ACR 2020 | Daily Highlights

Therapeutic drug monitoring under infliximab

THERAPEUTIC DRUG MONITORING COMPARED TO STANDARD TREATMENT OF PATIENTS STARTING INFLIXIMAB: RESULTS FROM A MULTICENTER RANDOMIZED CONTROLLED TRIAL OF 400 PATIENTS

Abstract: 2029
Authors: Silje Syversen et al.

» zum Abstract

Key content:
Insufficient response to TNF inhibitor therapy has been associated with low serum drug levels and the occurrence of anti-drug-antibodies (ADA). Optimization of therapy by therapeutic drug monitoring (TDM) has been proposed but the efficacy has not been established in clinical trials. The norwegian NOR-DRUM trial has analyzed in patients with various rheumatic diseases treated with infliximab whether TDM with dose adaption according to the drug levels measured in serum resulted in a better outcome as compared to standard treatment. 411 patients with various rheumatic diseases, including RA, PsA and axSpA were randomized to TDM or standard treatment. The primary endpoint, remission at wk 30 was reached in 53% in the TDM group and 54% in the conventional treatment group. 10% in the TDM group and 15% in the control group developed significant levels of ADA. Infusion reactions were less frequent in the TDM group (2.5%) vs the controls (8%).

Relevance:
This study shows that regular measurements of drug levels and increasing or decreasing the dose of a TNF inhibitor do not result in higher remission rates in various rheumatic diseases. Thus, there is no evidence for using TDM as a general strategy.

Zusammenfassung und Kommentar von:
Prof. Dr. Diego Kyburz
Basel