Predictive value of blood concentration of biologics on endoscopic inactivity in inflammatory bowel disease: A systematic review

Abstract

BACKGROUND Although blood concentration of biologics is an important composition of disease management in inflammatory bowel disease (IBD) patients, complexity and uncertainty of biological management encourage many disputes in predicting the outcome of IBD patients through blood concentration of biologics. AIM To verify the predictive value of blood concentration of biologics on endoscopic inactivity in IBD patients under different situations. METHODS We searched PubMed/MEDLINE, Embase, and Web of Science up to May 2020 and identified IBD patients as the research cohort as well as the correlations between blood concentration of biologics and endoscopic inactivity in IBD patients as the research direction. RESULTS A total of 23 articles with 30 clinical studies and 1939 IBD patients were included. The predictive cut-off value of blood concentration of infliximab on mucosal healing should be 2.7-10.6 μg/mL in IBD. Blood concentration of infliximab reaching 5.0-12.7 μg/mL or more increased the probability of fistula healing/closure in perianal fistulizing Crohn's disease. Blood concentration of adalimumab reaching 7.2-16.2 μg/mL or more could predict mucosal healing in IBD. The predictive cut-off value of blood concentration of adalimumab on fistula healing/closure should be 5.9-9.8 μg/mL in perianal fistulizing Crohn's disease. Blood concentration of vedolizumab surpassing 25.0 μg/mL indicated mucosal healing in ulcerative colitis patients under maintenance therapy and the predictive cut-off value of blood concentration on mucosal healing or endoscopic remission under induction therapy in IBD could be 8.0-28.9 μg/mL. CONCLUSION Blood concentration of biologics should not be utilized to predict endoscopic inactivity of IBD independently due to discrepancies in clinical studies, whereas conducting therapeutic drug monitoring intensively contributes to precise therapy.

Approach to loss of response to advanced therapies in inflammatory bowel disease

“…Furthermore, Singh et al [ 86 ] undertook a meta-analysis in UC patients which reported vedolizumab trough concentration ≥ 18.5-20.8 μg/mL at week 6, and ≥ 9.0-12.6 μg/mL during maintenance may be associated with clinical remission at week 14 and clinical/endoscopic/biochemical response or remission with maintenance therapy respectively. A systematic review by Cao et al [ 87 ] suggested a blood concentration of vedolizumab surpassing 25.0 μg/mL indicated mucosal healing in UC patients under maintenance therapy but was unable to provide a clear predictive cut-off value of blood concentration on mucosal healing or endoscopic remission under induction therapy in IBD reporting a range between 8.0 and 28.9 μg/mL.…”

“…The role for TDM prior to vedolizumab dose optimisation is not yet established but may be used depending on availability. There is significant heterogeneity in reported drug levels which correlate with clinical remission[ 75 , 86 , 87 ] and conflicting data regarding the utility of drug levels to predict clinical remission[ 88 , 89 ] and response to dose escalation[ 70 , 81 ]. We propose assessing for response to vedolizumab at approximately 12-24 weeks to allow adequate time for effect of vedolizumab dose escalation[ 68 , 70 , 72 , 74 ].…”