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

被引：4

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 33 条

[1]

[Anonymous], USTekinumab in Fistulising Perianal Crohn's Disease (CD): the USTAP CD Study. NCT04496063

[2] Efficacy of ustekinumab for active perianal fistulizing Crohn's disease: a systematic review and meta-analysis of the current literature [J].

Attauabi, Mohamed ;

Burisch, Johan ;

Seidelin, Jakob Benedict .

SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY, 2021, 56 (01) :53-58

[3] Ustekinumab is associated with superior treatment persistence but not with higher remission rates versus vedolizumab in patients with refractory Crohn's disease: results from a multicentre cohort study [J].

Bacsur, Peter ;

Matuz, Maria ;

Resal, Tamas ;

Miheller, Pal ;

Szamosi, Tamas ;

Schafer, Eszter ;

Sarlos, Patricia ;

Ilias, Akos ;

Szanto, Kata ;

Rutka, Mariann ;

Balint, Anita ;

Milassin, Agnes ;

Fabian, Anna ;

Bor, Renata ;

Szepes, Zoltan ;

Molnar, Tamas ;

Farkas, Klaudia .

THERAPEUTIC ADVANCES IN GASTROENTEROLOGY, 2022, 15

[4] High Risk of Anal and Rectal Cancer in Patients With Anal and/or Perianal Crohn's Disease [J].

Beaugerie, Laurent ;

Carrat, Fabrice ;

Nahon, Stephane ;

Zeitoun, Jean-David ;

Sabate, Jean-Marc ;

Peyrin-Biroulet, Laurent ;

Colombel, Jean-Frederic ;

Allez, Matthieu ;

Flejou, Jean-Francois ;

Kirchgesner, Julien ;

Svrcek, Magali .

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, 2018, 16 (06) :892-+

[5] Pharmacological Approach to the Management of Crohn's Disease Patients with Perianal Disease [J].

Bermejo, Fernando ;

Guerra, Ivan ;

Algaba, Alicia ;

Lopez-Sanroman, Antonio .

DRUGS, 2018, 78 (01) :1-18

[6] Recommendations of the Crohn's Disease and Ulcerative Colitis Spanish Working Group (GETECCU) for the treatment of perianal fistulas of Crohn's disease [J].

Bosca, Marta M. ;

Alos, Rafael ;

Maroto, Nuria ;

Gisbert, Javier P. ;

Beltran, Belen ;

Chaparro, Maria ;

Nos, Pilar ;

Minguez, Miguel ;

Hinojosa, Joaquin .

GASTROENTEROLOGIA Y HEPATOLOGIA, 2020, 43 (03) :155-168

[7] Ustekinumab for Perianal Crohn's Disease: The BioLAP Multicenter Study From the GETAID [J].

Chapuis-Biron, Constance ;

Kirchgesner, Julien ;

Pariente, Benjamin ;

Bouhnik, Yoram ;

Amiot, Aurelien ;

Viennot, Stephanie ;

Serrero, Melanie ;

Fumery, Mathurin ;

Allez, Matthieu ;

Siproudhis, Laurent ;

Buisson, Anthony ;

de Chambrun, Guillaume Pineton ;

Abitbol, Vered ;

Nancey, Stephane ;

Caillo, Ludovic ;

Plastaras, Laurianne ;

Savoye, Guillaume ;

Chanteloup, Elise ;

Simon, Marion ;

Dib, Nina ;

Rajca, Sylvie ;

Amil, Morgane ;

Parmentier, Anne-Laure ;

Peyrin-Biroulet, Laurent ;

Vuitton, Lucine .

AMERICAN JOURNAL OF GASTROENTEROLOGY, 2020, 115 (11) :1812-1820

[8] Vedolizumab for perianal Crohn's disease: a multicentre cohort study in 151 patients [J].

Chapuis-Biron, Constance ;

Bourrier, Anne ;

Nachury, Maria ;

Nancey, Stephane ;

Bouhnik, Yoram ;

Serrero, Melanie ;

Armengol-Debeir, Laura ;

Buisson, Anthony ;

Tran-Minh, My-Linh ;

Zallot, Camille ;

Fumery, Mathurin ;

Bouguen, Guillaume ;

Abitbol, Vered ;

Viennot, Stephanie ;

Chanteloup, Elise ;

Rajca, Sylvie ;

Dib, Nina ;

Parmentier, Anne-Laure ;

Peyrin-Biroulet, Laurent ;

Vuitton, Lucine .

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2020, 51 (07) :719-727

[9] Efficacy of Vedolizumab in Fistulising Crohn's Disease: Exploratory Analyses of Data from GEMINI 2 [J].

Feagan, Brian G. ;

Schwartz, David ;

Danese, Silvio ;

Rubin, David T. ;

Lissoos, Trevor W. ;

Xu, Jing ;

Lasch, Karen .

JOURNAL OF CROHNS & COLITIS, 2018, 12 (05) :621-626

[10] A global consensus on the classification, diagnosis and multidisciplinary treatment of perianal fistulising Crohn's disease [J].

Gecse, Krisztina B. ;

Bemelman, Willem ;

Kamm, Michael A. ;

Stoker, Jaap ;

Khanna, Reena ;

Ng, Siew C. ;

Panes, Julian ;

van Assche, Gert ;

Liu, Zhanju ;

Hart, Ailsa ;

Levesque, Barrett G. ;

D'Haens, Geert .

GUT, 2014, 63 (09) :1381-1392

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