Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of California (UC) Davis Medical Center, University of California Davis School of Medicine, Sacramento, CA, United States.
Division of Health Policy and Management, Department of Public Health Sciences, University of California (UC) Davis, Davis, CA, United States.
Front Immunol. 2022 Jun 17;13:859954. doi: 10.3389/fimmu.2022.859954. eCollection 2022.
Crohn's disease (CD) is an inflammatory bowel disease with increasing incidence and prevalence worldwide. Perianal fistulas are seen in up to 26% of CD patients and are often refractory to medical therapy. Current treatments for CD perianal fistulas (pCD) include antibiotics, biologics, and for refractory cases, fecal diversion (FD) with ileostomy or colostomy. Mesenchymal stem/stromal cell therapy (MSCs) is a new modality that have shown efficacy in treating pCD. MSCs locally injected into pCD can lead to healing, and a phase III clinical trial (ADMIRE-CD) showed 66% clinical response, leading to approval of MSCs (Alofisel, Takeda) in the European Union. It is unclear if MSCs would be more cost-effective than the current standard of FD. We therefore developed a decision tree model to determine the cost-effectiveness of MSCs compared to FD for pCD. Our study showed that both autologous and allogeneic MSCs are more cost-effective than FD in an academic medical center and even in a worst-case scenario with 100% chance of all complications for MSCs treatment and 0% chance of complications for FD, both allogeneic and autologous MSCs are still cost saving compared to FD.
克罗恩病（CD）是一种炎症性肠病，全球发病率和患病率呈上升趋势。高达 26%的 CD 患者会出现肛周瘘管，且这些瘘管通常对药物治疗有抗性。目前，CD 肛周瘘管（pCD）的治疗方法包括抗生素、生物制剂，对于难治性病例，则采用粪转流（FD）加回肠造口或结肠造口。间充质干细胞/基质细胞疗法（MSCs）是一种新的治疗模式，已被证明对治疗 pCD 有效。将 MSCs 局部注射到 pCD 中可以促进愈合，一项 III 期临床试验（ADMIRE-CD）显示 66%的临床应答率，从而导致欧盟批准 MSCs（Alofisel，武田）用于治疗 pCD。目前尚不清楚 MSCs 是否比目前的 FD 标准更具成本效益。因此，我们开发了一个决策树模型，以确定 MSCs 与 FD 治疗 pCD 的成本效益。我们的研究表明，在学术医疗中心，无论是自体还是同种异体 MSCs，其成本效益均优于 FD，即使在最不利的情况下，即 MSCs 治疗的所有并发症发生概率为 100%，FD 治疗的并发症发生概率为 0%，与 FD 相比，同种异体和自体 MSCs 仍然具有成本效益。
