P634 Ustekinumab and vedolizumab as first-line biological therapy for inflammatory bowel disease. A multicenter study based on the ENEIDA registry.
Calafat Sard, M.(1,2)*;Pascual, I.(3);Nos, P.(2,4); Barrio, J.(5); Gutiérrez, A.(2,6);Martín-Arranz, M.D.(7);Ricart, E.(2,8);Gomollón, F.(2,9);Sierra Ausín, M.(10); Huguet, J.M.(11);Guardiola, J.(12);Vera, I.(13);Varela, P.(14);Iglesias, E.(15);Garcia-Planella, E.(16);de Castro , L.(17);García Sepulcre , M.F.(18); Sicilia, B.(19);Fernández-Salazar, L.(20); Calvet, X.(2,21);Muñoz, F.(22); García-López, S.(23);Bermejo, F.(24);Ramos, L.(25);Martínez Montiel, P.(26);Lorente, R.(27);Cabriada, J.L.(28);Piqueras, M.(29);Marín-Jiménez, I.(30);Esteve, M.(2,31);Mesonero, F.(32); Sesé, E.(33);P. Gisbert, J.(2,34);Márquez, L.(35);Busquets, D.(36);Pajares, R.(37);Cañete, F.(2,38);Mañosa, M.(2,38);Domènech, E.(2,38);
(1)Hospital Universitari Germans Trias i Pujol, Gastroenterology Department-IBD Unit, Badalona, Spain;(2)CIBERehd, Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas, Madrid, Spain;(3)Hospital Clínic Universitari de València, Gastroenteroloy Department, Valencia, Spain;(4)Hospital Universitario y Politécnico la Fe, Gastroenterology Department, Valencia, Spain;(5)Hospital Universitario Río Hortega, Gastroenterology Department, Valladolid, Spain;(6)Hospital General Universitario Dr Balmis de Alicante- ISABIAL, Gastroenterology Department, Alicante, Spain;(7)Hospital Universitario La Paz, Gastroenterology Department, Madrid, Spain;(8)Hospital Clinic de Barcelona, Gastroenterology Department, Barcelona, Spain;(9)Hospital Clínico Universitario "Lozano Blesa"-Instituto de Investigación Sanitaria- IIS Aragón, Gastroenterology Department, Zaragoza, Spain;(10)Complejo Asistencial Universitario de León, Gastroenterology Department, León, Spain;(11)Consorcio Hospital General Universitario de Valencia, Gastroenterology Department, Valencia, Spain;(12)Hospital Universitari de Bellvitge, Gastroenterology Department, Hospitalet del Llobregat, Spain;(13)Hospital Universitario Puerta de Hierro Majadahonda, Gastroenterology Department, Majadahonda, Spain;(14)Hospital Universitario de Cabueñes, Gastroenterology Department, Gijón, Spain;(15)Hospital Universitario Reina Sofía de Córdoba, Gastroenterology Department, Córdoba, Spain;(16)Hospital de la Santa Creu i Sant Pau, Gastroenterology Department, Barcelona, Spain;(17)Hospital Alvaro Cunqueiro-Complexo Hospitalario Universitario de Vigo, Gastroenterology Department, Vigo, Spain;(18)Hospital General Universitario de Elche, Gastroenterology Department, Elche, Spain;(19)Hospital Universitario de Burgos, Gastroenterology Department, Burgos, Spain;(20)Hospital Clínico Universitario de Valladolid, Gastroenterology Department, Valladolid, Spain;(21)Corporació Sanitària Universitària Parc Taulí, Gastroenterology Department, Sabadell, Spain;(22)Hospital Universitario de Salamanca, Gastroenterology Department, Salamanca, Spain;(23)Hospital Universitario Miguel Servet, Gastroenterology Department, Zaragoza, Spain;(24)Hospital Universitario de Fuenlabrada- IdiPAZ, Gastroenterology Department, Fuenlabrada, Spain;(25)Hospital Universitario de Canarias, Gastroenterology Department, La Laguna, Spain;(26)Hospital Universitario Doce de Octubre, Gastroenterology Department, Madrid, Spain;(27)Hospital General Universitario de Ciudad Real, Gastroenterology Department, Ciudad Real, Spain;(28)Hospital Universitario de Galdakao, Gastroenterology Department, Galdakao, Spain;(29)Consorci Sanitari de Terrassa, Gastroenterology