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

被引：22

作者：

Casas-Deza, Diego ^{[1
,2
]}

Lamuela-Calvo, Luis Javier ^{[1
,2
]}

Gomollon, Fernando ^{[2
,3
,4
]}

Arbones-Mainar, Jose Miguel ^{[2
,5
]}

Caballol, Berta ^{[4
,6
]}

Gisbert, Javier P. ^{[4
,7
]}

Rivero, Montserrat ^{[8
]}

Sanchez-Rodriguez, Eugenia ^{[9
]}

Arias Garcia, Lara ^{[10
]}

Gutierrez Casbas, Ana ^{[4
,11
]}

Merino, Olga ^{[12
]}

Marquez, Lucia ^{[13
]}

Laredo, Viviana ^{[2
,3
]}

Martin-Arranz, Maria Dolores ^{[14
]}

Lopez Serrano, Pilar ^{[15
]}

Riestra Menendez, Sabino ^{[16
,17
]}

Gonzalez-Munoza, Carlos ^{[18
]}

de Castro Parga, Luisa ^{[19
]}

Calvo Moya, Marta ^{[20
]}

Fuentes-Valenzuela, Esteban ^{[21
]}

Esteve, Maria ^{[4
,22
]}

Iborra, Marisa ^{[23
]}

Dura Gil, Miguel ^{[24
]}

Barreiro-De Acosta, Manuel ^{[25
]}

Lorente-Poyatos, Rufo Humberto ^{[26
]}

Mancenido, Noemi ^{[27
]}

Calafat, Margalida ^{[4
,28
]}

Rodriguez-Lago, Iago ^{[29
]}

Guardiola Capo, Jordi ^{[30
]}

Antonia Payeras, Maria ^{[31
]}

Morales Alvarado, Victor Jair ^{[32
]}

Tardillo, Carlos ^{[33
]}

Bujanda, Luis ^{[4
,34
]}

Munoz-Nunez, Jose Fernando ^{[35
]}

Ber Nieto, Yolanda ^{[36
]}

Bermejo, Fernando ^{[37
]}

Almela, Pedro ^{[38
]}

Navarro-Llavat, Merce ^{[39
]}

Martinez Montiel, Pilar ^{[40
]}

Rodriguez Gutierrez, Cristina ^{[41
]}

Van Domselaar, Manuel ^{[42
]}

Sese, Eva ^{[43
]}

Martinez Perez, Teresa ^{[44
]}

Ricart, Elena ^{[4
,6
]}

Chaparro, Maria ^{[4
,7
]}

Jose Garcia, Maria ^{[8
]}

Lopez-Sanroman, Antonio ^{[9
]}

Sicilia, Beatriz ^{[10
]}

Orts, Beatriz ^{[45
]}

Lopez-Garcia, Alicia ^{[13
]}

机构：

[1] Univ Hosp Miguel Servet, Gastroenterol Dept, Zaragoza, Spain

[2] Inst Hlth Res Aragon IIS Aragon, Zaragoza, Spain

[3] Univ Hosp Lozano Blesa, Gastroenterol Dept, Zaragoza, Spain

[4] Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain

[5] Ctr Invest Biomed Red Fisiopatol Obesidad & Nutr, Inst Invest Sanitaria IIS Aragon, Inst Aragones Ciencias Salud IACS, Madrid, Spain

[6] Hosp Clin Barcelona, Barcelona Inst Invest Biomed August Pi & Sunyer I, Gastroenterol Dept, Barcelona, Spain

[7] Univ Autonoma Madrid UAM, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS Princesa, Gastroenterol Dept, Madrid, Spain

[8] Hosp Univ Marques de Valdecilla, Inst Invest IDIVAL Santander, Gastroenterol Dept, Santander, Spain

[9] Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid, Spain

[10] Hosp Univ Burgos, Gastroenterol Dept, Burgos, Spain

[11] Hosp Gen Alicante, Gastroenterol Dept, Alicante, Spain

[12] Hosp Univ Cruces, Gastroenterol Dept, Baracaldo, Spain

[13] Hosp del Mar, Gastroenterol Dept, Barcelona, Spain

[14] Univ Autonoma Madrid, Dept Gastroenterol, La Paz Univ Hosp, Sch Med,La Paz Hosp,Hosp La Paz Inst Hlth Res, Madrid, Spain

