Proactive TDM vs. conventional IBD management

July 12, 2022

Issue 13

Clinical Question

Does therapeutic drug monitoring for anti-TNF recipients improve outcomes?

Editor’s Bottom Line

Proactive therapeutic drug monitoring does not appear to offer an advantage over clinically-based adjustment of anti-TNF monoclonal antibody doses.

Reference

Nguyen NH, Solitano V, Vuyyuru SK, et al. Proactive Therapeutic Drug Monitoring vs. Conventional Management for Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis. Gastroenterol. Epub ahead of print June 23, 2022; https://www.gastrojournal.org/article/S0016-5085(22)00670-9/pdf?referrer=https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov%2F)

Synopsis

This systematic review and meta-analysis of nine randomized controlled trials (RCTs) included data from 709 patients with IBD randomized to undergo anti-tumor necrosis factor (TNF) treatment with their therapy guided by routine assessments of anti-TNF trough concentrations and regardless of disease activity. Outcomes in this proactive therapeutic drug monitoring (TDM) group were compared to those of 696 IBD patients randomized to have anti-TNF treatment guided by clinical observation and outcomes alone. Patients in the analysis were not required to be in clinical remission at the time of randomization to proactive TDM or conventional management.

A median of one year after randomization, patients in the proactive TDM arm were 56% more likely to undergo anti-TNF dose escalation, compared to those whose treatment was clinically guided (Risk Ratio [RR]:1.56; 95% Confidence Interval [CI], 1.25–1.94). Analysis also showed that 38% of those who underwent proactive TDM maintained clinical remission after a median of one year of follow-up, compared to 42% of those whose treatment was guided conventionally (RR: 0.96; 95% CI, 0.81–1.13).

Outcomes did not differ among IBD subtype and controlling for the effects of disease duration, use of concomitant immunomodulators, baseline disease activity and therapy optimization before randomization did not affect the association between TDM and IBD outcomes.

TDM also did not affect the likelihood of developing anti-drug antibodies, experiencing serious adverse events or discontinuing treatment, and it did not significantly impact the likelihood of achieving target anti-TNF trough concentrations (54.4% for TDM vs. 41.8% with conventional management; RR: 1.26; 95% CI, 0.95–1.66).

Details

Study Design: Systematic review and meta-analysis

Funding: No direct funding

Allocation: Not applicable

Setting: Multicenter

Level of Evidence: 1a