P410 safety of biological drugs for inflammatory bowel disease in elderly patients
Suarez Ferrer, C.J.(1);Mesonero, F.(2);Caballol, B.(3);Ballester, M.P.(4);Baston Rey, I.(5);Castaño Garcia, A.(6);Miranda Bautista, J.(7);Saiz Chumillas, R.(8);Benitez , J.M.(9);Sanchez Delgado, L.(10);Lopez-Garcia, A.(11);Rubin de Celix, C.(12);Lopez Sanroma, A.(2);Martin-Arranz, M.D.(13);Fernández-Clotet , A.(3);Merino Murgui , V.(14);Calviño Suárez , C.(15);Florez, P.(16);Lobato matilla, M.E.(7);Sicilia, B.(17);Soto Escribano, P.(18);Maroto Martin , C.(10);Alonso Abreu, I.(19);Melcarne, L.(20);Plaza Santos, R.(21);Marques Cami, M.(22);Caballero Mateos , A.(23);Gómez Díez , C.(24);Calafat, M.(25);Alonso Galan, H.(26);Vega Villaamil , P.(27);Castro Senosiain , B.(28);Guerro Moya , A.(29);Rodriguez Diaz , C.Y.(30);Spicakova, K.(31);Manceñido Marcos, N.(32);Molina, G.(33);De Castro, L.(34);Mañosa Ciria , M.(25);Barreiro-De Acosta , M.(15);
(1)Hospital Universitario La Paz, Gastroenterology Department. School of Medicine. Universidad Autónoma de Madrid. Hospital La Paz Institute forHealth Research- La Paz Hospital- Madrid, Madrid, Spain;(2)Hospital Universitario Ramon y Cajal, Gastroenterology, Madrid, Spain;(3)Hospital Clinic Barcelona, Gastroenterology, Barcelona, Spain;(4)Hospital Clinico de valencia, Gastroenterology, Valencia, Spain;(5)Hospital universitario Clinico de Santiago, Gastroenterology, Santiago de Compostela, Spain;(6)Hospital Universitario Central Asturias, Gastroenterology, Oviedo, Spain;(7)Hospital universitario Gregorio Marañon, Gastroenterology, Madrid, Spain;(8)Hospital Universitario Burgos, Gastroenterology, Burgos, Spain;(9)Hospital Reina Sofia, gastroenterology, Cordoba, Spain;(10)Hospital Universitario de Valladolid, Gastroenterology, Valladolid, Spain;(11)Hospital del Mar, gastroenterology, Barcelona, Spain;(12)Hospital Universitario de La Princesa- Instituto de Investigación Sanitaria Princesa IISIP., Gastroenterology, Madrid, Spain;(13)Gastroenterology Department. School of Medicine. Universidad Autónoma de Madrid. Hospital La Paz Institute forHealth Research- La Paz Hospital, Gastroenterology, Madrid, Spain;(14)Hospital Clinico of Valencia, gastroenterology, Valencia, Spain;(15)Hospital Universitario Clínico de Santiago, Gastroenterology, Santiago de Compostela, Spain;(16)Hospital Universitario Central de Asturias, gastroenterology, Oviedo, Spain;(17)Burgos University Hospital, gastroenterology, Burgos, Spain;(18)Hospital Universitario Reina Sofia, gastroenterology, Cordoba, Spain;(19)Hospital Universitario de Canarias, Gastroenterology, Tenerife, Spain;(20)Hospital Universitari Parc Taulli- Sabadel, Gastroenterology, Barcelona, Spain;(21)Hospital Infanta Leonor Vallecas, Gastroenterology, Madrid, Spain;(22)Hospital Arnau de Vilanova, Gastroenterology, Lleida, Spain;(23)Hospital Clinico San Cecilio, gastroenterology, Granada, Spain;(24)Hospital Universitario Cabueñes, gastroenterology, Gijon, Spain;(25)Hospital Germans Trias i Pujol, gastroenterology, Badalona, Spain;(26)Hospital Universitario Donostia, gastroenterology, San Sebastian, Spain;(27)Complexo Hospitalario Universitario de Ourense, gastroenterology, Orense, Spain;(28)Hospital Universitario Marqués de Valdecilla. IDIVAL, gastroenterology, Santander, Spain;(29)Complexo Hospitalario Universitario A Coruña, gastroenterology, A Coruña, Spain;(30)Hospital Universitario Nuestra Señora de la Candelaria, gastroenterology, Tenerife, Spain;(31)Hospital Universitario de Alava, gastroenterology, Vitoria, Spain;(32)Hospital Infanta Sofia, Gastroenterology, Madrid, Spain;(33)Hospital Universitario de Ferrol, Gastroenterology, Ferrol, Spain;(34)Hospital Universitario Álvaro Cunqueiro, gastroenterology, Vigo, Spain; on belhaf of young group of GETECCU
Background
The most feared adverse events related to biological treatment in patients with inflammatory bowel disease (IBD) are the development of tumors and / or serious infections. These events are generally more frequent in elderly patients, so the increased use of biological drugs in these patients today makes it necessary to assess the safety of these drugs in this population.
Methods
Patients have been retrospectively included with established diagnosis of IBD at age 65 at the time of initiating biological treatment(Infliximab, Adalimumab, Golimumab, Ustekinumab or Vedolizumab).Data regarding the development of oncological events during treatment have been collected. Variables related to infectious processes during biological treatment have also been included, documented by microbiological analysis and requiring systemic treatment and / or hospitalization(excluding bowel infection by CMV). Statistical analysis was performed with Stata 15.0,categorical variables were compared with the chi2 test for proportions
Results
1090 patients have been retrospectively included. Regarding the development of tumors, we observed an oncological event in 74 (6.9%). They developed in 30 patients (8%) with infliximab, 23 patients (7.1%) with adalimumab, 3 patients(11.1%) with golimumab, 10 patients (6.4%) with ustekinumab, and 8 (3, 8%) vedolizumab. It was significantly lower(p = 0.04) for the vedolizumab group compared to other treatments, however, statistical significance was not reached for the ustekinumab group (p = 0.5). 31% (23 patients) had an oncological history prior to the start of the biological treatment under study. The most frequently developed tumors were cutaneous, not melanocytic in 10 patients, lung in 10 patients and hematological tumors (7 non-Hodgkin lymphoma, 3 acute leukemias and 2 intestinal lymphomas), 7 bladder tumors, 5 prostate and 4 colorectal carcinoma.Regarding the development of infections, these occurred in 160 patients during biological treatment(14.9%), without differences between the different biological drugs used (p = 0.61): infliximab 61,(19.4%), adalimumab 39 (12.5%), golimumab 5(17.8%), ustekinumab 22(14.1%), and vedolizumab 34 (16.5%).Likewise, 85 (53.1%) require hospitalization due to the infectious process and in 51(31.9%), it is permanently suspended due to the infection.Until the end of the follow-up, 158 patients (36.4%) suspended the biological drug due to an adverse effect, with the time until suspension: 1.47 years(mean); SD:1.6
Conclusion
In our experience, the development of tumors is more frequent in patients who use anti-TNF compared to other targets, although its incidence is generally low. However, there are no differences in the development of infections between the different biological treatments.