دورية أكاديمية
Evaluation of exclusive enteral nutrition and corticosteroid induction treatment in new-onset moderate-to-severe luminal paediatric Crohn's disease.
| العنوان: | Evaluation of exclusive enteral nutrition and corticosteroid induction treatment in new-onset moderate-to-severe luminal paediatric Crohn's disease. |
|---|---|
| المؤلفون: | Jongsma MME; Department of Pediatric Gastroenterology, Erasmus Medical Centre-Sophia Children's Hospital, Room SP-2430, P.O. Box 2040, 3000, Rotterdam, CA, Netherlands., Vuijk SA; Department of Pediatric Gastroenterology, Erasmus Medical Centre-Sophia Children's Hospital, Room SP-2430, P.O. Box 2040, 3000, Rotterdam, CA, Netherlands., Cozijnsen MA; Department of Pediatric Gastroenterology, Erasmus Medical Centre-Sophia Children's Hospital, Room SP-2430, P.O. Box 2040, 3000, Rotterdam, CA, Netherlands., van Pieterson M; Department of Pediatric Gastroenterology, Erasmus Medical Centre-Sophia Children's Hospital, Room SP-2430, P.O. Box 2040, 3000, Rotterdam, CA, Netherlands., Norbruis OF; Department of Pediatric Gastroenterology, Isala Hospital, Zwolle, Netherlands., Groeneweg M; Department of Pediatric Gastroenterology, Maasstad Hospital, Rotterdam, Netherlands., Wolters VM; Department of Pediatric Gastroenterology, Utrecht Medical Centre-Wilhelmina Children's Hospital, Utrecht, Netherlands., van Wering HM; Department of Pediatric Gastroenterology, Amphia Hospital, Breda, Netherlands., Hojsak I; Referral Centre for Pediatric Gastroenterology and Nutrition, Children's Hospital Zagreb, University of Zagreb Medical School, Zagreb, Croatia., Kolho KL; Tampere University Hospital and University of Tampere, Tampere, Finland.; Children's Hospital, University of Helsinki, Helsinki, Finland., van Wijk MP; Department of Pediatric Gastroenterology, Amsterdam UMC-Emma Children's Hospital, VU University, Amsterdam, Netherlands., Teklenburg-Roord STA; Department of Pediatric Gastroenterology, Isala Hospital, Zwolle, Netherlands., de Meij TGJ; Department of Pediatric Gastroenterology, Amsterdam UMC-Emma Children's Hospital, VU University, Amsterdam, Netherlands., Escher JC; Department of Pediatric Gastroenterology, Erasmus Medical Centre-Sophia Children's Hospital, Room SP-2430, P.O. Box 2040, 3000, Rotterdam, CA, Netherlands., de Ridder L; Department of Pediatric Gastroenterology, Erasmus Medical Centre-Sophia Children's Hospital, Room SP-2430, P.O. Box 2040, 3000, Rotterdam, CA, Netherlands. l.deridder@erasmusmc.nl. |
| المصدر: | European journal of pediatrics [Eur J Pediatr] 2022 Aug; Vol. 181 (8), pp. 3055-3065. Date of Electronic Publication: 2022 Jun 08. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Springer Verlag Country of Publication: Germany NLM ID: 7603873 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-1076 (Electronic) Linking ISSN: 03406199 NLM ISO Abbreviation: Eur J Pediatr Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Berlin : Springer Verlag Original Publication: Berlin, New York, Springer-Verlag. |
| مواضيع طبية MeSH: | Azathioprine*/therapeutic use , Enteral Nutrition*, Adrenal Cortex Hormones/therapeutic use ; Child ; Crohn Disease ; Humans ; Remission Induction ; Treatment Outcome |
| مستخلص: | To induce remission in luminal paediatric Crohn's disease (CD), the ESPGHAN/ECCO guideline recommends treatment with exclusive enteral nutrition (EEN) or oral corticosteroids. In newly diagnosed moderate-to-severe paediatric CD patients, we determined the proportion of patients in which EEN or corticosteroids induced remission and maintained remission on azathioprine monotherapy. We included patients from the "TISKids" study assigned to the conventional treatment arm. Patients were aged 3-17 years and had new-onset, untreated luminal CD with weighted paediatric CD activity index (wPCDAI) > 40. Induction treatment consisted of EEN or oral corticosteroids; all received azathioprine maintenance treatment from