Complex perianal fistulas (CPF) in Crohn’s disease are difficult to treat, and standard therapies often struggle to achieve sustained healing. Darvadstrocel (DVS), an allogeneic adipose-derived mesenchymal stem cell therapy, has demonstrated efficacy in treating complex CPF in clinical trials.
This study combined data from a clinical trial (ADMIRE-CD) and two retrospective studies (INSPECT and PREFACE) to model healing and recurrence rates over time. It included 513 patients from multiple European countries and Israel and used statistical modeling to predict the long-term effectiveness of DVS versus standard of care (SoC) in patients with CPF.
The results suggest:
✔️ DVS led to faster healing compared to SoC
✔️ DVS-treated patients had longer relapse-free periods
✔️ At 24 months, 48% of DVS-treated patients were in sustained recovery vs. 35% with SoC
✔️ At 48 months, recovery rates were 49% for DVS vs. 32% for SoC
By integrating real-world evidence with clinical trial data, this study provides a predictive model for long-term CPF treatment strategies. These findings could help inform patient selection and optimize treatment plans for Crohn’s disease-associated fistulas.
