Ulcerative Colitis Resource Center

Ulcerative Colitis Resource Center

Perspective from Miguel Regueiro, MD
Disclosures: Syversen reports receiving personal fees from Thermo Fisher. Please see the study for all other authors’ relevant financial disclosures.
May 06, 2021
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TDM does not improve treatment efficacy during Remicade therapy for inflammatory diseases

Perspective from Miguel Regueiro, MD
Disclosures: Syversen reports receiving personal fees from Thermo Fisher. Please see the study for all other authors’ relevant financial disclosures.
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Proactive therapeutic drug monitoring vs. standard therapy did not significantly improve clinical remission rates over 30 weeks in patients with immune-mediated inflammatory diseases initiating Remicade therapy, according to study results.

“The findings do not support routine use of therapeutic drug monitoring during infliximab induction for improving disease remission rates,” Silje Watterdal Syversen, MD, PhD, from the division of rheumatology and research at Diakonhjemmet Hospital in Oslo, Norway, and colleagues wrote.

Syversen and colleagues conducted a randomized, parallel-group, open label clinical rial of 411 patients with ulcerative colitis, Crohn’s disease, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis or psoriasis, who were initiated on Remicade (infliximab, Janssen) therapy. Investigators recruited patients from 21 hospitals in Norway from May 1, 2017, to January 10, 2019, with final follow-up on November 5, 2019.

Researchers randomly assigned patients to proactive therapeutic drug monitoring (TDM) and interval adjustments based on scheduled monitoring of serum drug levels and antidrug antibodies (n = 207) or to standard infliximab therapy without drug or antibody monitoring (n = 204). Clinical remission at week 30 served as the primary endpoint.

“Among 411 randomized patients (mean age, 44.7 [SD, 14.9] years; 209 women [51%]), 398 (198 in the TDM group and 200 in the standard therapy group) received their randomized intervention and were included in the full analysis set,” Syversen and colleagues wrote.

Results showed 100 patients in the TDM group achieved clinical remission at 30 weeks and 106 patients in the standard therapy group (adjusted difference, 1.5%; 95% CI, –8.2% to 11.1%. Investigators observed adverse events in 135 patients in the TDM group and 139 patients in the standard therapy group.