P262 Effectiveness and safety of ustekinumab in elderly patients: Real world evidence from ENEIDA registry
Casas Deza, D.(1);Lamuela Calvo, L.J.(1);Arbonés Mainar, J.M.(2);Ricart, E.(3);Gisbert, J.P.(4);Rivero Tirado, M.(5);Sanchez Rodríguez, E.(6);Sicilia, B.(7);Gutierrez Casbas, A.(8);Merino Ochoa, O.(9);Márquez, L.(10);Laredo de la Torre, V.(11);Martin Arranz, M.D.(12);Lopez Serrano, P.(13);Riestra Menéndez, S.(14);Gonzalez Muñoza, C.(15);de Castro Parga, L.(16);Calvo Moya, M.(17);Garcia Alonso, J.(18);Esteve, M.(19);Iborra Colomino, M.(20);Dura Gil, M.(21);Barreiro de Acosta, M.(22);Lorente Poyatos, R.(23);Manceñido, N.(24);Caballo, B.(3);Calafat, M.(25);Rodríguez Lago, I.(26);Guardiola Capo, J.(27);Morales Alvarado, V.J.(28);Tardillo, C.(29);Bujanda, L.(30);Muñoz Nuñez, J.F.(31);Ber Nieto, Y.(32);Bermejo, F.(33);Chaparro, M.(4);Almela, P.(34);Navarro, M.(35);Domènech, E.(36);García López, S.(1);
(1)Hospital Universitario Miguel Servet, Servicio de Aparato Digestivo, Zaragoza, Spain;(2)Instituto Aragonés de Ciencias de la Salud, Unidad de investigación traslacional, Zaragoza, Spain;(3)Hospital Clinic, Servicio de Aparato Digestivo, Barcelona, Spain;(4)Hospital Universitario La Princesa, Servicio de Aparato Digestivo, Madrid, Spain;(5)Hospital Universitario Marqués de Valdecilla, Servicio de Aparato Digestivo, Santander, Spain;(6)Hospital Universitario Ramón y Cajal, Servicio de Aparato Digestivo, Madrid, Spain;(7)Hospital Universitario de Burgos, Servicio de Aparato Digestivo, Burgos, Spain;(8)Hospital General de Alicante, Servicio de Aparato Digestivo, Alicante, Spain;(9)Hospital Universitario de Cruces, Servicio de Aparato Digestivo, Baracaldo, Spain;(10)Hospital del Mar, Servicio de Aparato Digestivo, Barcelona, Spain;(11)Hospital Clínico Universitario Lozano Blesa, Servicio de Aparato Digestivo, Zaragoza, Spain;(12)Hospital Universitario La Paz, Servicio de Aparato Digestivo, Madrid, Spain;(13)Hospital Universitario Fundación de Alcorcón, Servicio de Aparato Digestivo, Alcorcón, Spain;(14)Hospital Universitario Central de Asturias, Servicio de Aparato Digestivo, Oviedo, Spain;(15)Hospital de la Santa Creu i Sant Pau, Servicio de Aparato Digestivo, Barcelona, Spain;(16)Complexo Hospitalario Universitario de Vigo, Servicio de Aparato Digestivo, Vigo, Spain;(17)Hospital Puerta del Hierro, Servicio de Aparato Digestivo, Madrid, Spain;(18)Hospital Universitario Rio Hortega, Servicio de Aparato Digestivo, Valladolid, Spain;(19)Hospital Mutua de Terrasa, Servicio de Aparato Digestivo, Terrasa, Spain;(20)Hospital Universitario La Fe, Servicio de Aparato Digestivo, Valencia, Spain;(21)Hospital Clínico Universitario de Valladolid, Servicio de Aparato Digestivo, Valladolid, Spain;(22)Hospital Universitario de Santiago, Servicio de Aparato Digestivo, Santiago de Compostela, Spain;(23)Hospital General de Ciudad Real, Servicio de Aparato Digestivo, Ciudad Real, Spain;(24)Hospital Infanta Sofía, Servicio de Aparato Digestivo, San Sebastián de los Reyes, Spain;(25)Hospital universitario German Trias i Pujol, Badalona, Badalona, Spain;(26)Hospital de Galdakao, Servicio de Aparato Digestivo, Galdakao, Spain;(27)Hospital Universitario de Bellvitge, Servicio de aparato digestivo, Hospitalet del Llobregat, Spain;(28)Hospital General de Granollers, Servicio de Aparato Digestivo, Granollers, Spain;(29)Hospital Nuestra Señora de la Candelaria, Servicio de Aparato Digestivo, Santa Cruz de Tenerife, Spain;(30)Hospital de Donostia, Servicio de Aparato Digestivo, San Sebastian, Spain;(31)Hospital Universitario de Salamanca, Servicio de Aparato Digestivo, Salamanca, Spain;(32)Hospital San Jorge, Servicio de Aparato digestivo, Huesca, Spain;(33)Hospital Universitario de Fuenlabrada, Servicio de Aparato Digestivo, Fuenlabrada, Spain;(34)Hospital General de Castellón, Servicio de Aparato Digestivo, Castellón, Spain;(35)Hospital Moises Broggi, Servicio de Aparato digestivo, San Juan Despí, Spain;(36)Hospital Universitario German Trias i Pujol, Servicio de Aparato Digestivo, Badalona, Spain; on behalf of the ENEIDA registry of GETECCU.
