Persistence, effectiveness and safety of ustekinumab and vedolizumab therapy for complex perianal fistula in Crohn's disease: The HEAL study from GETECCU

被引：1

作者：

Jose Casanova, Maria ^{[1
,2
]}

Caballol, Berta ^{[3
,4
]}

Jose Garcia, Maria ^{[5
,6
]}

Mesonero, Francisco ^{[7
]}

Rubin de Celix, Cristina ^{[1
,2
]}

Suarez-Alvarez, Patricia ^{[8
]}

Ferreiro-Iglesias, Rocio ^{[9
,10
]}

Martin-Rodriguez, Maria del Mar ^{[11
]}

de Francisco, Ruth ^{[12
,13
]}

Varela-Trastoy, Pilar ^{[14
]}

Bastida, Guillermo ^{[15
,16
]}

Carrillo-Palau, Marta ^{[17
]}

Nunez-Ortiz, Andrea ^{[18
]}

Ramirez-de la Piscina, Patricia ^{[19
]}

Ceballos, Daniel ^{[20
]}

Hervias-Cruz, Daniel ^{[21
]}

Munoz-Perez, Roser ^{[22
,23
]}

Velayos, Benito ^{[24
]}

Bermejo, Fernando ^{[25
,26
]}

Busquets, David ^{[27
]}

Cabacino, Manuel ^{[28
]}

Camo-Monterde, Patricia ^{[29
]}

Marin-Jimenez, Ignacio ^{[30
,31
]}

Munoz, Carmen ^{[32
]}

de la Pena-Negro, Luisa Carmen ^{[33
]}

Sierra-Moros, Eva ^{[34
]}

Barrio, Jesus ^{[35
]}

Brunet-Mas, Eduard ^{[36
,37
]}

Bujanda, Luis ^{[38
,39
]}

Canete, Fiorella ^{[40
,41
]}

Gomollon, Fernando ^{[42
,43
]}

Mancenido-Marcos, Noemi ^{[44
]}

Rodriguez-Lago, Iago ^{[45
]}

Rodriguez-Grau, Maria Carmen ^{[46
]}

Sicilia, Beatriz ^{[47
]}

Torra-Alsina, Sandra ^{[48
]}

Arranz-Hernandez, Laura ^{[49
]}

Carpio, Daniel ^{[50
]}

Garcia-Sepulcre, Mariana Fe A. ^{[51
]}

Gonzalez-Munoza, Carlos ^{[52
]}

Maria Huguet, Jose ^{[53
]}

Marquez-Mosquera, Lucia ^{[54
,55
]}

Lopez-Serrano, Maria Pilar ^{[56
]}

Ponferrada-Diaz, Angel ^{[57
]}

Chaparro, Maria ^{[1
,2
]}

Gisbert, Javier P. ^{[1
,2
]}

机构：

[1] Univ Autonoma Madrid UAM, Inst Invest Sanitaria Princesa IIS Princesa, Hosp Univ La Princesa, Dept Gastroenterol, Madrid, Spain

[2] CIBEREHD, Madrid, Spain

[3] IDIBAPS, Hosp Clin & Prov, Dept Gastroenterol, Barcelona, Spain

[4] CIBEREHD, Barcelona, Spain

[5] Hosp Univ Marques Valdecilla, Dept Gastroenterol, Santander, Spain

[6] IDIVAL, Santander, Spain

[7] Hosp Univ Ramon y Cajal, Dept Gastroenterol, Madrid, Spain

[8] Complejo Asistencial Univ Leon, Dept Gastroenterol, Leon, Spain

[9] Hosp Clin Univ Santiago de Compostela, Dept Gastroenterol, Santiago De Compostela, Spain

[10] Inst Invest Sanitaria Santiago de Compostela IDIS, Santiago De Compostela, Spain

[11] Hosp Univ Virgen de las Nieves, Dept Gastroenterol, Granada, Spain

[12] Hosp Univ Cent Asturias, Dept Gastroenterol, Oviedo, Spain

[13] ISPA, Oviedo, Spain

[14] Hosp Univ Cabuenes, Dept Gastroenterol, Gijon, Spain

[15] Hosp Univ & Politecn La Fe, Dept Gastroenterol, Valencia, Spain

[16] CIBEREHD, Valencia, Spain

[17] Hosp Univ Canarias, Dept Gastroenterol, San Cristobal la Laguna, Spain

[18] Hosp Univ Virgen del Rocio, Dept Gastroenterol, Seville, Spain

[19] Hosp HUA Alava, Dept Gastroenterol, Vitoria, Spain

[20] Hosp Univ Gran Canaria Dr Negrin, Dept Gastroenterol, Las Palmas Gran Canaria, Spain

