Une Approche Structurée du Suivi Thérapeutique Pharmacologique. Illustrée par l’optimisation thérapeutique des inhibiteurs du facteur de nécrose tumorale alpha

Details

Supervisors

LAURE Elens

Faculty

Faculté de pharmacie et des sciences biomédicales

Degree label

Master [120] en sciences pharmaceutiques, à finalité spécialisée

Abstract

Therapeutic Drug Monitoring (TDM) of anti-TNF-α agents in the treatment of Inflammatory Bowel Diseases (IBD) holds promising prospects for personalized and effective therapy. This thesis explores insights derived from a concrete example of TDM, emphasizing the need to construct structured programs based on accumulated pharmacometric knowledge. Indeed, in this study, we systematically delved into eight crucial questions to develop a structured TDM program. To commence, meticulous identification of TDM candidates relies on a thorough evaluation of pharmacokinetic and pharmacodynamic properties, coupled with robust clinical data. The second essential step, analytical validation, ensures measurement reliability by establishing robust analytical methods. Defining the appropriate dosage based on individual characteristics constitutes the third aspect, with special attention given to establishing therapeutic concentration ranges. This customization continues with the fourth question, aiming to set a target exposure for precise dose adjustments. Therapeutic interventions, the fifth element, rely on flexible strategies such as dose adjustments, the addition of immunomodulators, or even changing classes according to individual needs. To guide clinical decisions, it is essential to predefine the type of TDM program to implement (proactive and/or reactive). Assessing TDM effectiveness, the seventh question, is conducted through comparative studies, highlighting tangible benefits and challenges to overcome. Economic considerations of TDM, the eighth aspect, are scrutinized through cost-effectiveness analyses, underscoring the importance of ongoing evaluation to ensure economic viability. The results underscore the significance of reactive TDM to address non-response and proactive TDM to maintain optimal therapeutic concentration and monitor anti-drug antibody development. In conclusion, this structured approach to TDM provides compelling answers to personalize therapy, optimize clinical outcomes, and paves the way for personalized medicine focused on results, necessitating continuous collaboration to overcome current challenges.