title: Comparison of outcomes parameters for induction of remission in new onset pediatric Crohn's disease: evaluation of the porto IBD group "growth relapse and outcomes with therapy" (GROWTH CD) study.
abstract: BACKGROUND
  Robust evaluation of induction therapies using both clinical and inflammatory outcomes in pediatric Crohn's disease (CD) are sparse. We attempted to evaluate clinical, inflammatory, and composite outcomes of induction of remission therapies (normal C reactive protein [CRP] remission) in a large pediatric prospective multicenter study.
  
  
  METHODS
  Patients enrolled at diagnosis into the growth relapse and outcomes with therapy in Crohn's disease study were evaluated for disease activity, CRP, and fecal calprotectin at 8, 12 and 52 weeks after starting treatment. The primary endpoint was week-12 steroid-free remission defined by pediatric Crohn's disease activity index and CRP <0.5 mg/dL. The protocol required tapering off corticosteroids by week 11.
  
  
  RESULTS
  We analyzed 222 patients (mean age, 12.9 ± 3.2 yr) main evaluated treatment options included: 5-ASA (n = 29), exclusive enteral nutrition (n = 43), and corticosteroids (n = 114). Clinical remission at week 12 was achieved in 155 (73%) patients; both exclusive enteral nutrition and steroids were associated with normal CRP remission at week 12, although in a post hoc subgroup analysis exclusive enteral nutrition was superior in mild-to-moderate disease for this outcome. Among those in steroid-free remission in week 12, normal CRP predicted 1-year sustained remission (86% for normal CRP versus 61% for elevated CRP; P = 0.02). Baseline severity and early immunomodulation were similar in both groups.
  
  
  CONCLUSIONS
  Normal CRP steroid-free remission at week 12 was impacted by type of induction therapy, but not by early immunomodulation. It was associated with more corticosteroids-free remission at week 52 and a trend for less relapses.
authors.affiliation: 1Pediatric Gastroenterology and Nutrition Unit, Wolfson Medical center, Sackler School of Medicine, Tel Aviv University, Israel; 2Pediatric Gastroenterology Unit, Shaare Zedek Medical Center, Jerusalem, Israel; 3Institute of Biochemistry, Food Science and Nutrition,The Robert H. Smith Faculty of Agriculture, Food and Environment, The Hebrew University of Jerusalem, Jerusalem, Israel; 4Department of Pediatrics, Hospital, S. Joao, Porto, Portugal; 51st Department of Pediatrics, Semmelweis University, Budapest, Hungary; 6Pediatric Gastroenterology Unit, Meyer Children's Hospital, Haifa, Israel; 7Department of Pediatrics, University of Naples "Federico II," Naples, Italy; 8Department of Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherlands; 9Children's Hospital, Helsinki University Central Hospital, University of Helsinki, Helsinki, Finland; 10Department Pediatrics, Hvidovre Hospital, Hvidovre, Denmark; 11Department of Pediatric Gastroenterology, Hospital Sant Joan de Déu, Barcelona, Spain; 12Pediatric Gastroenterology Unit, University Hospital UZ Brussels, Brussels, Belgium; 13Department of Pediatric Gastroenterology and Hepatology, Dr. v Haunersches Kinderspital, Ludwig Maximilians University Munich, Munich, Germany; 14Unger-Vetlesens Institute, Lovisenberg Diakonale Hospital, Oslo, Norway; and 15Department of Pediatrics, Gastroenterology and Nutrition, Jagiellonian University Medical College, Cracow, Poland.
authors.forename: Arie
authors.initials: A
authors.lastname: Levine
authors.forename: Dan
authors.initials: D
authors.lastname: Turner
authors.forename: Tamar
authors.initials: T
authors.lastname: Pfeffer Gik
authors.forename: Jorge
authors.initials: J
authors.lastname: Amil Dias
authors.forename: Gabor
authors.initials: G
authors.lastname: Veres
authors.forename: Ron
authors.initials: R
authors.lastname: Shaoul
authors.forename: Annamaria
authors.initials: A
authors.lastname: Staiano
authors.forename: Johanna
authors.initials: J
authors.lastname: Escher
authors.forename: Kaija Leena
authors.initials: KL
authors.lastname: Kolho
authors.forename: Anders
authors.initials: A
authors.lastname: Paerregaard
authors.forename: Javier
authors.initials: J
authors.lastname: Martin de Carpi
authors.forename: Gigi
authors.initials: G
authors.lastname: Veereman Wauters
authors.forename: Sibylle
authors.initials: S
authors.lastname: Koletzko
authors.forename: Orit
authors.initials: O
authors.lastname: Shevah
authors.forename: Lenne
authors.initials: L
authors.lastname: Finnby
authors.forename: Malgorzata
authors.initials: M
authors.lastname: Sladek
mesh_terms: D000293:Adolescent; D017668:Age of Onset; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D002648:Child; D003113:Colonoscopy; D003424:Crohn Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D015212:Inflammatory Bowel Diseases / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D000069285:Infliximab; D007557:Israel / Q000453:epidemiology; D008297:Male; D011241:Prednisone / Q000627:therapeutic use*; D011446:Prospective Studies; D012008:Recurrence; D012074:Remission Induction / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D005938:Glucocorticoids; D007155:Immunologic Factors; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D011241:Prednisone