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Long-Term Effectiveness and Safety of Ustekinumab in Crohn’s Disease: Results from a Large Real-Life Cohort Study

2024; Multidisciplinary Digital Publishing Institute; Volume: 13; Issue: 23 Linguagem: Inglês

10.3390/jcm13237192

2077-0383

Giammarco Mocci, Antonio Tursi, Franco Scaldaferri, Daniele Napolitano, Daniela Pugliese, I. Capobianco, Bianca Bartocci, Valentina Blasi, Edoardo Savarino, Daria Maniero, Carlo Redavid, Greta Lorenzon, Antonio Cuomo, L. Donnarumma, Antonietta Gerarda Gravina, Raffaele Pellegrino, Giorgia Bodini, Andrea Pasta, Manuela Marzo, Mariaelena Serio, A. Scarcelli, Stefano Rodinò, Ladislava Sebkova, Giovanni Maconi, Giovanni Cataletti, Ileana Luppino, Davide Checchin, Antonio Ferronato, Federica Gaiani, Stefano Kayali, Carla Felice, Giuseppe Pranzo, Domenico Catarella, Dario D’Agostino, Elvira Bártolo, G Lombardi, Marta Patturelli, Emanuele Bendia, Laura Bolognini, Daniele Balducci, Claudia Quatraccioni, Francesco Martini, Caterina Mucherino, E D'Antonio, Laura Montesano, Giuliana Vespere, Silvia Sedda, V. D’Onofrio, Leonardo De Luca, Rocco Spagnuolo, Francesco Luzza, L. Fanigliulo, Giulia Rocco, Carlotta Sacchi, Costantino Zampaletta, Laurino Grossi, Roberto Lorenzetti, Giovanni Aragona, Patrizia Perazzo, Giacomo Forti, Leonardo Allegretta, Alessia Immacolata Cazzato, Stefano Scorza, Fabio Cortellini, P. Capone, Guido Daniele Villani, Michela Di Fonzo, Federico Iacopini, Paolo Tonti, Viviana Neve, Raffaele Colucci, Walter Elisei, Rita Monterubbianesi, Roberto Faggiani, Roberta Pica, Cristiano Pagnini, Maria Giovanna Graziani, M.C. Di Paolo, F M Onidi, Francesco Saba, Maria Pina Dore, Paolo Usai–Satta, Marcello Picchio, Alfredo Papa,

Autoimmune and Inflammatory Disorders

Background: Ustekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist approved for the treatment of Crohn’s disease (CD). Only limited real-life data on the long-term outcomes of CD patients treated with UST are available. This study assessed UST’s long-term effectiveness and safety in a large population-based cohort of moderate to severe CD patients. Methods: This was a multicenter, retrospective, observational cohort study that included both naïve and biologic-experienced patients treated with UST who achieved clinical remission or clinical response after at least one year of treatment. Clinical activity was scored according to the Harvey–Bradshaw Index (HBI). The primary endpoints were the maintenance or achievement of clinical remission after a further 12-month period of treatment, defined as an HBI of ≤5, and safety. Other endpoints included steroid-free remission, mucosal healing (MH), steroid discontinuation, and the need for treatment optimization during the follow-up. Results: Out of 562 CD patients, after an overall 24-month follow-up, clinical remission was present in 450 (80.0%) patients, and at 12 months, clinical remission was observed in 417/437 (95.4%) patients; 33/125 (26.4%) showed clinical response at 12 months (p = 0.000). A total of 38/103 (36.9%) patients achieved MH. Only 2.1% (12/562), 3% (17/562), and 1.1% (6/562) of patients required surgery, optimization, and re-induction, respectively. Adverse events occurred in eight patients (1.42%). According to a multivariate analysis, the only predictor of long-term remission was the presence of remission at the 12-month follow-up (p = 0.000). Conclusions: Long-term treatment with UST presents good efficacy and safety profiles in CD patients, especially for patients who achieve remission after one year.