Pharmacological Action Clinical Trial
Official title:
Pharmacogenomic in Colombian Patients With Rheumatoid Arthritis
The pharmacogenomics of the Colombian population with rheumatoid arthritis (RA), understood
as the individual response to drugs depending on the genome of each patient, can be an
explanation for the problems of effectiveness and safety that appear during the
pharmacotherapeutic treatment of RA.
Currently, there are limited studies on the pharmacogenomics of the Colombian population;
Therefore, it is necessary to identify and classify the genetic polymorphisms characteristic
of Colombian patients with RA, which influence the response of methotrexate, infliximab,
etanercept, adalimumab and thus contribute to precision medicine and medical prescription
according to the Specificity of the genome of each patient.
This project aims to determine the association of genetic polymorphisms with the response to
inhibitors of tumor necrosis factor alpha (TNFα) and methotrexate. To do this, a prospective
study of cases and controls will be performed in patients in 3 hospital of Colombia with
pharmacotherapeutic treatment of methotrexate, infliximab, etanercept, adalimumab, in
monotherapy or combination therapy.
As a result, it is expected to contribute to the performance of specific genetic tests for RA
and the generation of a pharmacogenomic basis of the Colombian population with RA.
Rheumatoid arthritis is an important public health problem; In recent years better health
outcomes have been achieved with the incorporation of synthetic and biological disease
modifying drugs. However, problems of variability in response are reported, leading to
ineffectiveness and adverse reactions in 30-40% of patients. In this sense, Pharmacogenomics,
through the study of genetic variants of proteins involved in the pharmacokinetics and
pharmacodynamics of drugs, becomes a way to maximize the efficacy and safety of
pharmacotherapy.
This work aims to give an overview of the pharmacogenomics of rheumatoid arthritis and the
possibility of using genetic tools to support the pharmacotherapeutic decision in the
clinical consultation, in order to improve the response to treatment of this disease.
The relevance of this study is to provide the possibility of applying the candidate genes
selected for their biological importance, either in the kinetics or by their relation in the
pharmacological action, in the identification of individuals at risk of adverse effects or
With probability of being resistant to the treatment. Therefore, it is expected that the
information generated will be able to be used in daily clinical practice, contributing to
identify the best therapeutic option (greater effectiveness and safety) in patients with
rheumatoid arthritis. In addition, it is expected that this type of information will
contribute to optimize the costs of care in this disease, which is classified in Colombia as
a high cost pathology, in which medicines can reach up to 86% of the total cost.
Overall, individuals respond differently to drug therapy and no medication is 100% effective
in all patients, which may be due to an alteration in the pharmacokinetics and
pharmacodynamics of drugs associated with conditions Genetic-environmental. In this context,
the study of candidate pharmacogenomic genes has been most successful in identifying and
explaining variation in pharmacological response, compared to candidate gene investigations
of the disease. Therefore, this work should contribute to the choice of the best therapeutic
option in patients with RA in Colombia and, thus, to strengthen the country's health sector.
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