Evidence map›Paper›PMID 31811562›Full record

Trial reportJournal of gastroenterology2020

Efficacy of apheresis as maintenance therapy for patients with ulcerative colitis in an open-label prospective multicenter randomised controlled trial.

Makoto Naganuma, Yoko Yokoyama, Satoshi Motoya, Kenji Watanabe, Koji Sawada, Fumito Hirai, Takayuki Yamamoto, Hiroyuki Hanai, Teppei Omori, Takanori Kanai and 2 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Guideline
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  4. Evolving Trends in Pediatric Inflammatory Bowel Disease Management in Japan: A Decade of Nationwide Data.JGH open : an open access journal of gastroenterology and hepatology · 2025
    Article
  5. Review
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  7. Comparison of earlyJGH open : an open access journal of gastroenterology and hepatology · 2024
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 1 country.

Makoto NaganumaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. nagamakoto@keio.jp.ORCID http://orcid.org/0000-0002-4244-3243
Yoko YokoyamaDepartment of Intestinal Inflammation Research, Hyogo College of Medicine, Hyogo, Japan.
Satoshi MotoyaInflammatory Bowel Disease Center, Sapporo Kosei General Hospital, Hokkaido, Japan.
Kenji WatanabeDepartment of Intestinal Inflammation Research, Hyogo College of Medicine, Hyogo, Japan.
Koji SawadaDojima General and Gastroenterology Clinic, Osaka, Japan.
Fumito HiraiInflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Takayuki YamamotoIBD Center, Yokkaichi Hazu Medical Center, Yokkaichi, Japan.
Hiroyuki HanaiIBD Center, Hamamatsu South Hospital, Hamamatsu, Japan.
Teppei OmoriInstitute of Gastroenterology and Hepatology, Tokyo Women's Medical University, Tokyo, Japan.
Takanori KanaiDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Toshifumi HibiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
CAPTAIN study Group
Hyogo Medical University · JPKeio University · JPFukuoka University · JPKitasato Institute Hospital · JPTokyo Women's Medical University · JPYokkaichi Social Insurance Hospital · JP

Funding

Asahi Kasei Pharma Corporation (JP) non-financial supportJIMRO Co., Ltd non-financial support
6 · The paper itself

Abstract

backgroundApheresis 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.

methodsWe 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.

resultsBetween 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.

conclusionsApheresis 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.

Indexed as

LeukapheresisRemission InductionAdultColitis, UlcerativeColonoscopyFemaleGranulocytesHumansMaleMiddle AgedMonocytesProspective StudiesSeverity of Illness IndexTime FactorsTreatment OutcomeEndoscopic remissionGranulocyte and monocyte adsorption apheresisLeukocytapheresis ulcerative colitisMaintenance therapy

Identifiers

PMID31811562
OpenAlexW2993480907

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.