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Infliximab Trough Levels Are Not Predictive of Relapse in Patients with IBD in Endoscopic Remission: A Multicenter Cohort Study

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Abstract

Background

Therapeutic drug monitoring (TDM) is important in optimizing use of biologics in inflammatory bowel diseases (IBD). However, the role of proactive TDM during remission remains uncertain.

Methods

This retrospective study included patients receiving infliximab (IFX) therapy at Massachusetts General Hospital or Erasmus University Medical Center. All eligible patients had completed induction phase of IFX and were in clinical and endoscopic remission. Our primary outcome was clinical relapse within 2 years after baseline. Multivariable regression models examined the association between infliximab trough levels during remission and relapse, need for IBD-related surgery or hospitalization.

Results

Our study cohort included 110 patients with IBD (72 CD, 38 UC) on IFX maintenance therapy. In total, 12 patients (10.9%) experienced relapse of disease over 2 years. The mean IFX trough level at baseline was 8.0 µg/mL (± 8.6) and did not differ between the institutions. 49.1% of patients had levels < 5 µg/mL and 2.7% had antibodies to infliximab at baseline. There was no difference in the mean IFX trough levels between patients who relapsed (7.5 µg/mL ± 3.7 µg/mL) over 24 months compared to those who did not (8.1 µg/mL ± 7.9 µg/mL, p = 0.815). On multivariable logistic regression analysis, IFX trough levels at baseline were not associated with relapse of disease over 24 months (OR 1.01, 95% CI 0.93–1.09, p = 0.856).

Conclusion

This retrospective multicenter study provides evidence that IFX trough levels during quiescent disease do not predict relapse over 2 years, suggestive that proactive TDM in this setting is not warranted.

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Acknowledgment

Dr. Ananthakrishnan has served on advisory boards for Abbvie, Takeda, and Merck. He is supported by research funding from the Crohn’s and Colitis Foundation, National Institutes of Health, Chleck Family Foundation, and Pfizer. Professor CJ van der Woude has served on advisory boards for Abbvie, Takeda, Pfizer, and Celltrion. She is supported by research funding from ZonMW, Tramedico, and Pfizer. Dr. Willrich reports intellectual property on the laboratory method to measure infliximab concentration (US patent #42580).

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Authors and Affiliations

  1. Division of Gastroenterology, Harvard Medical School, Massachusetts General Hospital Crohn’s and Colitis Center, 165 Cambridge Street, 9th Floor, Boston, MA, 02114, USA

    Nienke Z. Borren & Ashwin N. Ananthakrishnan

  2. Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands

    Nienke Z. Borren, Emma Paulides & C. Janneke van der Woude

  3. Department of Laboratory Medicine and Pathology, Mayo Clinic Rochester, Rochester, MN, USA

    Jody L. Frinack, Ryan N. Olson & Maria Alice V. Willrich

Authors
  1. Nienke Z. Borren
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  2. Emma Paulides
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  3. Jody L. Frinack
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  4. Ryan N. Olson
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  5. Maria Alice V. Willrich
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  6. C. Janneke van der Woude
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  7. Ashwin N. Ananthakrishnan
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Contributions

NZB and EP were involved in the study design, data acquisition, drafting of manuscript, and critical revision; JLF, RNO, MAW, and CJW contributed to the data acquisition and critical revision of manuscript; ANA was involved in the study design, data acquisition, critical revision of manuscript, and study supervision.

Corresponding author

Correspondence to Ashwin N. Ananthakrishnan.

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Borren, N.Z., Paulides, E., Frinack, J.L. et al. Infliximab Trough Levels Are Not Predictive of Relapse in Patients with IBD in Endoscopic Remission: A Multicenter Cohort Study. Dig Dis Sci 66, 3548–3554 (2021). https://doi.org/10.1007/s10620-020-06645-0

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  • DOI: https://doi.org/10.1007/s10620-020-06645-0

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