Effectiveness and Safety of Ustekinumab in Elderly Patients with Crohn's Disease: Real World Evidence From the ENEIDA Registry
Por:
Casas-Deza, D, Lamuela-Calvo, LJ, Gomollon, F, Arbones-Mainar, JM, Caballol, B, Gisbert, JP, Rivero, M, Sanchez-Rodriguez, E, Garcia, LA, Casbas, AG, Merino, O, Marquez, L, Laredo, V, Martin-Arranz, MD, Serrano, PL, Menendez, SR, Gonzalez-Munoza, C, Parga, LD, Moya, MC, Fuentes-Valenzuela, E, Esteve, M, Iborra, M, Gil, MD, Barreiro-De Acosta, M, Lorente-Poyatos, RH, Mancenido, N, Calafat, M, Rodriguez-Lago, I, Capo, JG, Payeras, MA, Alvarado, VJM, Tardillo, C, Bujanda, L, Munoz-Nunez, JF, Nieto, YB, Bermejo, F, Almela, P, Navarro-Llavat, M, Montiel, PM, Gutierrez, CR, Van Domselaar, M, Sese, E, Perez, TM, Ricart, E, Chaparro, M, Garcia, MJ, Lopez-Sanroman, A, Sicilia, B, Orts, B, Lopez-Garcia, A, Martin-Larraz, E, Perez-Calle, JL, de Francisco, R, Garcia-Planella, E, Domenech, E and Garcia-Loper, S
Publicada:
27 ene 2023
Ahead of Print:
1 ago 2022
Resumen:
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.
Filiaciones:
Casas-Deza, D:
Univ Hosp Miguel Servet, Gastroenterol Dept, Zaragoza, Spain
Inst Hlth Res Aragon IIS Aragon, Zaragoza, Spain
Lamuela-Calvo, LJ:
Univ Hosp Miguel Servet, Gastroenterol Dept, Zaragoza, Spain
Inst Hlth Res Aragon IIS Aragon, Zaragoza, Spain
Gomollon, F:
Inst Hlth Res Aragon IIS Aragon, Zaragoza, Spain
Univ Hosp Lozano Blesa, Gastroenterol Dept, Zaragoza, Spain
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Arbones-Mainar, JM:
Inst Hlth Res Aragon IIS Aragon, Zaragoza, Spain
Ctr Invest Biomed Red Fisiopatol Obesidad & Nutr, Inst Invest Sanitaria IIS Aragon, Inst Aragones Ciencias Salud IACS, Madrid, Spain
Caballol, B:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Hosp Clin Barcelona, Barcelona Inst Invest Biomed August Pi & Sunyer I, Gastroenterol Dept, Barcelona, Spain
Gisbert, JP:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Univ Autonoma Madrid UAM, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS Princesa, Gastroenterol Dept, Madrid, Spain
Rivero, M:
Hosp Univ Marques de Valdecilla, Inst Invest IDIVAL Santander, Gastroenterol Dept, Santander, Spain
Sanchez-Rodriguez, E:
Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid, Spain
Garcia, LA:
Hosp Univ Burgos, Gastroenterol Dept, Burgos, Spain
Casbas, AG:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Hosp Gen Alicante, Gastroenterol Dept, Alicante, Spain
Merino, O:
Hosp Univ Cruces, Gastroenterol Dept, Baracaldo, Spain
Marquez, L:
Hosp del Mar, Gastroenterol Dept, Barcelona, Spain
Laredo, V:
Inst Hlth Res Aragon IIS Aragon, Zaragoza, Spain
Univ Hosp Lozano Blesa, Gastroenterol Dept, Zaragoza, Spain
Martin-Arranz, MD:
Univ Autonoma Madrid, Dept Gastroenterol, La Paz Univ Hosp, Sch Med,La Paz Hosp,Hosp La Paz Inst Hlth Res, Madrid, Spain
Serrano, PL:
Hosp Univ Fdn Alcorcon, Gastroenterol Dept, Alcorcon, Spain
Menendez, SR:
Univ Hosp Cent Asturias, Gastroenterol Dept, Oviedo, Spain
Inst Invest Sanitaria Principado Asturias ISPA, Oviedo, Spain
Gonzalez-Munoza, C:
Hosp Santa Creu & Sant Pau, Gastroenterol Dept, Barcelona, Spain
Parga, LD:
Complexo Hosp Univ Vigo, Gastroenterol Dept, Vigo, Spain
Moya, MC:
Hosp Univ Puerto de Hierro, Gastroenterol Dept, Madrid, Spain
Fuentes-Valenzuela, E:
Univ Hosp Rio Hortega, Gastroenterol Dept, Valladolid, Spain
