OP15 Cyclic exclusive enteral nutrition to maintain longterm drug-free remission in Paediatric Crohn’s Disease: The CD HOPE study of the GETAID pédiatrique
Pigneur Arnaud, B.(1);Martinez-Vinson, C.(2);Bourmaud, A.(3);Swellen, G.(4);Duclaux-Loras, R.(5);Hugot, J.P.(2);Roman, C.(6);Dumant, C.(7);Spyckerelle, C.(8);Guinard Samuel, V.(9);Willot, S.(10);Dupont, C.(11);Breton, A.(12);Caron, N.(13);Chaillou, E.(14);Rebouissoux, L.(15);Triolo, V.(16);Bertrand, V.(17);Pages, J.(3);Djamal-Dine, D.(18);Bonneton, M.(19);Uhlen, S.(20);Catteau, N.(21);Coopman, S.(22);Viala, J.(2);Ruemmele, F.M.(1)
(1)Hospital Necker Enfants Malades, Department of Paediatric Gastroenterology, Paris, France;(2)Robert Debre Hospital Paris, Pediatric Gastroenterology, Paris, France;(3)Robert Debre Hospital Paris, Clinical Epidemiology, Paris, France;(4)CHU Rennes, Pediatric Gastroenterology, Rennes, France;(5)CHU Lyon, Pediatric Gastroenterology, Lyon, France;(6)APHM, Pediatric Gastroenterology, Marseille, France;(7)CHU Rouen, Pediatric Gastroenterology, Rouen, France;(8)Université Cathologique Lille, Pediatric Gastroenterology, Lille, France;(9)Hopital Trousseau, Pediatric Gastroenterology, Paris, France;(10)CHU Tours, Pediatric Gastroenterology, Tours, France;(11)CHU Caen, Pediatric Gastroenterology, Caen, France;(12)CHU Toulouse, Pediatric Gastroenterology, Toulouse, France;(13)CHU Clermont Ferrand, Pediatric Gastroenterology, Clermont Ferrand, France;(14)CHU Angers, Pediatric Gastroenterology, Angers, France;(15)CHU Bordeaux, Pediatric Gastroenterology, Bordeaux, France;(16)CHU Lenval, Pediatric Gastroenterology, Nice, France;(17)CH Le Havre, Pediatric Gastroenterology, Le Havre, France;(18)CHU Amiens, Pediatric Gastroenterology, Amiens, France;(19)CHRU Nancy, Pediatric Gastroenterology, Nancy, France;(20)CH Valenciennes, Pediatric Gastroenterology, Valenciennes, France;(21)CHU Nimes, Pediatric Gastroenterology, Nimes, France;(22)CHRU Lille, Pediatric Gastroenterology, Lille, France
Background
To address the question if pediatric CD patients responding to nutritional induction therapy can be maintained in remission on dietary therapy without the use of immunosuppressive drugs, we designed a prospective randomized trial (CD-HOPE) comparing cyclic exclusive enteral nutrition (EEN) to daily supplement over a 12 month period.
Methods
CD patients (6-17 years) who successfully completed at least 6 weeks of EEN with clinical remission (wPCDAI ≤12.5) were recruited in 21 sites of the French GETAID pédiatrique between 12.2014 and 09.2018. All drug therapy had to be stopped at least 4 weeks prior to inclusion. A total of 112 patients were screened with 100 patients randomized to group A cyclic EEN (100% of caloric requirement) every 8 weeks for 2 weeks or group B daily supplementary nutrition (25% of caloric requirement). Patient stratification according to age (< 10 years or older) and previous drug exposure or not. EEN and the nutritional supplement were in form of MODULEN IBD®. Except for the two weeks of EEN in group A food access was not restricted. Primary objective was the comparison of relapse rates at 12 months (defined as a wPCDAI >12.5 at two consecutive visits) between the two groups (log-rank test per protocol). Additional analyses were performed using a multivariate regression analysis and cox model.
Results
49 CD patients were randomized to group A (cyclic EEN) and 51 to group B (daily supplement) with 43/49 and 44/51 newly diagnosed patients without any previous drug exposure. Baseline characteristics were comparable between the two groups. Median age was 12 and 13 years, group A and B respectively. At the final 12 months visits a total of 25/49 patients (group A) remained in remission without disease activation compared to 12/51 patients (group B) (p=0.004) with a hazard ratio of 0.48 (0.29-0.80) (p= 0.0051). Kaplan Maier survival remission rates are shown in figure 1. Mean fecal calprotectine levels showed no significant difference between the two groups (297, 399 and 469 at month 0, 3, and 12 visits in group A and 480, 606, and 283 at month 0,3, and 12 visits in group B). Mucosal healing at M12 months was achieved in 25/49 patients (group A) and 18/51 patients (group B), with a mucosal healing rate of 52% (group A) and 33% (group B). Both treatment arms showed a significant catch-up growth.
Conclusion
This is first trial indicating that children/adolescents with CD responding to EEN as induction therapy can be maintained on remission with a nutritional therapy without immunosuppressors/biologics. However, daily nutritional supplement with normal access to food was not successful with a relapse rate of 76%.
This study was supported by an unrestricted grant from Nestlé Health Science and sponsored by APHP.