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P338 effectiveness and safety of biological therapies in elderly inflammatory bowel diseases patients results from a multi center study of Geteccu

Suarez Ferrer, C.J.(1);Mesonero , F.(2);Caballol, B.(3);Saiz Chumillas, R.(4);Bastón-Rey, I.(5);Rubin de Celix, C.(6);Melcarne, L.(7);Caballero Mateos, A.(8);Calafat, M.(9);Alonso Galan, H.(10);Vega Villaamil, P.(11);Castro Senosiain, B.(12);Rodriguez Diaz, C.Y.(13);Plaza Santos, R.(14);Marques Cami, M.(15);Rodriguez Grau, M.C.(16);Ramirez, F.(17);Lopez-García, A.(18);Gomez Pastrana, B.(19);Gonzalez Partida, I.(20);Botella Mateu, B.(21);Cuevas del Campo, L.(22);Gonzalez Peña, E.(23);Iyo, E.(24);Elosua Gonzalez, A.(25);Sainz, E.(26);Hernandez, L.(27);Perez Galindo, P.(28);Rueda Garcia, J.L.(29);Martin-Arranz, M.D.(29);Lopez Sanroman, A.(30);Fernandez-Clotet, A.(3);Sicilia, B.(4);Calviño Suárez, C.(5);Mañosa Ciria, M.(9);Barreiro-De Acosta, M.(5);

(1)Hospital Universitario La Paz, GASTROENTEROLOGY DEPARTMENT, Madrid, Spain;(2)Ramón y Cajal University Hospital. Madrid, Gastroenterology Department-, Madrid, Spain;(3)Hospital Clinic of Barcelona, Gastroenterology department, Barcelona, Spain;(4)Burgos University Hospital, Gastroenterology department, Burgos, Spain;(5)Hospital Universitario Clínico de Santiago, Gastroenterology department, Santiago de compostela, Spain;(6)Hospital Universitario de La Princesa- Instituto de Investigación Sanitaria Princesa IIS-IP., Gastroenterology deparment, Madrid, Spain;(7)Hospital Universitari Parc Taulli, Gastroenterology Department, Sabadel- Barcelona, Spain;(8)Hospital Clinico San Cecilio, Gastroenterology department, Granada, Spain;(9)Hospital Germans Trias i Pujol, Gastroenterology department, Badalona, Spain;(10)Hospital Comarcal de Guipuzcua, Gastroenterology Department, Donostia, Spain;(11)Complexo Hospitalario Universitario de Ourense, Gastroenterology department, Ourense, Spain;(12)Hospital Universitario Marqués de Valdecilla. IDIVAL, Gastroenterology Department, Santander, Spain;(13)Hospital Universitario Nuestra Señora de la Candelaria, Gastroenterology Department, Tenerife, Spain;(14)Infanta Leonor University Hospital, Gastroenterology department, Madrid, Spain;(15)Hospital Arnau de Vilanova, Gastroenterology Department, Lleida, Spain;(16)Hospital del Henares, Gastroenterology Department, Coslada- Madrid, Spain;(17)Ciudad Real University Hospital, Gastroenterology Department, Ciudad Real, Spain;(18)Hospital del Mar, Gastroenterology Department, Barcelona, Spain;(19)General Hospital of Mataro, Gastroenterology Department, Maresme-Barcelona, Spain;(20)Hospital Universitario puerta de hierro, Gastroenterology department, Majadahonda-Madrid, Spain;(21)Hospital Univesitario Infanta Cristina, Gastroenterology department, Parla-Madrid, Spain;(22)Getafe University Hospital, Gastroenterology department, Getafe-Madrid, Spain;(23)Hospital Royo Villanova, Gastroenterology department, Zaragoza, Spain;(24)Hospital Comarcal de Inca, Gastroenterology Department, Baleares, Spain;(25)Hospital Garcia Orcoyen, Gastroenterology department, Estella-Navarra, Spain;(26)Hospital Xara Assistencial Althaia de Manressa, Gastroenterology Department, Barcelona, Spain;(27)Hospital Santos Reyes, Gastroenterology department, Aranda del duero-Burgos, Spain;(28)Pontevedra University Hospital Complex, Gastroenterology department, Pontevedra, Spain;(29)School of Medicine. Universidad Autónoma de Madrid. Hospital La Paz Institute forHealth Research- La Paz Hospita, Gastroenterology Department, Madrid, Spain;(30)Ramón y Cajal University Hospital, Gastroenterology deparment, Madrid, Spain; On behalf of the young GETECCU group

Background

Biological drugs are being increasingly used for the treatment of inflammatory bowel diseases (IBD) in elderly patients. Despite the particular characteristics of this population subgroup, the efficacy and safety of these treatments in real clinical practice is poorly evaluated.

Methods

Retrospective and multicenter study of GETECCU, carried out in 28 Spanish hospitals. Patients with IBD who started biological treatment (Infliximab, Adalimumab, Golimumab, Ustekinumab or Vedolizumab) aged 65 years or older were included. Efficacy (clinical- at the criteria of the responsible physician-, biochemical and endoscopic) was assessed at 12-14 weeks and at 52 weeks of treatment. Adverse effects such as tumors or serious infections were also recorded.

Results

A total of 570 patients were included, baseline characteristics are shown in Table 1. Biologics  used were: Infliximab (214, 37.5%), Adalimumab (167, 29.3%), Golimumab (16, 2.8%), Ustekinumab (73, 12.8%) and Vedolizumab (100, 17.5%). 

After 12-14 weeks of treatment, in 38.7% (220) of the cases clinical remission had been achieved and in 47.7% (270) there was clinical response without remission. However, 80 patients (13.9%) had no response, resulting in treatment discontinuation due to primary failure.

At week 52, only 379 patients (66.5%) continued on biological treatment: 216 (57%) were in clinical remission (216, 57.0%) while 129 (34%) had response without remission and 34 (9%)had no response. In addition, 119 patients (21%) had an endoscopic study performed: 47 (39,5%) presented with endoscopic remission, 38 (31,9%) with mild activity, 28 (23,5%) with moderate activity and 6, (5.1%) with severe activity.

At the end of the follow-up, only 60% of the patients continued on biological treatment, being the reason for withdraw lack of efficacy or due to the report of adverse side effects. 

Regarding treatment safety in this population, 12.1% (68 patients) suffered an infectious complication with a microbiological diagnosis, requiring hospitalization in 62.1% of the cases. In addition, 39 patients (6.9%) were diagnosed with a tumor until the end of the follow-up, noting that 34.2% of the cases continued on biological therapy after the diagnosis. Likewise, in 25 patients (36.8%) this infection forced discontinuation of biological treatment. Finally, 10 patients stopped biological treatment due to a serious adverse reaction to it

Conclusion

Response rates to biological treatment in elderly patients are similar to those described in the general population, with approximately one third of failures happening during the first year. However, a remarkable proportion of patients developed a serious adverse effect that could be related to treatment

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