학술논문
Ustekinumab safety and effectiveness in patients with ulcerative colitis: results from a large real-life study
Document Type
Article
Author
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
Source
Expert Opinion on Biological Therapy; February 2024, Vol. 24 Issue: 1-2 p101-109, 9p
Subject
Language
ISSN
14712598; 17447682
Abstract
ABSTRACTBackgroundUstekinumab (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 naïve 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.