TDM in chronic inflammatory diseases

Clinical information

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 conventional 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 may help to alleviate the clinical symptoms. However, once the optimal concentration range has been reached, increasing the dose further will not significantly improve symptoms and may lead to secondary loss of response or unwanted side effects. To ensure appropriate levels in the body, the drug dose must be adjusted taking into account how the biologic is metabolised in the patient. Monitoring of the patient’s response to these biologics is key to managing treatments thus ensuring maximum efficacy and reduce risk for loss of response.

Therapeutic drug monitoring (TDM) is the monitoring of drug levels and presence of anti-drug antibodies (ADA) 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 ensures that the level of the biologic in the individual is within the defined therapeutic range prior to subsequent biotherapy administrations. For these reasons, TDM is seen as a pillar of personalised medicine to improve the management of chronic inflammatory diseases.

Therapy monitoring

Continuous therapy monitoring of drug and ADA levels allows individual adjustment of the drug dose or administration interval, ensuring individualised, targeted and cost-efficient patient management.  

Proactive TDM is the regular monitoring of drug and ADA levels in patients during the induction phase to understand how the biologic is being metabolised in the patient’s body in order to optimise the dose and timing of biotherapy administration. This testing should continue 2 to 3 times per year during the maintenance phase. This allows dose adjustments to the biologic to ensure treatment efficacy and clinical remission, thereby preventing recurrence of symptoms.

Reactive TDM is the monitoring of drug levels in patients in the maintenance phase and is used following a loss of response in order to adjust the treatment and restore clinical response.

Both TDM strategies have been shown to be effective in supporting patient management and reducing treatment costs. 

A drastic decrease in the drug level is an indication that the patient is producing 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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Therapeutic drug monitoring in inflammatory bowel diseases

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