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

<b>Background:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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 (<i>p</i> = 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 (<i>p</i> = 0.000). <b>Conclusions</b>: Long-term treatment with UST presents good efficacy and safety profiles in CD patients, especially for patients who achieve remission after one year.

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Publication Details

Journal
Journal of Clinical Medicine
Published
2024-11-27
DOI
https://doi.org/10.3390/jcm13237192
Citations
8
Primary Topic
Inflammatory Bowel Disease
Type
article
Field-Weighted Citation Impact
4.40

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article

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

Rita Monterubbianesi, Fabio Cortellini, P. Capone, Domenico Catarella et al.
8 citations
Journal of Clinical Medicine
Inflammatory Bowel Disease
4.40
article

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

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

Abstract

<b>Background:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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 (<i>p</i> = 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 (<i>p</i> = 0.000). <b>Conclusions</b>: Long-term treatment with UST presents good efficacy and safety profiles in CD patients, especially for patients who achieve remission after one year.

Journal of Clinical MedicineVol. 13(23)
Università Cattolica del Sacro Cuore (IT), University of Parma (IT), University of Padua (IT), University of Sassari (IT), University of Campania "Luigi Vanvitelli" (IT), Azienda Ospedaliera San Giovanni Addolorata (IT), Policlinico Umberto I (IT), Agostino Gemelli University Polyclinic (IT), Ospedale Antonio Cardarelli (IT), Luigi Sacco Hospital (IT), ASL Roma (IT), AULSS 2 Marca Trevigiana (IT), San Salvatore Hospital (IT), Ospedale di Spoleto (IT), Ospedale A. Perrino (IT), Ospedale Garibaldi (IT), Azienda Ospedaliero Universitaria Ospedali Riuniti (IT), Ospedale Veris Delli Ponti Scorrano (IT), Azienda Ospedaliera S.Maria (IT), Ospedale di Belcolle (IT), Ospedale Infermi di Rimini (IT), IRCCS San Camillo Hospital (IT), Ospedale Annunziata di Cosenza (IT), Ospedale L. Bonomo (IT), Ospedale Regina Margherita (IT), Guglielmo da Saliceto Hospital (IT), Ospedale Santa Maria Goretti (IT), Ca' Foncello Hospital (IT), Ospedale Policlinico San Martino (IT), Azienda Ospedaliera Pugliese Ciaccio (IT), Ospedale D. Cotugno (IT), Ospedale SS. Annunziata (IT), Ospedale Civile di Venezia (IT), Azienda Ospedaliera G. Brotzu (IT), University of Genoa (IT)
Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, Sanofi, Gilead Sciences, Biogen, Regeneron Pharmaceuticals, Celltrion, Grifols
Good health and well-being
Openalex Percentile: Top 5%
Inflammatory Bowel Disease
4.40
DOIOpen Access PDFOpenAlex
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