[15] Hosp Univ Fdn Alcorcon, Gastroenterol Dept, Alcorcon, Spain

[16] Univ Hosp Cent Asturias, Gastroenterol Dept, Oviedo, Spain

[17] Inst Invest Sanitaria Principado Asturias ISPA, Oviedo, Spain

[18] Hosp Santa Creu & Sant Pau, Gastroenterol Dept, Barcelona, Spain

[19] Complexo Hosp Univ Vigo, Gastroenterol Dept, Vigo, Spain

[20] Hosp Univ Puerto de Hierro, Gastroenterol Dept, Madrid, Spain

[21] Univ Hosp Rio Hortega, Gastroenterol Dept, Valladolid, Spain

[22] Hosp Mutua Terrasa, Gastroenterol Dept, Terrassa, Spain

[23] Hosp Univ & Politecn La Fe, Gastroenterol Dept, Valencia, Spain

[24] Hosp Clin Univ Valladolid, Gastroenterol Dept, Valladolid, Spain

[25] Hosp Univ Santiago, Gastroenterol Dept, Santiago De Compostela, Spain

[26] Hosp Gen Ciudad Real, Gastroenterol Dept, Ciudad Real, Spain

[27] Hosp Univ Infanta Sofia, Gastroenterol Dept, San Sebastian Los Reyes, Spain

[28] Hosp Badalona Germans Trias & Pujol, Gastroenterol Dept, Badalona, Spain

[29] Biocruces Bizkaia HRI, Gastroenterol Dept, Galdakao, Spain

[30] Hosp Univ Bellvitge, Gastroenterol Dept, Lhospitalet De Llobregat, Spain

[31] Hosp Son Espases, Gastroenterol Dept, Palma De Mallorca, Spain

[32] Hosp Gen Granollers, Gastroenterol Dept, Granollers, Spain

[33] Hosp Nuestra Senora de la Candelaria, Gastroenterol Dept, Santa Cruz De Tenerife, Spain

[34] Univ Pais Vasco UPV EHU, Inst Biodonostia, San Sebastian, Spain

[35] Hosp Univ Salamanca, Gastroenterol Dept, Salamanca, Spain

[36] Hosp San Jorge, Gastroenterol Dept, Huesca, Spain

[37] Hosp Univ Fuenlabrada, Gastroenterol Dept, Fuenlabrada, Spain

[38] Hosp Gen Castello, Gastroenterol Dept, Castellon de La Plana, Spain

[39] Hosp Moises Broggi, Gastroenterol Dept, St Joan Despi, Spain

[40] Hosp 12 Octubre, Gastroenterol Dept, Madrid, Spain

[41] Complejo Univ Navarra, Gastroenterol Dept, Pamplona, Spain

[42] Hosp Torrejon, Gastroenterol Dept, Torrejon, Spain

[43] Hosp Arnau Vilanova, Gastroenterol Dept, Lleida, Spain

[44] Hosp Virgen de la Luz, Gastroenterol Dept, Cuenca, Spain

[45] Hosp Gen Univ Alicante, ISABIAL, Clin Pharmacol, Isabial, Spain

[46] La Paz Univ Hosp, Dept Gastroenterol, Madrid, Spain

[47] La Paz Hosp, Hosp La Paz Inst Hlth Res, Madrid, Spain

来源：

JOURNAL OF CROHNS & COLITIS | 2023年 / 17卷 / 01期

关键词：

Crohn's disease; ustekinumab; elderly; inflammatory bowel disease; treatment; INFLAMMATORY-BOWEL-DISEASE; ANTI-TNF THERAPY; OLDER-ONSET; INFECTION; EFFICACY; RISK; DISCONTINUATION; MULTICENTER; INDUCTION; PHENOTYPE;

D O I：

10.1093/ecco-jcc/jjac108

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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.

引用

页码：83 / 91

页数：9

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