Persistence, effectiveness and safety of ustekinumab and vedolizumab therapy for complex perianal fistula in Crohn's disease: The HEAL study from GETECCU
Por:
Jose Casanova, Maria, Caballol, Berta, Jose Garcia, Maria, Mesonero, Francisco, Rubin de Celix, Cristina, Suarez-Alvarez, Patricia, Ferreiro-Iglesias, Rocio, Martin-Rodriguez, Maria del Mar, de Francisco, Ruth, Varela-Trastoy, Pilar, Bastida, Guillermo, Carrillo-Palau, Marta, Nunez-Ortiz, Andrea, Ramirez-de la Piscina, Patricia, Ceballos, Daniel, Hervias-Cruz, Daniel, Munoz-Perez, Roser, Velayos, Benito, Bermejo, Fernando, Busquets, David, Cabacino, Manuel, Camo-Monterde, Patricia, Marin-Jimenez, Ignacio, Munoz, Carmen, de la Pena-Negro, Luisa Carmen, Sierra-Moros, Eva, Barrio, Jesus, Brunet-Mas, Eduard, Bujanda, Luis, Canete, Fiorella, Gomollon, Fernando, Mancenido-Marcos, Noemi, Rodriguez-Lago, Iago, Rodriguez-Grau, Maria Carmen, Sicilia, Beatriz, Torra-Alsina, Sandra, Arranz-Hernandez, Laura, Carpio, Daniel, Garcia-Sepulcre, Mariana Fe A., Gonzalez-Munoza, Carlos, Maria Huguet, Jose, Marquez-Mosquera, Lucia, Lopez-Serrano, Maria Pilar, Ponferrada-Diaz, Angel, Chaparro, Maria, Gisbert, Javier P.
Publicada:
1 nov 2024
Ahead of Print:
1 oct 2024
Resumen:
Background: The efficacy of ustekinumab and vedolizumab for treating
complex perianal fistula in Crohn's disease has been barely studied. We
aimed to assess treatment persistence, clinical remission, and safety of
these drugs in this context.
Methods: Crohn's disease patients who had received ustekinumab or
vedolizumab for the indication of active complex perianal fistula, were
included. Clinical remission was defined according to Fistula Drainage
Assessment Index (no drainage through the fistula upon gentle pressure)
based on physicians' assessment.
Results: Of 155 patients, 136 received ustekinumab, and 35 vedolizumab
(16 received both). Median follow-up for ustekinumab was 27 months.
Among those on ustekinumab, 54 % achieved remission, and within this
group, 27 % relapsed during follow-up. The incidence rate of relapse was
11 % per patient-year. Multivariate analysis found no variables
associated with treatment discontinuation or relapse. Median follow-up
time for patients receiving vedolizumab was 19 months. Remission was
achieved in 46 % of the patients receiving vedolizumab, and among them,
20 % relapsed during follow-up. The incidence rate of relapse was 7 %
per patient-year. Adverse events were mild in 6 % on ustekinumab and 8 %
on vedolizumab.
Conclusion: Ustekinumab and vedolizumab appear effective, achieving
remission in around half of complex perianal fistula patients, with
favorable safety profiles. (c) 2024 Editrice Gastroenterologica Italiana
S.r.l. Published by Elsevier Ltd. All rights are reserved, including
those for text and data mining, AI training, and similar technologies.