Esteve, M:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Hosp Mutua Terrasa, Gastroenterol Dept, Terrassa, Spain
Iborra, M:
Hosp Univ & Politecn La Fe, Gastroenterol Dept, Valencia, Spain
Gil, MD:
Hosp Clin Univ Valladolid, Gastroenterol Dept, Valladolid, Spain
Barreiro-De Acosta, M:
Hosp Univ Santiago, Gastroenterol Dept, Santiago De Compostela, Spain
Lorente-Poyatos, RH:
Hosp Gen Ciudad Real, Gastroenterol Dept, Ciudad Real, Spain
Mancenido, N:
Hosp Univ Infanta Sofia, Gastroenterol Dept, San Sebastian Los Reyes, Spain
Calafat, M:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Hosp Badalona Germans Trias & Pujol, Gastroenterol Dept, Badalona, Spain
Rodriguez-Lago, I:
Biocruces Bizkaia HRI, Gastroenterol Dept, Galdakao, Spain
Capo, JG:
Hosp Univ Bellvitge, Gastroenterol Dept, Lhospitalet De Llobregat, Spain
Payeras, MA:
Hosp Son Espases, Gastroenterol Dept, Palma De Mallorca, Spain
Alvarado, VJM:
Hosp Gen Granollers, Gastroenterol Dept, Granollers, Spain
Tardillo, C:
Hosp Nuestra Senora de la Candelaria, Gastroenterol Dept, Santa Cruz De Tenerife, Spain
Bujanda, L:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Univ Pais Vasco UPV EHU, Inst Biodonostia, San Sebastian, Spain
Munoz-Nunez, JF:
Hosp Univ Salamanca, Gastroenterol Dept, Salamanca, Spain
Nieto, YB:
Hosp San Jorge, Gastroenterol Dept, Huesca, Spain
Bermejo, F:
Hosp Univ Fuenlabrada, Gastroenterol Dept, Fuenlabrada, Spain
Almela, P:
Hosp Gen Castello, Gastroenterol Dept, Castellon de La Plana, Spain
Navarro-Llavat, M:
Hosp Moises Broggi, Gastroenterol Dept, St Joan Despi, Spain
Montiel, PM:
Hosp 12 Octubre, Gastroenterol Dept, Madrid, Spain
Gutierrez, CR:
Complejo Univ Navarra, Gastroenterol Dept, Pamplona, Spain
Van Domselaar, M:
Hosp Torrejon, Gastroenterol Dept, Torrejon, Spain
Sese, E:
Hosp Arnau Vilanova, Gastroenterol Dept, Lleida, Spain
Perez, TM:
Hosp Virgen de la Luz, Gastroenterol Dept, Cuenca, Spain
Ricart, E:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Hosp Clin Barcelona, Barcelona Inst Invest Biomed August Pi & Sunyer I, Gastroenterol Dept, Barcelona, Spain
Chaparro, M:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Univ Autonoma Madrid UAM, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS Princesa, Gastroenterol Dept, Madrid, Spain
Garcia, MJ:
Hosp Univ Marques de Valdecilla, Inst Invest IDIVAL Santander, Gastroenterol Dept, Santander, Spain
Lopez-Sanroman, A:
Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid, Spain
Sicilia, B:
Hosp Univ Burgos, Gastroenterol Dept, Burgos, Spain
Orts, B:
Hosp Gen Univ Alicante, ISABIAL, Clin Pharmacol, Isabial, Spain
Lopez-Garcia, A:
Hosp del Mar, Gastroenterol Dept, Barcelona, Spain
Martin-Larraz, E:
La Paz Univ Hosp, Dept Gastroenterol, Madrid, Spain
La Paz Hosp, Hosp La Paz Inst Hlth Res, Madrid, Spain
Perez-Calle, JL:
Hosp Univ Fdn Alcorcon, Gastroenterol Dept, Alcorcon, Spain
de Francisco, R:
Univ Hosp Cent Asturias, Gastroenterol Dept, Oviedo, Spain
Inst Invest Sanitaria Principado Asturias ISPA, Oviedo, Spain
Garcia-Planella, E:
Hosp Santa Creu & Sant Pau, Gastroenterol Dept, Barcelona, Spain
:
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain
Hosp Badalona Germans Trias & Pujol, Gastroenterol Dept, Badalona, Spain
Garcia-Loper, S:
Univ Hosp Miguel Servet, Gastroenterol Dept, Zaragoza, Spain
Inst Hlth Res Aragon IIS Aragon, Zaragoza, Spain
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