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. 2023 Jan 27;17(1):83-91.
doi: 10.1093/ecco-jcc/jjac108.

Effectiveness and Safety of Ustekinumab in Elderly Patients with Crohn's Disease: Real World Evidence From the ENEIDA Registry

Diego Casas-Deza  1   2 , Luis Javier Lamuela-Calvo  1   2 , Fernando Gomollón  2   3   4 , José Miguel Arbonés-Mainar  2   5 , Berta Caballol  4   6 , Javier P Gisbert  4   7 , Montserrat Rivero  8 , Eugenia Sánchez-Rodríguez  9 , Lara Arias García  10 , Ana Gutiérrez Casbas  4   11 , Olga Merino  12 , Lucía Márquez  13 , Viviana Laredo  2   3 , María Dolores Martín-Arranz  14 , Pilar López Serrano  15 , Sabino Riestra Menéndez  16 , Carlos González-Muñoza  17 , Luisa de Castro Parga  18 , Marta Calvo Moya  19 , Esteban Fuentes-Valenzuela  20 , Maria Esteve  4   21 , Marisa Iborra  22 , Miguel Dura Gil  23 , Manuel Barreiro-De Acosta  24 , Rufo Humberto Lorente-Poyatos  25 , Noemí Manceñido  26 , Margalida Calafat  4   27 , Iago Rodríguez-Lago  28 , Jordi Guardiola Capo  29 , Maria Antonia Payeras  30 , Víctor Jair Morales Alvarado  31 , Carlos Tardillo  32 , Luis Bujanda  4   33 , José Fernando Muñoz-Nuñez  34 , Yolanda Ber Nieto  35 , Fernando Bermejo  36 , Pedro Almela  37 , Mercè Navarro-Llavat  38 , Pilar Martínez Montiel  39 , Cristina Rodríguez Gutiérrez  40 , Manuel Van Domselaar  41 , Eva Sesé  42 , Teresa Martínez Pérez  43 , Elena Ricart  4   6 , María Chaparro  4   7 , María José García  8 , Antonio López-Sanromán  9 , Beatriz Sicilia  10 , Beatriz Orts  44 , Alicia López-García  13 , Eduardo Martín-Arranz  45 , José Lázaro Pérez-Calle  15 , Ruth de Francisco  16 , Esther García-Planella  17 , Eugeni Domènech  4   27 , Y Santiago García-López  1   2
Affiliations

Effectiveness and Safety of Ustekinumab in Elderly Patients with Crohn's Disease: Real World Evidence From the ENEIDA Registry

Diego Casas-Deza et al. J Crohns Colitis. .

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.

Keywords: Crohn’s disease; elderly; inflammatory bowel disease; treatment; ustekinumab.

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