A prospective randomised controlled trial of a pharmacogenetic test in the NHS
Medicines can produce benefits for patients but also have the potential to cause harmful effects (adverse reactions). Some patients may develop adverse reactions to a medicine that are caused by genetic variation. Pharmacogenetics research investigates the gene variant behind the reactions to medicines. Pharmacogenetic testing can be potentially useful as it provides genetic information to guide the safe and effective prescription of medicines.
Nowgen is running the first randomised controlled trial of a pharmacogenetic test in the NHS. TARGET aims to establish the clinical benefit of using a genetic test as a predictor of serious adverse reactions to the commonly presecribed drug, azathioprine.
TPMT: Azathioprine Response to Genotyping and Enzyme Testing (TARGET)
Azathioprine is a medicine used in the treatment of inflammatory conditions such as rheumatoid arthritis. In a small number of cases, it gives rise to a severe, sometimes fatal, adverse reaction that affects the body’s ability to produce cells to fight infections (called neutroapaenia). Nowgen is running the first randomised controlled trial of a pharmacogenetic test in the NHS to establish the clinical benefit of the test as a predictor of this serious adverse reaction and evaluate the tests role in reducing the likelihood of such an adverse reaction occurring. Our involvement in this project is to assess the value for money of thiopurine methyltransferase (TPMT) genotyping in reducing the number of adverse drug reactions associated with prescribing azathioprine.
The first patient was recruited to the study in October 2005 and we aim to recruit 500 patients to the study by the end of 2007. The results will be available autumn 2008.
Lead Investigator
Bill Ollier
Co-investigators
Bill Newman, Katherine Payne, Kay Poulton, Julie Andrews, Rachel Elliott, David Ray, Rob Elles, Brian Houston, Ian Bruce, Jon Schaffer, Chris Griffiths, Steve Roberts
TARGET staff:
Karen Tricker, Emily Fargher, Jane Alder, Sudeep Parameshwar, Debbie Payne
Department of Health
Fargher EA, Tricker K, Newman B, Elliott RA, Roberts S, Shaffer J, Bruce I & Payne K. Current use of pharmacogenetic testing: a national survey of thiopurine methyltransferase (TPMT) testing prior to azathioprine prescription.
Journal of Clinical Pharmacy & Therapeutics 2007; 32: 187-195
Fargher EA, Eddy C, Newman W, Qasim F, Tricker K, Elliott RA, Payne K.Patients’ and healthcare professionals’ views on pharmacogenetic testing and its future delivery in the NHS. Pharmacogenomics. 2007 8(11):1511-1519.