P255. Exclusive enteral nutrition is superior to corticosteroids and mesalamine for achieving remission with normalization of CRP in new onset pediatric Crohn's disease
A. Levine1, M. Sladek2, R. Shaoul3, G. Veres4, J. Amil Dias5, J. Escher6, D. Turner7
1Wolfson Medical Center, Tel Aviv University, Pediatric Department, Holon, Israel; 2Jagiellonian University School of Medicine, Department Of Pediatrics, Krakow, Poland; 3Meyer Childrens Hospital, Pediatric GI unit, Haifa, Israel; 4Semmelweis University, pediatric Gastroenterology, Budapest, Hungary; 5Hospital San Joao, Pediatric Gastroenterology, Porto, Portugal; 6EsamusSophia Childrens Hospital, Pediatric Gastroenterology, Netherlands; 7Shaare Zedak Medical Center, Pediatric Gastroenterology Unit, Jerusalem, Israel
Background: Clinical trials often evaluate clinical response or remission using a disease specific disease activity index, Adverse outcomes of Crohn's disease may be related to ongoing inflammation, and normalization of CRP is not usually evaluated as an outcome. We therefore decided to evaluate the effect of therapy using a more stringent response variable, Normal CRP Remission (NCR) after induction of remission.
Methods: The Growth, Relapse and Outcomes with Therapy in CD (GROWTH) study is a prospective pediatric trial performed by the Porto IBD Group to evaluatte biomarkers for prediction of outcomes in paediatric CD. Children <17 years age were seen at baseline, 8 and 12 weeks thereafter), the pediatric CD activity index (PCDAI) was recorded, as well as CRP, physicians global assessment (PGA) of disease activity and treatments. Complete remission (NCR) was defined as composite of both PCDAI <10 points and CRP <0.5 mg/dL. Standardized treatments were initiated by the physicians' discretion (steroids (CS), 5‑ASA, exclusive enteral nutrition (EEN) or antibiotics with or without immunomodulators (IM). Corticosteroids were weaned by week 11, patients on steroids at week 12 were considered steroid dependent. Multivariate logistic regression models were constructed for each outcome controlling for baseline activity and use of IM.
Results: 150 children were enrolled, 141 (mean age 13.0 yrs) had all 3 visits and were included.129 had CRP measured at 12 weeks. An IM was started in 67%, corticosteroids in 79 (50.3%) patients, and EEN in 27 (19.1%) patients. Mean baseline PCDAIs for 5ASA, antibiotics, EEN and steroids were 22±9, 27±9, 31±15 and 36±14 respectively. Remission at 8 and 12 weeks was seen in 65% and 62%, normalization of CRP in 60% and 53% respectively. NCR was achieved only in 46/129 (35%). The only factor that predicted NCR was the choice of induction therapy (P = 0.013 as compared with P = 0.26 for IM and P = 0.72 for baseline PGA). Use of 5ASA was inversely associated with NCR. NCR corrected for severity was associated with CS or EEN as an induction therapy (26.6% steroids, 51% EEN). When comparing NCR corrected for disease severity by PCDAI and IM use at baseline, EEN was superior to steroids for achieving NCR (p = 0.019).
Conclusions: Normal CRP remission was achieved in only a third of patients at induction. Exclusive enteral nutrition, was superior to corticosteroids for achieving remission with normal CRP. Mesalamine was ineffective for achieving NCR even in milder disease activity.