P262 Effectiveness and safety of ustekinumab in elderly patients: Real world evidence from ENEIDA registry

Autor: Beatriz Sicilia, O. Merino Ochoa, C Gonzalez Muñoza, D Casas Deza, Matilde Navarro, Pedro Almela, E Sánchez Rodríguez, L J Lamuela Calvo, Elena Ricart, V J Morales Alvarado, Eduardo Doménech, J Guardiola Capo, Y Ber Nieto, J Garcia Alonso, B Caballo, S García López, Noemí Manceñido, M Dura Gil, J. F. Muñoz Nuñez, I Rodríguez Lago, C A Tardillo, J M Arbonés Mainar, R. Lorente Poyatos, S Riestra Menéndez, M I Calvo Moya, Laredo de la Torre, L De Castro Parga, M Rivero Tirado, A Gutiérrez Casbas, M Iborra Colomino, P Lopez Serrano, M. Barreiro De Acosta, M Calafat, M. Chaparro, Francisco Javier Bermejo, Lucía Márquez, M D Martín Arranz, Javier P. Gisbert, M Esteve, Luis Bujanda
Rok vydání: 2021
Předmět:
Zdroj: Journal of Crohn's and Colitis. 15:S298-S299
ISSN: 1876-4479
1873-9946
DOI: 10.1093/ecco-jcc/jjab076.388
Popis: Background Clinical trials and real-life studies with Ustekinumab in Crohn’s disease show its good efficacy and safety profile. However, there are hardly any data on elderly patients, who are excluded from these clinical trials. Our aim is to evaluate these variables in real-life practice. Methods Retrospective analysis of patients from the prospectively maintained ENEIDA registry treated with Ustekinumab for Crohn’s disease. Elderly patients were selected as those over 60 years old at the start of treatment. They were compared with 2 randomised controls from the same centre, aged less than 60 years, matched for smoking habit. The degree of comorbidity was assessed using the Charlson’s index. Clinical and biochemical activity and effectiveness were defined based on Harvey-Bradshaw index and calprotectin and CRP levels at weeks 16, 32 and 54, when available. Results A total of 648 patients were analysed, 212 elderly (mean age 67 [63.6;72.8] years) and 436 young (mean age 41.6 [32.6;50.0] years). No differences were observed between both groups in baseline variables except for the degree of comorbidity, higher in elderly patients (1.00 [0.00;2.00] vs 0.00 [0.00;0.00], p Clinical response rate was similar in both groups at week 16 (70.5% vs 76.6%, p=0.199), week 32 (67.6% vs 70.2% p=0.104) and week 54 (74% vs 74.9%, p=0.326). Steroid-free remission and biochemical response also showed no differences throughout follow-up. The rate of adverse effects was similar in both groups (14.2% vs 11.2%, p=0.350) except for the occurrence of de novo neoplasms, which was higher in the elderly group (0.69% vs 4.25%, p=0.003). The rate of severe infections (7.08 vs 7.34, p=1.000), the need for surgery (16.5% vs 20.0%, p=0.345) and the need for hospital admission (21.7% vs 19.0%, p=0.489) did not differ. Persistence of UST treatment was similar in both groups (log Rank test p=0.91). Conclusion Ustekinumab achieved clinical response in almost three-quarters of elderly patients, similar to the younger population, with no increase in the rate of infections or other adverse effects, with the exception of de novo neoplasms.
Databáze: OpenAIRE
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