Digestive Disease Week

Digestive Disease Week

May 19, 2019
3 min read

Therapeutic drug monitoring program improves clinical outcomes in pediatric IBD

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SAN DIEGO — Implementing a practice-wide therapeutic drug monitoring program may help improve several significant clinical outcomes in children with inflammatory bowel disease, according to study results presented at Digestive Disease Week.

In his presentation, John L. Lyles, MD, of the division of gastroenterology, hepatology and nutrition at Cincinnati Children’s Hospital Medical Center (CCHMC), said that therapeutic drug monitoring (TDM) has been beneficial for the treatment of patients with IBD, but evidence to support expanding and implementing a larger scale TDM program has been limited.

CCHMC instituted Remicade (infliximab, Janssen) and Humira (adalimumab, AbbVie) TDM guidelines in 2014 that included recommendations to monitor drug levels after induction and annually, while adjusting dose or frequency to achieve a drug level of more than 5 g/mL. Researchers compared outcomes in patients who started therapy before the TDM program was implemented (pre-TDM, 2011 to 2013; n = 108) and after (post-TDM, 2014 to 2017; n = 206) with a one-year washout period. They assessed sustained clinical remission (SCR), defined as physician global assessment of quiescent from 22 to 52 weeks and off corticosteroids at 52 weeks. Both groups had similar baseline characteristics, except for expected higher starting infliximab maintenance dose in the post-TDM group.

Lyles and colleagues found that 59% of patients in the post-TDM group achieved SCR compared with 42% in the pre-TDM group (risk difference 17.6%; 95% CI, 5.4-29%).

The TDM program also helped reduce incidence of high titer anti-drug antibodies and reduce anti-TNF cessation related to anti-drug antibodies.

“The implementation of a proactive anti-TNF therapeutic drug monitoring quality improvement program was not only feasible, but also improved sustained clinical remission rates, reduce incidence of high-tier anti-drug antibodies and reduced cessation due to antidrug antibodies,” Lyles concluded. – by Alex Young


Lyles JL, et al. Abstract 303. Presented at: Digestive Disease Week; May 18-21, 2019; San Diego.

Disclosures: Lyles reports no relevant financial disclosures. Please see the meeting disclosure index for all other authors’ relevant financial disclosures.