Cost-effectiveness of TPMT Pharmacogenetics

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether thiopurine S-methyltransferase (TPMT) genotyping prior to thiopurine use is cost-effective in patients with inflammatory bowel disease (IBD) in need of immune suppression.

The study is designed to test the hypothesis that optimization of initial thiopurine dose based on pre-treatment TPMT genotyping will maximize treatment efficacy and minimize adverse drug reactions (ADRs) resulting in reduced costs.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ZonMw: The Netherlands Organisation for Health Research and Development
• Collaborator: Radboud University
• Treatments: 6-Mercaptopurine; Azathioprine; Mercaptopurine

Criteria

Inclusion Criteria:

• Age 18 or older

• Diagnosis of a form of IBD

• Indication for azathioprine/6-MP treatment

• Patient giving (written) informed consent

Exclusion Criteria:

• Previous treatment with azathioprine/6-MP

• Co-prescription of allopurinol (this treatment blocks xanthine oxidase, an enzyme important for thiopurine metabolism)

• Baseline leukocyte count less then 3x10^9 per litre

• Reduced liver function at baseline

• Reduced renal function at baseline

• Known TPMT phenotype (enzyme activity / Therapeutic Drug Monitoring) or genotype

• Pregnancy or breastfeeding