Evgenia Papathanasiou, Alexandros Ioannou, Pavlos Pardalis, Giorgos Leonidakis, George Michalopoulos, Spilios Manolakopoulos, Spyridon Siakavellas, Angeliki Theodoropoulou, Athanasia Tasovasili, Olga Giouleme, Maria Tzouvala, Eftychia Tsironi, Nikos Viazis, Spyridon Michopoulos, Evanthia Zampeli
{"title":"Induction with upadacitinib in Crohn's disease: real-world experience from an early-access program in Greece.","authors":"Evgenia Papathanasiou, Alexandros Ioannou, Pavlos Pardalis, Giorgos Leonidakis, George Michalopoulos, Spilios Manolakopoulos, Spyridon Siakavellas, Angeliki Theodoropoulou, Athanasia Tasovasili, Olga Giouleme, Maria Tzouvala, Eftychia Tsironi, Nikos Viazis, Spyridon Michopoulos, Evanthia Zampeli","doi":"10.20524/aog.2025.0969","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Upadacitinib is a selective Janus kinase-1 inhibitor, approved for the management of Crohn's disease (CD) by the United States Food & Drug Administration. In Greece, upadacitinib was initially available through an early-access program. Our goal was to describe the real practice experience.</p><p><strong>Methods: </strong>This was a multicenter retrospective cohort study of patients with moderate-to-severe CD. The primary endpoint was clinical response, defined as a reduction ≥3 in the Harvey-Bradshaw index. Secondary endpoints included biochemical improvement. Outcomes were assessed at 4, 8 and 12 weeks.</p><p><strong>Results: </strong>A total of 24 CD patients received upadacitinib and were included in the analysis. Their mean age was 42.2 years (range 24-63). Eleven patients (45.8%) had ileocolonic CD and 5 (20.8%) CD colitis. Fourteen patients had active extraintestinal manifestations. The majority of patients (19/24) had ≥3 failed biologics. All of them had failed treatment with anti-tumor necrosis factor and 19 (79%) with ustekinumab. At 12 weeks, nearly all patients achieved a clinical response (85%). Of 13 patients with C-reactive protein >5 mg/L at baseline, 11 (84.6%) achieved normalization by week 8. Adverse events occurred in 3 patients (14.2%).</p><p><strong>Conclusion: </strong>In a small cohort of resistant CD patients, the short-term clinical efficacy of upadacitinib was high.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 3","pages":"306-310"},"PeriodicalIF":2.2000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12070345/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Gastroenterology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.20524/aog.2025.0969","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/4/28 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Upadacitinib is a selective Janus kinase-1 inhibitor, approved for the management of Crohn's disease (CD) by the United States Food & Drug Administration. In Greece, upadacitinib was initially available through an early-access program. Our goal was to describe the real practice experience.
Methods: This was a multicenter retrospective cohort study of patients with moderate-to-severe CD. The primary endpoint was clinical response, defined as a reduction ≥3 in the Harvey-Bradshaw index. Secondary endpoints included biochemical improvement. Outcomes were assessed at 4, 8 and 12 weeks.
Results: A total of 24 CD patients received upadacitinib and were included in the analysis. Their mean age was 42.2 years (range 24-63). Eleven patients (45.8%) had ileocolonic CD and 5 (20.8%) CD colitis. Fourteen patients had active extraintestinal manifestations. The majority of patients (19/24) had ≥3 failed biologics. All of them had failed treatment with anti-tumor necrosis factor and 19 (79%) with ustekinumab. At 12 weeks, nearly all patients achieved a clinical response (85%). Of 13 patients with C-reactive protein >5 mg/L at baseline, 11 (84.6%) achieved normalization by week 8. Adverse events occurred in 3 patients (14.2%).
Conclusion: In a small cohort of resistant CD patients, the short-term clinical efficacy of upadacitinib was high.