Long-term real-world data of ustekinumab in ulcerative colitis: the Stockholm Ustekinumab Study (STOCUSTE).

Autor:	Sabhan H; Gastroenterology Unit, Medical Department, Capio St Göran Hospital., Bello F; Division of Gastroenterology, Medical Department, Karolinska University Hospital, Stockholm., Muhsen S; Department of Medicine, Division of Gastroenterology and Hepatology, Danderyd Hospital, Danderyd., Borin A; Department of Medicine, South Hospital, Stockholm., Johansson F; Medical Library at Danderyd Hospital, Danderyd., Höög C; Division of Gastroenterology, Medical Department, Karolinska University Hospital, Stockholm.; Department of Medicine, Karolinska Institutet, Huddinge., Forsberg O; Janssen Cilag AB., Wennerström C; Janssen Cilag AB., Lördal M; Department of Medicine, Division of Gastroenterology and Hepatology, Danderyd Hospital, Danderyd., Almer S; Division of Gastroenterology, Medical Department, Karolinska University Hospital, Stockholm.; Department of Medicine, Karolinska Institutet, Solna, Stockholm, Sweden., Söderman C; Gastroenterology Unit, Medical Department, Capio St Göran Hospital.; Department of Medicine, Karolinska Institutet, Solna, Stockholm, Sweden.
Jazyk:	angličtina
Zdroj:	European journal of gastroenterology & hepatology [Eur J Gastroenterol Hepatol] 2024 Dec 01; Vol. 36 (12), pp. 1419-1425. Date of Electronic Publication: 2024 Sep 20.
DOI:	10.1097/MEG.0000000000002854
Abstrakt:	Background: Ustekinumab (UST) is an anti-interleukin-12/23 antibody used in the treatment of inflammatory bowel disease. This study includes patients treated at four hospitals in Stockholm to provide long-term real-world data. Methods: Retrospective study including patients diagnosed with ulcerative colitis and treated with UST between the years 2019 and 2021. Patients were followed until withdrawal of treatment, or until a predefined end of study, 31 July 2021. Disease activity was assessed with Physician Global Assessment (PGA); Ulcerative Colitis Endoscopic Index of Severity (UCEIS), laboratory parameters, and drug persistence. The primary outcome was steroid-free remission (PGA = 0) and response (decrease PGA ≥ 1 from baseline) at 3 and 12 months, respectively. Results: A total of 96 patients, 44 women and 52 men were included. The patients had either extensive colitis (69%), left-sided colitis (29%), or proctitis (3%). All but two patients were anti-TNF-experienced; 94 (98%) had failed ≥1, 59 (61%) ≥ 2, and 34 (35%) had failed ≥ 3 anti-TNF drugs. In addition, 28 (29%) had failed vedolizumab. At inclusion, 92/96 patients (96%) had active disease and four patients were in remission. Among patients who were treated with UST, 9/71 (13%) were in steroid-free remission at 3 months, and 26/33 (78%) were at 12 months. Withdrawal rates at 3 and 12 months, were 12 and 26%, respectively, mainly due to persisting disease activity (20%). Conclusion: In this group of patients with difficult-to-treat ulcerative colitis, UST was shown to be effective in the majority, with high drug persistence at 12 months in combination with a favorable safety profile. (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)
Databáze:	MEDLINE
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