Therapeutic drug monitoring (TDM) aims to prevent treatment failures, following an initial response to treatment. There are two major types of TDM. Reactive TDM measures serum drug levels and the presence of anti-drug antibodies (ADAs) in response to evidence of disease, while proactive TDM regularly assesses these parameters in order to better optimize drug concentrations.

The latest study from the NORDRUM trial assessed the efficacy of proactive TDM in patients with inflammatory disease receiving maintenance infliximab treatment. Infliximab is a monoclonal antibody treatment that targets the inflammatory molecule tumour necrosis factor-alpha (TNF-α).

The randomized, parallel-group, open-label clinical trial involved 458 adults with a range of inflammatory conditions including rheumatoid arthritis, inflammatory bowel disease (IBD), and psoriasis.

Patients were randomized to receive proactive TDM, with regular monitoring of serum drug levels and ADAs and consequent dose and interval adjustments, or standard infliximab treatment without drug or ADA level monitoring. The study lasted for one year.

The study found that sustained disease control without disease worsening was achieved in 74% of patients in the TDM group, compared to 56% in the standard treatment group. Rates for discontinuing infliximab and adverse events were similar in both groups.

The authors conclude that, in patients with immune-mediated inflammatory diseases undergoing maintenance therapy with infliximab, proactive TDM is more effective in improving disease control.

However, they say more research is needed to compare proactive TDM to reactive TDM, to look at the effects on long-term complications, and to assess the cost-effectiveness of proactive TDM.

Co-author Dr Nils Bolstad, Senior Consultant and attending physician at Oslo University Hospital, said: ‘We recommend proactive TDM at least for infliximab in maintenance phase. We’re not sure if it’s a beneficial approach for other drugs. It should be tested in proper trials before making it standard of care’.

Proactive TDM is already used in Norway for IBD and some rheumatological and dermatological conditions, however, only the Australian Inflammatory Bowel Diseases Consensus Working Group and the US gastroenterology research group BRIDGe officially recommend proactive TDM.

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Reference
1. Syversen SW, Jørgensen KK, Goll GL, et al. Effect of therapeutic drug monitoring vs standard therapy during maintenance infliximab therapy on disease control in patients with immune-mediated inflammatory diseases: a randomized clinical trial. JAMA. 2021;326(23):2375-84. doi:10.1001/jama.2021.21316

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