Persistence, Effectiveness, and Safety of Upadacitinib in Crohn's Disease and Ulcerative Colitis in Real Life: Results From a Spanish Nationwide Study (Ureal Study).
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García María José, Brenes Yanire, Vicuña Miren, Bermejo Fernando, Sierra-Ausín Mónica, Vicente Raquel, Arroyo María Teresa, Martínez Montiel Pilar, Villoria Albert, Ferrer Juan Ángel, Hernandez Vicent, Piñero Alexis, Carrillo-Palau Marta, Martín-Arranz María Dolores, Miranda-Bautista José, Pajares Ramón, Arranz Hernández Laura, Bejarano Ana, Guardiola Jordi, Iyo Eduardo, Muñoz-Villafranca Carmen, Talavera Aurora, Alonso-Galán Horacio, Barreiro-de Acosta Manuel, Bosca-Watts Maia, Vázquez Rey Teresa, Echarri Ana, Rodríguez-Grau María Del Carmen, Gutiérrez Ana, Huguet José María, López-Martín M Carmen, Mesonero Francisco, Pérez-Martínez Isabel, Plaza Rocío, Ramírez de la Piscina Patricia, Gisbert Javier P, Chaparro María
Аннотация
METHODS: Retrospective multicenter study of patients with IBD who received upadacitinib before 31st December 2022 and at least 12 weeks before the recruitment date. Clinical effectiveness was assessed based on partial Mayo score for ulcerative colitis (UC) and Harvey-Bradshaw index for Crohn's disease (CD).
RESULTS: We included 100 patients (68 with CD, and 32 with UC). Patients had previously received a median of 4 advanced therapies. Twenty-three discontinued the treatment (median follow-up 7.6 months). CD (vs UC) (hazard ratio 3.7; 95% confidence interval [CI]: 1.04-12.9) and age below 40 years at upadacitinib initiation (hazard ratio 2.4; 95% CI: 1.0-5.8) were associated with treatment discontinuation in multivariable analysis. Clinical remission for IBD was achieved in 59% of patients at week 8, 64% at week 12, and 42% at week 52. The proportion of patients with UC previously exposed to tofacitinib (n = 25) who achieved clinical remission was 78% at week 12, and 50% at week 52. Factors associated with clinical remission at week 12 were UC diagnosis (odds ratio [OR] 4.6; 95% CI: 1.3-17), mild or moderate activity at baseline (OR 8; 95% CI: 1.1-56), and not smoking (OR 4.4; 95% CI: 1.5-13). Dose escalation recaptured remission in 60% of patients with relapse. Eighty percent of patients with active immune-mediated diseases or extraintestinal manifestations improved with upadacitinib. Forty-three patients reported adverse events, 11 of them serious.
DISCUSSION: Upadacitinib is effective and safe for treating patients with highly refractory IBD, even in previously treated with Janus kinase inhibitors.