Volume 71, Issue 4 pp. 501-507
Original Article: Gastroenterology: Inflammatory Bowel Disease

Vedolizumab Trough Levels in Children With Anti-Tumor Necrosis Factor Refractory Inflammatory Bowel Disease

Martine A. Aardoom

Martine A. Aardoom

Department of Pediatric Gastroenterology, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam

Search for more papers by this author
Maria M.E. Jongsma

Maria M.E. Jongsma

Department of Pediatric Gastroenterology, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam

Search for more papers by this author
Annick de Vries

Annick de Vries

Department of Bioanalysis, Sanquin Diagnostic Services, Amsterdam, the Netherlands

Search for more papers by this author
Jasja Wolthoorn

Jasja Wolthoorn

Department of Bioanalysis, Sanquin Diagnostic Services, Amsterdam, the Netherlands

Search for more papers by this author
Lissy de Ridder

Lissy de Ridder

Department of Pediatric Gastroenterology, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam

Search for more papers by this author
Johanna C. Escher

Corresponding Author

Johanna C. Escher

Department of Pediatric Gastroenterology, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam

Address correspondence and reprint requests to Johanna C. Escher, MD, PhD, Department of Pediatric Gastroenterology, Erasmus Medical Center-Sophia Children's Hospital, Room SP-2430, Postbox 2040, 3000 CA Rotterdam, the Netherlands (e-mail: [email protected]).Search for more papers by this author
First published: 06 July 2020
Citations: 14

Drs Martine A. Aardoom and Maria M.E. Jongsma should be considered joint first authors.

Conflicts of interest: L.d.R. reports grants from ECCO and Pfizer and received consultancy fees from Abbvie, Celltrion, Malinckrodt, and Nestle outside the submitted work. J.C.E. received research support from MSD and Pfizer and consultancy fees from Janssen and Abbvie. The remaining authors report no conflicts of interest.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal's Web site (www.jpgn.org).

ABSTRACT

Objectives:

Inflammatory bowel disease (IBD) can be successfully treated with vedolizumab. Studies in adult IBD patients have shown that differences in response to vedolizumab may be related to variability in vedolizumab trough levels, but in children with pediatric-onset IBD data regarding vedolizumab trough levels are not available. Thus far, the role of trough levels in pediatric-onset IBD treatment remains unclear. We aimed to investigate predictors of vedolizumab trough levels in pediatric-onset IBD patients.

Methods:

Data from anti-tumor necrosis factor refractory pediatric-onset IBD patients who received vedolizumab were collected retrospectively. Vedolizumab trough levels were measured in serum samples collected before each infusion. A linear mixed model was conducted to analyze factors that influence trough levels.

Results:

Twenty-six pediatric-onset IBD patients (14 ulcerative colitis [UC]), 9 Crohn Disease [CD], 3 IBD-unclassified [IBD-U]) received 258 vedolizumab infusions. Mean vedolizumab trough level at week 6 was 29.9 μg/mL (SD 17.8), and 11.5 μg/mL (SD 4.9) during maintenance therapy. CD patients had significantly lower trough levels than IBD-U patients (β 15.2; 95% confidence interval [CI] −1.1 to 29.2; P = 0.036). Higher fecal calprotectin (β −0.009; 95% CI −0.02 to −0.003; P = 0.007) and C-reactive protein levels (β −0.4; 95% CI −0.72 to −0.04; P = 0.027) were associated with lower trough levels, whereas shortening of time between infusions led to higher trough levels (β −0.77; 95% CI −0.9 to 0.64; P < 0.001).

Conclusions:

In this group of pediatric-onset IBD patients, trough levels were significantly lower in CD patients compared with UC/IBD-U patients. Higher levels of inflammatory markers were associated with lower vedolizumab trough levels.

The full text of this article hosted at iucr.org is unavailable due to technical difficulties.