start of treatment. The primary outcome of this study was endoscopic remission defined as a SES-CD score < 3 without treatment escalation at week 10. Secondary outcomes included proportion of patients without treatment escalation at week 52. In total, 27/47 patients received EEN and 20/47 corticosteroids. At baseline, patient demographics and several inflammation parameters were similar between the two treatment groups. At 10 weeks, clinical remission rates were 7/23 (30%) for EEN and 7/19 (37%) for corticosteroids (p = 0.661). Twenty-nine of 47 consented to endoscopy at 10 weeks, showing endoscopic remission rates without treatment escalation in 2/16 (13%) of EEN-treated patients and in 1/13 (8%) of corticosteroid-treated patients (p = 1.00). At week 52, 23/27 (85%) EEN-treated patients received treatment escalation (median 14 weeks) and 13/20 (65%) corticosteroid-treated patients (median 27 weeks), p = 0.070.Conclusion: In children with moderate-to-severe newly diagnosed CD, induction treatment with EEN or CS regularly is insufficient to achieve endoscopic remission without treatment escalation at week 10. Trial registration number: NCT02517684 What is Known: • Endoscopic remission is associated with a low risk of disease progression. • FL-IFX was superior to conventional treatment in achieving and maintaining remission in paediatric patients with moderate-to-severe CD the first year from diagnosis. What is New: • In children with newly diagnosed moderate-to-severe CD, clinical remission rates and endoscopic remission rates without treatment escalation at week 10 were 30% and 13% after EEN and 37% and 8% after corticosteroid induction treatment. • The current treatment target was often not achieved by either EEN or corticosteroid induction treatment after bridging to azathioprine. (© 2022. The Author(s).) |
| References: | Cucchiara S, Isoldi S, Nobili V (2019) Lesson from epidemiology of paediatric Crohn’s disease. Dig Liver Dis 51:503–504. (PMID: 10.1016/j.dld.2018.12.020) Ghione S, Sarter H, Fumery M, Armengol-Debeir L, Savoye G, Ley D, Spyckerelle C et al (2018) Dramatic increase in incidence of ulcerative colitis and Crohn’s disease (1988–2011): a population-based study of French adolescents. Am J Gastroenterol 113:265–272. (PMID: 10.1038/ajg.2017.228) Peyrin-Biroulet L, Sandborn W, Sands BE, Reinisch W, Bemelman W, Bryant RV, D’Haens G et al (2015) Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): determining therapeutic goals for treat-to-target. Am J Gastroenterol 110:1324–1338. (PMID: 10.1038/ajg.2015.233) Danese S, Fiorino G, Peyrin-Biroulet L (2017) Early intervention in Crohn’s disease: towards disease modification trials. Gut 66:2179–2187. (PMID: 10.1136/gutjnl-2017-314519) van Rheenen PF, Aloi M, Assa A, Bronsky J, Escher JC, Fagerberg UL, Gasparetto M, Gerasimidis K, Griffiths A, Henderson P, Koletzko S, Kolho KL, Levine A, van Limbergen J, Martin de Carpi FJ, Navas-López VM, Oliva S, de Ridder L, Russell RK, Shouval D, Spinelli A, Turner D, Wilson D, Wine E, Ruemmele FM (2020) The medical management of paediatric Crohn's disease: an ECCO-ESPGHAN guideline update. J Crohns Colitis. Swaminath A, Feathers A, Ananthakrishnan AN, Falzon L, Li Ferry S (2017) Systematic review with meta-analysis: enteral nutrition therapy for the induction of remission in paediatric Crohn’s disease. Aliment Pharmacol Ther 46:645–656. (PMID: 10.1111/apt.14253) Fell JM, Paintin M, Arnaud-Battandier F, Beattie RM, Hollis A, Kitching P, Donnet-Hughes A, MacDonald TT, Walker-Smith JA (2000) Mucosal healing and a fall in mucosal pro-inflammatory cytokine mRNA induced by a specific oral polymeric diet in paediatric Crohn’s disease. Aliment Pharmacol Ther 14:281–289. (PMID: 10.1046/j.1365-2036.2000.00707.x) Aljebab F, Choonara I, Conroy S (2017) Systematic review of the toxicity of long-course oral corticosteroids in children. PLoS ONE 12:e0170259. (PMID: 