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P476 Effectiveness and safety of ustekinumab in ulcerative colitis: Real-world evidence from the ENEIDA registry

Chaparro, M.(1);Garre, A.(1);Iborra, M.(2);Sierra, M.(3);Barreiro-de Acosta, M.(4);Fernández-Clotet, A.(5);de Castro, L.(6);Boscá-Watts, M.(7);Casanova, M.J.(1);López-García, A.(8);Lorente, R.(9);Rodríguez, C.(10);Carbajo, A.Y.(11);Arroyo, M.T.(12);Gutiérrez, A.(13);Hinojosa, J.(14);Martínez-Pérez, T.(15);Villoria, A.(16);Bermejo, F.(17);Busquets, D.(18);Camps, B.(19);Cañete, F.(20);Manceñido, N.(21);Monfort, D.(22);Navarro-Llavat, M.(23);Pérez-Calle, J.L.(24);Ramos, L.(25);Rivero, M.(26);Angueira, T.(27);Camo, P.(28);Carpio, D.(29);García-de-la-Filia, I.(30);González-Muñoza, C.(31);Hernández, L.(32);Huguet, J.M.(33);Morales, V.J.(34);Sicilia, B.(35);Vega, P.(36);Domènech, E.(20);Gisbert, J.P.(1);

(1)Hospital Universitario de La Princesa- Instituto de Investigación Sanitaria Princesa IIS-IP- Universidad Autónoma de Madrid- and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBERehd, Gastroenterology Unit, Madrid, Spain;(2)Hospital Universitario y Politécnico La Fe and CIBERehd, Gastroenterology Unit, Valencia, Spain;(3)Complejo Asistencial Universitario de León, Gastroenterology Unit, León, Spain;(4)Hospital Clínico Universitario de Santiago-, Gastroenterology Unit, Santiago de Compostela, Spain;(5)Hospital Clìnic i Provincial and CIBERehd- IDIBAPS, Gastroenterology Unit, Barcelona, Spain;(6)Xerencia Xestion Integrada de Vigo- SERGAS. Research Group in Digestive Diseases- Galicia Sur Health Research Institute IIS Galicia Sur. SERGAS-UVIGO, Gastroenterology Unit, Vigo, Spain;(7)Hospital Clinico de Valencia. Universitat de València, Gastroenterology Unit, Valencia, Spain;(8)Hospital del Mar and Institut Hospital del Mar d’Investigacions Mèdiques, Gastroenterology Unit, Barcelona, Spain;(9)Hospital General Universitario de Ciudad Real, Gastrosenterology Unit, Ciudad Real, Spain;(10)Complejo Hospitalario de Navarra, Gastroenterology Unit, Pamplona, Spain;(11)Hospital Universitario Río Hortega. Gerencia Regional de Salud de Castilla y León SACYL, Gastroenterology unit, Valladolid, Spain;(12)HCU Lozano Blesa- IIS Aragón and CIBERed, Gastroenterology Unit, Zaragoza, Spain;(13)Hospital General Universitario de Alicante and CIBERehd- IIS ISABIAL, Gastroenterology Unit, Alicante, Spain;(14)Hospital de Manises, Gastroenterology Unit, Valencia, Spain;(15)Hospital Virgen de la Luz, Gastroenterology Unit, Cuenca, Spain;(16)Hospital Parc Taulí- Sabadell. Depàrtament de Medicina. Universitat Autònoma de Barcelona and CIBERehd, Gastroenterology Unit, Sabadell, Spain;(17)Hospital Universitario Fuenlabrada and Instituto de Investigación Sanitaria del Hospital La Paz IdiPAZ, Gastroenterology Unit, Madrid, Spain;(18)Hospital Universitario de Girona Dr. Josep Trueta, Gastroenterology Unit, Girona, Spain;(19)Hospital Universitario de Bellvitge, Gastroenterology Unit, Barcelona, Spain;(20)Hospital Universitari Germans Trials i Pujol and CIBERehd, Gastroenterology Unit, Badalona, Spain;(21)Hospital Infanta Sofía, Gastroenterology Unit, San Sebastián de los Reyes, Spain;(22)Consorci Sanitari de Terrassa, Gastroenterology Unit, Terrassa, Spain;(23)Hospital de Sant Joan Despí Moisès Broggi, Gastroenterology Unit, Barcelona, Spain;(24)Hospital Universitario Fundación Alcorcón, Gastroenterology Unit, Madrid, Spain;(25)Hospital Universitario de Canarias, Gastroenterology Unit, Santa Cruz de Tenerife, Spain;(26)Hospital Universitario Marqués de Valdecilla and IDIVAL, Gastroenterology Unit, Santander, Spain;(27)Hospital General de Tomelloso and CIBERehd, Gastroenterology Unit, Ciudad Real, Spain;(28)Hospital General San Jorge, Gastroenterology Unit, Huesca, Spain;(29)Complexo Hospitalario Universitario de Pontevedra, Gastroenterology Unit, Pontevedra, Spain;(30)Hospital Universitario Ramon y Cajal, Gastroenterology Unit, Madrid, Spain;(31)Hospital de la Santa Creu i Sant Pau, Gastroenterology Unit, Barcelona, Spain;(32)Hospital Santos Reyes, Gastroenterology Unit, Burgos, Spain;(33)Hospital General Universitario de Valencia, Gastroenterology Unit, Valencia, Spain;(34)Hospital General de Granollers, Gastroenterology Unit, Barcelona, Spain;(35)Hospital Universitario de Burgos, Gastroenterology Unit, Burgos, Spain;(36)Complejo Hospitalario Universitario de Ourense, Gastroenterology Unit, Ourense, Spain; On behalf of ENEIDA Study group

Background

The development program (UNIFI) has shown promising results of ustekinumab in ulcerative colitis (UC) treatment that should be confirmed in clinical practice.

Aims: Primary: to evaluate the durability of ustekinumab treatment in UC patients in clinical practice. Secondary: to assess the short-term response (at week 16) and the long-term effectiveness (at maximum follow-up) and to assess the safety of ustekinumab in clinical practice.

Methods

Patients included in the prospectively maintained ENEIDA registry who received at least one intravenous dose of ustekinumab due to active UC [Partial Mayo Score (PMS) >2] were included. Clinical activity and effectiveness were defined based on PMS.

Results

95 patients were included (table 1).





At week 16, 53% of patients had clinical response (including 35% of patients in remission) (figure 1). 





In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with clinical remission. Long-term remission is represented in figure 2.



36% of patients discontinued the treatment with ustekinumab during a median follow-up of 31 weeks. The probability of maintaining ustekinumab treatment was 87% at week 16, 63% at week 56, and 59% at week 72 (figure 3);



primary failure was the main reason for ustekinumab discontinuation. No variable was associated with risk of discontinuation. Three patients reported adverse events; one of them had a fatal severe SARS-CoV-2 infection.

Conclusion

Ustekinumab is effective both in the short and the long-term in real-life, even in a highly refractory cohort. Higher inflammatory burden at baseline correlated with lower probability of achieving remission. Safety was consistent with the known profile of ustekinumab.

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