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. 2023 Sep-Dec;24(14):1649-1656.
doi: 10.1080/14656566.2023.2230126. Epub 2023 Jun 28.

Use of tofacitinib as first or second-line therapy is associated with better outcomes in patients with ulcerative colitis: data from a real-world study

Antonio Tursi  1   2 , Giammarco Mocci  3 , Linda Cingolani  3 , Edoardo Savarino  3 , Roberta Pica  4 , Andrea Cocco  4 , Maddalena Zippi  4 , Daniele Napolitano  5 , Elisa Schiavoni  5 , Daniela Pugliese  5   6 , Franco Scaldaferri  5   6 , Francesco Costa  7 , Manuela Marzo  8 , Mariaelena Serio  9 , Antonella Scarcelli  9 , Laura Bolognini  10 , Emanuele Bendia  10 , Giovanni Maconi  11 , Rosanna Cannatelli  11 , Simona Piergallini  12 , Giorgia Bodini  13 , Francesco Calabrese  13 , Antonio Ferronato  14 , Giuseppe Pranzo  15 , Walter Elisei  16 , Rita Monterubbianesi  16 , Roberto Faggiani  16 , Stefano Rodinò  17 , Ladislava Sebkova  17 , Laurino Grossi  18 , Federica Gaiani  19 , Gianluigi Dè Angelis  19 , Roberto Lorenzetti  20 , Leonardo Allegretta  21 , Alessia Immacolata Cazzato  21 , Stefano Scorza  21 , Nicola Della Valle  22 , Rodolfo Sacco  22 , Giacomo Forti  23 , Raffaele Colucci  24 , Paolo Tonti  25 , Viviana Neve  25 , Giulia Rocco  26 , Carlotta Sacchi  26 , Costantino Zampaletta  26 , Cristiano Pagnini  27 , Maria Giovanna Graziani  27 , Maria Carla Di Paolo  27 , Francesca Maria Onidi  28 , Paolo Usai Satta  28 , Marcello Picchio  29 , Alfredo Papa  5   6
Affiliations

Use of tofacitinib as first or second-line therapy is associated with better outcomes in patients with ulcerative colitis: data from a real-world study

Antonio Tursi et al. Expert Opin Pharmacother. 2023 Sep-Dec.

Abstract

Background: Data regarding the real-world (RW) use of tofacitinib (TOF) in patients with ulcerative colitis (UC) are limited. We aimed to investigate TOF's RW efficacy and safety in Italian UC patients.

Research design and methods: A retrospective assessment of clinical and endoscopic activity was performed according to the Mayo score. The primary endpoints were to evaluate the effectiveness and safety of TOF.

Results: We enrolled 166 patients with a median follow-up of 24 (IQR 8-36) weeks. Clinical remission was achieved in 61/166 (36.7%) and 75/166 (45.2%) patients at 8-week and 24-week follow-ups, respectively. The optimization was requested in 27 (16.3%) patients. Clinical remission was achieved more frequently when TOF was used as a first/second line rather than a third/fourth line treatment (p = 0.007). Mucosal healing was reported in 46% of patients at the median follow-up time. Colectomy occurred in 8 (4.8%) patients. Adverse events occurred in 12 (5.4%) patients and severe in 3 (1.8%). One case of simple Herpes Zoster and one of renal vein thrombosis were recorded.

Conclusions: Our RW data confirm that TOF is effective and safe in UC patients. It performs remarkably better when used as the first/second line of treatment.

Keywords: Ulcerative colitis; real life; remission; safety; tofacitinib.

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