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Effect of therapeutic drug monitoring vs standard therapy during infliximab induction on disease remission in patients with chronic immune-mediated inflammatory diseases: A randomized clinical trial

JAMA May 12, 2021

Syversen SW, Goll GL, Jorgensen KK, et al. - This study sought to evaluate if therapeutic drug monitoring (TDM) during initiation of infliximab therapy improves treatment efficacy compared with standard infliximab therapy without TDM. Researchers designed a randomized, parallel-group, open-label clinical trial including a total of 411 adults with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn disease, or psoriasis initiating infliximab therapy in 21 hospitals in Norway. Individuals were enrolled from March 1, 2017, to January 10, 2019. Individuals were assigned randomly in a 1:1 ratio to receive proactive TDM with dose and interval adjustments based on scheduled monitoring of serum drug levels and antidrug antibodies (TDM group; n = 207) or standard infliximab therapy without drug and antibody level monitoring (standard therapy group; n = 204). Researchers enrolled 398 patients (198 in the TDM group and 200 in the standard therapy group) who received their randomized intervention among 411 randomized patients (mean age, 44.7 [SD, 14.9] years; 209 women [51%]). Proactive therapeutic drug monitoring, compared with standard therapy, did not significantly improve clinical remission rates over 30 weeks among patients with immune-mediated inflammatory diseases initiating treatment with infliximab. The data do not support the routine use of therapeutic drug monitoring during infliximab induction for improving disease remission rates.

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