NEW YORK (Reuters Health) – Studies to date have failed to demonstrate a clinical benefit of routine proactive therapeutic drug monitoring (TDM) in patients with inflammatory bowel disease (IBD) treated with tumor necrosis factor-alpha (TNFa) antagonists, researchers report in Gastroenterology.
Proactive TDM has been proposed to improve outcomes in patients with IBD treated with these agents, Dr. Siddharth Singh, director of the IBD Center, University of California, San Diego, and colleagues note in their paper.
To investigate further, they did a systematic review and meta-analysis of nine randomized controlled trials that compared proactive TDM with conventional management in a total of 1,405 patients with IBD treated with TNFa antagonists.
In the pooled analysis, there was no significant difference in the risk of failing to maintain clinical remission in patients who underwent proactive TDM versus conventional management (38% vs 42%; relative risk 0.96).
“These results were stable across subgroup analyses in patients with Crohn’s disease and ulcerative colitis and in patients treated with infliximab or adalimumab, and on meta-regression based on key patient, disease and treatment characteristics,” the investigators report.
“When specifically comparing against reactive TDM (dose adjustment in response to presence of active disease), no benefit was observed with proactive TDM. However, routine proactive TDM was associated with significantly higher rates of therapy escalation, without any differences in rates of development of anti-drug antibodies or success in achieving target trough concentrations, compared with conventional management,” they further report.
The authors acknowledge that most of the trials were performed during the maintenance phase. In only one trial was proactive TDM performed during induction therapy; no significant benefit was observed over conventional management.
“Overall, our findings suggest a lack of benefit for routine proactive TDM in patients with IBD treated with TNFa antagonists,” the study team writes.
“We cannot exclude the possibility of benefit in disease subtypes not represented in these RCT populations. Future trials focusing on potential benefit of TDM during induction therapy, or in a subset of patients with active disease and unfavorable pharmacokinetics who may be at high risk of immunogenicity, are warranted,” they conclude.
The study had no commercial funding.
SOURCE: Gastroenterology, online June 23, 2022.
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