Evidence map›Paper›PMID 31504528›Full record

SynthesisInflammatory bowel diseases2020

Corticosteroid-Free Remission vs Overall Remission in Clinical Trials of Moderate-Severe Ulcerative Colitis and Crohn's Disease.

John George, Siddharth Singh, Parambir S Dulai, Christopher Ma, Tran Nguyen, Brian G Feagan, William J Sandborn, Vipul Jairath

Abstract readComparative StudyMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Inflammatory bowel diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

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

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  14. A review of the therapeutic management of ulcerative colitis.Therapeutic advances in gastroenterology · 2022
    Review
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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

8 authors.

John GeorgeDepartment of Internal Medicine, Bridgeport Hospital-Yale New Haven Health, Bridgeport, Connecticut, USA.
Siddharth SinghDivision of Gastroenterology, University of California San Diego, La Jolla, California, USA.
Parambir S DulaiDivision of Gastroenterology, University of California San Diego, La Jolla, California, USA.
Christopher MaDivision of Robarts Clinical Trials Inc., London, Ontario, Canada.
Tran NguyenDivision of Robarts Clinical Trials Inc., London, Ontario, Canada.
Brian G FeaganDivision of Robarts Clinical Trials Inc., London, Ontario, Canada.
William J SandbornDivision of Gastroenterology, University of California San Diego, La Jolla, California, USA.
Vipul JairathDivision of Robarts Clinical Trials Inc., London, Ontario, Canada.

Funding

Comparative Risks and Benefits of Pharmacological Therapies for Older Patients with Inflammatory Bowel DiseasesK23DK117058 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SINGH, SIDDHARTH · 2018 to 2022
$971k
NIDDK NIH HHS K23 DK117058
6 · The paper itself

Abstract

backgroundWe summarized the protocol-specified corticosteroid tapering regimens in clinical trials of moderate-severe ulcerative colitis (UC) and Crohn's disease (CD) and calculated differences in rates of clinical remission vs corticosteroid-free clinical remission (CSF-CR).

methodsThrough a systematic literature review through February 28, 2019, we identified 16 randomized controlled trials (RCTs) of biologics or small molecules in patients with moderate-severe UC or CD who reported CSF-CR as an outcome. We estimated the relative risk and 95% confidence interval of achieving CSF-CR vs overall clinical remission in patients treated with active intervention or placebo through random-effects meta-analysis.

resultsAcross trials of UC (11 trials) and CD (5 trials), a median of 53% and 49% of participants were on corticosteroids at the time of trial entry, respectively. Participants were allowed to enter trials at a median corticosteroid dose (range) of 35 (20-40) mg/d. Doses were kept stable for a median (range) of 8 (5-10) weeks during induction therapy, after which a mandatory and structured taper was implemented, albeit with the investigators' discretion depending on clinical status. Pooled rates of CSF-CR in patients with UC and CD treated with placebo were 9.7% and 19.1%, respectively. In UC and CD trials, the rate of CSF-CR was 24% and 18% lower than the rate of overall clinical remission, respectively.

conclusionsProtocol-specified corticosteroid tapering regimens vary across trials. These findings will help to inform the design and interpretation of future clinical trials and highlight the need for standardization.

Indexed as

Adrenal Cortex HormonesBiological ProductsColitis, UlcerativeCrohn DiseaseHumansRandomized Controlled Trials as TopicRemission InductionAdrenal Cortex HormonesBiological Productsclinical trialsCrohn’s diseaseend pointsmaintenance therapyulcerative colitis

Identifiers

PMID31504528
PMCPMC8127062

What OpenQuestion holds

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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.