Uria Shani, Monica State, Radu Bogdan Mateescu, Ana-Maria Davidoiu, Lucian Negreanu, Isabel Silva, Fernando Magro, Charlie W Lees, Nikolas Plevris, Xavier Roblin, Sílvia Castellet-Farrús, Yago Gonzalez Lama, Shanshan Wang, Carolina Abad, Nicola Imperatore, Milan Lukas, Gabriela Vojtechova, Offir Ukashi, Shomron Ben-Horin, Stephane Nancey, Edoardo Savarino, Kamila Stawczyk-Eder, Piotr Eder, Alexandros Toskas, Nikolaos Kamperidis, Naila Arebi, Bernadett Farkas, Klaudia Farkas, Barbora Pipek, Premysl Falt, Konstantinos Karmiris, Pinelopi Nikolaou, Zeljko Krznaric, Marko Brinar, Frank Hoentjen, Lisa van Lierop, Manuel Barreiro-de Acosta, Marta Zaborowska, Edyta Zagorowicz, Daniela Pugliese, Giuseppe Cuccia, Marie Truyens, Uri Kopylov
{"title":"The effectiveness of second- and-third-line biologics in perianal Crohn's disease-a multicenter propensity score-matched study.","authors":"Uria Shani, Monica State, Radu Bogdan Mateescu, Ana-Maria Davidoiu, Lucian Negreanu, Isabel Silva, Fernando Magro, Charlie W Lees, Nikolas Plevris, Xavier Roblin, Sílvia Castellet-Farrús, Yago Gonzalez Lama, Shanshan Wang, Carolina Abad, Nicola Imperatore, Milan Lukas, Gabriela Vojtechova, Offir Ukashi, Shomron Ben-Horin, Stephane Nancey, Edoardo Savarino, Kamila Stawczyk-Eder, Piotr Eder, Alexandros Toskas, Nikolaos Kamperidis, Naila Arebi, Bernadett Farkas, Klaudia Farkas, Barbora Pipek, Premysl Falt, Konstantinos Karmiris, Pinelopi Nikolaou, Zeljko Krznaric, Marko Brinar, Frank Hoentjen, Lisa van Lierop, Manuel Barreiro-de Acosta, Marta Zaborowska, Edyta Zagorowicz, Daniela Pugliese, Giuseppe Cuccia, Marie Truyens, Uri Kopylov","doi":"10.1093/ecco-jcc/jjaf099","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and aims: </strong>Anti-tumor necrosis factor-α inhibitors (anti-TNFs) are the established treatment for perianal Crohn's disease (pCD), but relapse and non-response are common. Data on second- and third-line biologics are limited. We present the first direct comparison of second- and third-line biologics in pCD patients with active perianal disease previously treated with first-line anti-TNFs.</p><p><strong>Methods: </strong>A multicenter retrospective cohort study included adult patients with pCD who failed first-line anti-TNF. The primary outcome was clinical perianal response, with secondary outcomes of radiological response (magnetic resonance imaging or transrectal ultrasound) and healing, and clinical remission. Propensity score matching (PSM) was used to adjust for baseline differences.</p><p><strong>Results: </strong>A total of 486 pCD patients from 23 IBD centers were included, with 333/486 (68.5%) and 216/263 (82.1%) matched by PSM in the second and third-line treatment groups, respectively. In the second-line group, 62/78 (79.5%) of ustekinumab (UST)-treated patients achieved clinical perianal response, compared to 46/78 (58.9%) with vedolizumab (VDZ) (OR 4.47, 95% CI, 1.94-10.28, P < .001) and 38/78 (48.7%) with anti-TNFs (OR 5.29, 95% CI, 2.39-11.71, P < .001). In the third-line group, 38/49 (77.6%) of UST-treated patients achieved clinical perianal response, compared to 29/49 (59.2%) with VDZ (OR 9.96, 95% CI, 2.6-38.4, P < .001) and 27/49 (55.1%) with anti-TNFs (OR 12.03, 95% CI, 2.99-48.47, P < .001). UST-treated patients also had higher radiological response rates than VDZ (OR 3.28, 95% CI, 1.07-10.07, P = .038).</p><p><strong>Conclusion: </strong>In pCD patients failing anti-TNFs as first-line treatment, ustekinumab may be more effective than vedolizumab or another anti-TNF as second or third-line therapy.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":8.7000,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Crohn's & colitis","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/ecco-jcc/jjaf099","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Background and aims: Anti-tumor necrosis factor-α inhibitors (anti-TNFs) are the established treatment for perianal Crohn's disease (pCD), but relapse and non-response are common. Data on second- and third-line biologics are limited. We present the first direct comparison of second- and third-line biologics in pCD patients with active perianal disease previously treated with first-line anti-TNFs.
Methods: A multicenter retrospective cohort study included adult patients with pCD who failed first-line anti-TNF. The primary outcome was clinical perianal response, with secondary outcomes of radiological response (magnetic resonance imaging or transrectal ultrasound) and healing, and clinical remission. Propensity score matching (PSM) was used to adjust for baseline differences.
Results: A total of 486 pCD patients from 23 IBD centers were included, with 333/486 (68.5%) and 216/263 (82.1%) matched by PSM in the second and third-line treatment groups, respectively. In the second-line group, 62/78 (79.5%) of ustekinumab (UST)-treated patients achieved clinical perianal response, compared to 46/78 (58.9%) with vedolizumab (VDZ) (OR 4.47, 95% CI, 1.94-10.28, P < .001) and 38/78 (48.7%) with anti-TNFs (OR 5.29, 95% CI, 2.39-11.71, P < .001). In the third-line group, 38/49 (77.6%) of UST-treated patients achieved clinical perianal response, compared to 29/49 (59.2%) with VDZ (OR 9.96, 95% CI, 2.6-38.4, P < .001) and 27/49 (55.1%) with anti-TNFs (OR 12.03, 95% CI, 2.99-48.47, P < .001). UST-treated patients also had higher radiological response rates than VDZ (OR 3.28, 95% CI, 1.07-10.07, P = .038).
Conclusion: In pCD patients failing anti-TNFs as first-line treatment, ustekinumab may be more effective than vedolizumab or another anti-TNF as second or third-line therapy.
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