Trough Levels of Infliximab at Week 6 Are Predictive of Remission at Week 14 in Pediatric Crohn's Disease.
Journal
Journal of pediatric gastroenterology and nutrition
ISSN: 1536-4801
Titre abrégé: J Pediatr Gastroenterol Nutr
Pays: United States
ID NLM: 8211545
Informations de publication
Date de publication:
03 2020
03 2020
Historique:
pubmed:
28
10
2019
medline:
22
6
2021
entrez:
26
10
2019
Statut:
ppublish
Résumé
Infliximab (IFX) is a frequent therapeutic option for Crohn disease (CD) patients. Early detection of responders to IFX is critical for the management of CD in order to avoid long-term exposure to the drug without benefit. This retrospective study aimed at analysing which early parameters recorded during the induction period are able to predict response to IFX during the maintenance period in pediatric CD. Medical records of all CD patients ages from 2 to 18 years who received IFX at a tertiary IBD center were retrospectively analyzed. Children were classified in 3 groups according to their response at week 14 (W14) remission, clinical response or , no response. The factors recorded at W0, W2, and W6, which were associated with remission at W14 were analyzed using a logistic regression. Among the 111 patients included, 74.8% patients were responders to IFX at W14, including 38.7% in clinical remission and 36% with partial clinical response. Clinical remission at W14 was associated with normal growth (P < 0.01), and normal albuminemia (P = 0.01) at baseline, It was also associated with trough levels to IFX >8.3 μg/ml at week 6 (P < 0.01). Trough levels to IFX >8.3 μg/ml at week 6 are predictive of remission at W14 for luminal disease.
Identifiants
pubmed: 31651668
doi: 10.1097/MPG.0000000000002536
pii: 00005176-202003000-00010
doi:
Substances chimiques
Gastrointestinal Agents
0
Infliximab
B72HH48FLU
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
310-317Commentaires et corrections
Type : CommentIn
Références
Targan SR, Hanauer SB, van Deventer SJ, et al. A short term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. N Engl Med 1997; 337:1029–1035.
Hanauer SB, Feagan BG, Lichtenstein GR, et al. ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT 1 randomised trial. Lancet 2002; 359:1541–1549.
Hyams J, Crandall W, Kugathasan S, et al. REACH Study Group. Induction and maintenance infliximab therapy for the treatment of moderate-to-severe Crohn's disease in children. Gastroenterology 2007; 132:863–873.
Assa A, Hartman C, Weiss B, et al. Long-term outcome of tumor necrosis factor alpha antagonist's treatment in paediatric Crohn's disease. J Crohns Colitis 2013; 7:369–376.
Hyams JS, Lerer T, Griffiths A, et al. Pediatric Inflammatory Bowel Disease Collaborative Research Group. Long-term outcome of maintenance infliximab therapy in children with Crohn's disease. Inflamm Bowel Dis 2009; 15:816–822.
De Bie CI, Hummel TZ, Kindermann A, et al. The duration of effect of infliximab maintenance treatment in paediatric Crohn's disease is limited. Aliment Pharmacol Ther 2011; 33:243–250.
Crombé V, Salleron J, Savoye G, et al. Long-term outcome of treatment with infliximab in paediatric-onset Crohn's disease: a population-based study. Inflamm Bowel Dis 2011; 17:2144–2152.
Ben-Horin S, Chowers Y. Review article: loss of response to anti-TNF treatments in Crohn's disease. Aliment Pharmacol Ther 2011; 33:987–995.
Steenholdt C, Bendtzen K, Brynskov J, et al. Cut-off levels and diagnostic accuracy of infliximab trough levels and anti-infliximab antibodies in Crohn's disease. Scand J Gastroenterol 2011; 46:310–318.
Maser EA, Villela R, Silverberg MS, et al. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol 2006; 4:1248–1254.
Bortlik M, Duricova D, Malickova K, et al. Infliximab trough levels may predict sustained response to infliximab in patients with Crohn's disease. J Crohns Colitis 2013; 7:736–743.
