Related Experiment Video
Updated: Dec 20, 2025
Mechanistic Insight into the Development of TNBS-Mediated Intestinal Fibrosis and Evaluating the Inhibitory Effects of Rapamycin
Published on: September 12, 2019
Effect of a Practice-wide Anti-TNF Proactive Therapeutic Drug Monitoring Program on Outcomes in Pediatric Patients
John L Lyles1, Aditi A Mulgund2,3, Laura E Bauman1,4
1Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Insights
Implementing proactive therapeutic drug monitoring (TDM) for antitumor necrosis factor (TNF) therapy in inflammatory bowel disease significantly improved sustained clinical remission and reduced antidrug antibodies (ADAs). This quality improvement program demonstrated enhanced patient outcomes in pediatric gastroenterology.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Limited data exists on translating proactive antitumor necrosis factor (TNF) therapeutic drug monitoring (TDM) into practice-wide quality improvement (QI) for inflammatory bowel disease (IBD).
- Assessing the effectiveness of a TDM QI program in a large academic pediatric gastroenterology practice was the focus.
Purpose of the Study:
- To determine if a TDM QI program improved clinical outcomes in pediatric IBD patients on anti-TNF therapy.
- To evaluate the impact of proactive TDM on sustained clinical remission, antidrug antibodies (ADAs), and treatment cessation.
Main Methods:
- Instituted local anti-TNF TDM guidelines to proactively monitor and optimize drug levels (goal >5 μg/mL).
- Conducted a retrospective single-center cohort analysis comparing outcomes before (pre-TDM) and after (post-TDM) guideline implementation.
- Assessed sustained clinical remission (SCR22-52) and analyzed the independent effect using multivariable regression.
Main Results:
- Sustained clinical remission (SCR22-52) increased from 42% in the pre-TDM group to 59% in the post-TDM group (P = 0.004).
- The post-TDM group showed increased adjusted odds of achieving SCR22-52 (OR, 2.03; P = 0.003).
- The adjusted risk of high-titer antidrug antibodies (ADAs) was significantly lower (HR, 0.18; P < 0.001), as was cessation related to ADA (HR, 0.45; P = 0.003).
Conclusions:
- A practice-wide proactive anti-TNF TDM QI program effectively improved key clinical outcomes in pediatric IBD patients.
- The program led to better sustained clinical remission and reduced the incidence of high-titer ADAs.
- TDM QI implementation lowered anti-TNF treatment cessation rates related to ADA.
Background:
Reports on the feasibility and effectiveness of translating proactive, antitumor necrosis factor (TNF) therapeutic drug monitoring (TDM) for inflammatory bowel disease into practice-wide quality improvement (QI) are lacking. We aimed to determine whether a TDM QI program improved outcomes at a large academic pediatric gastroenterology practice.
Methods:
We instituted local anti-TNF TDM practice guidelines to proactively monitor and optimize drug levels (goal >5 μg/mL). We conducted a retrospective single-center cohort analysis of patient outcomes before (pre-TDM) and after (post-TDM) guideline institution and assessed the independent effect by multivariable regression. Primary outcome was sustained clinical remission (SCR22-52), defined as physician global assessment (PGA) of inactive from 22 to 52 weeks and off corticosteroids at 52 weeks.
Results:
We identified 108 pre-TDM and 206 post-TDM patients. The SCR22-52 was achieved in 42% of pre-TDM and 59% of post-TDM patients (risk difference, 17.6%; 95% CI, 5.4-29%; P = 0.004). The post-TDM group had an increased adjusted odds of achieving SCR22-52 (odds ratio, 2.03; 95% CI, 1.27-3.26; P = 0.003). The adjusted risk of developing high titer antidrug antibodies (ADAs) was lower in the post-TDM group (hazard ratio, 0.18; 95% CI, 0.09-0.35; P < 0.001). Although the risk of anti-TNF cessation for any reason was not significantly different, there was a lower adjusted risk of cessation related to any detectable ADA in the post-TDM group (hazard ratio, 0.45; 95% CI, 0.26-0.77; P = 0.003).
Conclusions:
A practice-wide proactive anti-TNF TDM QI program improved key clinical outcomes at our institution, including sustained clinical remission, incidence of high titer ADA, and anti-TNF cessation related to ADA.
More Related Videos
Related Concept Videos
01:24Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
01:29Inflammatory Bowel Disease IV: Pharmacological Management
Pharmacologic...
01:29Therapeutic Drug Monitoring: Affecting Factors
01:29Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
01:16Therapeutic Drug Monitoring: Overview and Classification
01:21Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids