1. Effectiveness and Safety of Ustekinumab in Elderly Patients with Crohn's Disease: Real World Evidence From the ENEIDA Registry
- Author
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Diego Casas-Deza, Luis Javier Lamuela-Calvo, Fernando Gomollón, José Miguel Arbonés-Mainar, Berta Caballol, Javier P Gisbert, Montserrat Rivero, Eugenia Sánchez-Rodríguez, Lara Arias García, Ana Gutiérrez Casbas, Olga Merino, Lucía Márquez, Viviana Laredo, María Dolores Martín-Arranz, Pilar López Serrano, Sabino Riestra Menéndez, Carlos González-Muñoza, Luisa de Castro Parga, Marta Calvo Moya, Esteban Fuentes-Valenzuela, Maria Esteve, Marisa Iborra, Miguel Dura Gil, Manuel Barreiro-De Acosta, Rufo Humberto Lorente-Poyatos, Noemí Manceñido, Margalida Calafat, Iago Rodríguez-Lago, Jordi Guardiola Capo, Maria Antonia Payeras, Víctor Jair Morales Alvarado, Carlos Tardillo, Luis Bujanda, José Fernando Muñoz-Nuñez, Yolanda Ber Nieto, Fernando Bermejo, Pedro Almela, Mercè Navarro-Llavat, Pilar Martínez Montiel, Cristina Rodríguez Gutiérrez, Manuel Van Domselaar, Eva Sesé, Teresa Martínez Pérez, Elena Ricart, María Chaparro, María José García, Antonio López-Sanromán, Beatriz Sicilia, Beatriz Orts, Alicia López-García, Eduardo Martín-Arranz, José Lázaro Pérez-Calle, Ruth de Francisco, Esther García-Planella, Eugeni Domènech, and y Santiago García-López
- Subjects
Crohn's disease ,treatment ,inflammatory bowel disease ,Gastroenterology ,General Medicine ,elderly ,ustekinumab - Abstract
Background and Aims Clinical trials and real-life studies with ustekinumab in Crohn’s disease [CD] have revealed a good efficacy and safety profile. However, these data are scarcely available in elderly patients. Therefore, we aim to assess the effectiveness and safety of ustekinumab in elderly patients with CD. Methods Elderly patients [>60 years old] from the prospectively maintained ENEIDA registry treated with ustekinumab due to CD were included. Every patient was matched with two controls under 60 years of age, according to anti-tumour necrosis factor use and smoking habit. Values for the Harvey–Bradshaw Index [HBI], endoscopic activity, C-reactive protein [CRP] and faecal calprotectin [FC] were recorded at baseline and at weeks 16, 32 and 54. Results In total, 648 patients were included, 212 of whom were elderly. Effectiveness was similar between young and elderly patients during the follow-up. Steroid-free remission was similar at week 16 [54.6 vs 51.4%, p = 0.20], 32 [53.0% vs 54.5%, p = 0.26] and 54 [57.8% vs 51.1%, p = 0.21]. Persistence of ustekinumab as maintenance therapy was similar in both age groups [log-rank test; p = 0.91]. There was no difference in the rate of adverse effects [14.2% vs 11.2%, p = 0.350], including severe infections [7.1% vs 7.3%, p = 1.00], except for the occurrence of de novo neoplasms, which was higher in older patients [0.7% vs 4.3%, p = 0.003]. Conclusions Ustekinumab is as effective in elderly patients with CD as it is in non-elderly patients. The safety profile also seems to be similar except for a higher rate of de novo neoplasms, probably related to the age of the elderly patients.
- Published
- 2022