Fistula Healing Is Low After Fecal Diversion Surgery in Perianal Crohn’s Disease

Johnson, Sheeva; Ko, Justine S.; Halabi, Wissam J.; Stondell, Jesse; Dave, Maneesh

doi:10.1093/ibd/izab210

Cited by 1 publication

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“…Many prior studies on FD have described symptomatic improvement but do not report actual objective fistula healing rate as determined by no fistula drainage despite gentle finger compression, exam under anesthesia, MRI pelvis, or endoscopic ultrasound. Our recent study evaluating fistula healing after FD as a primary endpoint showed fistula healing of 40% and is similar to two recent multicenter studies which reported between 36.8-42.2% fistula healing after FD, which is much lower than the summary estimate of 63.8% used in our study (8)(9)(10). At the same time, the MSC fistula healing rates are obtained from a robust phase III clinical trial (ADMIRE-CD) (5), and is similar to those reported in multiple studies including In conclusion, our study demonstrates that MSCs are more cost effective than FD for refractory pCD in an academic medical center.…”

Section: Discussionsupporting

confidence: 90%

Mesenchymal Stem/Stromal Cell Therapy Is More Cost-Effective Than Fecal Diversion for Treatment of Perianal Crohn’s Disease Fistulas

et al. 2022

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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.

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Section: Discussionsupporting

confidence: 90%