P764 Darvastrocel in Treatment of 152 Patients with Perianal Crohn's Disease - Observational Study

Abstract

Abstract Background Complex perianal fistulas significantly affect quality of life and treatment costs in patient with Crohn's disease (CD). Application of adult allogeneic expanded adipose-derived mesenchymal stem cells (Darvastrocel, Takeda Pharmaceuticals) represents novel treatment modality for this challenging condition. The aim of this study was to examine the long-term effects of Darvastrocel (DVS) in patients with complex perianal fistula associated with Crohn’s disease. Methods The study was conducted at two Czech medical facilities (NH Hospital, Horovice and ISCARE, Prague). All consecutive CD patients with complex perianal fistula (up to 2 internal and 3 external openings) treated by the same team with DVS between August 2019 and July 2023 were enrolled into the study and followed prospectively. All fistulas persist despite previous biologic and surgical treatment. The technique of DVS application was based on the ADMIRE CD study protocol and was in accordance with SPC. Fistula tract was curetted, internal opening closed and leak test performed under GA. DVS was applied below the internal opening and along the fistula tract subsequently. Perianal area was then assessed at week 3, month 3 and 6 and then every year postoperatively. Results In total, 152 patients (53.9% male, 46.1% female) with median age of 36.6 (20-72) years were enrolled (tab. 1). Primary success rate detected within the period of 19.8 (4.2-50.2) months after application was 80.3% (122 patients). Fistula recurred in 9 patients (at the site of original fistula in 6 and in a new location in 3 cases), resulting in a sustained healing rate of 74.3% (113 patients) observed within average of 27.2 months. The Perianal Crohn's Disease Index was significantly lower 3, 6, and 12 months after application in the healed compared to failed group - 1 (0-9), 0 (0-8) and 0 (0-9) vs. 7 (1-13, 8 (0-12) and 6 (0-12), p<0.005. Postoperatively, 48 patients (31.6%) were prescribed antibiotics due to inflammatory changes in perianal area. Out of 122 healed patients 31 (25.4%) received antibiotics for 17 (5-37) days, while 17 (56,6%) patients with treatment failure were treated for 16 (7-70) days. Conclusion This real-life study showed that Darvastrocel is highly effective in treatment of complex perianal Crohn’s disease resistant to conservative and surgical management. Moreover, for some patients (anal stricture, chronic changes in anorectum) this may be the only available therapeutic option. Intermittent antibiotic treatment did not affect long-term outcomes. We consider clinical response (crucial for the patient's quality of life) sufficient for predicting sustained long term remission.