Vedolizumab Trough Levels and Histological Healing During Maintenance Therapy in Ulcerative Colitis.
J Crohns Colitis. 2019 Jan 29;:
Authors: Pouillon L, Rousseau H, Busby-Venner H, De Carvalho Bittencourt M, Choukour M, Gauchotte G, Zallot C, Danese S, Baumann C, Peyrin-Biroulet L
Background & Aims: Histological healing may be the ultimate therapeutic goal in ulcerative colitis (UC). We investigated, for the first time, the association between vedolizumab trough levels and histological healing in UC.
Methods: This is a single-center retrospective cohort study including all consecutive UC patients on vedolizumab maintenance therapy who had a histological evaluation blindly to clinical data and underwent therapeutic drug monitoring, between June 2014 and March 2018. Per event analysis was performed. Histological healing was defined as a Nancy histological index ≤ 1.
Results: Thirty-five histological samples were analyzed. Median (IQR) vedolizumab trough levels were higher in the group with histological healing (31.5 (25-49.1) μg/mL) compared with the group without histological healing (15 (9-26.6) μg/mL, P=0.02). The higher vedolizumab trough level quartiles tended to be associated with greater rates of histological healing (P=0.10). A cut-off vedolizumab trough level of 25 μg/mL predicted histological healing with an accuracy of 74% and an area under the receiver operating curve of 0.62 (95% CI 0.58-0.92, P=0.004). Bivariate analysis identified vedolizumab trough level 25 µg/mL (P=0.006), a partial Mayo score ≤ 1 (P=0.008), C-reactive protein level < 5 mg/L (P=0.005) and a Mayo endoscopic subscore ≤ 1 (P=0.0004) as factors associated with histological healing.
Conclusions: Histological healing was associated with higher vedolizumab trough levels during maintenance therapy in UC. A vedolizumab trough level threshold of 25 μg/mL proved most optimal to predict histological healing according to the Nancy histological index. Confirmation of these data in larger, independent cohorts is needed.
PMID: 30698684 [PubMed – as supplied by publisher]