P498. Granulocytapheresis in steroid-dependent and steroid-resistant patients with inflammatory bowel disease: a prospective observational study
R. Sacco1, A. Romano1, M. Bertini1, G. Federici1, S. Metrangolo1, G. Parisi1, C. Giampietro2, A. Mazzoni2, C. Nencini2, F. Scatena2, G. Bresci1, 1Gastroenterology and Metabolic Diseases, Gastroenterology, Pisa, Italy, 2Pisa University Hospital, Transfusional Center, Pisa, Italy
Granulocytapheresis (GCA) has a mounting importance in the treatment of inflammatory bowel diseases (IBDs); however, the differential effectiveness of this treatment in steroid-resistant and steroid-refractory patients needs further investigation. We report the results of a prospective observational experience on the use of GCA in patients with either ulcerative colitis (UC) or Crohn's disease (CD) who were steroid-dependent (SD) or steroid-refractory (SR).
In total, 118 patients were evaluated: 83 were affected from UC (55 SD and 28 SR), and 35 from CD (22 SD and 13 SR). All patients were treated with GCA, using the AdacolumnTM system, an adsorption column which selectively binds granulocytes and monocytes, for one session/week for 5 consecutive weeks. Concomitant steroid treatment was not permitted. Disease activity was evaluated by clinical disease index (CAI) in patient with UC and by Crohn's Disease Activity Index (CDAI) in those with CD: a clinical remission was defined as CAI ≤6 or CDAI <150. All patients were followed for 12 months after the end of GCA.
All patients completed the study; no complications were reported. The remission rates at the end of GCA, 6 and 12 months are reported in Table 1, while the values of CAI and CDAI during the follow-up period are shown in Table 2.
|End of GCA||6 months||12 months|
|Overall (n = 83)||74%||69%||48%|
|SD (n = 55)||71%||67%||45%|
|SR (n = 28)||67%||64%||39%|
|Overall (n = 35)||65%||57%||43%|
|SD (n = 22)||63%||54%||41%|
|SR (n = 13)||61%||53%||38%|
|Baseline||6 months||12 months|
On the basis of this large observational experience, GCA appears effective and well tolerated for the treatment of UC and CD in patients who are either SD or SR. GCA might be therefore considered as a useful alternative therapeutic approach in these patients. However, these findings need further validation in randomized multicenter trials, with the aim to shed new lights on the use of GCA for the treatment of IBDs.