Filiaciones:
Univ Autonoma Madrid UAM, Inst Invest Sanitaria Princesa IIS Princesa,
Hosp Univ La Princesa, Dept Gastroenterol, Madrid, Spain
CIBERehd, Madrid, Spain
IDIBAPS, Hosp Clin & Prov, Dept Gastroenterol, Barcelona, Spain
CIBEREHD, Barcelona, Spain
Hosp Univ Marques Valdecilla, Dept Gastroenterol, Santander, Spain
IDIVAL, Santander, Spain
Hosp Univ Ramon y Cajal, Dept Gastroenterol, Madrid, Spain
Complejo Asistencial Univ Leon, Dept Gastroenterol, Leon, Spain
Hosp Clin Univ Santiago de Compostela, Dept Gastroenterol, Santiago De
Compostela, Spain
Inst Invest Sanitaria Santiago de Compostela IDIS, Santiago De
Hosp Univ Virgen de las Nieves, Dept Gastroenterol, Granada, Spain
Hosp Univ Cent Asturias, Dept Gastroenterol, Oviedo, Spain
ISPA, Oviedo, Spain
Hosp Univ Cabuenes, Dept Gastroenterol, Gijon, Spain
Hosp Univ & Politecn La Fe, Dept Gastroenterol, Valencia, Spain
CIBERehd, Valencia, Spain
Hosp Univ Canarias, Dept Gastroenterol, San Cristobal la Laguna, Spain
Hosp Univ Virgen del Rocio, Dept Gastroenterol, Seville, Spain
Hosp HUA Alava, Dept Gastroenterol, Vitoria, Spain
Hosp Univ Gran Canaria Dr Negrin, Dept Gastroenterol, Las Palmas Gran
Canaria, Spain
Hosp Gen Univ Ciudad Real, Dept Gastroenterol, Ciudad Real, Spain
Hosp Gen Univ Dr Balmis, Dept Gastroenterol, Alicante, Spain
CIBEREHD, Alicante, Spain
Hosp Clin Valladolid, Dept Gastroenterol, Valladolid, Spain
Hosp Univ Fuenlabrada, Dept Gastroenterol, Madrid, Spain
Inst Invest Hosp Univ La Paz IdiPAZ, Madrid, Spain
Hosp Univ Girona Dr Josep Trueta, Dept Gastroenterol, Girona, Spain
Hosp Gen Univ Castellon, Dept Gastroenterol, Castellon de La Plana,
Spain
Hosp Gen San Jorge, Dept Gastroenterol, Huesca, Spain
Hosp Univ Gregorio Maranon, Dept Gastroenterol, IiSGM, Madrid, Spain
Univ Complutense Madrid, Madrid, Spain
Hosp Univ Basurto, Dept Gastroenterol, Bilbao, Spain
Hosp Univ Bellvitge, Dept Gastroenterol, Barcelona, Spain
Hosp Univ Miguel Servet, Dept Gastroenterol, Zaragoza, Spain
Hosp Univ Rio Hortega, Dept Gastroenterol, Valladolid, Spain
Hosp Univ Parc Tauli, Dept Gastroenterol, Sabadell, Spain
Univ Pais Vasco UPV EHU, Biodonostia Hlth Res Inst, Hosp Univ Donostia,
Dept Gastroenterol, Donostia San Sebastian, Spain
CIBEREHD, Donostia San Sebastian, Spain
Hosp Badalona Germans Trias & Pujol, Dept Gastroenterol, Badalona, Spain
CIBEREHD, Badalona, Spain
Inst Invest Sanitaria Aragon IIS Aragon, Hosp Clin Univ Lozano Blesa,
Dept Gastroenterol, Zaragoza, Spain
CIBEREHD, Zaragoza, Spain
Hosp Univ Infanta Sofia, Dept Gastroenterol, Madrid, Spain
Inst Invest Sanitaria BioBizkaia, Hosp Univ Galdakao, Dept
Gastroenterol, Vizcaya, Spain
Hosp Univ Henares, Dept Gastroenterol, Madrid, Spain
Hosp Univ Burgos, Dept Gastroenterol, Burgos, Spain
Parc Sanitari Sant Joan Deu, Dept Gastroenterol, Sant Boi De Llobregat,
Hosp Univ Nuestra Senora Candelaria, Dept Gastroenterol, Santa Cruz De
Tenerife, CA, Spain
Complexo Hosp Univ Pontevedra, Dept Gastroenterol, Pontevedra, Spain
Hosp Gen Univ Elche, Dept Gastroenterol, Elche, Spain
Hosp Santa Creu & Sant Pau, Dept Gastroenterol, Barcelona, Spain
Consorcio Hosp Gen Univ Valencia, Dept Gastroenterol, Valencia, Spain
Hosp Mar, Dept Gastroenterol, Barcelona, Spain
Hosp Mar Med Res Inst IMIM, Barcelona, Spain
Hosp Univ Fdn Alcorcon, Dept Gastroenterol, Madrid, Spain
Hosp Univ Infanta Leonor, Dept Gastroenterol, Madrid, Spain
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