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OMORI Teppei
Department School of Medicine(Tokyo Women's Medical University Hospital), School of Medicine Position |
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| Article types | Original article |
| Language | English |
| Peer review | Non peer reviewed |
| Title | Efficacy of apheresis as maintenance therapy for patients with ulcerative colitis in an open-label prospective multicenter randomised controlled trial. |
| Journal | Formal name：Journal of gastroenterology Abbreviation：J Gastroenterol ISSN code：14355922/09441174 |
| Domestic / Foregin | Domestic |
| Volume, Issue, Page | 55(4),pp.390-400 |
| Author and coauthor | Naganuma Makoto, Yokoyama Yoko, Motoya Satoshi, Watanabe Kenji, Sawada Koji, Hirai Fumito, Yamamoto Takayuki, Hanai Hiroyuki, OMORI Teppei, Kanai Takanori, Hibi Toshifumi, |
| Publication date | 2020/04 |
| Summary | 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. |
| DOI | 10.1007/s00535-019-01651-0 |
| PMID | 31811562 |