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, Giammarco Mocci, Linda Cingolani, Edoardo Savarino, Roberta Pica, Andrea Cocco, Maddalena Zippi, Daniele Napolitano, Elisa Schiavoni, Daniela Pugliese, Franco Scaldaferri, Francesco Costa, Manuela Marzo, Mariaelena Serio, A. Scarcelli, Laura Bolognini, Emanuele Bendia, Giovanni Maconi, Rosanna Cannatelli, Simona Piergallini, Giorgia Bodini, Francesco Calabrese, Antonio Ferronato, Giuseppe Pranzo, Walter Elisei, Rita Monterubbianesi, Roberto Faggiani, Stefano Rodinò, Ladislava Sebkova, Laurino Grossi, Federica Gaiani, Gianluigi De Angelis, Roberto Lorenzetti, Leonardo Allegretta, Alessia Immacolata Cazzato, Stefano Scorza, Nicola Della Valle, Rodolfo Sacco, Giacomo Forti, Raffaele Colucci, Paolo Tonti, Viviana Neve, Giulia Rocco, Carlotta Sacchi, Costantino Zampaletta, Cristiano Pagnini, Maria Giovanna Graziani, Maria Carla Di Paolo, Francesca Maria Onidi, Paolo Usai–Satta, Marcello Picchio, Alfredo Papa
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.