Goals: Our primary goal was to evaluate whether anti-tumor necrosis factor (TNF)-α trough levels above author-determined thresholds are associated with increased rates of mucosal healing among patients with Crohn's disease and ulcerative colitis.
Background: The introduction of anti-TNF agents has considerably advanced the approach to the management of patients with inflammatory bowel disease (IBD). As use of anti-TNF therapy has increased, there has been new interest in algorithms focused on the monitoring of pharmacodynamics and pharmacokinetics to improve outcomes. In addition, there has been an increased focus on mucosal healing as marker of treatment success.
Study: We performed a systematic review and meta-analysis. The studies examined were restricted to randomized controlled trials and cohort studies with a high Jadad or Newcastle-Ottawa score.
Results: All pooled analyses were based on a random-effects model. Data from 2 randomized controlled trials and 5 observational studies (n=652) were included in the meta-analysis. Among patients with IBD, anti-TNF trough levels above prespecified values were associated with increased rates of mucosal healing (OR=5.57; 95% CI, 3.80-8.15). There was no heterogeneity detected (I=0, Q=5.88, df=6; P=0.436) and there was minimal evidence of publication bias present.
Conclusions: There is a strong relationship between anti-TNF trough levels and increased rates of mucosal healing among patients with IBD. Given the increased emphasis on mucosal healing as an outcome in practice and clinical trials, continued focus on the proactive use of pharmacokinetic testing appears warranted.