[21] Hosp Gen Univ Ciudad Real, Dept Gastroenterol, Ciudad Real, Spain

[22] Hosp Gen Univ Dr Balmis, Dept Gastroenterol, Alicante, Spain

[23] CIBEREHD, Alicante, Spain

[24] Hosp Clin Valladolid, Dept Gastroenterol, Valladolid, Spain

[25] Hosp Univ Fuenlabrada, Dept Gastroenterol, Madrid, Spain

[26] Inst Invest Hosp Univ La Paz IdiPAZ, Madrid, Spain

[27] Hosp Univ Girona Dr Josep Trueta, Dept Gastroenterol, Girona, Spain

[28] Hosp Gen Univ Castellon, Dept Gastroenterol, Castellon de La Plana, Spain

[29] Hosp Gen San Jorge, Dept Gastroenterol, Huesca, Spain

[30] Hosp Univ Gregorio Maranon, Dept Gastroenterol, IiSGM, Madrid, Spain

[31] Univ Complutense Madrid, Madrid, Spain

[32] Hosp Univ Basurto, Dept Gastroenterol, Bilbao, Spain

[33] Hosp Univ Bellvitge, Dept Gastroenterol, Barcelona, Spain

[34] Hosp Univ Miguel Servet, Dept Gastroenterol, Zaragoza, Spain

[35] Hosp Univ Rio Hortega, Dept Gastroenterol, Valladolid, Spain

[36] Hosp Univ Parc Tauli, Dept Gastroenterol, Sabadell, Spain

[37] CIBEREHD, Barcelona, Spain

[38] Univ Pais Vasco UPV EHU, Biodonostia Hlth Res Inst, Hosp Univ Donostia, Dept Gastroenterol, Donostia San Sebastian, Spain

[39] CIBEREHD, Donostia San Sebastian, Spain

[40] Hosp Badalona Germans Trias & Pujol, Dept Gastroenterol, Badalona, Spain

[41] CIBEREHD, Badalona, Spain

[42] Inst Invest Sanitaria Aragon IIS Aragon, Hosp Clin Univ Lozano Blesa, Dept Gastroenterol, Zaragoza, Spain

[43] CIBEREHD, Zaragoza, Spain

[44] Hosp Univ Infanta Sofia, Dept Gastroenterol, Madrid, Spain

[45] Inst Invest Sanitaria BioBizkaia, Hosp Univ Galdakao, Dept Gastroenterol, Vizcaya, Spain

[46] Hosp Univ Henares, Dept Gastroenterol, Madrid, Spain

[47] Hosp Univ Burgos, Dept Gastroenterol, Burgos, Spain

[48] Parc Sanitari Sant Joan Deu, Dept Gastroenterol, Sant Boi De Llobregat, Spain

[49] Hosp Univ Nuestra Senora Candelaria, Dept Gastroenterol, Santa Cruz De Tenerife, CA, Spain

[50] Complexo Hosp Univ Pontevedra, Dept Gastroenterol, Pontevedra, Spain

来源：

DIGESTIVE AND LIVER DISEASE | 2024年 / 56卷 / 11期

关键词：

Ustekinumab; Vedolizumab; Complex perianal fistula; SUBCUTANEOUS USTEKINUMAB; MULTICENTER; EXPERIENCE; MANAGEMENT; INFLIXIMAB; EFFICACY;

D O I：

10.1016/j.dld.2024.05.009

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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.

