Therapeutic drug monitoring (TDM) refers to the principle of using concentrations of biopharmaceuticals in the blood to make therapeutic decisions. EULAR – the European Alliance of Rheumatological Associations – has developed a set of new “points to consider” to support TDM in people with inflammatory rheumatic and musculoskeletal disorders (RMD). This publication appears in the May 2022 issue Annals of rheumatic diseases. The new points are evidence-based and consensus-based statements regarding the clinical utility of TDM in RMD. Generally, active use of TDM is not recommended, but reactive TDM may be considered in certain clinical situations.
In rheumatology, interest in TDM is increasing. This is supported by the growing body of evidence that TDM may be useful in several clinical situations, such as loss of response to therapy, interpretation of side effects, and for determining dose adjustment. However, there are gaps in knowledge about the potential uses of TDM, and many rheumatologists are unaware of the pharmacokinetic properties of the biopharmaceuticals they prescribe.
Although the label of biopharmaceuticals usually has a dosing recommendation, studies have shown that individual patients ’drug levels differ. This finding suggests potential benefits for dose optimization. However, the new points emphasize that, despite the association with the clinical response, the use of blood concentrations to indicate dosage is not recommended due to the lack of a defined optimal range for most biopharmaceuticals for most indications.
New EULAR recommendations have been developed by an interdisciplinary task force of eight European countries with health professionals from Rheumatology, Bioanalytical Science, Health Economics and Clinical Pharmacy. There was also a partner from the EULAR EMEUNET program and three patient representatives. The work was completed in accordance with EULAR standard operating procedures. All the information included in the final work was based on a systematic review of the literature and a consensus of experts.
In total, six main principles and 13 points were formulated. The principles define two broad categories of TDM: proactive (routine testing regardless of clinical situation) and reactive (testing in response to specific scenarios). The principles also reinforce the basic pharmacokinetic and pharmacodynamic principles that apply to all classes of biopharmaceuticals. The important point is that TDM should be part of a collaborative decision-making process between the patient and healthcare professionals, taking into account the individual experience and preferences of the patient.
“Need to Consider” emphasizes the clinical usefulness of measuring and interpreting the concentration of biopharmaceuticals in the blood as well as antibodies against drugs in specific clinical scenarios. They emphasize that measurements should be performed in a tested laboratory, preferably using sequential analysis over a long period of time when measuring antibodies to drugs.
This new publication highlights the potential clinical usefulness of measuring and interpreting the concentration of biopharmaceuticals in the blood and antibodies to drugs, but puts this next to factors that affect these parameters, such as dose, interval of administration, body weightco-treatment with methotrexate, disease activity and adherence to treatment.
As the area develops rapidly, more data is expected to become available, which may prompt to update these points, which will need to be considered in the coming years. Future research should focus on providing evidence of the efficacy and safety of TDM, as well as on a robust economic assessment of its usefulness in patients with various RMDs.
Charlotte LM Krieckaert et al, EULAR points out that it is necessary to consider therapeutic monitoring of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases, Annals of rheumatic diseases 2022 DOI: 10.1136 / annrheumdis-2022-222155
Provided by the European Alliance of Rheumatological Associations
Citation: New items for therapeutic drug monitoring in people with rheumatic diseases (2022, May 18) obtained May 18, 2022 from https://medicalxpress.com/news/2022-05-therapeutic-drug-people-rheumatic-disease .html
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