Understanding Pharmacokinetic Sampling when Personalising Drug Treatments: implications for analysis
Speakers and details of their talks are as follows:
Dr Nina Wilkinson (University of Newcastle) on behalf of BADBIR and BSTOP study groups, and the PSORT consortium
Personalising adalimumab treatment of patients with psoriasis: a UK, multi-centre, longitudinal observational cohort study
Psoriasis is a common, chronic condition which affects the quality of life of more than one million people in the UK. Biological therapy has revolutionised the management of moderate to severe psoriasis, but not all patients respond and some lose response over time. Drug levels, which are strongly influenced by anti-drug antibodies (ADA), consistently correlate with treatment outcomes across multiple inflammatory diseases with limited data in psoriasis. The aim of this study was therefore to investigate the clinical utility of therapeutic drug monitoring to optimise outcomes in psoriasis, using the exemplar TNF antagonist, adalimumab.
Adults enrolled onto the British Association of Dermatologists Biologic Interventions Register (BADBIR) were recruited into this UK, multi-centre observational cohort study (Biomarkers of Systemic Treatment Outcomes in Psoriasis; BSTOP 2011 onwards, n=60 participating centres). Serial samples were taken during adalimumab therapy and analysed for adalimumab level and ADAs.
Data from this cohort were used to determine: (i) the therapeutic range and; (ii) whether drug levels predict response at 6 months using both descriptive techniques and multivariable mixed effect regression models.
PSORT is MRC funded and has industry partners who have contributed funding for this work.
Dr Joe Standing (UCL)
Pharmacometrics: Statistical Pharmacology
In this talk I will introduce nonlinear mixed effects (multi-level) modelling and how it is applied to pharmacokinetics and pharmacodynamics in drug development and beyond. Worked examples will then be used to show how such approaches can reveal pitfalls of ignoring biological prior information on the system generating the data of interest, and also how the approach can be used to optimise clinical trial design and in personalised medicine.
Please note you do not need to be an RSS member to attend, all are welcome. The event is free to attend and there is no need to register.
Tea/coffee from 2.30pm
Organiser Name Isabelle Smith
Organising Group(s) RSS Leeds/Bradford Local Group