P363 Growing up with ileal pouch: Adult-patient controlled and coetaneous population-based long-term evaluation of patients undergoing pouch surgery in the developmental age

Abstract

disease (CD). We updated our first experience with unselected stem cell autotransplantation in refractory CD. Methods: Ten patients (4 male, age 22 46 years) with active moderate-severe CD (median CDAI 340, range 236 395; four with perianal disease), refractory or intolerant to multiple drugs including anti-TNF-alpha agents and immunosuppressors, were enrolled. Unselected PBSCs were collected after mobilisation with CTX 1.5 g/m2 and G-CSF 10mcg/kg. The conditioning regimen included CTX 50mg/kg on days 5 to 2 and rabbit ATG 2.5mg/kg on days 4 to 2. Toxicity, clinical remission (CDAI <150), endoscopic remission (SES-CD) and extramucosal response (ultrasound sonography [US]) were assessed after mobilisation and at 3, 12 months and then every year after stem cells reinfusion. Results: No improvement was confirmed after mobilisation (median CDAI 364, range 201 404). Eight patients were in clinical remission at the first month (median CDAI 141, range 90 198). At the third month, all patients were in clinical remission (median CDAI 91, range 56 132) despite discontinuation of all medications. After a median follow-up of 56 (range 23 68) months, clinical remission was maintained in 80%, 50%, 40%, 30% and 30% at the 1st, 2nd, 3rd, 4th and 5th year after HSCT, respectively. Complete mucosal healing was observed in 50% and 60% after 3 and 12 months, respectively, but maintained in only 30% at their last visit. Perianal fistulas closure was observed in 3/4 patients. No deaths or life-threatening infections occurred. Unexpected adverse events included a perianal abscess after mobilisation in one patient, pleural and pericardial effusions in another, BK virusrelated macrohaematuria in one case, and acute pielonephritis in another patient, all rapidly resolved with conservative treatment. Conclusions: Unselected CD34+ cells transplantation can induce and maintain both clinical and endoscopic remission in refractory CD patients.