Real-world efficacy and safety of vedolizumab in managing ulcerative colitis versus Crohn’s disease: results from an Italian multicenter study
Giammarco Mocci, Antonio Tursi, Giovanni Maconi, Giovanni Cataletti, Beatrice Mantia, Mariaelena Serio, A. Scarcelli, Cristiano Pagnini, Maria Giovanna Graziani, Maria Carla Di Paolo, Giuseppe Pranzo, Ileana Luppino, Pietro Paese, Walter Elisei, Rita Monterubbianesi, Roberto Faggiani, Antonio Ferronato, Barbara Perini, Edoardo Savarino, Francesca Maria Onidi, Laura Elena Carreto Binaghi, Paolo Usai–Satta, Elisa Schiavoni, Daniele Napolitano, Franco Scaldaferri, Daniela Pugliese, Roberta Pica, Andrea Cocco, Maddalena Zippi, Stefano Rodinò, Ladislava Sebkova, Giulia Rocco, Carlotta Sacchi, Costantino Zampaletta, Federica Gaiani, Gianluigi De Angelis, Stefano Kayali, L. Fanigliulo, Roberto Lorenzetti, Leonardo Allegretta, Stefano Scorza, Antonio Cuomo, L. Donnarumma, Nicola Della Valle, Rodolfo Sacco, Giacomo Forti, Elisabetta Antonelli, Gabrio Bassotti, Chiara Iannelli, Francesco Luzza, Giovanni Aragona, Patrizia Perazzo, Angelo Lauria, Simona Piergallini, Raffaele Colucci, Maria Antonia Bianco, C. Meucci, GianMarco Giorgetti, Valeria Clemente, Serafina Fiorella, Antônio Penna, Antonio De Medici, Marcello Picchio, Alfredo Papa
Abstract
Background Vedolizumab (VDZ) can be used to treat refractory ulcerative colitis (UC) and Crohn’s disease (CD). We assessed whether there are differences in treating UC vs CD with VDZ.Research design and methods Mayo score in UC and the Harvey-Bradshaw Index (HBI) in CD scored the clinical activity. Achievement and maintenance of clinical remission during the follow-up, and safety were the primary endpoints.Results 729 patients (475 with UC and 254 with CD), median follow-up of 18 (IQR 6-36) months, were enrolled. Clinical remission at the 6th month of treatment was achieved in 488 (66.9%) patients (74.4% in CD vs 62.9% in UC, p<0.002) while, during the follow-up, no difference was found (81.5% in the UC group and 81.5% pts in the CD group; p=0.537). The clinical remission at the 6th month of treatment (p=0.001) and being naïve to biologics (p<0.0001) were significantly associated with prolonged clinical remission. The clinical response was significantly higher in UC (90.1%) vs CD (84.3%) (p=0.023), and surgery occurred more frequently in CD (1.9% in UC vs 5.1% in CD, p=0.016).Conclusion We found differences when using VDZ in UC vs CD in real life. These parameters can help the physician predict this drug’s longterm efficacy.