OC.11.4 LONG TERM EFFICACY OF GRANULOCYTE-MONOCYTE-APHERESIS IN ULCERATIVE COLITIS. THE ITALIAN REGISTRY OF THERAPEUTIC APHERESIS
Background and aim: 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. Material and 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. Conclusions: Data collected on a large sample of steroid-resistant or steroidrefractory 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.
Leukocytapheresis for steroid-dependent ulcerative colitis in clinical practice: results of a nationwide Spanish registry
Background: Several small, prospective, open studies suggest that leukocytapheresis might be efficient in patients with steroid-dependent ulcerative colitis (UC). Aim: To evaluate the short- and long-term effectiveness of leukocytapheresis for the management of steroid-dependent UC in clinical practice. Methods: A Web-based, nationwide database specifically designed to record the efficacy and safety data of leukocytapheresis therapy in UC was available from September 2007 in Spain. Clinical data were collected at treatment baseline, 1 month after the last apheresis session (initial efficacy), and 6 and 12 months thereafter (long-term efficacy). Remission was defined as a Mayo Clinic index ≤2 together with complete steroid withdrawal and response as a decrease of ≥3 from the baseline score. Results: A total of 142 steroid-dependent UC patients were included in the registry, most of them treated with the Adacolumn™ system. In 69% of patients thiopurine therapy failed to achieve steroid-free clinical remission. Initial clinical remission was obtained in 37% of cases. The initial corticosteroid dose, the number and frequency of apheresis sessions, or the previous failure of thiopurines and/or infliximab did not influence the initial remission rate, but a greater decrease in CRP levels was associated with a higher probability to obtain initial remission. At 6 and 12 months, 41 and 36% of patients were in clinical remission, respectively. Only one serious adverse effect was recorded. Conclusions: In clinical practice, apheresis allows long-term steroid-free clinical remission in up to one third of steroid-dependent UC patients, even in those with prior failure of thiopurines.
Predictors of clinical response in patients with ulcerative colitis treated with granulocyte-monocyte apheresis: analysis of the apheresis registry data.
Pietro Manuel Ferraro 1, Valeria D’Ovidio, Giampaolo Bresci, Marco Astegiano, Beatrice Principi, Renata D’Inca’, Roberto Testa, Daniela Valpiani, Luisa Guidi, Alessandro Armuzzi, Francesco Costa, Annalisa Aratari, Maurizio Vecchi, Roberto De Franchis, Vincenza Di Leo, Chiara Ricci, Gabriele Riegler, Elisabetta Colombo, Giuseppe Repaci, Pierenrico Lecis, Michele Silla, Stefano Passalacqua, G Ital Nefrol. Jan-Feb 2012;29 Suppl 54:S144-6.
We analyzed predictors of clinical response after a cycle of granulocytemonocyte apheresis in 173 patients with ulcerative colitis. Hemoglobin levels independently predicted good clinical outcome.
The Italian registry of therapeutic apheresis: Granulocyte-monocyte apheresis in the treatment of inflammatory bowel disease. A multicentric study.
Stefano Passalacqua 1, Pietro Manuel Ferraro, Giampaolo Bresci, Valeria D’Ovidio, Marco Astegiano, Mariabeatrice Principi, Roberto Testa, Renata D’Incà, Daniela Valpiani, Alessandro Armuzzi, Renato Sablich, Flaminia Cavallaro, Francesco Costa, Vincenza Di Leo, Elisabetta Colombo, Alessia Santini, Annalisa Aratari, Pierenrico Lecis, Valeria Saladino, Gabriele Riegler, Marino Marco, Francesca Calella, Chiara Ricci, Maria Luisa Guidi, Giuseppe Repaci, Michele Silla, J Clin Apher. 2011 Dec;26(6):332-7.
Leukocytes are thought to play an important role in the pathogenesis of inflammatory bowel diseases; granulocyte-monocyte adsorptive (GMA) apheresis, an extracorporeal technique aimed at removing activated circulating leukocytes from the blood, may represent a safe and effective therapeutic tool in these patients. The Italian Registry of Therapeutic Apheresis performed an observational, multicentric study involving 24 Gastroenterology Units. In this study, laboratory data and clinical outcomes of 230 patients (148 males, mean age 43.5 years) affected with ulcerative colitis (UC, n = 194) or Crohn’s disease (CD, n = 36) who underwent one or more cycles of GMA were analyzed. Each cycle consisted of five GMA treatments. The patients were followed up for a mean of 8.7 (min. 3 to max. 12) months. At 3 months, positive outcome was achieved in 77.7% of UC patients (72.0% remission, 5.7% clinical response) and 61.3% of CD patients (54.8% remission, 6.5% clinical response). The cumulative proportion of positive outcome at 12 months was 87.1% for UC patients (83.7% remission, 3.4% clinical response) and 77.4% for CD patients (74.2% remission, 3.2% clinical response). No single clinical or laboratory parameter among those analyzed (age, sex, disease characteristics, history of smoking, medication history, baseline values of clinical activity index (CAI)/Crohn’s disease activity index (CDAI), hemoglobin, white blood cells count, and erythrocyte sedimentation rate) was independently associated with clinical outcome. The procedure was well tolerated with no significant adverse effects registered.
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