Rosen MJ, Dhawan A, Saeed SA. Inflammatory bowel disease in children and adolescents. JAMA Pediatr. 2015;169:1053.
Article PubMed PubMed Central Google Scholar
Pigneur B, Seksik P, Viola S, Viala J, Beaugerie L, Girardet JP, et al. Natural history of Crohnʼs disease: comparison between childhood- and adult-onset disease. Inflamm Bowel Dis. 2010;16:953–61.
Hyams J, Crandall W, Kugathasan S, Griffiths A, Olson A, Johanns J, et al. Induction and maintenance infliximab therapy for the treatment of moderate-to-severe Crohn’s disease in children. Gastroenterology. 2007;132:863–73.
Article PubMed CAS Google Scholar
Hyams J, Damaraju L, Blank M, Johanns J, Guzzo C, Winter HS, et al. Induction and maintenance therapy with infliximab for children with moderate to severe ulcerative colitis. Clin Gastroenterol Hepatol. 2012;10:391-9.e1.
Article PubMed CAS Google Scholar
Hyams JS, Griffiths A, Markowitz J, Baldassano RN, Faubion WA, Colletti RB, et al. Safety and efficacy of adalimumab for moderate to severe Crohn’s disease in children. Gastroenterology. 2012;143:365-74.e2.
Article PubMed CAS Google Scholar
Faubion WA, Dubinsky M, Ruemmele FM, Escher J, Rosh J, Hyams JS, et al. Long-term efficacy and safety of adalimumab in pediatric patients with Crohnʼs Disease. Inflamm Bowel Dis. 2017;23:453–60.
Croft NM, Faubion WA, Kugathasan S, Kierkus J, Ruemmele FM, Shimizu T, et al. Efficacy and safety of adalimumab in paediatric patients with moderate-to-severe ulcerative colitis (ENVISION I): a randomised, controlled, phase 3 study. Lancet Gastroenterol Hepatol. 2021;6:616–27.
Farr R, Karam L, Kitagawa S, Kellermayer R. Infliximab can be effective in pediatric patients with ulcerative colitis and primary failure of adalimumab. Ann Clin Lab Sci. 2022;52:796–801.
Alvisi P, Arrigo S, Cucchiara S, Lionetti P, Miele E, Romano C, et al. Efficacy of adalimumab as second-line therapy in a pediatric cohort of Crohn’s disease patients who failed infliximab therapy: the Italian society of pediatric gastroenterology, hepatology, and nutrition experience. BTT. 2019;13:13–21.
Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology—drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349:1157–67.
Article PubMed CAS Google Scholar
Martinez-Vinson C, Lemoine A, Bouhnik Y, Braithwaite B, Fohlen-Weill A, Addison J. PERFUSE: non-interventional cohort study of patients receiving infliximab biosimilar sb2: results in pediatric patients. J Pediatr Gastroenterol Nutr. 2023;76:451–9.
Article PubMed CAS Google Scholar
Dipasquale V, Pellegrino S, Ventimiglia M, Cucinotta U, Citrano M, Graziano F, et al. Real-life experience of infliximab biosimilar in pediatric-onset inflammatory bowel disease: data from the sicilian network for inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2022;34:1007–14.
Richmond L, Curtis L, Garrick V, Rogers P, Wilson M, Tayler R, et al. Biosimilar infliximab use in paediatric IBD. Arch Dis Child. 2018;103:89–91.
Gervais L, McLean LL, Wilson ML, Cameron C, Curtis L, Garrick V, et al. Switching from originator to biosimilar infliximab in paediatric inflammatory bowel disease is feasible and uneventful. J pediatr gastroenterol nutr. 2018;67:745–8.
Article PubMed CAS Google Scholar
Chanchlani N, Mortier K, Williams LJ, Muhammed R, Auth MKH, Cosgrove M, et al. Use of infliximab biosimilar versus originator in a pediatric united kingdom inflammatory bowel disease induction cohort. J Pediatr Gastroenterol Nutr. 2018;67:513–9.
Article PubMed CAS Google Scholar
Nikkonen A, Kolho K. Infliximab and its biosimilar produced similar first-year therapy outcomes in patients with inflammatory bowel disease. Acta Paediatr. 2020;109:836–41.
