Effectiveness and safety of ustekinumab in bio-naïve Crohn’s disease patients: a multicentre observational retrospective study

Autor: Valdés Delgado Teresa, Olmedo Martín Rául, Iborra Marisa, Herrera de Guisé Claudia, Fuentes-Valenzuela Esteban, Melcarne Luigi, Martín-Rodríguez Mª Mar, Kolle Casso Lilyan, De Castro Parga Luisa, Ponferrada Díaz Ángel, Vicente Lidón Raquel, Manceñido Marcos Noemí, Velayos Jiménez Benito, Lázaro Sáez Marta, López Cauce Beatriz, Mesonero Gismero Francisco, Gilabert Álvarez Pau, Argüelles-Arias Federico
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Therapeutic Advances in Gastroenterology, Vol 16 (2023)
Druh dokumentu: article
ISSN: 1756-2848
17562848
DOI: 10.1177/17562848231153560
Popis: Background: Clinical trials have demonstrated the efficacy and safety of ustekinumab in Crohn’s disease (CD). However, more data are necessary on the effectiveness of ustekinumab in bio-naïve patients in real-life studies. Objectives: The aim of our study was to evaluate the effectiveness and safety of ustekinumab in patients with CD refractory or intolerant to conventional therapy and without previous exposure to biological drugs. Design: We performed a nationwide, observational, retrospective, multicentre study including patients with CD, in which ustekinumab was used as the first biological drug. Methods: The corticosteroid-free clinical and biological response and remission were analysed at weeks 16, 24, 52 and 72. Clinical remission was defined as Harvey–Bradshaw index ⩽ 4 and biological remission as a faecal calprotectin (FC)
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