Thématique :
Originalité :
Solidité :
Doit faire évoluer notre pratique :
Dans certains cas
Nom du veilleur :
Docteur Stéphane NAHON
Coup de coeur :
Clinical Gastroenterology and Hepatology
  2017 Nov;15(11):1750-1757.e3.  
  doi: 10.1016/j.cgh.2016.11.02  
  Association Between Low Trough Levels of Vedolizumab During Induction Therapy for Inflammatory Bowel Diseases and Need for Additional Doses Within 6 Months.  
  Williet N, Boschetti G, Fovet M, Di Bernado T, Claudez P, Del Tedesco E, Jarlot C, Rinaldi L, Berger A, Phelip JM, Flourie B, Nancey S, Paul S, Roblin X  



We investigated whether serum trough levels of vedolizumab, a humanized monoclonal antibody against integrin α4β7, during the induction phase of treatment can determine whether patients will need additional doses (optimization of therapy) within the first 6 months.


We conducted an observational study of 47 consecutive patients with Crohn's disease (CD; n = 31) or ulcerative colitis (UC; n = 16) who had not responded to 2 previous treatment regimens with antagonists of tumor necrosis factor and were starting therapy with vedolizumab at 2 hospitals in France, from June 2014 through April 2016. All patients were given a 300-mg infusion of vedolizumab at the start of the study, Week 2, Week 6, and then every 8 weeks; patients were also given corticosteroids during the first 4-6 weeks. Patients not in remission at Week 6 were given additional doses of vedolizumab at Week 10 and then every 4 weeks (extended therapy or optimization). Remission at Week 6 of treatment was defined as CD activity score below 150 points for patients with CD and a partial Mayo Clinic score of <3 points, without concomitant corticosteroids, for patients with UC. Blood samples were collected each week and serum levels of vedolizumab and antibodies against vedolizumab were measured using an enzyme-linked immunosorbent assay. Median trough levels of vedolizumab and interquartile ranges were compared using the nonparametric Mann-Whitney test. The primary objective was to determine whether trough levels of vedolizumab measured during the first 6 weeks of induction therapy associated with the need for extended treatment within the first 6 months.


Based on response to therapy at Week 6, extended treatment was required for 30 of the 47 patients (23 patients with CD and 7 patients with UC). At Week 2, trough levels of vedolizumab for patients selected for extended treatment were 23.0 μg/mL (interquartile range, 14.0-37.0 μg/mL), compared with 42.5 μg/mL in patients who did not receive extended treatment (interquartile range, 33.5-50.7; P = .15). At Week 6, trough levels of vedolizumab <18.5 μg/mL were associated with need for extended therapy (100% positive predictive value, 46.2%; negative predictive value; area under the receiver operating characteristic curve, 0.72) within the first 6 months. Among patients who required extended treatment at Week 10, all of those with trough levels of vedolizumab <19.0 μg/mL at Week 6 had achieved clinical remission 4 weeks later (secondary responders).


In a prospective study of patients with CD or UC receiving induction therapy with vedolizumab, low trough levels of vedolizumab at Week 6 (<19.0 μg/mL) are associated with need for additional doses (given at Week 10 and then every 4 weeks). All patients receiving these additional doses achieved a clinical response 4 weeks later.


Question posée
Un taux résiduel bas de vedolizumab à S6 permet-il d’optimiser le traitement ?
Question posée
Dans ce travail français, chez des patients ayant une maladie de Crohn ou une RCH, un taux résiduel à S6 <19 μg/mL permet d’identifier les patients pour qui une optimisation du traitement à une perfusion / 4sem permet d’obtenir une rémission clinique.

Ce travail des équipes Stéphanoises et Lyonnaises montrent que le dosage du taux résiduel de vedolizumab à S6 permet d’optimiser dès la semaine 10 le rythme des perfusions à une perfusion toutes les 4 semaines quand le taux résiduel est <19 μg/mL.