Effectiveness and Safety of Ustekinumab in Ulcerative Colitis: Real-world Evidence from the ENEIDA Registry
Por:
Chaparro, M, Garre, A, Iborra, M, Sierra-Ausin, M, Barreiro-de Acosta, M, Fernandez-Clotet, A, de Castro, L, Bosca-Watts, M, Casanova, M, Lopez-Garcia, A, Lorente, R, Rodriguez, C, Carbajo, A, Arroyo, M, Gutierrez, A, Hinojosa, J, Martinez-Perez, T, Villoria, A, Bermejo, F, Busquets, D, Camps, B, Canete, F, Mancenido, N, Monfort, D, Navarro-Llavat, M, Perez-Calle, J, Ramos, L, Rivero, M, Angueira, T, Monterde, P, Carpio, D, Garcia-de-la-Filia, I, Gonzalez-Munoza, C, Hernandez, L, Huguet, J, Morales, V, Sicilia, B, Vega, P, Vera, I, Zabana, Y, Nos, P, Alvarez, P, Calvino-Suarez, C, Ricart, E, Hernandez, V, Minguez, M, Marquez, L, Cruz, D, Iturria, S, Barrio, J, Gargallo-Puyuelo, C, Frances, R, Hinojosa, E, del Moral, M, Calvet, X, Algaba, A, Aldeguer, X, Guardiola, J, Manosa, M, Pajares, R, Piqueras, M, Garcia-Bosch, O, Serrano, P, Castro, B, Lucendo, A, Montoro, M, Ortiz, E, Mesonero, F, Garcia-Planella, E, Fuentes, D, Bort, I, Delgado-Guillena, P, Arias, L, Iglesias, A, Calvo, M, Esteve, M, Domenech, E and Gisbert, J
Publicada:
1 nov 2021
Ahead of Print:
1 abr 2021
Resumen:
Background and Aims: The development programm UNIFI has shown promising results of ustekinumab in ulcerative colitis [UC] treatment which should be confirmed in clinical practice. We aimed to evaluate the durability, effectiveness, and safety of ustekinumab in UC in real life.
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. Short-term response was assessed at Week 16.
Results: A total of 95 patients were included. At Week 16, 53% of patients had response [including 35% of patients in remission]. In the multivariate analysis, elevated serum C-reactive protein was the only variable significantly associated with lower likelihood of achieving remission. Remission was achieved in 39% and 33% of patients at Weeks 24 and 52, respectively; 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; 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.
Conclusions: Ustekinumab is effective in both 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.
Filiaciones:
Chaparro, M:
Univ Autonoma Madrid, Gastroenterol Dept, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP, Madrid, Spain
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Gastroenterol Dept, Madrid, Spain
Garre, A:
Univ Autonoma Madrid, Gastroenterol Dept, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP, Madrid, Spain
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Gastroenterol Dept, Madrid, Spain
Iborra, M:
Hosp Univ & Politecn La Fe, Gastroenterol Dept, Valencia, Spain
CIBERehd, Gastroenterol Dept, Valencia, Spain
Sierra-Ausin, M:
Hosp Univ Leon, Gerencia Reg Salud Castilla & Leon, Gastroenterol Dept, Leon, Spain
Barreiro-de Acosta, M:
Hosp Clin Univ Santiago, Gastroenterol Dept, Santiago De Compostela, Spain
Fernandez-Clotet, A:
Hosp Clin Barcelona, Gastroenterol Dept, Barcelona, Spain
IDIBAPS, CIBERehd, Gastroenterol Dept, Barcelona, Spain
de Castro, L:
SERGAS UVIGO, Galicia Sur Hlth Res Inst, Res Grp Digest Dis, Xerencia Xest Integrada Vigo,Gastroenterol Dept, Vigo, Spain
Bosca-Watts, M:
Univ Valencia, Hosp Clin Valencia, Gastroenterol Dept, Valencia, Spain
Casanova, M:
Univ Autonoma Madrid, Gastroenterol Dept, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP, Madrid, Spain
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Gastroenterol Dept, Madrid, Spain
