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Carlsen A, Omdal R, Karlsen L, et al. Determination of lower cut-off levels of adalimumab associated with biochemical remission in Crohn's disease. JGH Open. 2019;4(3):410-416doi: 10.1002/jgh3.12266.
Carlsen, A., Omdal, R., Karlsen, L., Kvaløy, J. T., Aabakken, L., Steinsbø, �. �., Bolstad, N., Warren, D., Lundin, K. E. A., & Grimstad, T. (2020). Determination of lower cut-off levels of adalimumab associated with biochemical remission in Crohn's disease. JGH open : an open access journal of gastroenterology and hepatology, 4(3), 410-416. https://doi.org/10.1002/jgh3.12266
Carlsen, Arne, et al. "Determination of lower cut-off levels of adalimumab associated with biochemical remission in Crohn's disease." JGH open : an open access journal of gastroenterology and hepatology vol. 4,3 (2020): 410-416. doi: https://doi.org/10.1002/jgh3.12266
Carlsen A, Omdal R, Karlsen L, Kvaløy JT, Aabakken L, Steinsbø Ø, Bolstad N, Warren D, Lundin KEA, Grimstad T. Determination of lower cut-off levels of adalimumab associated with biochemical remission in Crohn's disease. JGH Open. 2019 Oct 06;4(3):410-416. doi: 10.1002/jgh3.12266. eCollection 2020 Jun. PMID: 32514446; PMCID: PMC7273736.
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JGH Open. 2019 Oct 06;4(3):410-416. doi: 10.1002/jgh3.12266. eCollection 2020 Jun.

Determination of lower cut-off levels of adalimumab associated with biochemical remission in Crohn's disease.

JGH open : an open access journal of gastroenterology and hepatology

Arne Carlsen, Roald Omdal, Lars Karlsen, Jan Terje Kvaløy, Lars Aabakken, Øyvind Steinsbø, Nils Bolstad, David Warren, Knut Erik Aslaksen Lundin, Tore Grimstad

Affiliations

  1. Gastroenterology Unit, Department of Internal Medicine Stavanger University Hospital Stavanger Norway.
  2. Department of Clinical Science, Faculty of Medicine University of Bergen Bergen Norway.
  3. Clinical Immunology Unit, Department of Internal Medicine Stavanger University Hospital Stavanger Norway.
  4. Department of Mathematics and Physics University of Stavanger Stavanger Norway.
  5. Research Department Stavanger University Hospital Stavanger Norway.
  6. Department of Transplantation Medicine Oslo University Hospital Rikshospitalet Oslo Norway.
  7. Department of Medical Biochemistry Oslo University Hospital Radiumhospitalet Oslo Norway.
  8. KG Jebsen Celiac Disease Research Centre University of Oslo Oslo, Norway.

PMID: 32514446 PMCID: PMC7273736 DOI: 10.1002/jgh3.12266

Abstract

BACKGROUND AND AIM: Adalimumab is administered and dosed using a standardized treatment regimen. Although therapeutic drug monitoring (TDM) may help optimize treatment efficacy, the lower cut-off concentration of adalimumab needed to retain disease remission has not been established. This cross-sectional study of patients with Crohn's disease on stable medication aimed to determine a lower therapeutic drug concentration threshold of adalimumab associated with biochemical disease remission.

METHODS: C-reactive protein (CRP) and fecal calprotectin were used as established markers and albumin as an explorative marker of disease activity. Time since introduction, treatment interval, drug dosage, serum drug concentration and antidrug antibodies, disease duration, age, and sex were recorded.

RESULTS: The study included 101 patients who were divided into "active disease" and "remission" groups for inflammatory markers based on cut-off levels of 5 mg/L for CRP and 50 mg/kg for fecal calprotectin. Cut-off levels for albumin of 36.5 and 41.5 g/L were also added as further indicatives of remission. Receiver operating characteristic analysis found optimal thresholds for adalimumab associated with remission at 6.8-7.0 mg/L for the combination of CRP and fecal calprotectin and when combining CRP, fecal calprotectin, and albumin.

CONCLUSIONS: In patients with Crohn's disease, serum adalimumab of at least 6.8 mg/L was associated with biochemical disease remission based on CRP and fecal calprotectin, supporting the use of TDM to ensure disease control. Albumin should be further tested in this setting.

© 2019 The Authors. JGH Open: An open access journal of gastroenterology and hepatology published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Keywords: Crohn's disease; adalimumab; lower cut‐off; remission; therapeutic drug monitoring

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