I NH Bekhti¹, R Bouguesri¹, A Memou¹, Manouni², K Reguig³ and H Toumi¹*

¹Pharmacovigilance Service, EHU Oran, Algeria
²Hepatogastro-Enterology service, EHU Oran, Algeria
³Epidemiology service, EHU Oran, Algeria

*Corresponding Author: H Toumi, Pharmacovigilance Service, EHU Oran, Algeria.

Received: January 25, 2018; Published: March 12, 2018

Citation: H Toumi., et al. “The Interest of Therapeutic Drug Monitoring of Infliximab”. Acta Scientific Pharmaceutical Sciences 2.4 (2018).

Abstract

  The pharmaceutical industry develops an increasingly sophisticated biomedicines, which by their conception targets some specific pathological mechanisms, and have improved the management of various inflammatory diseases, for example chimeric antiTNFα monoclonal antibodies such as Infliximab (IFX). However, the frequent occurrence of primary or secondary treatment failure, the high immunogenicity of this molecule, the problems of pharmacokinetic and pharmacodynamic variability as well as the strict conditions of interchangeability of its biosimilars make their use delicate. It is therefore recommended to determine for each patient the level of response to this treatment and to guide a therapeutic decision. So, we’re talking about the Therapeutic Drug Monitoring (TDM).

  The main objective of this work is to justify the interest of the TDM, to evaluate the effectiveness of the IFX, to analyze the predictive factors of treatment failure, to evaluate the tolerance by the detection of side effects and to estimate the cost of optimization strategies. For this purpose, a retrospective mono-centric prospective retrieval analysis was performed on the cohort of patients with IBD followed between 2012 and 2017 in the Hepato-gastroenterology department of the EHU Oran.

  The cohort selected eight patients. Our correlation study of biological and clinical data, showed abnormally low values in remission or abnormally high thrust, suggesting that biological parameters are not strongly correlated with the effectiveness of IFX. In parallel, the study of the sensitivity confirmed these results. In our analysis, treatment failure occurred in 62.5% of cases after 3 to 16 months of treatment. Optimization was required in 37.5% of patients in our cohort. To avoid a failure, it was recommended to optimize 1 patient out of 3 under IFX. When applying this data to the additional cost of optimization strategies, the additional cost of the annual IFX treatment then ranges between 878970 and 5273820 Da per year. Thus, although these optimization strategies are identical to those of the literature, it is interesting to note that these strategies are taken at random and are the opposite of evidence- based medicine.

  Our primary results justify the interest of the IFX’s TDM to improve the management of patients on IFX. Further, prospective and randomized studies will be needed to demonstrate that the integration of this pharmacological parameter into the therapeutic strategy can modify the prognosis in the medium and long term of patients with IBD.

Keywords: Biomedicines; Infliximab; Failure; Optimisation; Therapeutic drug monitoring; Cost

Copyright: © 2018 H Toumi., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.