scholarly journals Therapeutic drug monitoring of vedolizumab in inflammatory bowel disease: current data and future directions

2018 ◽  
Vol 11 ◽  
pp. 175628481877278 ◽  
Author(s):  
Mark G. Ward ◽  
Miles P. Sparrow ◽  
Xavier Roblin
Keyword(s):  
Inflammatory Bowel Disease ◽  
Therapeutic Drug Monitoring ◽  
Clinical Outcomes ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Response Relationship ◽  
Drug Levels ◽  
Exposure Response ◽  
Inflammatory Bowel

The introduction of vedolizumab, a lymphocyte adhesion inhibitor, has expanded the relatively limited therapeutic armamentarium available for Crohn’s disease and ulcerative colitis. Despite its effectiveness, both primary nonresponse and secondary loss of response to vedolizumab do occur, as is observed with the use of anti-tumour necrosis factor (TNF) therapy. Further, in a proportion, onset of efficacy may be relatively slow. A large body of data support an exposure–response relationship with anti-TNF drug levels, which has led to therapeutic drug monitoring becoming incorporated into everyday clinical management. The influence of patient and disease factors on the pharmacokinetics of anti-TNF levels, including immunogenicity, has also been examined. The role of therapeutic drug monitoring with vedolizumab is less clear. This review summarizes the available evidence on the pharmacokinetics and pharmacodynamics of vedolizumab in inflammatory bowel disease and how drug levels, immunogenicity and other factors influence clinical outcomes. Vedolizumab clearance is increased with very high body weight and hypoalbuminaemia, but is not influenced by the addition of an immunomodulator. Immunogenicity is uncommon. α4β7 receptor saturation occurs at low serum vedolizumab drug levels, and measuring it alone is insufficient to predict clinical outcomes. Using quartile analysis of vedolizumab drug levels, there appears to be a modest exposure–response relationship during induction. Drug levels at week 6 of approximately >20 μg/ml have been shown to be associated with improved clinical outcomes, including subsequent mucosal healing rates during maintenance and avoiding the need to dose escalate due to lack of response. There are currently insufficient data to support the routine use of therapeutic drug monitoring during maintenance therapy. Further studies to elucidate the role of therapeutic drug monitoring of vedolizumab are needed.

scholarly journals P368 Proactive Therapeutic Drug Monitoring is more effective than Conventional Management in Inducing Fecal Calprotectin remission in Inflammatory Bowel Disease

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S386-S386
Author(s):  
J Pedro ◽  
I Rodrigues ◽  
S Fernandes ◽  
A R Gonçalves ◽  
S Bernardo ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Therapeutic Drug Monitoring ◽  
Clinical Outcomes ◽  
Bowel Disease ◽  
Drug Monitoring ◽  
Clinical Remission ◽  
Therapeutic Drug ◽  
Conventional Management ◽  
Inflammatory Bowel

Abstract Background Proactive therapeutic drug monitoring (pTDM) may potentially improve disease control and treatment outcomes in inflammatory bowel disease. Methods Using a prospectively maintained database we compared 135 patients following a pTDM protocol aiming at an Infliximab trough level (IFXTL) between 5-10 µg/mL with sequential measurements of Fc, with 108 patients from a retrospective group under conventional management (noTDM). We evaluated the rates of Fc remission (<250 µg/g), and other clinical outcomes at 2-years of follow up. Results pTDM associated with higher rates of Fc remission (69.6% vs 50.0%; P=0.002), and steroid-free clinical remission (78.4% vs 55.2%, P=0.028) with a trend for clinical remission (79.3% vs 68.5%, P=0.075). There was no difference in treatment discontinuation (P=0.195), hospitalization (P=0.156), and surgery (P=0.110). Higher IFXTL associated with Fc remission at week 14 (6.59 vs 2.96 µg/mL, P<0.001), and at the end follow-up (8.10 vs 5.03 μg/mL, P=0.001). Fc remission associated with higher rates of clinical remission (85.8% vs 56.8% P<0.001), steroid-free clinical remission (86.9% vs 50.0% P<0.001), and lower rates of IFX discontinuation (8.8% vs 36.8%, P<0.001), and hospitalization (13.5% vs 33.7%, P<0.001) with a non-significant trend for surgery (6.1% vs 12.6%, P=0.101). Conclusion PTDM was more effective than conventional management in inducing Fc remission which associated with improved clinical outcomes.

A Systematic Review on Cost-effectiveness Analyses of Therapeutic Drug Monitoring for Patients with Inflammatory Bowel Disease: From Immunosuppressive to Anti-TNF Therapy

2020 ◽  
Author(s):  
Jiaqi Yao ◽  
Xinchan Jiang ◽  
Joyce H S You
Keyword(s):  
Systematic Review ◽  
Inflammatory Bowel Disease ◽  
Cost Effectiveness ◽  
Therapeutic Drug Monitoring ◽  
Clinical Outcomes ◽  
Bowel Disease ◽  
Drug Monitoring ◽  
Standard Care ◽  
Therapeutic Drug ◽  
Inflammatory Bowel

Abstract Background There is a growing body of primary evidence on the cost-effectiveness of applying therapeutic drug monitoring (TDM) for inflammatory bowel disease (IBD) management with various drug therapies and strategies. Objectives The aim of this study was to conduct a systematic review on model-based cost-effectiveness analyses of applying TDM for IBD management. Methods Literature search was conducted (up to October 2019) in Medline (Ovid), Embase (Ovid), Web of Science, Scopus, CINAHL Complete, and the Centre for Reviews and Dissemination. Studies published in the English language that met inclusion criteria were included: (1) patients with IBD, (2) TDM-based treatment was compared with a comparator, (3) types of analysis were cost-benefit, cost-consequence, cost-effectiveness, cost-utility, or cost analysis, and (4) analyses conducted by model-based evaluation. The study quality was assessed using Consolidated Health Economic Evaluation Reporting Standards. Results Six studies on drug monitoring for IBD patients (1 azathioprine and 5 infliximab) published in 2005 to 2019 were included. All studies targeted on patients with Crohn’s disease and reported TDM strategies to save cost when comparing with standard care. Four analyses evaluated both economic and clinical outcomes. Three analyses found the TDM strategies (for treatment initiation, advancement of therapy, or proactive monitoring) to improve clinical outcomes. One study found TDM strategies (reflex testing and concurrent testing) to gain lower quality-adjusted life years than standard care. Four of six (66.7%) studies achieved good to excellent rankings in quality assessment. Conclusions Compared with standard treatment without TDM, the TDM-guided strategies were consistently found to be cost-saving or cost-effective.

Therapeutic drug monitoring with vedolizumab in inflammatory bowel disease

2020 ◽  
Vol 65 (4) ◽  
Author(s):  
Daniela Pugliese ◽  
Giuseppe Privitera ◽  
Fabrizio Pizzolante ◽  
Antonio Gasbarrini ◽  
Luisa Guidi ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Therapeutic Drug Monitoring ◽  
Bowel Disease ◽  
Drug Monitoring ◽  
Therapeutic Drug ◽  
Inflammatory Bowel
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