| Title: |
P544 Ustekinumab safety and effectiveness in ulcerative colitis patients: results from a large real-life study |
| Authors: |
Mocci, G; Scaldaferri, F; Pugliese, D; Savarino, E; Bodini, G; Cuomo, A; Donnarumma, L; Maconi, G; Cataletti, G; Rodino, S; Sebkova, L; Ferronato, A; Gaiani, F; Marzo, M; Luppino, I; Paese, P; Elisei, W; Monterubbianesi, R; Faggiani, R; Napolitano, D; Grossi, L; Serio, M; Scarcelli, A; Lorenzetti, R; Allegretta, L; Rocco, G; Zampaletta, C; Bolognini, L; Meucci, C; Colucci, R; Tonti, P; Della Valle, N; Piga, R; Forti, G; Onidi, F M; Usai Satta, P; Picchio, M; Papa, A; Tursi, A |
| Source: |
Journal of Crohn's and Colitis ; volume 18, issue Supplement_1, page i1065-i1066 ; ISSN 1873-9946 1876-4479 |
| Publisher Information: |
Oxford University Press (OUP) |
| Publication Year: |
2024 |
| Description: |
Background Ustekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist recently approved for treating ulcerative colitis (UC), but with limited real-world data. We assessed therefore the effectiveness and safety of UST in UC patients in a real-world setting Methods This is a multicentre, retrospective, observational cohort study. The primary endpoint was the clinical remission rate (partial Mayo score, PMS, ≤1). Other endpoints were corticosteroid-free remission (CSFR) rate, clinical response rate (PMS reduction of at least 2 points), and faecal calprotectin (FC) reduction at week 24. Results We included 256 consecutive UC patients (M/F 139/117, median age 52). The clinical remission and clinical response rates at 8 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 8 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 biologics (finding not confirmed at week 24). Adverse events occurred in six patients (2.3%), whereas four patients (1.6%) underwent colectomy. Conclusion This large real-world study shows that UST effectively and safely treats UC patients. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1093/ecco-jcc/jjad212.0674 |
| Availability: |
https://doi.org/10.1093/ecco-jcc/jjad212.0674; https://academic.oup.com/ecco-jcc/article-pdf/18/Supplement_1/i1065/56348812/jjad212.0674.pdf |
| Rights: |
https://academic.oup.com/pages/standard-publication-reuse-rights |
| Accession Number: |
edsbas.8C9362CE |
| Database: |
BASE |