1. Early vedolizumab trough levels predict mucosal healing in inflammatory bowel disease: a multicentre prospective observational study
- Author
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N Williet, M. De Carvalho Bittencourt, Lieven Pouillon, Camille Zallot, Stéphane Nancey, Stéphane Paul, Laurent Peyrin-Biroulet, W. Yacoub, Anthony Lopez, T. Di-Bernado, Xavier Roblin, Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Department of Gastroenterology and Hepatology, University Medical Centre, Groupe Immunité des Muqueuses et Agents Pathogènes (GIMAP), Université Jean Monnet [Saint-Étienne] (UJM), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), DE CARVALHO, MARCELO, Service d'Hépato-gastro-entérologie [CHRU Nancy], Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Imelda General Hospital, Ingénierie Moléculaire et Physiopathologie Articulaire (IMoPA), Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Service d'Hépatologie et de Gastroentérologie [Lyon], Hospices Civils de Lyon (HCL), Centre International de Recherche en Infectiologie - UMR (CIRI), École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université Jean Monnet - Saint-Étienne (UJM), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon)-Université Claude Bernard Lyon 1 (UCBL), and Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
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Adult ,Male ,medicine.medical_specialty ,Population ,Antibodies, Monoclonal, Humanized ,Gastroenterology ,Inflammatory bowel disease ,Vedolizumab ,03 medical and health sciences ,0302 clinical medicine ,Interquartile range ,Internal medicine ,medicine ,Humans ,Pharmacology (medical) ,Prospective Studies ,Intestinal Mucosa ,Prospective cohort study ,education ,ComputingMilieux_MISCELLANEOUS ,education.field_of_study ,Wound Healing ,Mucous Membrane ,Hepatology ,medicine.diagnostic_test ,business.industry ,Endoscopy ,[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,Middle Aged ,medicine.disease ,Inflammatory Bowel Diseases ,Prognosis ,Confidence interval ,[SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,3. Good health ,Treatment Outcome ,Therapeutic drug monitoring ,030220 oncology & carcinogenesis ,Trough level ,030211 gastroenterology & hepatology ,Female ,Drug Monitoring ,business ,medicine.drug - Abstract
SummaryBackground The correlation between vedolizumab trough levels during induction therapy and mucosal healing remains unknown. Aim To compare early vedolizumab trough levels in patients with and without mucosal healing within the first year after treatment initiation. Methods We prospectively collected vedolizumab trough levels in all inflammatory bowel disease patients at weeks 2, 6 and 14 of vedolizumab treatment in three French referral centres between 1 June 2014 and 31 March 2017. Results of every patient that underwent mucosal assessment by magnetic resonance imaging and/or endoscopy in the first year after treatment initiation were analysed. Results Median vedolizumab trough levels in the overall population (n = 82) were 27 μg/mL (interquartile range, IQR 21.2-33.8 μg/mL) at week 2, 23 μg/mL (IQR 15-34.5 μg/mL) at week 6 and 10.7 μg/mL (IQR 4.6-20.4 μg/mL) at week 14. Only median vedolizumab trough levels at week 6 differed between patients with and without mucosal healing within the first year after treatment initiation (26.8 vs 15.1 μg/mL, P = 0.035). A cut-off trough level of 18 μg/mL at week 6 predicted mucosal healing within the first year after the start of vedolizumab with an area under the receiver operating curve of 0.735 (95% confidence interval 0.531-0.939). A vedolizumab trough level above 18 μg/mL at week 6 was the only independent variable associated with mucosal healing within the first year of treatment (odds ratio 15.7, 95% confidence interval 2.4-173.0, P = 0.01). Conclusion Early therapeutic drug monitoring might improve timely detection of vedolizumab-treated patients in need for an intensified dosing regimen.
- Published
- 2018
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