引用

页码：1845 / 1853

页数：9

共 50 条

[31] Health Care Costs of Complex Perianal Fistula in Crohn's Disease
Chaparro, M.
Zanotti, C.
Burgueno, P.
Vera, I.
Bermejo, F.
Marin-Jimenez, I.
Yela, C.
Lopez, P.
Martin, M. D.
Taxonera, C.
Botella, B.
Pajares, R.
Ponferrada, A.
Calvo, M.
Algaba, A.
Perez, L.
Casis, B.
Mate, J.
Orofino, J.
Lara, N.
Garcia-Losa, M.
Badia, X.
Gisbert, J. P.
DIGESTIVE DISEASES AND SCIENCES, 2013, 58 (12) : 3400 - 3406
[32] Health Care Costs of Complex Perianal Fistula in Crohn’s Disease
M. Chaparro
C. Zanotti
P. Burgueño
I. Vera
F. Bermejo
I. Marín-Jiménez
C. Yela
P. López
M. D. Martín
C. Taxonera
B. Botella
R. Pajares
A. Ponferrada
M. Calvo
A. Algaba
L. Pérez
B. Casis
J. Maté
J. Orofino
N. Lara
M. García-Losa
X. Badia
J. P. Gisbert
Digestive Diseases and Sciences, 2013, 58 : 3400 - 3406
[33] Comparative safety and effectiveness of vedolizumab to tumour necrosis factor antagonist therapy for Crohn's disease
Bohm, Matthew
Xu, Ronghui
Zhang, Yiran
Varma, Sashidhar
Fischer, Monika
Kochhar, Gursimran
Boland, Brigid
Singh, Siddharth
Hirten, Robert
Ungaro, Ryan
Shmidt, Eugenia
Lasch, Karen
Jairaith, Vipul
Hudesman, David
Chang, Shannon
Lukin, Dana
Swaminath, Arun
Sands, Bruce E.
Colombel, Jean-Frederic
Kane, Sunanda
Loftus, Edward V., Jr.
Shen, Bo
Siegel, Corey A.
Sandborn, William J.
Dulai, Parambir S.
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2020, 52 (04) : 669 - 681
[34] Effectiveness and safety of ustekinumab dose escalation in Crohn's disease: a multicenter observational study
Olmedo-Martin, Raul
Vazquez-Moron, Juan Maria
Martin-Rodriguez, Maria del Mar
Lazaro-Saez, Marta
Hernandez-Martinez, Alvaro
Arguelles-Arias, Federico
REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS, 2023, 115 (12) : 686 - 692
[35] A Case of an Uncomplicated Pregnancy on Dual Biologic Therapy With Ustekinumab and Vedolizumab for Crohn's Disease
Amini, Shayan
Abraham, Bincy P.
Glassner, Kerri
AMERICAN JOURNAL OF GASTROENTEROLOGY, 2024, 119 (10S): : S2581 - S2582
[36] The Use of Combination Vedolizumab and Ustekinumab in Crohn's Disease: A Retrospective Cohort Study
Glassner, Kerri
Wang, Lin
Ezeana, Chika
Wong, Stephen
Abraham, Bincy P.
AMERICAN JOURNAL OF GASTROENTEROLOGY, 2020, 115 : S355 - S355
[37] Effectiveness and safety of darvadstrocel in patients with complex perianal fistulizing Crohn's disease: a systematic review
Fousekis, Fotios S.
Mpakogiannis, Konstantinos
Lianos, Georgios D.
Koukoudis, Anastasios
Christodoulou, Dimitrios K.
Papaconstantinou, Ioannis
Katsanos, Konstantinos H.
ANNALS OF GASTROENTEROLOGY, 2024, 37 (01): : 46 - 53
[38] Effectiveness and Safety of Ustekinumab as Rescue Therapy in Multi-Drug Resistant Crohn's Disease
Ginard, Daniel
Khorrami, Sam
Marin-Jimenez, Ignacio
Chaparro, Maria
Aguas, Mariam
Munoz, Fernando
Martinez-Gonzalez, Javier
Cabriada, Jose Luis
Garcia-Sanchez, Valle
Villoria, Albert
Casellas, Francesc
Sanso, Andreu
Riera, Joan
Hervias, Daniel
Garcia, S.
Garcia, Esther
Gisbert, Javier P.
GASTROENTEROLOGY, 2012, 142 (05) : S355 - S355
[39] Dual Biologic Therapy Induces Remission in Refractory Crohn's Disease With Vedolizumab and Ustekinumab
Hassan, Syed Adeel
Perry, Courtney
Carey, Patrick
Colohan, Durham
Eltaher, Mohamed Gebril
Dawoud, Nabila
Elkammar, Mahmoud
Rasheed, Waqas
Mayne, Casie
Stuffelbeam, Amy
Flomenhoft, Deborah
Barrett, Terrence A.
CROHNS & COLITIS 360, 2025, 7 (01)
[40] Real-world clinical effectiveness and safety of vedolizumab and ustekinumab in biologic-naive patients with Crohn's disease: Results from the EVOLVE Expansion study
Ferrante, M.
Christensen, B.
Bressler, B.
Brett, N.
Bassel, M.
Kamble, P.
Adsul, S.
Gianchetti, L.
Scharl, M.
JOURNAL OF CROHNS & COLITIS, 2023, 17 : 768 - 769

← 1 2 3 4 5 →