Baert F, Drobne D, Gils A, et al. Early trough levels and antibodies to infliximab predict safety and success of reinitiation of infliximab therapy. Clin Gastroenterol Hepatol 2014; 12:1474.e2–1481.e2.
Roblin X, Marotte H, Rinaudo M, et al. Association between pharmacokinetics of adalimumab and mucosal healing in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol 2014; 12:80.e2–84.e2.
Paul S, Del Tedesco E, Marotte H, et al. Therapeutic drug monitoring of infliximab and mucosal healing in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis 2013; 19:2568–2576.
Cornillie F, Hanauer SB, Diamond RH, et al. Postinduction serum infliximab trough level and decrease of C-reactive protein level are associated with durable sustained response to infliximab: a retrospective analysis of the ACCENT I trial. Gut 2014; 63:1721–1727.
Bor R, Farkas K, Fábián A, et al. Clinical role, optimal timing and frequency of serum infliximab and anti-infliximab antibody level measurements in patients with inflammatory bowel disease. PLoS One 2017; 12:e0172916.
Naviglio S, Lacorte D, Lucafò M, et al. Causes of treatment failure in children with inflammatory bowel disease treated with infliximab: a pharmacokinetic study. J Pediatr Gastroenterol Nutr 2019; 68:37–44.
Singh N, Rosenthal CJ, Melmed GY, et al. Early infliximab trough levels are associated with persistent remission in paediatric patients with inflammatory bowel disease. Inflamm Bowel Dis 2014; 20:1708–1713.
Stein R, Lee D, Leonard MB, et al. Serum infliximab, antidrug antibodies, and tumor necrosis factor predict sustained response in pediatric Crohn's disease. Inflamm Bowel Dis 2016; 22:1370–1377.
van Hoeve K, Dreesen E, Hoffman, et al. Adequate infliximab exposure during induction predicts remission in paediatric patients with inflammatory bowel disease. J Pediatr Gastroenterol Nutr 2019; 68:847–853.
Hämäläinen A, Sipponen T, Kolho KL, et al. Serum infliximab concentrations in paediatric inflammatory bowel disease. Scand J Gastroenterol 2013; 48:35–41.
Merras-Salmio L, Kolho KL. Clinical use of infliximab trough levels and antibodies to infliximab in paediatric patients with inflammatory bowel disease. J Pediatr Gastroenterol Nutr 2017; 64:272–278.
Hoekman DR, Brandse JF, de Meij TG, et al. The association of infliximab trough levels with disease activity in paediatric inflammatory bowel disease. Scand J Gastroenterol 2015; 50:1110–1117.
Ungar B, Glidai Y, Yavzori M, et al. Association between infliximab drug and antibody levels and therapy outcome in paediatric inflammatory bowel diseases. J Pediatr Gastroenterol Nutr 2018; 67:507–512.
Van Hoeke K, Dreesen E, Hoffman I, et al. Higher infliximab trough levels are associated with better outcome in paediatric patients with inflammatory bowel disease. J Crohns Colitis 2018; 12:1316–1325.
Pariente B, Cosnes J, Danese S, et al. Development of the Crohn's disease digestive damage score, the Lemann score. Inflamm Bowel Dis 2011; 17:1415–1422.
Levine A, Koletzko S, Turner D, et al. European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. ESPGHAN revised Porto criteria for the diagnosis of inflammatory bowel disease in children and adolescents. J Pediatr Gastroenterol Nutr 2014; 58:795–806.
Farrell RJ, Alsahli M, Jeen YT, et al. Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn's disease: a randomized controlled trial. Gastroenterology 2003; 124:917–924.
Levine A, Griffiths A, Markowitz J, et al. Paediatric modification of the Montreal classification for inflammatory bowel disease: the Paris classification. Inflamm Bowel Dis 2011; 17:1314–1321.
Hyams JS, Ferry GD, Mandel FS, et al. Development and validation of a paediatric Crohn's disease activity index. J Pediatr Gastroenterol Nutr 1991; 12:439–447.