Article PubMed CAS Google Scholar
McClinchie MG, Lakhani A, Abdel-Rasoul M, McNicol M, Shkhkhalil AK, Boyle BB, et al. Similar growth outcomes in children with inflammatory bowel disease initiated on infliximab originator or biosimilar. J Pediatr Gastroenterol Nutr. 2023;77:499–504.
Article PubMed CAS Google Scholar
Dipasquale V, Alibrandi A, Pellegrino S, Ramistella V, Romano C. Factors that influence infliximab biosimilar trough levels in the pediatric inflammatory bowel disease population. Expert Rev Clin Immunol. 2024;20:237–44.
Article PubMed CAS Google Scholar
Sieczkowska-Golub J, Meglicka M, Plocek A, Banaszkiewicz A, Jarzębicka D, Toporowska-Kowalska E, et al. Induction therapy with biosimilar infliximab in children with Crohn disease. J Pediatr Gastroenterol Nutr. 2017;65:285–8.
Article PubMed CAS Google Scholar
Cheon JH, Nah S, Kang HW, Lim YJ, Lee SH, Lee SJ, et al. Infliximab biosimilar CT-P13 observational studies for rheumatoid arthritis, inflammatory bowel diseases, and ankylosing spondylitis: pooled analysis of long-term safety and effectiveness. Adv Ther. 2021;38:4366–87.
Article PubMed CAS Google Scholar
Gianolio L, Armstrong K, Swann E, Shepherd R, Henderson P, Wilson DC, et al. Effectiveness of switching to subcutaneous infliximab in pediatric inflammatory bowel disease patients on intravenous maintenance therapy. J Pediatr Gastroenterol Nutr. 2023;77:235–9.
Article PubMed CAS Google Scholar
Hinshaw A, Cares K, Thomas R, El-Baba M. Efficacy of infliximab biosimilar for maintenance therapy in pediatric inflammatory bowel disease following infliximab originator. JPGN Rep. 2022;3:e256.
Article PubMed PubMed Central Google Scholar
van Hoeve K, Dreesen E, Hoffman I, Van Assche G, Ferrante M, Gils A, et al. Efficacy, pharmacokinetics, and immunogenicity is not affected by switching from infliximab originator to a biosimilar in pediatric patients with inflammatory Bowel disease. Ther Drug Monit. 2019;41:317–24.
Kang B, Lee Y, Lee K, Choi YO, Choe YH. Long-term outcomes after switching to CT-P13 in pediatric-onset inflammatory bowel disease: a single-center prospective observational study. Inflamm Bowel Dis. 2018;24:607–16.
Sieczkowska J, Jarzębicka D, Banaszkiewicz A, Plocek A, Gawronska A, Toporowska-Kowalska E, et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary Observ ECCOJC. 2016;10:127–32.
Bergqvist V, Kadivar M, Molin D, Angelison L, Hammarlund P, Olin M, et al. Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease. Therap Adv Gastroenterol. 2018;11:175628481880124.
Lund JL, Richardson DB, Stürmer T. The active comparator, new user study design in pharmacoepidemiology: historical foundations and contemporary application. Curr Epidemiol Rep. 2015;2:221–8.
Article PubMed PubMed Central Google Scholar
Tuppin P, Rudant J, Constantinou P, Gastaldi-Ménager C, Rachas A, de Roquefeuil L, et al. Value of a national administrative database to guide public decisions: from the système national d’information interrégimes de l’Assurance Maladie (SNIIRAM) to the système national des données de santé (SNDS) in France. Revue d’Épidémiologie et de Santé Publique. 2017;65:S149–67.
Roland N, Baricault B, Weill A, Bouillon K, Dray-Spira R, Duranteau L, et al. Association between doses of levonorgestrel intrauterine systems and subsequent use of psychotropic drugs in France. JAMA. 2023;329:257.
Article PubMed CAS Google Scholar
Kolla E, Weill A, Zaidan M, De Martin E, Colin De Verdiere S, Semenzato L, et al. COVID-19 hospitalization in solid organ transplant recipients on immunosuppressive therapy. JAMA Netw Open. 2023;6:2342006.
Le Vu S, Bertrand M, Botton J, Jabagi MJ, Drouin J, Semenzato L, et al. Risk of guillain-barré syndrome following COVID-19 vaccines: a nationwide self-controlled case series study. Neurology. 2023;101:e2094-102.
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