P475. Granulocyte and Monocyte Apheresis (GMA) - Adacolumn® in mild to moderate ulcerative colitis patients with steroid resistance or dependence and azathioprine intolerance or resistance: a prospective multicenter study (preliminary data)
G. Imperiali1, M.M. Terpin2, A. Amato1, A. Bortoli3, G. Meucci4, 1Valduce Hospital, Gastroenterology, Como, Italy, 2Legnano Hospital, Gastroenterology, Legnano, Italy, 3Rho Hospital, Gastroenterology, Rho, Italy, 4S. Giuseppe Hospital, Gastroenterology, Milano, Italy
The use of Granulocyte and Monocyte Apheresis (GMA) in patients with ulcerative colitis (UC) has not yet found its precise indication.
The aim of this study was to evaluate the efficacy of GMA in patients steroid-resistant or dependent and azathioprine-intolerant or resistant, in terms of suspending steroids and avoiding biologic therapy and surgery.
In this prospective multicentric study (GSMII - Gruppo Studio Malattie Infiammatorie Intestinali) we enrolled consecutively patients with: (a) diagnosis of UC (excluding proctitis) at least one year old; (b) mild to moderate disease activity (CAI between 5 and 12); (c) steroid dependence or resistance and azathioprine resistance or intolerance. In conclusion all patients potential candidates for a biologic therapy or surgery.
At the enrollment clinical, laboratory (complete blood count, coagulation tests, C-reactive protein) and endoscopic assessment were collected. GMA was performed once per week for 5 consecutive weeks. The tapering of the steroid was started after the fourth treatment. Clinical and laboratory were monitored at 3, 6 and 12 months. Adverse events and therapeutic modifications were registered.
Currently, 30 patients were enrolled in the study, 25 of whom have completed follow-up. 11/25 (44%) patients discontinued the steroid and did not need biologics nor surgery, 2/25 (8%) patients have reduced, but not suspended, the steroid, while not requesting biologic therapy nor surgery and 12/25 (48%) patients started therapy with biological or underwent colectomy.
Preliminary data of the study show that a cycle of 5 sessions of GMA is effective in maintaining steroid-free and avoiding surgery and biological therapy in 44% mild to moderate ulcerative colitis patients with steroid dependence or resistance and azathioprine intolerance or resistance. Whether the results will be definitively confirmed, this group of patients could benefit from the maximum effectiveness of the treatment with Adacolumn.