In severe cases of rheumatic diseases, chronic inflammatory bowel diseases, multiple sclerosis and psoriasis, biotechnologically produced monoclonal antibodies are often used as therapeutic agents when patients do not respond adequately to basic therapeutics or these are contraindicated. The biologics act as selective inhibitors of pathogenetically relevant target structures.
Biologics have the potential to influence the natural course of these progressive diseases. Treatment with increasing doses helps to alleviate the clinical symptoms. However, once the optimal range of concentration has been reached, increasing the dose further will not significantly improve symptoms and may even cause side effects. To determine the optimal range, the drug dose must be adjusted individually.
Therapeutic drug monitoring (TDM) is the monitoring of drug levels in the blood for the determination of an individual's optimal dose. This helps to avoid underdosing with insufficient effect and overdosing with severe side effects, and to set the target value accurately. TDM is therefore seen as a pillar of personalised medicine to improve the management of chronic inflammatory diseases.
Continuous therapy monitoring of drug levels allows individual adjustment of the drug dose or injection interval, ensuring individualised, targeted and cost-efficient patient management.
Proactive TDM is the regular monitoring of drug levels in patients who are responding well to treatment (responders). In this way, it is possible to identify at an early stage what are known as supratherapeutic drug levels, where the symptoms cannot be improved further by taking more medication.
Reactive TDM is the monitoring of drug levels in patients who do not respond to therapy (non-responders) to find out why. Both TDM strategies have been shown to be effective in reducing the costs of patient treatment and management.
A drastic decrease in the drug level is an indication that the patient is producing anti-drug antibodies (ADA). These endogenous antibodies complex the drug, leading to early elimination from the body and/or inhibition of the mechanism of action. In particular, high levels of ADA can lead to a loss of the drug's medical effect and the need for a change of drug or agent.
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