No Improved Outcomes With Therapeutic Drug Monitoring in IBD Treatment

Stomach ache symptom of irritable bowel syndrome, Chronic Diarrhea, Colon, stomach pain,Crohn’s Disease, Gastroesophageal Reflux Disease (GERD), gallstone,gastric pain, Appendicitis.
Researchers compared outcomes of therapeutic drug monitoring and conventional management in patients with inflammatory bowel disease receiving treatment with TNF-α antagonists.

Proactive therapeutic drug monitoring had little clinical benefit for patients with inflammatory bowel disease (IBD) receiving tumor necrosis factor (TNF)-a antagonists, according to study results published in Gastroenterology.

Researchers conducted a systematic review and meta-analysis, searching publication databases through February 2022 for randomized controlled trials of TNF-a antagonist interventions for IBD that used therapeutic drug monitoring or biologic dose adjustments.

Of 5462 articles identified, researchers included 9 trials in the analysis. Six studies investigated infliximab and 3, adalimumab. The target trough concentration was greater than 3 mg/ml for infliximab and either greater than 5 or greater than 10 mg/ml for adalimumab.

Eight of the trials were conducted among adult patient populations and 1 study recruited pediatric patients. The patient populations were 29% to 65% female, 5% to 50% were on concomitant immunomodulators, and all but 2 trials recruited patients with long-standing disease.

Proactive therapeutic drug monitoring was no more effective than conventional management at 1 year (risk ratio [RR], 0.96; 95% CI, 0.81-1.13; I2=36%). Similar findings were observed when stratifying patients by Crohn disease (CD; RR, 0.87; 95% CI, 0.66-1.15; I2=48%), ulcerative colitis (UC; RR, 0.88; 95% CI, 0.72-1.07; I2=3%), receiving maintenance therapy (RR, 0.94; 95% CI, 0.78-1.13), induction therapy (RR, 1.15; 95% CI, 0.73-1.80), infliximab (RR, 0.97; 95% CI, 0.76-1.24), or adalimumab (RR, 0.93; 95% CI, 0.72-1.20).

Similarly, proactive therapeutic drug monitoring was no more effective than reactive therapeutic drug monitoring (RR, 0.99; 95% CI, 0.78-1.25; I2, 48%) in studies that did not allow for dose escalation regardless of disease activity (RR, 0.88; 95% CI, 0.73-1.07; I2, 0%) or among patients that had undergone therapeutic drug monitoring prior to randomization (RR, 1.04; 95% CI, 0.88-1.22; I2=15%).

No significant effects were observed for age (P=.58), remission status at baseline (P =.33), concomitant use of immunomodulators (P =.30), disease duration (P =.23), sex (P =.19), proportion of patients with CD (P =.17), or the proportion of patients with prior therapeutic drug monitoring (P =.11).

Patients who received proactive therapeutic drug monitoring were more likely to have dose escalation (RR, 1.56; 95% CI, 1.25-1.94; I2=44%).

Study limitations included differences among patients in the selected trials, such as the proportion of patients who underwent previous optimization therapy, limited data on patients who achieved endoscopic and/or biologic remission, and inconsistent reporting on potential harms from proactive therapeutic drug monitoring.

“We observed no benefit of proactive [therapeutic drug monitoring] compared with conventional management, in achieving and/or maintaining clinical remission in patients with IBD,” the study authors wrote. “We cannot exclude the possibility of benefit in disease subtypes not represented in these RCT populations.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.


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. Gastroenterology. Published online June 23, 2022. doi:10.1053/j.gastro.2022.06.052