Turner D, Griffiths AM, Walters TD, et al. Appraisal of the pediatric Crohn's disease activity index on four prospectively collected datasets: recommended cutoff values and clinimetric properties. Am J Gastroenterol 2010; 105:2085–2092.
Candon S, Mosca A, Ruemmele F, et al. Clinical and biological consequences of immunization to infliximab in paediatric Crohn's disease. Clin Immunol 2006; 118:11–19.
Ruemmele FM, Veres G, Kolho KL, et al. European Crohn's and Colitis Organisation; European Society of Pediatric Gastroenterology, Hepatology and Nutrition. Consensus guidelines of ECCO/ESPGHAN on the medical management of paediatric Crohn's disease. J Crohns Colitis 2014; 8:1179–1207.
Kennedy NA, Heap GA, Green HD, et al. UK Inflammatory Bowel Disease Pharmacogenetics Study Group. Predictors of anti-TNF treatment failure in anti-TNF-naive patients with active luminal Crohn's disease: a prospective, multicentre, cohort study. Lancet Gastroenterol Hepatol 2019; 4:341–353.
Papamichael K, van Stappen T, Vande Casteele N, et al. Infliximab concentration thresholds during induction therapy are associated with short-term mucosal healing in patients with ulcerative colitis. Clin Gastroenterol Hepatol 2016; 14:543–549.
Dreesen E, Baert F, Laharie D, et al. Monitoring a combination of calprotectin and infliximab identifies patients with mucosal healing of Crohn's disease. Clin Gastroenterol Hepatol 2019; S1542-3565(19)30551-8.
Vande Casteele N, Jeyarajah J, Jairath V, et al. Infliximab exposure-response relationship and thresholds associated with endoscopic healing in patients with ulcerative colitis. Clin Gastroenterol Hepatol 2018; 17:1814.e1–1821.e1.
Beltrán B, Iborra M, Sáez-González E, et al. Fecal Calprotectin pretreatment and induction infliximab levels for prediction of primary nonresponse to infliximab therapy in Crohn's disease. Dig Dis 2019; 37:108–115.
Bar-Yoseph H, Levhar N, Selinger L, et al. Early drug and anti-infliximab antibody levels for prediction of primary nonresponse to infliximab therapy. Aliment Pharmacol Ther 2018; 47:212–218.
Fasanmade AA, Adedokun OJ, Olson A, et al. Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis. Int J Clin Pharmacol Ther 2010; 48:297–308.
Lee KM, Jeen YT, Cho JY, et al. IBD study Group of Korean Association for the Study of Intestinal Diseases. Efficacy, safety, and predictors of response to infliximab therapy for ulcerative colitis: a Korean multicenter retrospective study. J Gastroenterol Hepatol 2013; 28:1829–1833.
Zampeli E, Gizis M, Siakavellas SI, et al. Predictors of response to anti-tumor necrosis factor therapy in ulcerative colitis. World J Gastrointest Pathophysiol 2014; 5:293–303.
Armuzzi A, Pugliese D, Danese S, et al. Infliximab in steroid- dependent ulcerative colitis: effectiveness and predictors of clinical and endoscopic remission. Inflamm Bowel Dis 2013; 19:1065–1072.
Fasanmade AA, Adedokun OJ, Blank M, et al. Pharmacokinetic properties of infliximab in children and adults with Crohn's disease: retrospective analysis of data from 2 phase III clinical trials. Clin Ther 2011; 33:946–964.
Dotan I, Ron Y, Yanai H, et al. Patient factors that increase infliximab clearance and shorten half-life in inflammatory bowel disease: a population pharmacokinetic study. Inflamm Bowel 2014; 20:2247–2259.
Turner D, Ruemmele FM, Orlanski-Meyer E, et al. Management of paediatric ulcerative colitis, part 1: ambulatory care-an evidence-based guideline from European Crohn's and Colitis Organization and European Society of Paediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr 2018; 67:257–291.