Yoko Yokoyama1, Katsuyoshi Matsuoka2, Taku Kobayashi3, Koji Sawada4, Tateshi Fujiyoshi5, Takafumi Ando6, Yoshifumi Ohnishi7, Tetsuya Ishida8, Masashi Oka9, Masahiro Yamada10, Takashi Nakamura11, Tomoko Ino11, Toyoko Numata11, Hirofumi Aoki11, Jun-Ichi Sakou11, Masahiro Kusada11, Tomoki Maekawa12, Toshifumi Hibi13. 1. Division of Lower Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan. 2. Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan. 3. Center for Advanced IBD Research and Treatment, Kitasato University, Kitasato Institute Hospital, Tokyo, Japan. 4. Ikoma Digestive Tract Internal Medicine Clinic, Osaka, Japan. 5. Fujiyoshi Clinic, Kumamoto, Japan. 6. Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan. 7. Department of Gastroenterology, National Hospital Organization Shizuoka Medical Center, Shizuoka, Japan. 8. Department of Gastroenterology, Oita Red Cross Hospital, Oita, Japan. 9. Department of Gastroenterology and Hepatology, Faculty of Medicine, Saitama Medical University, Saitama, Japan. 10. Department of Gastroenterology, Toyohashi Municipal Hospital, Toyohashi, Japan. 11. Japan Operation Division, Blood Purification Business Unit, Scientific and Technical Affairs Department, Asahi Kasei Medical Co. Ltd., Tokyo, Japan. 12. Product Vigilance and Quality Assurance Department, Regulatory Affairs, Product Vigilance and QA Division, Asahi Kasei Medical Co. Ltd., Tokyo, Japan. 13. Center for Advanced IBD Research and Treatment, Kitasato University, Kitasato Institute Hospital, Tokyo, Japan. Electronic address: thibi@insti.kitasato-u.ac.jp.
Abstract
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.
RCT Entities:
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.