Het Nederlands Platform voor Farmaceutisch Onderzoek (NPFO) presenteert onderzoek in de farmaceutische wetenschappen. De nadruk ligt op klinische toepassing zoals medicatieveiligheid, patiëntenzorg, formulering, analyse, farmacologie en casuïstiek.
Therapeutic drug monitoring of adalimumab in inflammatory bowel disease patients
OBJECTIVE
Adalimumab (ADA) trough levels correlate with clinical remission. Despite suggestions that therapeutic drug monitoring of ADA can optimize treatment in this population, it is not yet implemented in clinical practice. This study was conducted to provide more insight in ADA trough levels and antibodies to adalimumab (ATA) in an inflammatory bowel disease (IBD) population already treated with adalimumab.
DESIGN
We carried out a prospective cohort study in IBD outpatients already treated with adalimumab.
METHODS
Patient demographics were collected from the electronic hospital information system. Blood was drawn for determination of ADA trough levels and ATAs. Disease activity indices for Crohn’s disease and ulcerative colitis and quality of life scores were obtained by a questionnaire.
RESULTS
A total of 92 patients was included. ADA levels varied from < 0.1 to 20.2 mg/L. Mean ADA level was 7.7 mg/L (SD = 4.5), 4 patients developed ATAs. ADA levels ≤ 5 mg/L were demonstrated in 27 patients (29%). The ADA level was not significantly associated with remission (P = 0.391). Quality of life score correlated with ADA level (P = 0.031).
CONCLUSION
Therapeutic drug monitoring in inflammatory bowel disease outpatients revealed large interindividual differences in adalimumab trough levels. These levels were subtherapeutic in nearly a third of patients. We think, despite no significant correlation was found between adalimumab trough level and disease activity, therapeutic drug monitoring has the potential to individualize treatment in inflammatory bowel disease patients using adalimumab.
No evidence for an association between renal function and serious bleeding events in patients treated with coumarins
BACKGROUND
Although anticoagulation therapy is closely monitored in the Netherlands, coumarin-induced serious bleeding events are still observed. Current literature suggests that renal impairment may contribute to this.
OBJECTIVE
To explore the association between renal function and bleeding events during coumarin treatment.
DESIGN
A nested case-control study was conducted using data from the PHARMO Database Network.
METHODS
Patients hospitalised for a bleeding event during coumarin treatment were selected as cases and matched on sex, birth year, and geographic region with a maximum of two controls using coumarins without hospitalisation for bleeding. All values of estimated glomerular filtration rates (eGFRs) in the year before index date (case hospitalisation date) were selected and compared between cases and controls using logistic regression analyses.
RESULTS
In total, 2224 cases were matched to 4398 controls (61% male; mean age ± SD = 75 ± 11 and 78 ± 11 years for cases and controls, respectively). Availability of eGFR values was higher among cases compared with controls (mean eGFR values ± SD = 4.5 ± 7.1 versus 3.2 ± 5.5), reflected in the significantly shorter time since last eGFR value (at index date, mean ± SD = 2.7 ± 3.0 versus 3.8 ± 3.1 months; odds ratio [OR] = 0.91, 95%CI = 0.89-0.92). No statistically significant difference was found for the mean eGFR value in the year before index date (mean ± SD 65.7 ± 22.8 versus 64.6 ± 20.9 mL/min/1.73 m; OR per 10 units = 0.99, 95%CI = 0.96-1.02).
CONCLUSION
No association between renal function and serious bleeding events during coumarin treatment was observed.