GastroenterolHepatol. 2024Dec;47(10):502197.doi:10.1016/j.gastrohep.2024.502197. Epub 2024 May 6.

Cristina Suárez Ferrer ¹, Francisco Mesonero Gismero ², Berta Caballol ³, Maria Pilar Ballester ⁴, Iria Bastón Rey ⁵, Andrés Castaño García ⁶, Jose Miranda Bautista ⁷, Rosa Saiz Chumillas ⁸, Jose Manuel Benitez ⁹, Laura Sanchez-Delgado ¹⁰, Alicia López-García ¹¹, Cristina Rubin de Celix ¹², Inmaculada Alonso Abreu ¹³, Luigi Melcarne ¹⁴, Rocío Plaza Santos ¹⁵, Miquel Marques-Camí ¹⁶, Antonio Caballero Mateos ¹⁷, César Gómez Díez ¹⁸, Margalida Calafat ¹⁹, Horacio Alonso Galan ²⁰, Pablo Vega Vilaamil ²¹, Beatriz Castro Senosiain ²², Andrea Guerro Moya ²³, Carmen Yolanda Rodriguez Diaz ²⁴, Katerina Spicakova ²⁵, Noemi Manceñido Marcos ²⁶, Gema Molina ²⁷, Luisa de Castro Parga ²⁸, Andres Rodriguez Angulo ²⁹, Lidia Cuevas Del Campo ³⁰, Maria Del Carmen Rodriguez Grau ³¹, Fernando Ramirez ³², Barbara Gomez Pastrana ³³, Irene Gonzalez Partida ³⁴, Belen Botella Mateu ³⁵, Elena Peña Gonzalez ³⁶, Eduardo Iyo ³⁷, Alfonso Elosua Gonzalez ³⁸, Empar Sainz Arnau ³⁹, Luis Hernandez Villalba ⁴⁰, Pablo Perez Galindo ⁴¹, Leyanira Torrealba Medina ⁴², Sara Monsalve Alonso ⁴³, Jose Antonio Olmos Perez ⁴⁴, Carmen Dueñas Sadornil ⁴⁵, Laura Garcia Ramirez ⁴⁶, María Dolores Martín-Arranz ⁴⁶, Antonio López Sanroman ², Agnès Fernández ³, Victor Merino Murgui ⁴, Cristina Calviño Suárez ⁵, Pablo Flórez-Diez ⁶, María Elena Lobato Matilla ⁷, Beatriz Sicilia ⁸, Pilar Soto Escribano ⁹, Carlos Maroto Martin ¹⁰, Míriam Mañosa ¹⁹, Manuel Barreiro-De Acosta ⁵; On belhaf of Young group of GETECCU

Author information

¹Gastroenterology Department, School of Medicine, Universidad Autónoma de Madrid, Hospital La Paz Institute for Health Research, La Paz Hospital, Madrid, Spain. Electronic address: cristinajulia.suarez@salud.madrid.org.

²Gastroenterology Department, Ramón y Cajal University Hospital, Madrid, Spain.

³Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.

⁴Gastroenterology Department, Hospital Clinico of Valencia, Valencia, Spain.

⁵Gastroenterology Department, Hospital Universitario Clínico de Santiago, Santiago de Compostela, Spain.

⁶Gastroenterology Department, Hospital Universitario Central de Asturias, Oviedo, Spain.

⁷Gastroenterology Department, Hospital Universitario Gregorio Marañon, Madrid, Spain.

⁸Gastroenterology Department, Hospital Universitario de Burgos, Burgos, Spain.

⁹Gastroenterology Department, Hospital Universitario Reina Sofia, Cordoba, Spain.

¹⁰Gastroenterology Department, Hospital Universitario Rio Hortega, Valladolid, Spain.

¹¹Gastroneterology Department, Hospital del Mar, IMIM (Institut de Recerca Hospital del Mar ó Research Institute Hospital del Mar), Barcelona, Spain.

¹²Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IISIP), Madrid, Spain.

¹³Gastroenterology Department, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.

¹⁴Gastroenterology Department, Hospital Universitari Parc Taulli, Sabadel, Barcelona, Spain.

¹⁵Gastroenterology Department, Infanta Leonor University Hospital, Madrid, Spain.

¹⁶Gastroenterology Department, Hospital Arnau de Vilanova, Lleida, Spain.

¹⁷Gastroenterology Department, Hospital Clinico San Cecilio, Granada, Spain.

¹⁸Gastroenterology Department, Hospital Universitario Cabueñes, Gijón, Spain.

¹⁹Gastroenterology Department, Hospital Germans Trias i Pujol, Badalona, Ciberehd, Spain.

²⁰Gastroenterology Department, Hospital Universitario Donostia, Donostia, Spain.

²¹Gastroenterology Department, Complexo Hospitalario Universitario de Ourense, Spain.

²²Gastroenterology Department, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.

²³Gastroenterology Department, Complexo Hospitalario Universitario A Coruña, Spain.

