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 rheumatic patients
OBJECTIVE and DESIGN
Adalimumab (ADA) is effective in the treatment of rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Despite suggestions that therapeutic drug monitoring (TDM) of ADA can optimize treatment of this population, it is not routinely implemented in clinical practice. We therefore carried out a prospective observational cohort study by measuring ADA levels in a population of patients with rheumatic diseases and related those levels to disease activity.
METHODS
Patient demographics were collected from the electronic hospital information system. Blood drawn before the regular outpatient visit was used for determination of ADA trough levels and antibodies against ADA (ATA). Objectified disease activity measurements were obtained at the appointment: DAS28 for RA, ASDAS for AS, and clinical assessment for SpA.
RESULTS
A total of 174 patients was included. ADA levels varied from less than 0.1 to 22.0 mg/L. The mean ADA level was 6.8 mg/L (standard deviation = 4.2). 5 patients (2,9%) developed ATA. The ADA level was significantly associated with remission (P = 0.002). The mean ADA level was 7.6 mg/L in patients in remission and 5.1 mg/L in patients with active disease. Use of immunosuppressants, frequency of administration, and body mass index were identified as significant covariates.
CONCLUSION
TDM of ADA demonstrated large interindividual differences in ADA levels. ADA trough levels were significantly associated with disease activity. TDM has the potential to individualize treatment and further research needs to show if it increases cost-effectiveness of this expensive therapy.
A practical guide for probiotics applied to the case of antibiotic-associated diarrhea in The Netherlands
BACKGROUND
Antibiotic-associated diarrhea (AAD) is a side-effect frequently associated with the use of broad spectrum antibiotics. Although a number of clinical studies show that co-administration of specific probiotics reduces the risk for AAD, there is still unclarity among healthcare professionals on the recommendation of probiotic products.
OBJECTIVE
This paper aims to provide a practical guide to inform healthcare professionals, patients and consumers about the exact product characteristics of available probiotics with a proven efficacy to prevent AAD.
DESIGN and METHODS
The workflow in this paper includes three consecutive steps: a systematic review of relevant clinical studies for effective probiotics by a meta-analysis, compilation of a list of available probiotic products, and recommendation of probiotic products that match effective formulations. Our systematic review on the efficacy of probiotics for the prevention of AAD included only studies with randomized, double blind placebo-controlled trials, a clear definition of antibiotic associated diarrhea, and a probiotic administration regime for at least the duration of the antibiotic therapy.
RESULTS
Using our inclusion criteria, we selected 32 out of 128 identified trials and pooled the results of these studies for each specific dairy product and food supplement. The results indicate a total of seven single or multiple-strain formulations favoring the probiotic treatment group, with the strain Lactobacillus rhamnosus GG being the most effective (relative risk ratio of probiotic versus placebo 0.30 with 95% CI 0.16 - 0.5). We selected products for recommendation from a compiled list of all probiotic dairy products and food supplements available in The Netherlands and categorized them into groups of products showing effects against the incidence of AAD in at least one, two, or three independent clinical studies. We excluded all products which did not unambiguously declare on the label the specific probiotic strain(s) and the number of colony forming units.
CONCLUSION
Here, we present a practical guide that informs healthcare professionals and patients on the availability of probiotic products with a proven efficacy for the prevention of AAD.