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.
Article first published online 2 January 2014
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.
Reprints: Arie Levine, MD, Pediatric Gastroenterology and Nutrition Unit, Wolfson Medical Center, Sackler School of Medicine, Tel Aviv University, 62 Halohamim Street, Holon 58100, Israel (e-mail: firstname.lastname@example.org).
Supported by grants from the European Crohn's Colitis Organization (ECCO) and the A.L Thrasher Foundation (A.L.).
The authors have no conflicts of interest to disclose.
A. Levine, D. Turner, and M. Sladek are senior authors.
Received September 30, 2013
Accepted October 22, 2013