initials: FD
authors.lastname: Bushman
authors.forename: Gary D
authors.initials: GD
authors.lastname: Wu
authors.forename: James D
authors.initials: JD
authors.lastname: Lewis
mesh_terms: D000293:Adolescent; D001691:Biological Therapy; D002648:Child; D003424:Crohn Disease / Q000628:therapy*; D004750:Enteral Nutrition; D005247:Feeding Behavior; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011379:Prognosis; D011446:Prospective Studies; D011788:Quality of Life; D012074:Remission Induction; D014409:Tumor Necrosis Factor-alpha / Q000627:therapeutic use*
chemical_list: D014409:Tumor Necrosis Factor-alpha