Evidence map›Paper›PMID 31041545›Full record

Trial reportJournal of gastroenterology2019

Withdrawal of thiopurines in Crohn's disease treated with scheduled adalimumab maintenance: a prospective randomised clinical trial (DIAMOND2).

Tadakazu Hisamatsu, Shingo Kato, Reiko Kunisaki, Minoru Matsuura, Masakazu Nagahori, Satoshi Motoya, Motohiro Esaki, Norimasa Fukata, Satoko Inoue, Takeshi Sugaya and 12 more

Abstract readEquivalence TrialMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 7 pooled it
3.4field-weighted citation impact, top 8% 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

19 citing papers in PubMed, 7 syntheses or guidelines pooled it, 30 citations in OpenAlex.

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  14. Stopping Anti-TNF in CD Remitters: Cons.Inflammatory intestinal diseases · 2022
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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

22 authors at 15 institutions in 1 country.

Tadakazu HisamatsuDivision of Gastroenterology and Hepatology, Third Department of Internal Medicine, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka-shi, Tokyo, 181-8611, Japan. thisamatsu@ks.kyorin-u.ac.jp.ORCID http://orcid.org/0000-0002-1178-3536
Shingo KatoDepartment of Gastroenterology and Hepatology, Saitama Medical Centre, Saitama Medical University, Saitama, Japan.
Reiko KunisakiInflammatory Bowel Disease Centre, Yokohama City University Medical Center, Kanagawa, Japan.
Minoru MatsuuraDepartment of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Masakazu NagahoriDepartment of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.
Satoshi MotoyaInflammatory Bowel Disease Center, Sapporo Kosei General Hospital, Sapporo, Japan.
Motohiro EsakiDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Norimasa FukataThird Department of Internal Medicine, Kansai Medical University, Osaka, Japan.
Satoko InoueDepartments of Gastroenterology, Kobe City Medical Center General Hospital, Hyogo, Japan.
Takeshi SugayaDepartment of Internal Medicine, Japan Red Cross Ashikaga Hospital, Tochigi, Japan.
Hirotake SakurabaDepartment of Gastroenterology and Hematology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Fumihito HiraiInflammatory Bowel Disease Center, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Kenji WatanabeDivision of Gastroenterology, Osaka City General Hospital, Osaka, Japan.
Takanori KanaiDepartment of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan.
Makoto NaganumaDepartment of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan.
Hiroshi NakaseDepartment of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Yasuo SuzukiDepartment of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan.
Mamoru WatanabeDepartment of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.
Toshifumi HibiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Masanori NojimaCenter for Translational Research, Institute of Medical Science Hospital, University of Tokyo, Tokyo, Japan.
Takayuki MatsumotoDivision of Gastroenterology, Department of Medicine, Iwate Medical University, Morioka, Japan.
DIAMOND2 Study Group
Tokyo Medical and Dental University · JPHirosaki University · JPIwate Medical University · JPKansai Medical University · JPKyorin University · JPAshikaga Red Cross Hospital · JPFukuoka University · JPHyogo Medical University · JPKeio University · JPKitasato Institute Hospital · JPKyoto University · JPKyushu University · JPSapporo Medical University · JPToho University · JPYokohama City University Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe risk:benefit ratio of concomitant use of thiopurines with scheduled adalimumab (ADA) maintenance therapy for Crohn's disease is controversial. The aim of this study is to identify the influence of withdrawal of thiopurines in patients in remission with combination therapy in an open-label, randomised, controlled trial (DIAMOND2; UMIN000009596).

methodsPatients in corticosteroid-free clinical remission (CFCR) for ≥ 6 months with ADA (40 mg, s.c., every other week) scheduled maintenance combined with thiopurines were randomised into two groups, "continue" (Con) or "discontinue" (Dis) group of thiopurines, whereas all other patients kept receiving scheduled ADA maintenance therapy for 52 weeks. The primary endpoint was the proportion of patients in CFCR at week 52. Secondary endpoints were endoscopic remission (ER), trough levels of ADA in serum, and safety.

resultsFifty patients were randomised to Con or Dis groups. Characteristics of patients were not significantly different between the groups. CFCR and ER prevalence at week 52 were not significantly different between groups (log rank, P = 0.704, P = 1.000, respectively). Trough levels of ADA were not significantly different between groups (P = 0.515). The proportion of patients with AAA positivity at week 52 was not significantly different (P = 0.437). ER at week 0 was involved in ER and triple remission at week 52. No serious adverse effects were observed in either group.

conclusionContinuation of thiopurines > 6 months offers no clear benefit over scheduled ADA monotherapy. CFCR, ER, and ADA trough level at week 52 were not significantly different between groups. ER at week 0 may be involved in better long-term clinical outcomes.

Indexed as

AdalimumabAdolescentAdultAgedAzathioprineBiomarkersC-Reactive ProteinCrohn DiseaseDrug Administration ScheduleDrug Therapy, CombinationEndoscopy, GastrointestinalFemaleGastrointestinal AgentsHumansImmunosuppressive AgentsMaleAdalimumabAzathioprineBiomarkersC-Reactive ProteinGastrointestinal AgentsImmunosuppressive AgentsTumor Necrosis Factor InhibitorsAdalimumabCrohn’s diseaseThiopurines

Identifiers

PMID31041545
OpenAlexW2942618334

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.