P404. Normal CRP remission as an outcome parameter in pediatric Crohn's disease: Evaluation of the Porto IBD Group “Growth Relapse and Outcomes With Therapy” (GROWTH CD) cohort study
M. Sladek1, D. Turner2, T. Pfeffer Gik3, J. Amil Dias4, G. Veres5, R. Shaoul6, A. Staiano7, J. Escher8, K.-L. Kolho9, A. Paerregaard10, J. Martin de Carpi11, G. Veereman Wauters12, S. Koletzko13, O. Shevah3, L. Finnby14, A. Levine3, 1Jagiellonian University Medical College, Department of Pediatrics, Gastroenterology and Nutrition, Krakow, Poland, 2Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Pediatric Gastroenterology, Jerusalem, Israel, 3Wolfson Medical Center, Tel Aviv University, Pediatric Gastroenterology, Tel Aviv, Israel, 4Hospital, S. Joao, Department of Pediatrics, Porto, Portugal, 5Semmelweis University, Pediatric Gastroenterology, Budapest, Hungary, 6Meyer Children's Hospital, Pediatric Gastroenterology, Haifa, Israel, 7University of Naples “Federico II”, Pediatrics, Naples, Italy, 8Erasmus MC-Sophia Children's Hospital, Pediatric Gastroenterology, Rotterdam, Netherlands, 9Children's Hospital, Helsinki University Central Hospital, Pediatric Gastroenterology, Helsinki, Finland, 10Hvidovre Hospital, Pediatrics, Hvidovre, Denmark, 11Hospital Sant Joan de Déu, Pediatric Gastroenterology, Barcelona, Spain, 12University Hospital UZ Brussels, Pediatric Gastroenterology, Brussels, Belgium, 13Dr. v Haunersches Kinderspital, Ludwig Maximilians University Munich, Pediatric Gastroenterology, Munich, Germany, 14Lovisenberg Diakonale Hospital, Unger-Vetlesens Institute, Oslo, Norway
In Crohn's disease, induction of remission in clinical trials as well as clinical practice is usually evaluated by symptom reduction or clinical disease activity indices. However, complications and relapse stem from ongoing inflammation, thus a composite outcome evaluating both clinical symptoms and a measure of inflammation might be a more rigorous measure for long term outcomes. We attempted to evaluate clinical, inflammatory and composite outcomes of induction of remission therapies in a large pediatric prospective multicenter study.
Children with new onset Crohn's disease were enrolled at diagnosis into the GROWTH CD study, and evaluated for disease activity, CRP, and fecal calprotectin at 8 and 12 & 52 weeks after starting treatment. The primary end point was week 12 steroid-free remission defined by PCDAI (<10 points) and CRP <0.5 mg/dL. The protocol required standardized therapies with 5ASA, corticosteroids (CS) or exclusive enteral nutrition. Tapering off CS was required by week 11.
We analyzed 222 patients, mean age 12.9±3.2 years. Clinical remission at week 12 was achieved in 155 (73%) of patients, however steroid free Normal CRP Remission (NCR) was achieved in only 33% of patients. Among those in steroid free remission at week 12, normal CRP predicted one-year sustained remission (86% for normal CRP vs. 61% for elevated CRP; P = 0.02). Baseline disease severity and early use of immunomodulation (IMM) did not differ between groups.
|Normal CRP remission (n = 89)||Clinical remission + elevated CRP (n = 53)||No remission (n = 58)|
|Baseline PCDAI||33.4±14.4 (NS)||32.6±12.9 (NS)||33.4±11.9|
|Baseline CRP (mg/dl)||3.2±3.6**||6.8±9.8***||4.9±5.8|
|Baseline IMM||60% (54/89) (NS)||62.2% (33/53) (NS)||46.5% (27/58)|
|CS free remission wk 52||86% (63/73)**||61.3% (27/44)***||13.8% (8/58)|
|Relapse by wk 52||28% (21/73)|
(p = 0.067)
|45.4% (20/44) (NS)||44.8% (26/58)|
|**p < 0.01 between Normal CRP CS Free remission at week 12 and CS free clinical remission with elevated CRP.|
***p < 0.01 between clinical remission at week 12 with elevated CRP and no remission at week 12.
Normal CRP steroid free remission at week 12 was associated with more CS free remission at week 52 and a trend for less relapses.