Lopez-Garcia, A:
Hosp del Mar, Gastroenterol Dept, Barcelona, Spain
Inst Hosp del Mar Invest Med, Gastroenterol Dept, Barcelona, Spain
Lorente, R:
Hosp Clin Univ Lozano Blesa, IIS Aragon, Gastroenterol Dept, Zaragoza, Spain
CIBERehd, Gastroenterol Dept, Zaragoza, Spain
Rodriguez, C:
Complejo Hosp Navarra, Gastroenterol Dept, Navarra, Spain
Carbajo, A:
Hosp Univ Rio Hortega, Gerencia Reg Salud Castilla & Leon SACYL, Gastroenterol Dept, Valladolid, Spain
Arroyo, M:
CIBERehd, Gastroenterol Dept, Zaragoza, Spain
HCU Lozano Blesa, IIS Aragon, Gastroenterol Dept, Zaragoza, Spain
:
Hosp Gen Univ Alicante, Gastroenterol Dept, Alicante, Spain
IIS ISABIAL Alicante, CIBERehd, Gastroenterol Dept, Alicante, Spain
Hinojosa, J:
Hosp Manises, Gastroenterol Dept, Valencia, Spain
Martinez-Perez, T:
Hosp Virgen de la Luz, Gastroenterol Dept, Cuenca, Spain
Villoria, A:
CIBERehd, Gastroenterol Dept, Zaragoza, Spain
Hosp Parc Tauli, Gastroenterol Dept, Sabadell, Spain
Univ Autonoma Barcelona, Dept Med, Gastroenterol Dept, Barcelona, Spain
Bermejo, F:
Hosp Univ Fuenlabrada, Gastroenterol Dept, Madrid, Spain
Inst Invest Sanitaria Hosp La Paz IdiPAZ, Gastroenterol Dept, Madrid, Spain
Busquets, D:
Hosp Univ Girona Dr Josep Trueta, Gastroenterol Dept, Girona, Spain
Camps, B:
Hosp Univ Bellvitge, Gastroenterol Dept, Barcelona, Spain
Canete, F:
Hosp Univ Germans Trials & Pujol, Gastroenterol Dept, Badalona, Spain
CIBERehd, Gastroenterol Dept, Badalona, Spain
Mancenido, N:
Hosp Infanta Sofia, Gastroenterol Dept, San Sebastian Los Reyes, Spain
Monfort, D:
Consorci Sanitari Terrassa, Gastroenterol Dept, Terrassa, Spain
Navarro-Llavat, M:
Hosp St Joan Despi Moises Broggi, Gastroenterol Dept, Barcelona, Spain
Perez-Calle, J:
Hosp Univ Fdn Alcorcon, Gastroenterol Dept, Madrid, Spain
Ramos, L:
Hosp Univ Canarias, Gastroenterol Dept, Santa Cruz De Tenerife, Spain
Rivero, M:
Hosp Univ Marques de Valdecilla, Gastroenterol Dept, Santander, Spain
IDIVAL, Gastroenterol Dept, Santander, Spain
Angueira, T:
Hosp Gen Tomelloso, Gastroenterol Dept, Ciudad Real, Spain
CIBERehd, Gastroenterol Dept, Ciudad Real, Spain
Monterde, P:
Hosp Gen San Jorge, Gastroenterol Dept, Huesca, Spain
Carpio, D:
Complexo Hosp Univ Pontevedra, Gastroenterol Dept, Pontevedra, Spain
Garcia-de-la-Filia, I:
Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid, Spain
Gonzalez-Munoza, C:
Hosp Santa Creu & Sant Pau, Gastroenterol Dept, Barcelona, Spain
Hernandez, L:
Hosp Santos Reyes, Gastroenterol Dept, Burgos, Spain
Huguet, J:
Hosp Gen Univ Valencia, Gastroenterol Dept, Valencia, Spain
Morales, V:
Hosp Gen Granollers, Gastroenterol Dept, Barcelona, Spain
Sicilia, B:
Hosp Univ Burgos, Gastroenterol Dept, Burgos, Spain
Vega, P:
Complejo Hosp Univ Ourense, Gastroenterol Dept, Orense, Spain
Vera, I:
Hosp Univ Puerta de Hierro Majada, Gastroenterol Dept, Madrid, Spain
Zabana, Y:
Hosp Univ Mutua Terrassa, Gastroenterol Dept, Terrassa, Spain
CIBERehd, Gastroenterol Dept, Terrassa, Spain
Nos, P:
Hosp Univ & Politecn La Fe, Gastroenterol Dept, Valencia, Spain
CIBERehd, Gastroenterol Dept, Valencia, Spain
Alvarez, P:
Hosp Univ Leon, Gerencia Reg Salud Castilla & Leon, Gastroenterol Dept, Leon, Spain
Calvino-Suarez, C:
Hosp Clin Univ Santiago, Gastroenterol Dept, Santiago De Compostela, Spain
Ricart, E:
Hosp Clin Barcelona, Gastroenterol Dept, Barcelona, Spain
IDIBAPS, CIBERehd, Gastroenterol Dept, Barcelona, Spain
Hernandez, V:
SERGAS UVIGO, Galicia Sur Hlth Res Inst, Res Grp Digest Dis, Xerencia Xest Integrada Vigo,Gastroenterol Dept, Vigo, Spain
Minguez, M:
Univ Valencia, Hosp Clin Valencia, Gastroenterol Dept, Valencia, Spain
Marquez, L:
Hosp del Mar, Gastroenterol Dept, Barcelona, Spain
Inst Hosp del Mar Invest Med, Gastroenterol Dept, Barcelona, Spain
Cruz, D:
Hosp Clin Univ Lozano Blesa, IIS Aragon, Gastroenterol Dept, Zaragoza, Spain
CIBERehd, Gastroenterol Dept, Zaragoza, Spain
Iturria, S:
Complejo Hosp Navarra, Gastroenterol Dept, Navarra, Spain
Barrio, J:
Hosp Univ Rio Hortega, Gerencia Reg Salud Castilla & Leon SACYL, Gastroenterol Dept, Valladolid, Spain
Gargallo-Puyuelo, C:
CIBERehd, Gastroenterol Dept, Zaragoza, Spain
HCU Lozano Blesa, IIS Aragon, Gastroenterol Dept, Zaragoza, Spain
:
Miguel Hernandez Univ, IIS Isabial Hosp Gen Univ Alicante, Dept Clin Med, Hepat & Intestinal Immunobiol Grp,Gastroenterol D, Alicante, Spain
CIBERehd, Gastroenterol Dept, Alicante, Spain
Hinojosa, E:
Hosp Manises, Gastroenterol Dept, Valencia, Spain
del Moral, M:
Hosp Virgen de la Luz, Gastroenterol Dept, Cuenca, Spain
Calvet, X:
CIBERehd, Gastroenterol Dept, Zaragoza, Spain
Hosp Parc Tauli, Gastroenterol Dept, Sabadell, Spain
Univ Autonoma Barcelona, Dept Med, Gastroenterol Dept, Barcelona, Spain
Algaba, A:
Hosp Univ Fuenlabrada, Gastroenterol Dept, Madrid, Spain
Inst Invest Sanitaria Hosp La Paz IdiPAZ, Gastroenterol Dept, Madrid, Spain
Aldeguer, X:
Hosp Univ Girona Dr Josep Trueta, Gastroenterol Dept, Girona, Spain
Guardiola, J:
Hosp Univ Bellvitge, Gastroenterol Dept, Barcelona, Spain
Manosa, M:
Hosp Univ Germans Trials & Pujol, Gastroenterol Dept, Badalona, Spain
CIBERehd, Gastroenterol Dept, Badalona, Spain
Pajares, R:
Hosp Infanta Sofia, Gastroenterol Dept, San Sebastian Los Reyes, Spain
Piqueras, M:
Consorci Sanitari Terrassa, Gastroenterol Dept, Terrassa, Spain
Garcia-Bosch, O:
Hosp St Joan Despi Moises Broggi, Gastroenterol Dept, Barcelona, Spain
Serrano, P:
Hosp Univ Fdn Alcorcon, Gastroenterol Dept, Madrid, Spain
Castro, B:
Hosp Univ Marques de Valdecilla, Gastroenterol Dept, Santander, Spain
IDIVAL, Gastroenterol Dept, Santander, Spain
Lucendo, A:
Hosp Gen Tomelloso, Gastroenterol Dept, Ciudad Real, Spain
CIBERehd, Gastroenterol Dept, Ciudad Real, Spain
Montoro, M:
Hosp Gen San Jorge, Gastroenterol Dept, Huesca, Spain
Ortiz, E:
Complexo Hosp Univ Pontevedra, Gastroenterol Dept, Pontevedra, Spain
Mesonero, F:
Hosp Univ Ramon y Cajal, Gastroenterol Dept, Madrid, Spain
Garcia-Planella, E:
Hosp Santa Creu & Sant Pau, Gastroenterol Dept, Barcelona, Spain
Fuentes, D:
Hosp Santos Reyes, Gastroenterol Dept, Burgos, Spain
Bort, I:
Hosp Gen Univ Valencia, Gastroenterol Dept, Valencia, Spain
Delgado-Guillena, P:
Hosp Gen Granollers, Gastroenterol Dept, Barcelona, Spain
Arias, L:
Hosp Univ Burgos, Gastroenterol Dept, Burgos, Spain
Iglesias, A:
Complejo Hosp Univ Ourense, Gastroenterol Dept, Orense, Spain
Calvo, M:
Hosp Univ Puerta de Hierro Majada, Gastroenterol Dept, Madrid, Spain
Esteve, M:
Hosp Univ Mutua Terrassa, Gastroenterol Dept, Terrassa, Spain
CIBERehd, Gastroenterol Dept, Terrassa, Spain
Domenech, E:
Hosp Univ Germans Trials & Pujol, Gastroenterol Dept, Badalona, Spain
CIBERehd, Gastroenterol Dept, Badalona, Spain
Gisbert, J:
Univ Autonoma Madrid, Gastroenterol Dept, Hosp Univ La Princesa, Inst Invest Sanitaria Princesa IIS IP, Madrid, Spain
Ctr Invest Biomed Red Enfermedades Hepat & Digest, Gastroenterol Dept, Madrid, Spain
Green Published
|