Background
Clinical trials and real-life studies with Ustekinumab in Crohn's disease show its good efficacy and safety profile. However, there are hardly any data on elderly patients, who are excluded from these clinical trials. Our aim is to evaluate these variables in real-life practice.
Methods
Retrospective analysis of patients from the prospectively maintained ENEIDA registry treated with Ustekinumab for Crohn's disease. Elderly patients were selected as those over 60 years old at the start of treatment. They were compared with 2 randomised controls from the same centre, aged less than 60 years, matched for smoking habit. The degree of comorbidity was assessed using the Charlson’s index. Clinical and biochemical activity and effectiveness were defined based on Harvey-Bradshaw index and calprotectin and CRP levels at weeks 16, 32 and 54, when available.
Results
A total of 648 patients were analysed, 212 elderly (mean age 67 [63.6;72.8] years) and 436 young (mean age 41.6 [32.6;50.0] years). No differences were observed between both groups in baseline variables except for the degree of comorbidity, higher in elderly patients (1.00 [0.00;2.00] vs 0.00 [0.00;0.00], p<0.001) and previous anti-TNF use, lower in the elderly (3.44% vs 15.2%, p<0.001). Baseline clinical and biochemical activity was similar in both groups.
Clinical response rate was similar in both groups at week 16 (70.5% vs 76.6%, p=0.199), week 32 (67.6% vs 70.2% p=0.104) and week 54 (74% vs 74.9%, p=0.326). Steroid-free remission and biochemical response also showed no differences throughout follow-up.
The rate of adverse effects was similar in both groups (14.2% vs 11.2%, p=0.350) except for the occurrence of de novo neoplasms, which was higher in the elderly group (0.69% vs 4.25%, p=0.003). The rate of severe infections (7.08 vs 7.34, p=1.000), the need for surgery (16.5% vs 20.0%, p=0.345) and the need for hospital admission (21.7% vs 19.0%, p=0.489) did not differ.
Persistence of UST treatment was similar in both groups (log Rank test p=0.91).| Table 1. Characteristics of the study population | |||
|---|---|---|---|
| Variable | > 60 years N=436 | < 60 years N=212 | p-value |
| Female gender, N (%) | 208 (47.7%) | 109 (51.4%) | 0.422 |
| Corticosteroids at baseline, N (%) | 127 (29.3) | 54 (25.5) | 0.352 |
| Prior anti-TNF treatment, N (%) | 421 (96.66) | 180 (84.8) | <0.001 |
| HB at baseline [RIQ] | 6.00 [3.00;9.75] | 6.00 [4.00;9.00] | 0.503 |
| Calprotectine at baseline mg/kg [RIQ] | 395 [169;887] | 456 [214;984] | 0.436 |
| CRP at baseline mg/dl [RIQ] | 2.08 [0.55;4.90] | 2.07 [0.54;5.11] | 0.691 |
Conclusion
Ustekinumab achieved clinical response in almost three-quarters of elderly patients, similar to the younger population, with no increase in the rate of infections or other adverse effects, with the exception of de novo neoplasms.