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Real-world efficacy and safety of vedolizumab in managing ulcerative colitis versus Crohn’s disease: results from an Italian multicenter study

2023; Taylor & Francis; Volume: 23; Issue: 3 Linguagem: Inglês

10.1080/14712598.2023.2185510

1744-7682

Giammarco Mocci, Antonio Tursi, Giovanni Maconi, Giovanni Cataletti, Beatrice Mantia, Mariaelena Serio, A. Scarcelli, Cristiano Pagnini, Maria Giovanna Graziani, M.C. Di Paolo, Giuseppe Pranzo, Ileana Luppino, Pietro Paese, Walter Elisei, Rita Monterubbianesi, Roberto Faggiani, Antonio Ferronato, Barbara Perini, Edoardo Savarino, F M 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,

Celiac Disease Research and Management

ABSTRACTABSTRACTBackground 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.KEYWORDS: Crohn's diseaseulcerative colitisvedolizumabremissionsafety Declaration of interestG Maconi has served as speaker and/or has received advisory board fees for AlfaSigma, Arena, Janssen, Gilead and Roche. D Pugliese has received speaker fees from AbbVie, MSD, Takeda, Janssen and Pfizer. F Scaldaferri has served as lecturer for Sanofi. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.Reviewer disclosuresPeer reviewers on this manuscript have no relevant financial or other relationships to disclose.Ethics statementThe authors state that they conducted the study according to clinical practice guidelines and the principles of the Declaration of Helsinki. All patients gave written informed consent before undergoing endoscopy and VDZ treatment. According to Italian law, retrospective studies do not need patients' consent to use their anonymized data for medical research, nor specific permission from Ethics Committees for sharing patient's databases except for simple communication of the study beginning. However, Ethics Committee approval for this retrospective study was obtained from 'Brotzu' Hospital (Cagliari, Italy, PROT. PG/2022/6364), the reference center for this study. The anonymized dataset was provided by and utilized with permission from A Tursi.Author contributionsConception and design: G Mocci, A Tursi, A Papa.Acquisition and collection of data: All authors.Analysis and interpretation of data: A Tursi, W Elisei, M Picchio, G Maconi, A Papa.Drafting of the paper or revising it critically for intellectual content: A Tursi, G Maconi, E Savarino, W Elisei, G Bassotti, M Picchio, A Papa.Final approval of the version to be published: All authors.Additional informationFundingThis paper was not funded.