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Effect of Tofacitinib on One-Year Colectomy Risk in Anti-TNF Refractory Ulcerative Colitis: A Prospective Multicenter Italian Study

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Abstract

Background

Tofacitinib is an oral Janus kinase inhibitor recently approved to induce and maintain remission in ulcerative colitis (UC).

Aims

Considering the number of anti-TNF non-responders, this study aims to assess the effectiveness and safety of tofacitinib in a cohort of multi-failure patients with moderate-to-severe UC at 52 weeks.

Methods

From January 2021 to March 2023, we performed a prospective multicenter study observing adult patients with moderate-to-severe UC starting tofacitinib after an anti-TNF failure for a 52-week-long period. Effectiveness and safety were assessed in terms of colectomy rate, clinical remission and response, endoscopic remission, steroid-free clinical remission, and rate of adverse events.

Results

We included 58 patients with UC with an age of 42 ± 14.4 years, 59% males, 96.6% left-sided or pancolitis, who were failure to a single (65.5%) or more than one anti-TNF (34.5%). Only 6 (10.3%) patients underwent colectomy. Colectomy was clinically associated with the necessity and the number of extra cycles of tofacitinib 10 mg bid at W8 (p = 0.023) and W24 (p = 0.004), and with a higher partial Mayo score at W8 (p = 0.025). At W52, clinical remission, clinical response, and steroid-free clinical remission were 53.4%, 43.1%, and 48.3%, respectively. Of 22 performed colonoscopies at W52, 11 (50%) showed endoscopic remission. Adverse events occurred in 14 (24.1%) patients, but only 2 (3.4%) led to tofacitinib discontinuation.

Conclusions

In a real-life setting of patients with anti-TNF refractory UC, tofacitinib has proved to be effective in preventing colectomy and inducing clinical and endoscopic remission at 52 weeks with a good safety profile.

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Data availability

Data are available upon reasonable request.

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Authors and Affiliations

  1. Gastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy

    Anna Maria Carvalhas Gabrielli, Francesca Ferretti, Camilla Maria Monico, Giovanni Maconi, Stefania Carmagnola, Sandro Ardizzone & Rosanna Cannatelli

  2. Internal Medicine and Rheumatology Unit, ASST Fatebenefratelli-Sacco, Milan, Italy

    Enrico Tombetti

  3. Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy

    Enrico Tombetti & Giovanni Maconi

  4. Gastroenterology and Digestive Endoscopy Dept, ASST Ospedale Maggiore Di Crema, Crema, Italy

    Samanta Romeo, Saverio Alicante, Roberto Bertè & Elisabetta Buscarini

  5. Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico Di Milano, Milan, Italy

    Nicole Piazza O Sed & Flavio Caprioli

  6. Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy

    Flavio Caprioli

  7. Department of Clinical and Sperimental Sciences, University of Brescia, Brescia, Italy

    Anna Maria Mazzola & Chiara Ricci

  8. Gastroenterology Department, Policlinico Tor Vergata, Rome, Italy

    Elisabetta Lolli

  9. Villa Stuart Multi-Speciality Clinic, Rome, Italy

    Maria Lia Scribano

  10. Gastroenterology Unit, Spedali Civili Di Brescia, Brescia, Italy

    Chiara Ricci

Authors
  1. Anna Maria Carvalhas Gabrielli
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Contributions

All authors have contributed to and agreed on the content of the manuscript. In particular, AMCG, RC, FF, SR, and SA planned the study; AMCG, RC, and FF drafted the article, collected and interpreted data. All other authors were involved in data collection and critical revision of the article for important intellectual content. All authors approved the final version of the manuscript including the authorship list.

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Correspondence to Anna Maria Carvalhas Gabrielli.

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Carvalhas Gabrielli, A.M., Ferretti, F., Monico, C.M. et al. Effect of Tofacitinib on One-Year Colectomy Risk in Anti-TNF Refractory Ulcerative Colitis: A Prospective Multicenter Italian Study. Dig Dis Sci (2024). https://doi.org/10.1007/s10620-024-08394-w

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