A multicenter, retrospective, observational study of the clinical outcomes and risk factors for relapse of ulcerative colitis at 1 year after leukocytapheresis.

BACKGROUND: Extracorporeal leukocytapheresis (LCAP) is effective for inducing remission of ulcerative colitis (UC). This retrospective observational study aimed to evaluate the clinical outcome at 1 year and identify risk factors for relapse of UC after LCAP. METHODS: Patients with active UC treated with LCAP between 2010 and 2012 were enrolled from 54 medical facilities in Japan. Clinical data evaluated at 1 year after the last LCAP session included the incidence of relapse, 1-year cumulative relapse-free rate, risk factors for relapse, and history of re-induction treatment following relapse. Relapse was defined by the addition of treatment to induce remission. The primary endpoint was the 1-year cumulative relapse-free rate. Secondary endpoints were risk factors for relapse and outcomes of re-induction treatment after relapse. RESULTS: For 314 patients, the 1-year cumulative relapse-free rate was 63.6%. Following LCAP, a Lichtiger clinical activity index (CAI) of 3 or 4 and high leukocyte count (cut-off value: 7790/mm3) were associated with a greater risk of relapse. Intensive LCAP (≥4 sessions within the first 2 weeks) was associated with favorable long-term outcomes in corticosteroid-refractory patients. The response rate was 85.1% among 30 patients who required re-treatment with LCAP. CONCLUSIONS: The majority of patients (>60%) with UC treated with LCAP achieved clinical remission within 1 year and remained relapse-free. A higher Lichtiger CAI and leukocyte count following LCAP were risk factors for relapse. Re-induction therapy with LCAP was effective for relapse of UC.

Safety and efficacy of cell-free and concentrated ascites reinfusion therapy (CART) in refractory ascites: Post-marketing surveillance results.

We performed post-marketing surveillance to evaluate the safety and efficacy of cell-free and concentrated ascites reinfusion therapy (CART). In total, 356 CART sessions in 147 patients at 22 centers were performed. The most common primary disease was cancer (128 cases, 300 sessions). Mean amount of ascites collected was 3.7 L, and mean concentration ratio was 9.2. Mean amount of reinfused protein was 67.8 g (recovery rate, 72.0%). Performance status, dietary intake, urine volume, body weight and abdominal circumference were significantly improved after CART. Body temperature increased significantly, by 0.3°C on average. Concomitant steroids and/or NSAIDs use before reinfusion was significantly and negatively associated with increases in body temperature. Most adverse events were fever and chills. This study examined a large number of patients compared with previous studies, and showed that CART is an effective and relatively safe treatment for refractory ascites, such as malignant ascites.

Safety and Tolerability of Nafamostat Mesilate and Heparin as Anticoagulants in Leukocytapheresis for Ulcerative Colitis: Post Hoc Analysis of a Large-Scale, Prospective, Observational Study.

Nafamostat mesilate is the first anticoagulant of choice for leukocytapheresis (LCAP) with a Cellsorba E column for treating ulcerative colitis (UC). However, because of complications, mainly due to allergy to nafamostat mesilate, heparin may be used as a substitute. To evaluate the safety and tolerability of nafamostat mesilate and heparin as anticoagulants in LCAP for UC, we conducted post hoc analysis of data from a large-scale, prospective, observational study of LCAP, which was conducted at 116 medical facilities in Japan between May 2010 and December 2012. Of 832 patients included in this analysis, nafamostat mesilate and heparin were used in 676 (81.3%) and 113 (13.6%), respectively. There were no significant differences in the incidence of adverse reactions (8.6% vs. 7.1%) and intrafilter pressure increases (12.7% vs. 16.8%) between the nafamostat mesilate and heparin groups. Adverse reactions of hemorrhage or blood pressure decreases associated with heparin use were not observed. There were no significant differences in rates of clinical remission (69.1% vs. 68.1%) and mucosal healing (62.9% vs. 63.6%) between the nafamostat mesilate and heparin groups. Thus, the safety and tolerability were comparable in the nafamostat mesilate and heparin groups, indicating that both nafamostat mesilate and heparin can be well tolerated as anticoagulants in LCAP for UC.

A large-scale, prospective, observational study of leukocytapheresis for ulcerative colitis: treatment outcomes of 847 patients in clinical practice.

BACKGROUND AND AIMS: Leukocytapheresis is an extracorporeal therapy for ulcerative colitis. However, no large-scale study on leukocytapheresis has been reported. This large-scale, prospective, observational study aimed to evaluate the treatment outcomes of leukocytapheresis for active ulcerative colitis in clinical practice. METHODS: Patients with active ulcerative colitis treated with leukocytapheresis using a Cellsorba E column between May 2010 and December 2012 were enrolled from 116 medical facilities in Japan. RESULTS: A total of 847 patients were enrolled, and 623 were available for efficacy analysis. Out of 847 patients, 80.3% of the patients had moderate to severe disease activity, and 67.6% were steroid refractory. As concomitant medications, 5-aminosalicylic acids, corticosteroids, and thiopurines were administered to 94.8%, 63.8%, and 32.8% of the patients, respectively. In addition, infliximab and tacrolimus were concomitantly used in 5.8% and 12.3%, respectively. Intensive leukocytapheresis (≥4 leukocytapheresis sessions within the first 2 weeks) was used in >70% of the patients. Adverse events were seen in 10.3% (87/847), which were severe in only 5 patients (0.6%). Any concomitant medications did not increase the incidence of adverse events. Intensive leukocytapheresis was as safe as the conventional weekly procedure. The overall clinical remission rate was 68.9% (429/623), and the mucosal healing rate was 62.5% (145/232). Clinical remission was achieved more frequently and rapidly in the intensive group than in the weekly group. CONCLUSIONS: This large-scale study indicates that leukocytapheresis, including intensive procedure, is a safe and effective therapeutic option for active ulcerative colitis.