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Document Type |
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Thesis |
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Document Title |
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Pharmacogenomics Of Vedolizumab in Inflammatory Bowel Disease تأثير التنوع الوراثي على الاستجابة لدواء الفيدوليزوماب لدى المصابين بأمراض الأمعاء الالتهابية |
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Subject |
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Faculty of medicine |
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Document Language |
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Arabic |
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Abstract |
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Background & Aims Vedolizumab is an anti-α4β7 integrin monoclonal antibody used to treat moderate-to-severe inflammatory bowel disease (IBD). The aim of the study was to assess the effectiveness of the induction of vedolizumab trough level in predicting short-term (week 14) clinical outcomes , and variables that affect the response on Saudi Arabian patients.
Methods This prospective, real-life observational study included a total of 16 consecutive patients (4 Crohn's disease [CD] and 12 ulcerative colitis [UC]) with a confirmed diagnosis of IBD and generally naïve to receiving vedolizumab therapy. Using ELISA assay, vedolizumab induction trough and peak levels were measured at weeks 0, 2, and 6. The follow-up assessment was at week 14, where clinical outcomes were measured using the partial Mayo score for UC, and the Crohn’s disease activity score (CDAI), and the Harvey Bradshaw index (HBI) for CD.
Results At week 14, 9 patients (52.9%) out of 16 patients demonstrated response to therapy; clinical remission was reported in 5 patients (29.4%), and in 4 cases, a clinical response was noted (23.5%). Clinical remission at week 14 was linked significantly with week 6 median vedolizumab levels in responders (25.1 µg/ml 95% CI: 16.5-42.9) compared to non-responders (7.7µg/ml, 95% CI: 4.6-10.6) (P = 0.002). Receiver operator curve (ROC) analysis at week 6 identified a cut-off > 8.00 µg/mL for short-term clinical remission. Also, at week 14, Body Mass Index (BMI) and gender significantly correlated with week 6 vedolizumab trough levels (P = 0.02, P = 0.03, respectively). No other independent covariates correlated with drug levels at any time point examined.
Conclusions: Week 6 early vedolizumab trough level measurements in IBD patients predicted short-term week 14 clinical remission. At week 6, vedolizumab trough levels > 8.00 µg/ml may represent a potential drug concentration target to achieve short-term clinical remission.
Keywords: Therapeutic drug monitoring; Ulcerative colitis; Vedolizumab; Pharmacokinetics; Crohn’s disease |
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Supervisor |
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Prof. Sameer Alharthi |
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Thesis Type |
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Master Thesis |
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Publishing Year |
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1445 AH
2023 AD |
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Co-Supervisor |
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Dr. Mahmoud Mosli |
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Added Date |
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Wednesday, October 25, 2023 |
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Researchers
| دعاء عمر سري | Anbarserry, Doaa Omar | Researcher | Doctorate | |
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