Evidence map›Paper›PMID 27304428›Full record

Trial reportExperimental dermatology2017

Efficacy and safety of ustekinumab treatment in adults with moderate-to-severe atopic dermatitis.

Saakshi Khattri, Patrick M Brunner, Sandra Garcet, Robert Finney, Steven R Cohen, Margeaux Oliva, Riana Dutt, Judilyn Fuentes-Duculan, Xiuzhong Zheng, Xuan Li and 9 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Experimental dermatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 3 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

59 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Systemic treatments for eczema: a network meta-analysis.The Cochrane database of systematic reviews · 2020
    Pooled it
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Critical Players and Therapeutic Targets in Chronic Itch.International journal of molecular sciences · 2022
    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

19 authors.

Saakshi KhattriThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Patrick M BrunnerThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Sandra GarcetThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Robert FinneyDepartment of Dermatology, Jefferson Medical College, Philadelphia, PA, USA.
Steven R CohenDivision of Dermatology, Department of Medicine, Albert Einstein College of Medicine, New York, NY, USA.
Margeaux OlivaThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Riana DuttThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Judilyn Fuentes-DuculanThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Xiuzhong ZhengThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Xuan LiThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Kathleen M BonifacioThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Norma KunjraviaThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Israel CoatsThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Inna CuetoThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Patricia GilleaudeauThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Mary Sullivan-WhalenThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Mayte Suárez-FariñasThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
James G KruegerThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
Emma Guttman-YasskyThe Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.

Funding

Developing, Demonstrating, and Disseminating Innovative Programs to Achieve Translational SuccessUL1TR001866 · NCATS · ROCKEFELLER UNIVERSITY · PI COLLER, BARRY, KRUEGER, JAMES G · 2016 to 2025
$40.6M
Transforming Translational Science and Education to Benefit Human HealthUL1TR000043 · NCATS · ROCKEFELLER UNIVERSITY · PI COLLER, BARRY · 2012 to 2015
$26.8M
NCATS NIH HHS UL1 TR000043NCATS NIH HHS UL1 TR001866
6 · The paper itself

Abstract

Atopic dermatitis (AD) is the most common inflammatory skin disease, but treatment options for moderate-to-severe disease are limited. Ustekinumab is an IL-12/IL-23p40 antagonist that suppresses Th1, Th17 and Th22 activation, commonly used for psoriasis patients. We sought to assess efficacy and safety of ustekinumab in patients with moderate-to-severe AD. In this phase II, double-blind, placebo-controlled study, 33 patients with moderate-to-severe AD were randomly assigned to either ustekinumab (n=16) or placebo (n=17), with subsequent crossover at 16 weeks, and last dose at 32 weeks. Background therapy with mild topical steroids was allowed to promote retention. Study endpoints included clinical (SCORAD50) and biopsy-based measures of tissue structure and inflammation, using protein and gene expression studies. The ustekinumab group achieved higher SCORAD50 responses at 12, 16 (the primary endpoint) and 20 weeks compared to placebo, but the difference between groups was not significant. The AD molecular profile/transcriptome showed early robust gene modulation, with sustained further improvements until 32 weeks in the initial ustekinumab group. Distinct and more robust modulation of Th1, Th17 and Th22 but also Th2-related AD genes was seen after 4 weeks of ustekinumab treatment (i.e. MMP12, IL-22, IL-13, IFN-γ, elafin/PI3, CXCL1 and CCL17; P<.05). Epidermal responses (K16, terminal differentiation) showed faster (4 weeks) and long-term regulation (32 weeks) from baseline in the ustekinumab group. No severe adverse events were observed. Ustekinumab had clear clinical and molecular effects, but clinical outcomes might have been obscured by a profound "placebo" effect, most likely due to background topical glucocorticosteroids and possibly insufficient dosing for AD.

Indexed as

AdultChemokine CCL17Chemokine CXCL1Cross-Over StudiesDermatitis, AtopicDermatologic AgentsDouble-Blind MethodElafinFemaleGene Expression ProfilingHumansInterferon-gammaInterleukin-13Interleukin-22InterleukinsMaleCCL17 protein, humanChemokine CCL17Chemokine CXCL1CXCL1 protein, humanDermatologic AgentsElafinIL13 protein, humanInterferon-gammaInterleukin-13Interleukin-22InterleukinsMatrix Metalloproteinase 12MMP12 protein, humanPI3 protein, humanUstekinumabatopic dermatitisIL-12IL-22IL-23p40ustekinumab

Identifiers

PMID27304428
PMCPMC5502835

What OpenQuestion holds

Textmetadata
LicenceTDM
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.