Wouda, E.H.D. (2019) Association between Adalimumab Drug Levels and Side Effects, Trough Levels, Disease Activity and Inflammatory Biomarkers in Patients with known Inflammatory Bowel Disease. thesis, Medicine.
Full text available on request.Abstract
Introduction: Therapeutic drug monitoring (TDM) of anti-tumour necrosis factor (TNF) monoclonal antibodies is important in clinical practice. Adequate Adalimumab (ADA) drug concentrations are known to be associated with improved disease control, but data are few in the real world on their association with therapy-related adverse events and IBD disease behaviour. We aimed to determine whether ADA concentrations are associated with the prevalence of therapy-related adverse events and clinical remission. The second aim of this study was to define whether TDM for ADA should be performed at trough. Methods: A cross-sectional study was undertaken on IBD patients receiving maintenance ADA therapy at a single academic center. Serum samples were drawn during routine blood work collection. Baseline demographic data, faecal calprotectin values and information on therapy-related adverse events were collected. ADA levels were assayed using a commercial assay (Immundiagnostik). An elevated FC was defined as a FC concentration >250 mcg/g. Association between ADA levels, FC concentration, treatment-related adverse events and the time between injection and sampling was evaluated. P values <0.05 were considered significant in analyses. Results: N=34 IBD patients were included. Median [range] ADA level was numerically higher in subjects with a normal versus elevated FC: 14.9 AU/ml [4–37.9] vs. 10.2 AU/ml [0.69–24.3] p=0.16. There was no association between ADA levels and therapy-related adverse effects adverse events (p=0.86) and no significant correlation between drug levels and duration of time from last dose administration (p=0.28). Conclusion: ADA drug levels remain relatively stable at different points between ADA injections. Higher ADA drug levels are associated with a numerically increased likelihood of mucosal healing assessed by faecal calprotectin. Increased ADA drug levels do not appear to be associated with more frequent therapy-related adverse events.
| Item Type: | Thesis (UNSPECIFIED) |
|---|---|
| Supervisor name: | Boxtel, Dr. O. van |
| Supervisor name: | Kevans, Dr. D. |
| Faculty: | Medical Sciences |
| Date Deposited: | 16 Oct 2020 07:34 |
| Last Modified: | 16 Oct 2020 07:34 |
| URI: | https://umcg.studenttheses.ub.rug.nl/id/eprint/2781 |
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