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Outcome of tacrolimus and vedolizumab after corticosteroid and anti-TNF failure in paediatric severe colitis
  1. Blaise Hamel1,
  2. May Wu1,
  3. Elizabeth O Hamel2,
  4. Dorsey M Bass3,
  5. K T Park3
  1. 1 Department of Pharmacy, Lucile Packard Children’s Hospital, Palo Alto, California, USA
  2. 2 Department of Biology, Stanford University, Stanford, California, USA
  3. 3 Department of Pediatrics, Stanford Children’s Inflammatory Bowel Disease Center, Division of Gastroenterology, Stanford University School of Medicine, Stanford, California, USA
  1. Correspondence to Dr K T Park; ktpark{at}stanford.edu

Abstract

Background Severe colitis flare from ulcerative colitis (UC) or Crohn’s disease (CD) may be refractory to corticosteroids and antitumour necrosis factor (TNF) agents resulting in high colectomy rates. We aimed to describe the utility of tacrolimus to prevent colectomy during second-line vedolizumab initiation after corticosteroid and anti-TNF treatment failure in paediatric severe colitis.

Methods A retrospective cohort analysis was performed between 1 October 2014 and 31 October 2016 at a single tertiary care centre. Inclusion criteria were patients with severe colitis who received tacrolimus before or during vedolizumab induction and previous exposure to anti-TNF therapy with or without corticosteroids. The initiation of tacrolimus was clinician dependent based on an institutional protocol.

Results Twelve patients (10 UC, two CD; median age 16 years; three female) received at least one dose of vedolizumab 10 mg/kg (max of 300 mg) due to anti-TNF therapy failure and persistent flare not responsive to corticosteroids. Of the 12 patients, eight (67%) and four (33%) had failed one or two anti-TNF agents, respectively. Tacrolimus was initiated for acute disease severity during hospitalisation (58%) or ongoing flare during outpatient care (42%). 9 (75%) of 12 patients avoided colectomy or inflammatory bowel disease-related surgery at 24 weeks and eight (68%) continued on vedolizumab maintenance with no adverse events out to 80 weeks.

Conclusion We report real-world data on the outcome of tacrolimus around vedolizumab initiation in paediatric UC or CD after corticosteroid and anti-TNF therapy treatment failure. Our pilot experience indicates a potential benefit of concomitant tacrolimus when initiating vedolizumab therapy.

  • vedolizumab
  • tacrolimus
  • acute severe colitis
  • colectomy
  • ulcerative colitis
  • Crohn’s disease
  • inflammatory bowel disease

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors BH and KTP contributed equally to the design of the study. BH, MW and EOH collected and analysed the data. BH and KTP wrote the article and all the other authors contributed with critical revision of the manuscript for important intellectual content and interpretation of the data. All authors read and approved the final version of the manuscript.

  • Funding No funding was obtained for this research. KP has received research support from Janssen and Takeda unrelated to this work.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval Stanford University Institutional Review Board.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Correction notice This article has been corrected since it first published. The spelling of the word ’corticosteroid' in the article title has been corrected.