P544 Comparison of the efficacy of a second intravenous or subcutaneous anti-TNF in the treatment of ulcerative colitis: Real-world data from the ENEIDA registry

P. Torres-Rodriguez1, F. Cañete1,2, M. Calafat1, R. Sánchez-Aldehuelo3, M. Rivero4,5, M. Iborra2,6, M. González-Vivo7, I. Vera8, L. de Castro9, L. Bujanda2,10,11,12, M. Barreiro-de Acosta13, X. Calvet2,14, J.M. Benítez15,16, M. Llorente17, G. Surís18, L. Arias-García19, M. David20, A. Castaño-García21, F.J. Garcia-Alonso22, L. Rufo23, J.A. Ferrer24, P. Camo25, J.P. Gisbert2,26, J.M. Huguet27, R. Pajares28, V. Morales29, J. Llaó30, A. Rodríguez31, C. Rodríguez32, M. Navarro33, F. Gomollón2,34, M. Carrillo-Palau35, E. Sesé36, P. Almela37, P. Ramírez de la Piscina38, I. Rodríguez-Lago39, M. Papo40, M. Vela41, M. Mañosa1,2, E. Domènech1,2, on behalf of the Eneida-GETECCU investigators

1Hospital Universitari Germans Trias I Pujol, Department of Gastroenterology, Badalona, Spain, 2Department of Gastroenterology and Hepatology, CIBEREHD, Madrid, Spain, 3Department of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Madrid, Spain, 4Department of Gastroenterology, Hospital Universitario Marqués de Valdecilla, Santander, Spain, 5Department of Gastroenterology, IDIVAL, Santander, Spain, 6Department of Gastroenterology, Hospital Universitari i Politècnic La Fe, Valencia, Spain, 7Department of Gastroenterology, Hospital del Mar, Barcelona, Spain, 8Department of Gastroenterology, Hospital Universitario Puerta de Hierro, Majadahonda, Spain, 9Department of Gastroenterology, Complejo Hospitalario Universitario de Vigo, Vigo, Spain, 10Department of Gastroenterology, Hospital Universitario Donostia, San Sebastián, Spain, 11Department of Gastroenterology, Universidad del País Vasco UPV/EHU, San Sebastián, Spain, 12Department of Gastroenterology, Instituto Biodonostia, San Sebastián, Spain, 13Department of Gastroenterology, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain, 14Department of Gastroenterology, Corporació Sanitària Universitària Parc Taulí, Sabadell, Spain, 15Department of Gastroenterology, Hospital Universitario Reina Sofía, Córdoba, Spain, 16Department of Gastroenterology, IMIBIC, Córdova, Spain, 17Department of Gastroenterology and Hepatology, Hospital Universitario Miguel Servet, Zaragoza, Spain, 18Department of Gastroenterology, Hospital Universitari de Bellvitge, L’Hospitalet de Llobregat, Spain, 19Department of Gastroenterology, Hospital Universitario de Burgos, Burgos, Spain, 20Department of Gastroenterology, Consorci Sanitari Terrassa, Terrassa, Spain, 21Department of Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Spain, 22Department of Gastroenterology, Hospital Universitario Río Hortega, Valladolid, Spain, 23Department of Gastroenterology, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain, 24Department of Gastroenterology, Hospital Universitario Fundación de Alcorcón, Madrid, Spain, 25Department of Gastroenterology, Hospital General San Jorge, Huesca, Spain, 26Department of Gastroenterology, Hospital Universitario de La Princesa, Madrid, Spain, 27Department of Gastroenterology, Hospital General Universitario de Valencia, Valencia, Spain, 28Department of Gastroenterology, Hospital Universitario Infanta Sofía, Madrid, Spain, 29Department of Gastroenterology and Hepatology, Hospital General de Granollers, Granollers, Spain, 30Department of Gastroenterology, Althaia Xarxa Assistencial Universitària de Manresa, Manresa, Spain, 31Department of Gastroenterology, Hospital General Universitario de Alicante, Alicante, Spain, 32Department of Gastroenterology, Complejo Hospitalario de Navarra, Navarra, Spain, 33Department of Gastroenterology, Hospital Moisès Broggi, Sant Joan Despí, Spain, 34Department of Gastroenterology, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain, 35Department of Gastroenterology, Hospital Universitario de Canarias, La Laguna, Spain, 36Department of Gastroenterology, Hospital Universitario Arnau de Vilanova, Lleida, Spain, 37Department of Gastroenetology, Hospital General Universitario de Castellón, Castellón, Spain, 38Department of Gastroenterology, Hospital Universitario de Álava, Vitoria, Spain, 39Department of Gastroenterology, Hospital de Galdakao-Usansolo, Galdakao, Spain, 40Department of Gastroenterology, Hospital Universitario Joan XXIII, Tarragona, Spain, 41Department of Gastroenterology, Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain

Background

Three anti-TNFs (one intravenous and two subcutaneous) are licensed for the treatment of ulcerative colitis (UC). However, it is not known if the efficacy of a second anti-TNF changes on whether it is intravenous or subcutaneous; this could justify the indication of biological agents with a different mechanism of action in second line. The aim of this study was to compare the efficacy of a second subcutaneous or intravenous anti-TNF in UC.

Methods

Patients from the prospectively maintained ENEIDA registry treated with consecutively intravenous and subcutaneous anti-TNF, who were naïve to biological agents, were identified. Patients were classified according to the administration route of the first anti-TNF in: IVi (intravenous initially) or SCi (subcutaneous initially). Patients treated for extraintestinal manifestations or pouchitis were excluded. Clinical activity and effectiveness were defined based on Partial Mayo Score (PMS) at baseline, 14 and 52 weeks. Loss of response, dose-escalation and treatment discontinuation were also assessed.

Results

372 UC patients were included (270 IVi and 102 SCi). Both cohorts were similar in clinical-epidemiological characteristics, except for a higher proportion of patients with moderate-to-severe clinical activity at the beginning of the first anti-TNF in the IVi group (82% vs. 71%; p = 0.017) and at the beginning of the second anti-TNF (62% vs. 74%; p = 0.04). Clinical response and remission rates at week 14 for the second anti-TNF were 41% and 29% in IVi vs. 47% and 25% in SCi, respectively (p = ns). At week 52, clinical response/remission rates of the second anti-TNF were 37%/32% in IVi vs. 40%/29% in SCi (p = ns). A higher response rate at 14 weeks with the second anti-TNF was detected in the SCi group (40% vs. 68%; p = 0.012) when the reason for withdrawal of the first anti-TNF was secondary loss of response. The cumulative persistence of the second anti-TNF treatment in IVi and SCi were 55% and 54% after 1 year, and 41% and 40% after 2 years, respectively (p = ns). The SCi group had lower rates of dose-escalation with the second anti-TNF than IVi (34% and 29% in SCi vs. 57% and 49% in EVi, at 12 and 24 months, respectively -p = 0.004-). Dose-escalation of the first anti-TNF and moderate-to-severe clinical activity at the beginning of the second anti-TNF were associated with a lower probability of remission with the second anti-TNF in the short- and long-term.

Conclusion

The efficacy of infliximab after failure/intolerance of a subcutaneous anti-TNF is similar to that of subcutaneous anti-TNFs after infliximab failure/intolerance.