10.1371/journal.pone.0170259) Jongsma MME, Aardoom MA, Cozijnsen MA, van Pieterson M, de Meij T, Groeneweg M, Norbruis OF, Wolters VM, van Wering HM, Hojsak I, Kolho KL, Hummel T, Stapelbroek J, van der Feen C, van Rheenen PF, van Wijk MP, Teklenburg-Roord STA, Schreurs MWJ, Rizopoulos D, Doukas M, Escher JC, Samsom JN, de Ridder L (2020) First-line treatment with infliximab versus conventional treatment in children with newly diagnosed moderate-to-severe Crohn's disease: an open-label multicentre randomised controlled trial. Gut. Cozijnsen MA, van Pieterson M, Samsom JN, Escher JC, de Ridder L (2016) Top-down Infliximab Study in Kids with Crohn’s disease (TISKids): an international multicentre randomised controlled trial. BMJ Open Gastroenterol 3:e000123. (PMID: 10.1136/bmjgast-2016-000123) Ruemmele FM, Veres G, Kolho KL, Griffiths A, Levine A, Escher JC, Amil Dias J et al (2014) Consensus guidelines of ECCO/ESPGHAN on the medical management of pediatric Crohn’s disease. J Crohns Colitis 8:1179–1207. (PMID: 10.1016/j.crohns.2014.04.005) Turner D, Griffiths AM, Walters TD, Seah T, Markowitz J, Pfefferkorn M, Keljo D, Waxman J, Otley A, LeLeiko NS, Mack D, Hyams J, Levine A (2012) Mathematical weighting of the pediatric Crohn’s disease activity index (PCDAI) and comparison with its other short versions. Inflamm Bowel Dis 18:55–62. (PMID: 10.1002/ibd.21649) Daperno M, D’Haens G, Van Assche G, Baert F, Bulois P, Maunoury V, Sostegni R, Rocca R, Pera A, Gevers A, Mary JY, Colombel JF, Rutgeerts P (2004) Development and validation of a new, simplified endoscopic activity score for Crohn’s disease: the SES-CD. Gastrointest Endosc 60:505–512. (PMID: 10.1016/S0016-5107(04)01878-4) Adler J, Gebremariam A, Eder SJ, French KR, Singer AA, Lewis JD, Sandberg KC, Picoraro JA, Moran CJ, Goyal A, Rosh J (2019) P083 validation of a new physician global assessment colonoscopy score (PGA-CS) for pediatric Crohn’s disease. Inflamm Bowel Dis 25:Page S39. De Ridder, L. Top-down Infliximab Study in Kids With Crohn's Disease (TISKids). 2015 August 7 [last updated 2021 August 19]. In: ClinicalTrials.gov[Internet]. U.S. National Library of Medicine. Available from: https://clinicaltrials.gov/ct2/show/study/NCT02517684 . ClinicalTrials.gov Identifier: NCT02517684. Hermanussen M, Cole J (2003) The calculation of target height reconsidered. Horm Res 59:180–183. (PMID: 12649571) Dutch Growth Research Foundation. Growth Analyser Research Calculation Tool [Internet]. Rotterdam, the Netherlands. Growth Analyser BV. Available from: https://growthanalyser.org/products/professional-use/research-calculation-tools-rct . Access date 25 March 2020. Borrelli O, Cordischi L, Cirulli M, Paganelli M, Labalestra V, Uccini S, Russo PM, Cucchiara S (2006) Polymeric diet alone versus corticosteroids in the treatment of active pediatric Crohn’s disease: a randomized controlled open-label trial. Clin Gastroenterol Hepatol 4:744–753. (PMID: 10.1016/j.cgh.2006.03.010) Berni Canani R, Terrin G, Borrelli O, Romano MT, Manguso F, Coruzzo A, D’Armiento F, Romeo EF, Cucchiara S (2006) Short- and long-term therapeutic efficacy of nutritional therapy and corticosteroids in paediatric Crohn’s disease. Dig Liver Dis 38:381–387. (PMID: 10.1016/j.dld.2005.10.005) Grover Z, Burgess C, Muir R, Reilly C, Lewindon PJ (2016) Early mucosal healing with exclusive enteral nutrition is associated with improved outcomes in newly diagnosed children with luminal Crohn’s disease. J Crohns Colitis 10:1159–1164. (PMID: 10.1093/ecco-jcc/jjw075) Cohen-Dolev N, Sladek M, Hussey S, Turner D, Veres G, Koletzko S, Martin de Carpi J, Staiano A, Shaoul R, Lionetti P, Amil Dias J, Paerregaard A, Nuti F, Pfeffer Gik T, Ziv-Baran T, Ben Avraham Shulman S, Sarbagili Shabat C, Sigall Boneh R, Russell RK, Levine A (2018) Differences in outcomes over time with exclusive enteral nutrition compared with steroids in children with mild to moderate Crohn’s disease: results from