Pharmacovigilance thérapeutique des agents biologiques dans un contexte de maladie intestinale inflammatoire
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Mots-clés :
pharmacovigilance thérapeutique, agents biologiques, maladies inflammatoires de l'intestinRésumé
Les agents biologiques ont révolutionné la prise en charge des patients atteints de maladies intestinales inflammatoires (MII), qu'il s'agisse de la colite ulcéreuse (CU) ou de la maladie de Crohn (MC). Il existe plusieurs classes d'agents biologiques utilisés pour traiter les MII, notamment les anticorps monoclonaux dirigés contre le TNF, l'intégrine, l'IL12/23 et l'IL-23. Malgré l'efficacité des anti-TNF, environ 30 % des patients sont des non-répondeurs prrimaires (NRP) et 50 % perdent la réponse au fil du temps (perte de réponse secondaire [PRS]). La pharmacovigilance thérapeutique est un outil permettant d’optimiser la posologie des médicaments biologiques en mesurant les concentrations minimales de médicaments et les anticorps anti-médicaments (AAM). Les concentrations de médicaments sont positivement corrélées aux bienfaits thérapeutiques, mais des questions subsistent quant à savoir comment, quand et pour qui effectuer une pharmacovigilance thérapeutique. La mise en œuvre est entravée par plusieurs facteurs tels que les variations des cibles optimales des médicaments, les différents types de tests de détection des médicaments, la pharmacocinétique individuelle et la gravité de la maladie. Au cours des dernières années, divers groupes d’experts ont fourni des lignes directrices sur la pharmacovigilance thérapeutique réactive pour les traitements anti-TNF; cependant, les connaissances sur le rôle de la pharmacovigilance thérapeutique proactive, ainsi que de la pharmacovigilance thérapeutique réactive pour les produits biologiques non anti-TNF, sont encore lacunaires. La déclaration de consensus d’experts la plus récente et la plus complète, publiée dans l’American Journal of Gastroenterology (AJG), a tenté de combler cette lacune en préconisant l’utilisation de la pharmacovigilance thérapeutique réactive pour les médicaments anti-TNF, ainsi que de la pharmacovigilance thérapeutique proactive dans certains scénarios.
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