Ustekinumab safety and effectiveness in patients with ulcerative colitis: results from a large real-life study

dataset

posted on 2024-01-22, 10:40 authored by Antonio Tursi, Giammarco Mocci, Franco Scaldaferri, Daniele Napolitano, Rossella Maresca, Daniela Pugliese, Gianluca Semprucci, Edoardo Savarino, Antonio Cuomo, Laura Donnarumma, Giorgia Bodini, Andrea Pasta, Giovanni Maconi, Giovanni Cataletti, Giuseppe Pranzo, Stefano Rodinò, Ladislava Sebkova, Francesco Costa, Antonio Ferronato, Federica Gaiani, Manuela Marzo, Ileana Luppino, Giulia Fabiano, Pietro Paese, Walter Elisei, Rita Monterubbianesi, Roberto Faggiani, Laurino Grossi, Mariaelena Serio, Antonella Scarcelli, Roberto Lorenzetti, Leonardo Allegretta, Stefania Chiri, Giuseppina Grasso, Elisabetta Antonelli, Gabrio Bassotti, Rocco Spagnuolo, Francesco Luzza, Libera Fanigliulo, Giulia Rocco, Carlotta Sacchi, Costantino Zampaletta, Chiara Rocchi, Laura Bolognini, Emanuele Bendia, Maria Antonia Bianco, Pietro Capone, Costantino Meucci, Raffaele Colucci, Paolo Tonti, Viviana Neve, Nicola Della Valle, Carla Felice, Roberta Pica, Andrea Cocco, Giacomo Forti, Francesca Maria Onidi, Paolo Usai Satta, Davide Checchin, Antonietta Gerarda Gravina, Raffaele Pellegrino, Marcello Picchio, Alfredo Papa

Ustekinumab (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.

This 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.

We 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.

This real-world study shows that UST effectively and safely treats patients with UC.