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P424. Long term efficacy of granulocyte-monocyte-apheresis in ulcerative colitis. The Italian Registry of Therapeutic Apheresis

R. Sacco1, V. D'Ovidio2, S. Passalacqua3, P. Ferraro3, M.B. Principi4, M. Astegiano5, R. Testa6, R. D'Incà7, A. Armuzzi8, D. Valpiani9, M.L. Guidi10, F. Costa1, A.L. Aratari11, C. Ricci12, G. Riegler13, E. Colombo14, G. Repaci15, P. Lecis16, M. Silla17, M. Vecchi18, G. Bresci1, 1Pisa University Hospital, Gastroenterology, Pisa, Italy, 2Policlinico Umberto I, Gastroenterology, Rome, Italy, 3Catholic University, Nephrology, Rome, Italy, 4University of Bari, Gastroenterology, Bari, Italy, 5ASO Molinette, Gastroenterology, Turin, Italy, 6S.Corona Hospital, Gastroenterology, Pietra Ligure, Italy, 7University of Padova, Gastroenterology, Padova, Italy, 8Columbus University, Internal Medicine, Roma, Italy, 9Ospedale Morgagni, Gastroenterology, Forli', Italy, 10Catholic University, Gastroenterology, Rome, Italy, 11San Filippo Neri Hospital, Gastroenterology, Rome, Italy, 12Spedali Civili, Gastroenterology, Brescia, Italy, 13SUN University, Gastroenterology, Napoli, Italy, 14AUC Careggi, Gastroenterology, Firenze, Italy, 15Azienda Ospedaliera Legnano, Gastroenterology, Magenta, Italy, 16Ospedale S.Martino, Gastroenterology, Belluno, Italy, 17Ospedale di Vasto, Gastroenterology, Vasto, Italy, 18San Donato Milanese Hospital, Gastroenterology, San Donato Milanese, Italy

Background

Granulocyte-monocyte-apheresis (GMA) is effective in the treatment of ulcerative colitis (UC). However, all published studies evaluated a low number of patients, with an overall limited follow-up. This observational study investigates the long-term efficacy of GMA in a large number of patients included in the Italian Registry of Therapeutic Apheresis.

Methods

Data of patients with mild/moderate UC treated with a standard protocol of GMA (5 sessions in 5 weeks) were evaluated. All patients had failed to respond to mesalamine or sulphasalazine, and were under steroid treatment. Clinical evaluations were performed at 3, 12 and 24 months since the end of GMA session. The following parameters were assessed: incidence of clinical remission (CAI [Colits Active Index] <4); CAI; erythrocyte sedimentation rate (ESR); c-reactive protein (CRP); white cells blood count (WBC). Endoscopical evaluations were performed at a 3-month follow-up: the incidence of endoscopical remission (EAI [endoscopical activity index] 0/1) was assessed.

Results

Data for 347 patients (214 males, age 46.3 years; CAI 7.47) were available; 288 patients were either steroid-resistant or steroid-dependent. The proportion of patients with remission of disease was 66% at 3 months, 77% at 12 months and 78% at 24 months. At 24 months, all other efficacy parameters had improved from baseline: CAI (7.47 vs 3.47), ESR (35.87 vs 24.1 mm/h), CRP (4.31 vs 2.75 mg/dl) and WBC (8.61 vs 7.19) (p < 0.001 for all comparisons).

Endoscopic data were available for 107 patients. The incidence of mucosal healing was 47% and all patients with mucosal healing presented a clinical remission over the entire follow-up period.

No major adverse events were reported during GMA sessions.

Conclusion

Data collected on a large sample of steroid-resistant or steroid-refractory patients included in the Italian Registry of Therapeutic Apheresis show that GMA is a safe and effective procedure over a long-term follow-up. Mucosal healing appears strongly associated with clinical remission.