the GROWTH CD study. J Crohns Colitis 12:306–312. (PMID: 10.1093/ecco-jcc/jjx150) Pigneur B, Lepage P, Mondot S, Schmitz J, Goulet O, Dore J, Ruemmele FM (2019) Mucosal healing and bacterial composition in response to enteral nutrition vs steroid-based induction therapy-a randomised prospective clinical trial in children with Crohn’s disease. J Crohns Colitis 13:846–855. (PMID: 10.1093/ecco-jcc/jjy207) Oliva S, Thomson M, de Ridder L, Martín-de-Carpi J, Van Biervliet S, Braegger C, Dias JA, Kolacek S, Miele E, Buderus S, Bronsky J, Winter H, Navas-López VM, Assa A, Chong SKF, Afzal NA, Smets F, Shaoul R, Hussey S, Turner D, Cucchiara S (2018) Endoscopy in pediatric inflammatory bowel disease: a position paper on behalf of the Porto IBD Group of the European Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr 67:414–430. (PMID: 10.1097/MPG.0000000000002092) Logan M, Clark CM, Ijaz UZ, Gervais L, Duncan H, Garrick V, Curtis L, Buchanan E, Cardigan T, Armstrong L, Delahunty C, Flynn DM, Barclay AR, Tayler R, McDonald E, Milling S, Hansen RK, Gerasimidis K, Russell RK (2019) The reduction of faecal calprotectin during exclusive enteral nutrition is lost rapidly after food re-introduction. Aliment Pharmacol Ther 50:664–674. (PMID: 10.1111/apt.15425) Miller T, Suskind DL (2018) Exclusive enteral nutrition in pediatric inflammatory bowel disease. Curr Opin Pediatr 30:671–676. (PMID: 10.1097/MOP.0000000000000660) Grover Z, Lewindon P (2015) Two-year outcomes after exclusive enteral nutrition induction are superior to corticosteroids in pediatric Crohn’s disease treated early with thiopurines. Dig Dis Sci 60:3069–3074. (PMID: 10.1007/s10620-015-3722-9) Ricciuto A, Aardoom M, Orlanski-Meyer E, Navon D, Carman N, Aloi M, Bronsky J, Däbritz J, Dubinsky M, Hussey S, Lewindon P, Martín De Carpi J, Navas-López VM, Orsi M, Ruemmele FM, Russell RK, Veres G, Walters TD, Wilson DC, Kaiser T, de Ridder L, Turner D, Griffiths AM, Steering Committee (2021) Predicting outcomes in pediatric Crohn’s disease for management optimization: systematic review and consensus statements from the Pediatric Inflammatory Bowel Disease-Ahead Program. Gastroenterology 160(403–436):e426. Dziechciarz P, Horvath A, Shamir R, Szajewska H (2007) Meta-analysis: enteral nutrition in active Crohn’s disease in children. Aliment Pharmacol Ther 26:795–806. (PMID: 10.1111/j.1365-2036.2007.03431.x) Grover Z, Muir R, Lewindon P (2014) Exclusive enteral nutrition induces early clinical, mucosal and transmural remission in paediatric Crohn’s disease. J Gastroenterol 49:638–645. (PMID: 10.1007/s00535-013-0815-0) Turner D, Griffiths AM, Wilson D, Mould DR, Baldassano RN, Russell RK, Dubinsky M, Heyman MB, de Ridder L, Hyams J, Martin de Carpi J, Conklin L, Faubion WA, Koletzko S, Bousvaros A, Ruemmele FM (2019) Designing clinical trials in paediatric inflammatory bowel diseases: a PIBDnet commentary. Gut. Harris RE, Aloi M, de Ridder L, Croft NM, Koletzko S, Levine A, Turner D, Veereman G, Neyt M, Bigot L, Ruemmele FM (2020) Protocol for a multinational risk-stratified randomised controlled trial in paediatric Crohn’s disease: methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or high risk for aggressive disease course. BMJ Open 10:e034892. |
| معلومات مُعتمدة: | WI213008 Pfizer Pharmaceuticals; 113202001 Netherlands ZONMW_ ZonMw |
| فهرسة مساهمة: | Keywords: Adolescent; Child; Crohn’s disease; Endoscopic remission; Inflammatory bowel disease; Mucosal healing |
| المشرفين على المادة: | 0 (Adrenal Cortex Hormones) MRK240IY2L (Azathioprine) |
| SCR Disease Name: | Pediatric Crohn's disease |
| تواريخ الأحداث: | Date Created: 20220607 Date Completed: 20220808 Latest Revision: 20221228 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC9352605 |
| DOI: | 10.1007/s00431-022-04496-7 |
| PMID: | 35672586 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1432-1076 |
|---|---|
| DOI: | 10.1007/s00431-022-04496-7 |