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Advances in Therapeutic Drug Monitoring of Biologic Therapies in Inflammatory Bowel Disease: 2015 in Review

  • Inflammatory Bowel Disease (G Lichtenstein, Section Editor)
  • Published:
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Opinion statement

Monoclonal antibody therapy directed against tumor necrosis factor-alpha (anti-TNFs) has revolutionized the care of patients with Crohn’s disease and ulcerative colitis. These large proteins are potentially immunogenic. Early clinical trials demonstrated an association with both serum concentrations of these agents as well as the presence of antidrug antibodies generated by the host with loss of response. More recent research has provided further evidence to confirm the impact of low drug trough concentrations and antidrug antibodies on subsequent clinical course in CD and UC. Given these clinical implications, treatment algorithms have been developed to aid clinicians in interpreting trough drug levels and antibody concentrations in those with confirmed active disease. Several studies have demonstrated the utility of these approaches. Furthermore, there are growing data supporting the use of therapeutic drug monitoring in a prospective fashion in those patients who are clinically stable on anti-TNF therapies to ensure they are receiving appropriate dosing and have not yet developed antibodies. In addition, for those who have developed low-level antibodies, increasing the dose of an anti-TNF or adding an immunomodulator may help to overcome this immunologic response. Further research is required to assess these proposed strategies, as well as to determine the role of trough drug level assessment and antibody testing for new anti-TNFs and biologic medication with alternative mechanisms of action.

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Acknowledgments

A special thank you to Dr. Gary Falk for taking the time to review this manuscript.

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Authors and Affiliations

  1. Crohn’s and Colitis Center, Division of Gastroenterology, University of Colorado School of Medicine, 12605 E. 16th Ave., Aurora, CO, 80045, USA

    Frank I. Scott MD MSCE

  2. Center for IBD, Perelman Center for Advanced Medicine, Perelman School of Medicine of the University of Pennsylvania, One Convention Avenue, 7- South, Room 753, Philadelphia, PA, 19104, USA

    Gary R. Lichtenstein MD

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  1. Frank I. Scott MD MSCE
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Correspondence to Frank I. Scott MD MSCE.

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Conflict of Interest

Frank I. Scott has received research grant funding from Takeda Pharmaceuticals and a Career Development award from the NIH (NIDDK Grant K08-DK095951). Gary R. Lichtenstein has received consultancy fees from Abbott Corporation/Abbvie, Actavis, Alaven, Ferring, Hospira, Janssen Orthobiotech, Luitpold/American Regent, Pfizer Pharmaceuticals, Prometheus Laboratories, Inc., Romark, Salix Pharmaceuticals/Valeant, Santarus, Shire Pharmaceuticals, Takeda, UCB, and Warner Chilcotte. Dr. Lichtenstein also has received honorarium payments from Ironwood and Luitpold/American Regent.

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This article is part of the Topical Collection on Inflammatory Bowel Disease

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Scott, F.I., Lichtenstein, G.R. Advances in Therapeutic Drug Monitoring of Biologic Therapies in Inflammatory Bowel Disease: 2015 in Review. Curr Treat Options Gastro 14, 91–102 (2016). https://doi.org/10.1007/s11938-016-0085-z

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