Evidence map›Paper›PMID 27472988›Full record

Observational studyBMC gastroenterology2016

Clinical efficacy of adalimumab in Crohn's disease: a real practice observational study in Japan.

Fuminao Takeshima, Daisuke Yoshikawa, Syuntaro Higashi, Tomohito Morisaki, Hidetoshi Oda, Maho Ikeda, Haruhisa Machida, Kayoko Matsushima, Hitomi Minami, Yuko Akazawa and 5 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMC gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Observational
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

15 authors.

Fuminao TakeshimaDepartment of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan. ftake@nagasaki-u.ac.jp.
Daisuke YoshikawaDepartment of Gastroenterology and Hepatology, Sasebo City General Hospital, 9-3 Hirase-cho, Sasebo City, Nagasaki, 857-8511, Japan.
Syuntaro HigashiDepartment of Gastroenterology, National Hospital Organization Nagasaki Medical Center, 2-1001-1 Kubara, Ohmura City, Nagasaki, 856-8562, Japan.
Tomohito MorisakiDepartment of Gastroenterology and Hepatology, National Hospital Organization Ureshino Medical Center, 2436 Ureshino-cho, Ureshino City, Saga, 843-0393, Japan.
Hidetoshi OdaDepartment of Gastroenterology and Hepatology, Sasebo Chuo Hospital, 15 Yamato-cho, Sasebo City, Nagasaki, 857-1195, Japan.
Maho IkedaDepartment of Internal Medicine, Kouseikai Hospital, 1-3-12 Hayama, Nagasaki City, Nagasaki, 852-8053, Japan.
Haruhisa MachidaDepartment of Internal Medicine, Shunkaikai Inoue Hospital, 6-12 Takara-machi, Nagasaki City, Nagasaki, 850-0045, Japan.
Kayoko MatsushimaDepartment of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
Hitomi MinamiDepartment of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
Yuko AkazawaDepartment of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
Naoyuki YamaguchiDepartment of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
Ken OhnitaDepartment of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
Hajime IsomotoDepartment of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
Masato UenoIntegrated Marketing Department, Eisai Co., Ltd., 13-1 Nishigoken-cho, Shinjuku-ku, Tokyo, 162-0812, Japan.
Kazuhiko NakaoDepartment of Gastroenterology and Hepatology, Graduate School of Biomedical Science, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are few reports of the efficacy of adalimumab (ADA) for clinical remission and preventing postoperative recurrence in Crohn's disease (CD) in Asian real practice settings. We conducted a Japanese multicenter retrospective observational study.

methodsWe evaluated patients with CD who were treated with ADA at 11 medical institutions in Japan to investigate the clinical efficacy of remission up to 52 weeks and the associated factors to achieve remission with a CD Activity Index (CDAI) < 150. The effects of preventing postoperative recurrence were also evaluated.

resultsIn 62 patients, the remission rates were 33.9, 74.2, 75.8, 77.4, and 66.1 % at 0, 4, 12, 26, and 52 weeks, respectively. Although 10 patients discontinued treatment due to primary nonresponse, secondary nonresponse, or adverse events, the ongoing treatment rate at 52 weeks was 83.9 %. Comparison of remission and non-remission on univariate analysis identified colonic type and baseline CDAI value as significant associated factors (P < 0.05). In 16 patients who received ADA to prevent postoperative recurrence, the clinical remission maintenance rate was 93.8 % and the mucosal healing rate was 64.3 % during a mean postoperative follow-up period of 32.3 months.

conclusionsADA effectively induced remission and prevented postoperative recurrence in patients with CD in a real practice setting.

Indexed as

AdalimumabAdultAnti-Inflammatory AgentsCrohn DiseaseFemaleHumansJapanMaleMiddle AgedRemission InductionRetrospective StudiesSecondary PreventionAdalimumabAnti-Inflammatory AgentsAdalimumabCrohn’s diseaseJapanese patientsPreventing postoperative recurrenceReal practice

Identifiers

PMID27472988
PMCPMC4966785

What OpenQuestion holds

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Registered trials

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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.