Issue 17

Clinical Question

Is there any clinical benefit to monitoring adalimumab (ADA) serum trough levels in patients with Crohn’s disease (CD)?

Editor’s Bottom Line

Yes. Higher ADA trough levels are associated with an increased rate of disease remission.

Editorial Note

As standard of care, anti-TNF trough levels should be determined whenever loss of response occurs. Low levels in the absence of antibodies would imply dose optimization (i.e., increased dose).

Much needs to be learned relative to biologic drug levels. Specifically, therapeutic ranges may differ for individual patients and disease burden will likely affects drug levels. Stay tuned as science unravels these and other elements.

Reference

Bodini G, Giannini EG, Savarino V, et al. Adalimumab trough serum levels and anti-adalimumab antibodies in the long-term clinical outcome of patients with Crohn’s disease. Scand J Gastroenterol. 2016 Sep;51(9):1081–6. https://www.ncbi.nlm.nih.gov/pubmed/27207330

Synopsis

Eligible patients responded to ADA monotherapy for induction of moderate–severe CD by week 12. The patients were assessed every 2 months to confirm if they remained in remission (CRP<5 mg/dl, HBI≤5) and determine median ADA trough serum levels and level of anti-ADA antibodies (AAA >1.7 U/ml).

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At week 48, 10 of the 23 patients had sustained clinical remission, 9 had ongoing mild disease and 4 developed moderate–severe disease and stopped ADA.

At week 102 (range: 73–112 weeks), 8 of the original 23 patients remained in remission, while 6 patients and 3 patients had mild and moderate–severe disease, respectively.

At week 48, AAA positivity was significantly associated with lower ADA levels and a trend was found at the end of follow-up.

Details

Study Design: Prospective observational cohort study
Funding: Not reported
Allocation: n/a
Setting: Italy
Level of Evidence: 1b (Oxford Levels of Evidence)

The summary and conclusion in this issue of E-mentoring in IBD pertains to the manuscript(s) being reviewed, and should be considered in the context of what is already known surrounding the topic and incorporated into practice as deemed appropriate by the individual learner.