W Yacoub1, N Williet2, L Pouillon1,3, T Di-Bernado2, M De Carvalho Bittencourt4, S Nancey5,6, A Lopez1, S Paul7,8, C Zallot1, X Roblin2,8, L Peyrin-Biroulet1. 1. INSERM U954 and Department of Hepato-Gastroenterology, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France. 2. Department of Hepato-Gastroenterology, University Hospital of Saint-Etienne, Saint-Etienne, France. 3. Imelda GI Clinical Research Centre, Imeldaziekenhuis Bonheiden, Bonheiden, Belgium. 4. IMOPA UMR 7365 and Department of Immunology, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France. 5. Department of Gastroenterology, Lyon-Sud Hospital, Hospices Civils of Lyon, Pierre Bénite, France. 6. INSERM U1111 and International Centre for Research in Infectiology, Lyon, France. 7. Department of Immunology, University Hospital of Saint-Etienne, Saint-Etienne, France. 8. EA-3064, Groupe Immunité des Muqueuses et Agents Pathogènes (GIMAP), Saint-Etienne, France.
Abstract
BACKGROUND: 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.
BACKGROUND: 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 diseasepatients 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.
Authors: Jurij Hanžel; Nejc Sever; Ivan Ferkolj; Borut Štabuc; Nataša Smrekar; Tina Kurent; Matic Koželj; Gregor Novak; Griet Compernolle; Sophie Tops; Ann Gils; David Drobne Journal: United European Gastroenterol J Date: 2019-03-19 Impact factor: 4.623
Authors: Konstantinos Papamichael; Adam S Cheifetz; Gil Y Melmed; Peter M Irving; Niels Vande Casteele; Patricia L Kozuch; Laura E Raffals; Leonard Baidoo; Brian Bressler; Shane M Devlin; Jennifer Jones; Gilaad G Kaplan; Miles P Sparrow; Fernando S Velayos; Thomas Ullman; Corey A Siegel Journal: Clin Gastroenterol Hepatol Date: 2019-03-27 Impact factor: 11.382
Authors: Luisa Guidi; Daniela Pugliese; Tommaso Panici Tonucci; Lorenzo Bertani; Francesco Costa; Giuseppe Privitera; Barbara Tolusso; Clara Di Mario; Eleonora Albano; Gherardo Tapete; Elisa Gremese; Alfredo Papa; Antonio Gasbarrini; Gian Ludovico Rapaccini; Alessandro Armuzzi Journal: United European Gastroenterol J Date: 2019-09-03 Impact factor: 4.623