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Effectiveness of Tofacitinib for Hospitalized Patients with Acute Severe Ulcerative Colitis: Case Series

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Abstract

Background

Treatment options for acute severe ulcerative colitis (ASUC) are limited. Tofacitinib, an approved treatment for moderate to severe ulcerative colitis, could be a potential rescue therapy for ASUC given its rapid onset of action.

Objective

To evaluate the effectiveness of tofacitinib in hospitalized patients with ASUC refractory to standard therapy in a real-world setting.

Methods

Retrospective observational study of hospitalized adult patients with ASUC treated with tofacitinib between January 2019 and September 2020 at five Canadian centers. We extracted patient demographics, clinical status, biomarkers (C-reactive protein and fecal calprotectin), endoscopic findings, and colectomy-free rate at admission, 30 days, 90 days, and 6 months after tofacitinib initiation.

Results

Eight patients with symptoms refractory to standard rescue therapy (corticosteroids ± infliximab if infliximab-naïve prior to admission) were treated with tofacitinib. During index hospitalization, clinical response was observed in 5/8 patients. The median time to discharge post-tofacitinib initiation was 5 days (IQR 5.0–6). At 30 and 90 days, all five responders were in clinical remission. At 6 months, only 3/5 responders remained in clinical remission. The colectomy-free rate was 37.5% during the follow-up period (two colectomies occurred within 30 days; one occurred within 90 days). No drug-related adverse reaction occurred.

Conclusion

In this small case-series, tofacitinib was an effective rescue therapy in patients with refractory ASUC. These findings need to be evaluated in a randomized controlled trial.

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Funding

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Authors and Affiliations

  1. Division of Gastroenterology and Hepatology, University of Toronto, Toronto, ON, Canada

    Yasi Xiao

  2. Hopital Pierre-Boucher, Longueuil, Canada

    Nicolas Benoit

  3. Department of Medicine, Western University, London, ON, Canada

    Rocio Sedano & Vipul Jairath

  4. Department of Epidemiology and Biostatistics, Western University, London, ON, Canada

    Vipul Jairath

  5. Alimentiv Inc., London, ON, Canada

    Vipul Jairath

  6. Department of Medicine (Division of Gastroenterology) and Farncombe, Family Digestive Health Research Institute, McMaster University, Hamilton, ON, Canada

    Neeraj Narula

  7. Department of Medicine, University of Ottawa, Ottawa, Canada

    Jeffrey D. McCurdy

  8. The Ottawa Hospital Research Institute, Ottawa, Canada

    Jeffrey D. McCurdy

  9. Division of Gastroenterology, Department of Medicine, IBD Centre of BC, University of British Columbia, Vancouver, Canada

    Greg Rosenfeld

  10. Division of Gastroenterology, Department of Medicine, McGill University Health Center, Montreal General Hospital 1650 Avenue Cedar C7-200, Montreal, QC, H3G 1A4, Canada

    Waqqas Afif, Peter L. Lakatos & Talat Bessissow

  11. 1st Department of Medicine, Semmelweis University, Budapest, Hungary

    Peter L. Lakatos

Authors
  1. Yasi Xiao
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  2. Nicolas Benoit
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  3. Rocio Sedano
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  4. Vipul Jairath
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  5. Neeraj Narula
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  6. Jeffrey D. McCurdy
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  7. Greg Rosenfeld
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  8. Waqqas Afif
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  9. Peter L. Lakatos
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  10. Talat Bessissow
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Contributions

YX contributed data collection, data analysis, and manuscript preparation, NB contributed data collection and manuscript preparation, RS contributed data collection and manuscript preparation, VJ contributed data collection and manuscript preparation, NN contributed data collection and manuscript preparation, JDM contributed data collection and manuscript preparation, GR contributed data collection and manuscript preparation, WA contributed data collection and manuscript preparation, PLL contributed data collection and manuscript preparation, and TB contributed conception of project, data analysis, manuscript preparation, and supervision of project.

Corresponding author

Correspondence to Talat Bessissow.

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Conflict of interest

Yasi Xiao, Rocio Sedano, Nicolas Benoit have no disclosures. Talat Bessissow has received honoraria from Abbvie, Alimentiv Inc (formerly Robarts Clinical Trials), Bristol Myers Squibb, Ferring, Gilead, Janssen, Merck, Pfizer, Roche, Sandoz, Takeda. Jeffrey McCurdy has been a speaker and/or advisory board member and/or consultant: abbvie, Janssen, Pfizer, Takeda, Fresenius Kabi, Neeraj Narula holds a McMaster University Department of Medicine Internal Career Award. Neeraj Narula has received honoraria from Janssen, Abbvie, Takeda, Pfizer, Merck, Sandoz, Novartis, and Ferring. Peter L Lakatos has been a speaker and/or advisory board member: AbbVie, Amgen, Arena Pharmaceuticals, Ferring, Fresenius Kabi, Genetech, Gilead, Janssen, Merck, Mylan, Pharmacosmos, Pfizer, Roche, Takeda, Tillots and Viatris and has received unrestricted research grant: AbbVie, MSD and Pfizer. Vipul Jaraith has received has received consulting fees from AbbVie, Alimentiv Inc (formerly Robarts Clinical Trials), Arena pharmaceuticals, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, GlaxoSmithKline, Genetech, Gilead, Janssen, Merck, Mylan, Pendopharm, Pfizer, Roche, Sandoz, Takeda, Topivert; speaker’s fees from, Abbvie, Ferring, Janssen, Pfizer, Shire, Takeda. Greg Rosenfled has consulted for Abbvie, Janssen, Alimentiv Inc., Bristol Myers Squibb, Eli Lilly, Mylan, Ferring, Fresenius Kabi, Roche, Merck, Pfizer and Takeda. Speaker for Abbvie, Janssen, Pfizer, Ferring, Takeda, Fresenius Kabi. Waqqas Afif has received consultancy fees from Abbvie, Amgen, Arena Pharmaceuticals, Dynacare, Fresenius Kabi, Janssen, Merck, Novartis, Pfizer, Sandoz, Takeda.

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Xiao, Y., Benoit, N., Sedano, R. et al. Effectiveness of Tofacitinib for Hospitalized Patients with Acute Severe Ulcerative Colitis: Case Series. Dig Dis Sci 67, 5213–5219 (2022). https://doi.org/10.1007/s10620-022-07439-2

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  • DOI: https://doi.org/10.1007/s10620-022-07439-2

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