Filgotinib effectiveness and safety as second or third-line therapy in patients with ulcerative colitis: data from a real-world study.

IF 3.9 Q2 GASTROENTEROLOGY & HEPATOLOGY

Intestinal Research Pub Date : 2025-09-29 DOI:10.5217/ir.2025.00067

Antonio Tursi, Giammarco Mocci, Francesco Costa, Linda Ceccarelli, Edoardo Savarino, Caterina De Barba, Caterina Mucherino, Elvira D'Antonio, Laura Montesano, Manuela Marzo, Franco Scaldaferri, Daniele Napolitano, Daniela Pugliese, Antonietta Gerarda Gravina, Raffaele Pellegrino, Rocco Spagnuolo, Francesco Luzza, Antonio Cuomo, Laura Donnarumma, Giovanni Maconi, Giovanni Cataletti, Lorenzo Bertani, Giorgia Bodini, Andrea Pasta, Simona Piergallini, Mariaelena Serio, Antonella Scarcelli, Pietro Capone, Fabio Cortellini, Stefano Rodino, Ladislava Sebkova, Giuliana Vespere, Silvia Sedda, Vittorio D'Onofrio, Leonardo De Luca, Federica Gaiani, Stefano Kayali, Cristiano Pagnini, Maria Giovanna Graziani, Maria Carla Di Paolo, Leonardo Allegretta, Alessia Immacolata Cazzato, Stefano Scorza, Antonio Ferronato, Davide Giuseppe Ribaldone, Giovanni Aragona, Patrizia Perazzo, Giacomo Forti, Michela Di Fonzo, Federico Iacopini, Roberta Pica, Claudio Cassieri, Francesca Maria Onidi, Paolo Usai Satta, Walter Elisei, Marcello Picchio, Alfredo Papa

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引用次数: 0

Abstract

Background/aims: Real-world data on the use of filgotinib (FILGO) in patients with ulcerative colitis (UC) are limited. This study aims to provide consistent results on the effectiveness and safety of FILGO in treating UC.

Methods: A retrospective assessment of clinical and endoscopic activity was conducted in a cohort of patients with UC according to the full Mayo score. The primary co-endpoints of the study were the evaluation of the effectiveness and safety of FILGO.

Results: We enrolled 102 patients with a median follow-up of 24 weeks (interquartile range, 8-24 weeks). At 8 weeks and the end of follow-up, clinical remission was achieved by 38 (37.2%) and 47 (46.1%) patients, respectively. Clinical remission was achieved in 13 of 18 patients (72.2%) receiving first-line therapy, 7 of 19 patients (36.8%) receiving second-line therapy, and 27 of 65 patients (41.5%) receiving third-line therapy (P= 0.002). Clinical remission at 8 weeks predicted clinical remission at the end of follow-up (P= 0.021). Age > 40 years (P= 0.046) and being on second- or third-line of treatment (P= 0.005) were negative predictors for clinical remission. Seventy-one patients (69.6%) achieved a clinical response. At endoscopic evaluation, mucosal healing was observed in 18 out of 30 patients (60.0%). Steroid-free remission was present in 38 out of 46 patients (82.6%). Five patients (4.9%) needed colectomy. Adverse events were recorded in 6 patients (5.8%): 2 cases (2%) were severe, requiring discontinuation of FILGO.

Conclusions: Our real-world data confirms that FILGO is safe and effective for patients with UC. Its efficacy is significantly improved when used as a first-line treatment.

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非戈替尼作为溃疡性结肠炎患者二线或三线治疗的有效性和安全性：来自现实世界研究的数据

背景/目的：关于非戈替尼（filgotinib， FILGO）在溃疡性结肠炎（UC）患者中的应用的真实数据是有限的。本研究旨在为FILGO治疗UC的有效性和安全性提供一致的结果。方法：根据Mayo评分对UC患者进行临床和内镜活动回顾性评估。该研究的主要共同终点是评价FILGO的有效性和安全性。结果：我们纳入了102例患者，中位随访时间为24周（四分位数间距为8-24周）。在8周和随访结束时，分别有38例（37.2%）和47例（46.1%）患者达到临床缓解。接受一线治疗的18例患者中有13例（72.2%）达到临床缓解，接受二线治疗的19例患者中有7例（36.8%）达到临床缓解，接受三线治疗的65例患者中有27例（41.5%）达到临床缓解（P= 0.002）。8周临床缓解预测随访结束时临床缓解（P= 0.021）。年龄0 ~ 40岁（P= 0.046）和接受二线或三线治疗（P= 0.005）是临床缓解的负向预测因子。71例患者（69.6%）达到临床缓解。在内镜评估中，30例患者中有18例（60.0%）粘膜愈合。46例患者中有38例（82.6%）出现无类固醇缓解。5例（4.9%）患者需要结肠切除术。不良事件6例（5.8%）：2例（2%）严重，需要停药。结论：我们的实际数据证实，FILGO对UC患者是安全有效的。作为一线治疗，其疗效显著提高。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Intestinal Research GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

7.40

自引率

10.20%

发文量

审稿时长

38 weeks

期刊介绍： Intestinal Research (Intest Res) is the joint official publication of the Asian Organization for Crohn''s and Colitis (AOCC), Chinese Society of IBD (CSIBD), Japanese Society for IBD (JSIBD), Korean Association for the Study of Intestinal Diseases (KASID), Taiwan Society of IBD (TSIBD) and Colitis Crohn''s Foundation (India) (CCF, india). The aim of the Journal is to provide broad and in-depth analysis of intestinal diseases, especially inflammatory bowel disease, which shows increasing tendency and significance. As a Journal specialized in clinical and translational research in gastroenterology, it encompasses multiple aspects of diseases originated from the small and large intestines. The Journal also seeks to propagate and exchange useful innovations, both in ideas and in practice, within the research community. As a mode of scholarly communication, it encourages scientific investigation through the rigorous peer-review system and constitutes a qualified and continual platform for sharing studies of researchers and practitioners. Specifically, the Journal presents up-to-date coverage of medical researches on the physiology, epidemiology, pathophysiology, clinical presentations, and therapeutic interventions of the intestinal diseases. General topics of interest include inflammatory bowel disease, colon and small intestine cancer or polyp, endoscopy, irritable bowel syndrome and other motility disorders, infectious enterocolitis, intestinal tuberculosis, and so forth. The Journal publishes diverse types of academic materials such as editorials, clinical and basic reviews, original articles, case reports, letters to the editor, brief communications, perspective, statement or commentary, and images that are useful to clinicians and researchers.