McShane Cathy, Varley Rachel, Fennessy Anne, Byron Clodagh, Campion John Richard, Hazel Karl, Costigan Conor, Ring Eabha, Marrinan Alan, Judge Ciaran, Sugrue Kathleen, Cullen Garret, Dunne Cara, Hartery Karen, Iacucci Marietta, Kelly Orlaith, Leyden Jan, McKiernan Susan, O'Toole Aoibhlinn, Sheridan Juliette, Slattery Eoin, Boland Karen, McNamara Deirdre, Egan Laurence, Ghosh Subrata, Doherty Glen, McCarthy Jane, Kevans David
Department of Gastroenterology, St. James's Hospital, Dublin, Ireland; Wellcome - HRB Clinical Research Facility, St. James's Hospital, James's Street, Dublin, Ireland; Trinity Academic Gastroenterology Group, Trinity College Dublin, Ireland.
Mercy University Hospital, Cork, Ireland.
Dig Liver Dis. 2025 Jan;57(1):274-281. doi: 10.1016/j.dld.2024.08.055. Epub 2024 Sep 21.
A significant proportion of inflammatory bowel disease (IBD) patients fail to respond to advanced therapies. Combining advanced therapies may improve treatment outcome. This study aimed to assess the effectiveness, adverse events, and costs associated with combining advanced therapies in IBD patients.
Combination advanced therapy was defined as the concurrent use of two biological agents or one biological agent with a small molecule therapy. Clinical data, including disease characteristics, treatment regimens, and adverse events, were collected from electronic patient records. Clinical response rates, biochemical markers, and treatment costs were evaluated.
The study included 109 IBD patients receiving combination advanced therapies from 9 academic centers in Ireland. Corticosteroid-free clinical response rates at 12 weeks and 52 weeks were 39 % and 38 %, respectively. Adverse events occurred in 26 % of therapeutic trials, with disease-related events being the most common. Notably, there were 3 cases of non-melanomatous skin cancer and 10 infectious complications. The annual cost of maintenance therapy for combination advanced therapies ranged from €17,560 to €30,724 per patient.
Combination advanced therapies demonstrated effectiveness and acceptable safety profiles in a cohort of treatment-refractory IBD patients. Further large, prospective trials are required to definitively evaluate the role of combination advanced therapies in IBD.
相当一部分炎症性肠病(IBD)患者对先进疗法无反应。联合使用先进疗法可能会改善治疗效果。本研究旨在评估IBD患者联合使用先进疗法的有效性、不良事件和成本。
联合先进疗法定义为同时使用两种生物制剂或一种生物制剂与一种小分子疗法。从电子病历中收集临床数据,包括疾病特征、治疗方案和不良事件。评估临床缓解率、生化指标和治疗成本。
该研究纳入了来自爱尔兰9个学术中心的109例接受联合先进疗法的IBD患者。12周和52周时无皮质类固醇临床缓解率分别为39%和38%。26%的治疗试验发生了不良事件,其中与疾病相关的事件最为常见。值得注意的是,有3例非黑色素瘤皮肤癌和10例感染并发症。联合先进疗法维持治疗的年成本为每位患者17,560欧元至30,724欧元。
联合先进疗法在一组治疗难治性IBD患者中显示出有效性和可接受的安全性。需要进一步进行大规模的前瞻性试验来明确评估联合先进疗法在IBD中的作用。