Department, Terrassa, Spain;(30)Hospital General Universitario Gregorio Marañón, Gastroenterology Department, Madrid, Spain;(31)Hospital Universitari Mutua Terrassa, Gastroenterology Department, Terrassa, Spain;(32)Hospital Universitario Ramón y Cajal, Gastroenterology Department, Madrid, Spain;(33)Hospital Universitario Arnau de Vilanova de Lleida, Gastroenterology Department, Lleida, Spain;(34)Hospital Universitario de la Princesa- IIS-Princesa- UAM- Madrid, Gastroenterology Department, Madrid, Spain;(35)Hospital del Mar de Barcelona, Gastroenterology Department, Barcelona, Spain;(36)Hospital Universitari de Girona Doctor Josep Trueta, Gastroenterology Department, Girona, Spain;(37)Hospital Universitario Infanta Sofía, Gastroenterology Department, Madrid, Spain;(38)Hospital Universitari Germans Trias i Pujol, Gastroenterology Department, Badalona, Spain; on behalf of GETECCU.
Background
The use of ustekinumab (UST) and vedolizumab (VDZ) as first line therapy for inflammatory bowel disease (IBD) is increasing due to safety reasons and contraindications of anti-TNFs. However, there are no studies evaluating their efficacy and safety in clinical practice under these circumstances. Thus, our aims were to describe bionaïve patients’ characteristics starting VDZ or UST and to evaluate treatment persistence of these drugs and their safety profile in this scenario.
Methods
Descriptive, retrospective and multicenter study based on the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD –GETECCU). All IBD patients never exposed to biological agents who started VDZ or UST as first-line biological treatment were identified.
Results
Out of 29,450 IBD patients ever exposed to biological drugs included in the ENEIDA registry, 924 patients met the inclusion criteria. Of these, 366 (40%) started UST and 558 (60%) VDZ as first line biological therapy.
UST group: 48% women, 90% Crohn's disease (43% ileal; 13% colic; 43.5% ileocolic; 31% upper gastrointestinal involvement; 25% stricturing behaviour; 12% penetrating, 18% perianal disease), 10% ulcerative colitis (74% extensive, 17% left-sided, 9% proctitis), 27% had extraintestinal manifestations (EIM). Median age at the beginning of UST was 57 years (IQR 57-70), 17% patients had a past history of malignancy and, 34% had associated comorbidities. UST indication was luminal activity except in 2% for perianal disease and 5% for EIM. At the end of follow-up (median 14 months [IQR 6-30]), 12 patients (3.3%) developed adverse effects (AEs) that led to treatment discontinuation in the majority of them (92%).
VDZ group: 44% women, 42% Crohn's disease (44% ileal; 18% colic; 38% ileocolic; 25% upper gastrointestinal involvement; 28% stricturing behaviour; 13% penetrating; 7% perianal disease), 58% ulcerative colitis (50% extensive, 42% left-sided, 8% proctitis), 17% had EIM. The median age at the beginning was 61 years (IQR 48-71), 24% had past history of malignancy and, 34% associated comorbidities. The indication was exclusively luminal activity. At the end of follow-up (median 21 months [IQR 8-36]), 36 patients (6.5%) had AEs, that lead to treatment withdrawal in 67% of them (24 patients).
Cumulative treatment persistence rates were 78%, 60% and 50% for VDZ and 85%, 75% and 66% for UST at 12, 24 and 36 months, respectively (P<0.001).
Conclusion
In clinical practice, VDZ and UST are used first-line particularly in elderly patients with comorbidities. Both treatments have a good safety profile and a high persistence of treatment, being superior for ustekinumab.