Evidence map›Paper›PMID 32445049›Full record

SynthesisDigestive diseases and sciences2021

Ustekinumab Does Not Increase Risk of Adverse Events: A Meta-Analysis of Randomized Controlled Trials.

Vineet S Rolston, Jessica Kimmel, Violeta Popov, Brian P Bosworth, David Hudesman, Lisa B Malter, Simon Hong, Shannon Chang

Abstract readMeta-AnalysisSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Digestive diseases and sciences, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.3field-weighted citation impact, top 12% 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

10 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
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 at 2 institutions in 1 country.

Vineet S RolstonDivision of Gastroenterology, NYU School of Medicine, New York, NY, USA.ORCID 0000-0001-7975-8508
Jessica KimmelDivision of Gastroenterology, NYU School of Medicine, New York, NY, USA.
Violeta PopovDivision of Gastroenterology, NYU School of Medicine, New York, NY, USA.
Brian P BosworthDivision of Gastroenterology, NYU Langone Medical Center, 240 E 38th Street, 23rd Floor, New York, NY, 10016, USA.
David HudesmanDivision of Gastroenterology, NYU Langone Medical Center, 240 E 38th Street, 23rd Floor, New York, NY, 10016, USA.
Lisa B MalterDivision of Gastroenterology, NYU School of Medicine, New York, NY, USA.
Simon HongDivision of Gastroenterology, NYU School of Medicine, New York, NY, USA.
Shannon ChangDivision of Gastroenterology, NYU Langone Medical Center, 240 E 38th Street, 23rd Floor, New York, NY, 10016, USA. Shannon.Chang@nyumc.org.
New York University · USNYU Langone Health · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

GOALS AND

backgroundUstekinumab (UST) is a monoclonal antibody inhibitor of IL-12/IL-23 approved for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). We conducted a meta-analysis to compare rates of adverse events (AEs) in randomized controlled trials (RCTs) of UST for all indications. STUDY: A systematic search was performed of MEDLINE, Embase, and PubMed databases through November 2019. Study inclusion included RCTs comparing UST to placebo or other biologics in patients aged 18 years or older with a diagnosis of an autoimmune condition.

resultsThirty RCTs with 16,068 patients were included in our analysis. Nine thousand six hundred and twenty-six subjects were included in the UST vs placebo analysis. There was no significant difference in serious or mild/moderate AEs between UST and placebo with an OR of 0.83 (95% CI 0.66, 1.05) and 1.08 (95% CI 0.99, 1.18), respectively, over a median follow-up time of 16 weeks. In a sub-analysis of CD and UC trials, no difference in serious or mild/moderate AEs in UST versus placebo was seen.

conclusionsUST was not associated with an increase in short-term risk of AEs.

Indexed as

AdultColitis, UlcerativeCrohn DiseaseFemaleHumansImmunosuppressive AgentsMaleMiddle AgedRandomized Controlled Trials as TopicRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeUstekinumabImmunosuppressive AgentsUstekinumabCrohn’s diseaseInflammatory bowel diseaseUlcerative colitisUstekinumab

Identifiers

PMID32445049
OpenAlexW3027824663

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.