A Prospective Cohort Study to Assess the Relevance of Vedolizumab Drug Level Monitoring in IBD Patients

Autor: Michael Zorn, Christina Christ, Franz Hartmann, Juergen Stein, Philip Esters, Hermann Schulze, Axel Dignass
Rok vydání: 2017
Předmět:
Male
0301 basic medicine
Severity of Illness Index
Inflammatory bowel disease
Mass Spectrometry
Tertiary Care Centers
0302 clinical medicine
Germany
Medicine
Prospective Studies
Young adult
Prospective cohort study
media_common
Crohn's disease
Gastroenterology
Middle Aged
Ulcerative colitis
C-Reactive Protein
Treatment Outcome
030220 oncology & carcinogenesis
Regression Analysis
Female
030211 gastroenterology & hepatology
Drug Monitoring
medicine.drug
Adult
Drug
medicine.medical_specialty
Adolescent
media_common.quotation_subject
Antibodies
Monoclonal
Humanized

Vedolizumab
Drug levels
Young Adult
03 medical and health sciences
Internal medicine
Severity of illness
Humans
Relevance (information retrieval)
Aged
Hepatology
Tumor Necrosis Factor-alpha
business.industry
Inflammatory Bowel Diseases
medicine.disease
digestive system diseases
030104 developmental biology
Trough level
business
Chromatography
Liquid
Zdroj: Gastroenterology. 152:S753
ISSN: 0016-5085
Popis: Vedolizumab (VDZ) drug monitoring strategies in inflammatory bowel disease (IBD) patients have not been systematically investigated so far. We evaluated the correlation between VDZ trough levels (VTL) and the treatment response in IBD.Fifty-one patients with active IBD on or starting a therapy with VDZ were enrolled in this prospective and observational single centre study. Disease activity indices, blood tests, and anthropometric parameters were assessed over a time period of 6 months. One hundred and fifty-five VDZ serum trough levels were measured directly before the next scheduled application using liquid chromatography mass spectrometry (LC-MS/MS).VDZ treatment was found to be clinically effective (Harvey Bradshaw Index (HBI) dropping from 10 to 5.5 points (p .0005) in Crohn's disease (CD) patients; partial Mayo score (pMS) from 4.4 to 2.1 points (p .0005) in ulcerative colitis patients (UC). CRP levels tended to decrease and haemoglobin levels to increase under VDZ therapy. CD patients with a serum CRP level lower than 5 mg/l exhibited significantly higher VTL than those with elevated CRP levels (34.9 versus 21.7 µg/ml, p = .00153). UC patients with haemoglobin levels higher 12 g/dl at the time of VTL measurement had significantly higher VTL compared to patients with lower haemoglobin levels (35.4 versus 15.6 µg/ml, p .0005).Our data suggest a significant correlation between VTL and response to therapy in IBD patients (higher VTL associated with better response).
Databáze: OpenAIRE