²⁴Gastroenterology Department, Hospital Universitario Nuestra Señora de la Candelaria, Tenerife, Spain.

²⁵Gastroenterology Department, Hospital Universitario de Alava, Vitoria, Spain.

²⁶Gastroenterology Department, Hospital Universitario Infanta Sofia, Madrid, Spain.

²⁷Gastroenterology Department, Hospital Universitario de Ferrol, A Coruña, Spain.

²⁸Gastroenterology Department, Hospital Universitario Álvaro Cunqueiro, Vigo, Spain.

²⁹Gastroenterology Department, Hospital Universitario de Alicante, Spain.

³⁰Gastroenterology Department, Getafe University Hospital, Madrid, Spain.

³¹Gastroenterology Department, Hospital del Henares,Coslada, Madrid, Spain.

³²Gastroneterology Department, Ciudad Real University Hospital, Ciudad Real, Spain.

³³Gastroenterology Department, General Hospital of Mataro, Maresme-Barcelona, Spain.

³⁴Gastroenterology Department, Puerta de Hierro University Hospital, Majadahonda, Madrid, Spain.

³⁵Gastroenterology Department, Hospital Univesitario Infanta Cristina, Parla, Madrid, Spain.

³⁶Gastroenterology Department, Hospital Royo Villanova, Zaragoza, Spain.

³⁷Gastroenterology Department, Hospital Comarcal de Inca, Baleares, Spain.

³⁸Gastroenterology Department, Hospital Garcia Orcoyen, Estella, Navarra, Spain.

³⁹Gastroenterology Department, Hospital Xara Assistencial Althaia de Manressa, Spain.

⁴⁰Gastroenterology Department, Hospital Santos Reyes, Aranda de Duero, Burgos, Spain.

⁴¹Gastroenterology Department, Pontevedra University Hospital Complex, Pontevedra, Spain.

⁴²Gastroenterology Department, Hospital Universitari de Girona Doctor Josep Trueta, Girona, Spain.

⁴³Gastroenterology Department, Hospital Infanta Elena, Valdemoro, Madrid, Spain.

⁴⁴Gastroenterology Department, Hospital Rey Juan Carlos de Móstoles, Madrid, Spain.

⁴⁵Gastroenterology Department, Hospital Universitario de Caceres, Caceres, Spain.

⁴⁶Gastroenterology Department, School of Medicine, Universidad Autónoma de Madrid, Hospital La Paz Institute for Health Research, La Paz Hospital, Madrid, Spain.

Abstract

Introduction: Biological therapies used for the treatment of inflammatory bowel disease (IBD) have shown to be effective and safe, although these results were obtained from studies involving mostly a young population, who are generally included in clinical trials. The aim of our study was to determine the efficacy and safety of the different biological treatments in the elderly population.

Methods: Multicenter study was carried out in the GETECCU group. Patients diagnosed with IBD and aged over 65 years at the time of initiating biological therapy (infliximab, adalimumab, golimumab, ustekinumab or vedolizumab) were retrospectively included. Among the patients included, clinical response was assessed after drug induction (12 weeks of treatment) and at 52 weeks. Patients' colonoscopy data in week 52 were assessment, where available. Regarding complications, development of oncological events during follow-up and infectious processes occurring during biological treatment were collected (excluding bowel infection by cytomegalovirus).

Results: A total of 1090 patients were included. After induction, at approximately 12-14 weeks of treatment, 419 patients (39.6%) were in clinical remission, 502 patients (47.4%) had responded without remission and 137 patients (12.9%) had no response. At 52 weeks of treatment 442 patients (57.1%) had achieved clinical remission, 249 patients had responded without remission (32.2%) and 53 patients had no response to the treatment (6.8%). Before 52 weeks, 129 patients (14.8%) had discontinued treatment due to inefficacy, this being significantly higher (p<0.0001) for Golimumab - 9 patients (37.5%) - compared to the other biological treatments analyzed. With respect to tumor development, an oncological event was observed in 74 patients (6.9%): 30 patients (8%) on infliximab, 23 (7.14%) on adalimumab, 3 (11.1%) on golimumab, 10 (6.4%) on ustekinumab, and 8 (3.8%) on vedolizumab. The incidence was significantly lower (p=0.04) for the vedolizumab group compared to other treatments. As regards infections, these occurred in 160 patients during treatment (14.9%), with no differences between the different biologicals used (p=0.61): 61 patients (19.4%) on infliximab, 39 (12.5%) on adalimumab, 5 (17.8%) on golimumab, 22 (14.1%) on ustekinumab, and 34 (16.5%) on vedolizumab.

Conclusions: Biological drug therapies have response rates in elderly patients similar to those described in the general population, Golimumab was the drug that was discontinued most frequently due to inefficacy. In our experience, tumor development was more frequent in patients who used anti-TNF therapies compared to other targets, although its incidence was generally low and that this is in line with younger patients based on previous literature.