Makoto Naganuma1, Yoko Yokoyama2, Satoshi Motoya3, Kenji Watanabe2, Koji Sawada4, Fumito Hirai5, Takayuki Yamamoto6, Hiroyuki Hanai7, Teppei Omori8, Takanori Kanai9, Toshifumi Hibi10. 1. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. nagamakoto@keio.jp. 2. Department of Intestinal Inflammation Research, Hyogo College of Medicine, Hyogo, Japan. 3. Inflammatory Bowel Disease Center, Sapporo Kosei General Hospital, Hokkaido, Japan. 4. Dojima General and Gastroenterology Clinic, Osaka, Japan. 5. Inflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Japan. 6. IBD Center, Yokkaichi Hazu Medical Center, Yokkaichi, Japan. 7. IBD Center, Hamamatsu South Hospital, Hamamatsu, Japan. 8. Institute of Gastroenterology and Hepatology, Tokyo Women's Medical University, Tokyo, Japan. 9. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. 10. Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Abstract
BACKGROUND:Apheresis therapy involves the selective removal of leukocytes and is used to induce remission in ulcerative colitis (UC) patients. The aim of this study was to demonstrate the efficacy and safety of apheresis therapy for maintaining UC remission. METHODS: We conducted a multicenter, prospective, randomised-control trial of patients with remitting UC induced by granulocyte and monocyte adsorption apheresis or leukocytapheresis. Patients were randomly assigned to the apheresis group (twice per month for 12 months) or the control group (no apheresis treatment) using a 1:1 allocation ratio. The primary endpoint was the rate of cumulative clinical remission (Mayo score ≤ 2) at 12 months. The secondary endpoints were the rates of clinical remission, endoscopic remission, and complete endoscopic remission at 12 months. RESULTS:Between March 2013 and March 2017, 164 patients were enrolled. The cumulative remission rate at 12 months was 46.6% in the apheresis group and 36.4% in the control group (p = 0.1621). The rate of endoscopic remission at 12 months was significantly higher in the apheresis group than in the control group (42.5% vs. 25.9%) p = 0.0480). The rate of clinical remission (47.5% vs.32.1%, p = 0.0540) and complete endoscopic remission (33.8% vs.19.8%, p = 0.0513) tended to be higher in the apheresis than in the control group; however, the difference was not significant. No severe adverse events were observed in either group. CONCLUSIONS:Apheresis was well tolerated as maintenance therapy for UC although the cumulative clinical remission rate at 12 months was comparable between the apheresis and control groups.
RCT Entities:
BACKGROUND: Apheresis therapy involves the selective removal of leukocytes and is used to induce remission in ulcerative colitis (UC) patients. The aim of this study was to demonstrate the efficacy and safety of apheresis therapy for maintaining UC remission. METHODS: We conducted a multicenter, prospective, randomised-control trial of patients with remitting UC induced by granulocyte and monocyte adsorption apheresis or leukocytapheresis. Patients were randomly assigned to the apheresis group (twice per month for 12 months) or the control group (no apheresis treatment) using a 1:1 allocation ratio. The primary endpoint was the rate of cumulative clinical remission (Mayo score ≤ 2) at 12 months. The secondary endpoints were the rates of clinical remission, endoscopic remission, and complete endoscopic remission at 12 months. RESULTS: Between March 2013 and March 2017, 164 patients were enrolled. The cumulative remission rate at 12 months was 46.6% in the apheresis group and 36.4% in the control group (p = 0.1621). The rate of endoscopic remission at 12 months was significantly higher in the apheresis group than in the control group (42.5% vs. 25.9%) p = 0.0480). The rate of clinical remission (47.5% vs.32.1%, p = 0.0540) and complete endoscopic remission (33.8% vs.19.8%, p = 0.0513) tended to be higher in the apheresis than in the control group; however, the difference was not significant. No severe adverse events were observed in either group. CONCLUSIONS: Apheresis was well tolerated as maintenance therapy for UC although the cumulative clinical remission rate at 12 months was comparable between the apheresis and control groups.
Authors: K Sawada; K Ohnishi; T Kosaka; S Chikano; Y Yokota; A Egashira; H Izawa; M Yamamura; K Amano; M Satomi; T Shimoyama Journal: Ther Apher Date: 1997-08
Authors: Paul Rutgeerts; William J Sandborn; Brian G Feagan; Walter Reinisch; Allan Olson; Jewel Johanns; Suzanne Travers; Daniel Rachmilewitz; Stephen B Hanauer; Gary R Lichtenstein; Willem J S de Villiers; Daniel Present; Bruce E Sands; Jean Frédéric Colombel Journal: N Engl J Med Date: 2005-12-08 Impact factor: 91.245
Authors: William J Sandborn; Brian G Feagan; Colleen Marano; Hongyan Zhang; Richard Strauss; Jewel Johanns; Omoniyi J Adedokun; Cynthia Guzzo; Jean-Frederic Colombel; Walter Reinisch; Peter R Gibson; Judith Collins; Gunnar Järnerot; Toshifumi Hibi; Paul Rutgeerts Journal: Gastroenterology Date: 2013-06-02 Impact factor: 22.682