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. 2024 Nov 27;13(23):7192.
doi: 10.3390/jcm13237192.

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

Giammarco Mocci  1 , Antonio Tursi  2   3 , Franco Scaldaferri  4   5 , Daniele Napolitano  4 , Daniela Pugliese  4   5 , Ivan Capobianco  4 , Bianca Bartocci  4 , Valentina Blasi  4 , Edoardo V Savarino  6 , Daria Maniero  6 , Carlo Redavid  6 , Greta Lorenzon  6 , Antonio Cuomo  7 , Laura Donnarumma  7 , Antonietta Gerarda Gravina  8 , Raffaele Pellegrino  8 , Giorgia Bodini  9 , Andrea Pasta  9 , Manuela Marzo  10 , Mariaelena Serio  11 , Antonella Scarcelli  11 , Stefano Rodinò  12 , Ladislava Sebkova  12 , Giovanni Maconi  13 , Giovanni Cataletti  13 , Ileana Luppino  14 , Davide Checchin  15 , Antonio Ferronato  16 , Federica Gaiani  17 , Stefano Kayali  17 , Carla Felice  18 , Giuseppe Pranzo  19 , Domenico Catarella  20 , Dario D'Agostino  20 , Elisabetta Di Bartolo  20 , Giovanni Lombardi  21 , Marta Patturelli  21 , Emanuele Bendia  22 , Laura Bolognini  22 , Daniele Balducci  22 , Claudia Quatraccioni  22 , Francesco Martini  22 , Caterina Mucherino  23 , Elvira D'Antonio  23 , Laura Montesano  23 , Giuliana Vespere  24 , Silvia Sedda  24 , Vittorio D'Onofrio  24 , Leonardo De Luca  24 , Rocco Spagnuolo  25 , Francesco Luzza  25 , Libera Fanigliulo  26 , Giulia Rocco  27 , Carlotta Sacchi  27 , Costantino Zampaletta  27 , Laurino Grossi  28 , Roberto Lorenzetti  29 , Giovanni Aragona  30 , Patrizia Perazzo  30 , Giacomo Forti  31 , Leonardo Allegretta  32 , Alessia Immacolata Cazzato  32 , Stefano Scorza  32 , Fabio Cortellini  33 , Pietro Capone  34 , Guido Daniele Villani  34 , Michela Di Fonzo  35 , Federico Iacopini  35 , Paolo Tonti  36 , Viviana Neve  36 , Raffaele Colucci  37 , Walter Elisei  38 , Rita Monterubbianesi  38 , Roberto Faggiani  38 , Roberta Pica  39 , Cristiano Pagnini  40 , Maria Giovanna Graziani  40 , Maria Carla Di Paolo  40 , Francesca Maria Onidi  1 , Francesco Saba  1 , Maria Pina Dore  41 , Paolo Usai-Satta  1 , Marcello Picchio  42 , Alfredo Papa  4   5
Affiliations

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

Giammarco Mocci et al. J Clin Med. .

Abstract

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.

Keywords: Crohn’s disease; re-induction; remission; response; safety; ustekinumab.

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Conflict of interest statement

G.M. (Giammarco Mocci) served as speaker for and/or received advisory board fees from AbbVie, Amgen, Aurora Biopharma, Biogen, Celltrion, Chiesi, Fenix Pharma, Ferring, Galápagos, Janssen, MSD, Omega Pharma, Sandoz, Takeda, and Vifor Pharma; A.T. has served as a speaker and/or consultant for AbbVie, Bayer, Fenix Pharma, Galápagos, Janssen, Nalkein, Omega Pharma, and SILA; F.S. (Franco Scaldaferri) has served as a lecturer for AbbVie, Celltrion, Ferring, Janssen, Lilly, Pfizer, Sanofi, and Takeda; D.P. received speaker fees from AbbVie, MSD, Takeda, Janssen, and Pfizer; E.V.S. has served as a speaker for AbbVie, AGPharma, Alfasigma, Dr Falk, EG Stada Group, Fresenius Kabi, Grifols, Janssen, Innovamedica, Malesci, Pfizer, Reckitt Benckiser, Sandoz, SILA, Sofar, Takeda, and Unifarco and has served aa s consultant for Alfasigma, Amgen, Biogen, Bristol-Myers Squibb, Celltrion, Diadema Farmaceutici, Dr Falk, Fresenius Kabi, Janssen, Merck & Co., Reckitt Benckiser, Regeneron, Sanofi, Shire, SILA, Sofar, Synformulas GmbH, Takeda, and Unifarco; he received research support from Pfizer, Reckitt Benckiser, SILA, Sofar, and Unifarco; G.M. (Giovanni Maconi) has served as a speaker for and/or has received advisory board fees from AlfaSigma, Arena, Janssen, Gilead, and Roche; A.P. (Alfredo Papa) received speaker fees from Janssen. The remaining authors declare no competing interests.

Figures

Figure 1
Figure 1
Estimated cumulative clinical remission probability during follow-up in the study group.
Figure 2
Figure 2
Estimated cumulative clinical remission probability during follow-up in patients with or without clinical remission at 12-month follow-up; log-rank test.
Figure 3
Figure 3
(A). C-reactive protein values at baseline and during follow-up. Data are expressed as the median and interquartile range (error bars), according to the Friedman test. (B). Fecal calprotectin values at baseline and during follow-up. Data are expressed as the median and interquartile range (error bars), according to the Friedman test.
See this image and copyright information in PMC

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