1. Ustekinumab safety and effectiveness in patients with ulcerative colitis: results from a large real-life study
- Author
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Tursi, Antonio, Mocci, Giammarco, Scaldaferri, Franco, Napolitano, Daniele, Maresca, Rossella, Pugliese, Daniela, Semprucci, Gianluca, Savarino, Edoardo, Cuomo, Antonio, Donnarumma, Laura, Bodini, Giorgia, Pasta, Andrea, Maconi, Giovanni, Cataletti, Giovanni, Pranzo, Giuseppe, Rodinò, Stefano, Sebkova, Ladislava, Costa, Francesco, Ferronato, Antonio, Gaiani, Federica, Marzo, Manuela, Luppino, Ileana, Fabiano, Giulia, Paese, Pietro, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Grossi, Laurino, Serio, Mariaelena, Scarcelli, Antonella, Lorenzetti, Roberto, Allegretta, Leonardo, Chiri, Stefania, Grasso, Giuseppina, Antonelli, Elisabetta, Bassotti, Gabrio, Spagnuolo, Rocco, Luzza, Francesco, Fanigliulo, Libera, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Rocchi, Chiara, Bolognini, Laura, Bendia, Emanuele, Bianco, Maria Antonia, Capone, Pietro, Meucci, Costantino, Colucci, Raffaele, Tonti, Paolo, Neve, Viviana, Della Valle, Nicola, Felice, Carla, Pica, Roberta, Cocco, Andrea, Forti, Giacomo, Onidi, Francesca Maria, Usai Satta, Paolo, Checchin, Davide, Gravina, Antonietta Gerarda, Pellegrino, Raffaele, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Papa, Alfredo (ORCID:0000-0002-4186-7298), Tursi, Antonio, Mocci, Giammarco, Scaldaferri, Franco, Napolitano, Daniele, Maresca, Rossella, Pugliese, Daniela, Semprucci, Gianluca, Savarino, Edoardo, Cuomo, Antonio, Donnarumma, Laura, Bodini, Giorgia, Pasta, Andrea, Maconi, Giovanni, Cataletti, Giovanni, Pranzo, Giuseppe, Rodinò, Stefano, Sebkova, Ladislava, Costa, Francesco, Ferronato, Antonio, Gaiani, Federica, Marzo, Manuela, Luppino, Ileana, Fabiano, Giulia, Paese, Pietro, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Grossi, Laurino, Serio, Mariaelena, Scarcelli, Antonella, Lorenzetti, Roberto, Allegretta, Leonardo, Chiri, Stefania, Grasso, Giuseppina, Antonelli, Elisabetta, Bassotti, Gabrio, Spagnuolo, Rocco, Luzza, Francesco, Fanigliulo, Libera, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Rocchi, Chiara, Bolognini, Laura, Bendia, Emanuele, Bianco, Maria Antonia, Capone, Pietro, Meucci, Costantino, Colucci, Raffaele, Tonti, Paolo, Neve, Viviana, Della Valle, Nicola, Felice, Carla, Pica, Roberta, Cocco, Andrea, Forti, Giacomo, Onidi, Francesca Maria, Usai Satta, Paolo, Checchin, Davide, Gravina, Antonietta Gerarda, Pellegrino, Raffaele, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
- Abstract
BackgroundUstekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist recently approved for treating ulcerative colitis (UC) but with limited real-world data. Therefore, we evaluated the effectiveness and safety of UST in patients with UC in a real-world setting.Research design and methodsThis is a multicenter, retrospective, observational cohort study. The primary endpoints were the clinical remission rate (partial Mayo score, PMS, <= 1) and the safety of UST. Other endpoints were corticosteroid-free remission (CSFR) rate, clinical response rate (PMS reduction of at least 2 points), and fecal calprotectin (FC) reduction at week 24.ResultsWe included 256 consecutive patients with UC (M/F 139/117, median age 52). The clinical remission and clinical response rates at eight weeks were 18.7% (44/235) and 53.2% (125/235), respectively, and 27.6% (42/152) and 61.8% (94/152) at 24 weeks, respectively. At 24 weeks, CSFR was 20.3% (31/152), and FC significantly dropped at week 12 (p = 0.0004) and 24 (p = 0.038). At eight weeks, patients naive or with one previous biologic treatment showed higher remission (p = 0.002) and clinical response rates (p = 0.018) than patients previously treated with >= 2. Adverse events occurred in six patients (2.3%), whereas four patients (1.6%) underwent colectomy.ConclusionThis real-world study shows that UST effectively and safely treats patients with UC.
- Published
- 2024