Evidence map›Paper›PMID 29353025›Full record

Trial reportJournal of the American Academy of Dermatology2018

Efficacy and safety of fezakinumab (an IL-22 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by conventional treatments: A randomized, double-blind, phase 2a trial.

Emma Guttman-Yassky, Patrick M Brunner, Avidan U Neumann, Saakshi Khattri, Ana B Pavel, Kunal Malik, Giselle K Singer, Danielle Baum, Patricia Gilleaudeau, Mary Sullivan-Whalen and 9 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Academy of Dermatology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 150 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
150citing papers in PubMed, 4 pooled it
41.2field-weighted citation impact, top 1% 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

150 citing papers in PubMed, 4 syntheses or guidelines pooled it, 330 citations in OpenAlex.

  1. Pooled it
  2. Systemic treatments for eczema: a network meta-analysis.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Monoclonal Antibodies in Pediatric Atopic Dermatitis; Efficacy and Safety.Current therapeutic research, clinical and experimental · 2026
    Review
  7. Atopic Dermatitis: New Targets and Emerging Systemic Therapies.American journal of clinical dermatology · 2026
    Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Review
  15. Interleukin-24 in type 2 immune diseases.Frontiers in immunology · 2026
    Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Article

90 more citing papers are in PubMed but not listed here.

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 at 4 institutions in 3 countries.

Emma Guttman-YasskyDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; Laboratory for Investigative Dermatology, The Rockefeller University, New York, New York. Electronic address: Emma.Guttman@mountsinai.org.
Patrick M BrunnerLaboratory for Investigative Dermatology, The Rockefeller University, New York, New York.
Avidan U NeumannInstitute of Environmental Medicine, University Center for Health Sciences at the Klinikum Augsburg, Technical University Munich and Helmholtz Zentrum München - German Research Center for Environmental Health, Augsburg, Germany; Swiss Institute of Allergy and Asthma Research, University of Zürich, Davos, Switzerland; Berlin-Brandenburg Center for Regenerative Therapies, Charité University Hospital Berlin, Berlin, Germany.
Saakshi KhattriDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.
Ana B PavelDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.
Kunal MalikDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.
Giselle K SingerDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.
Danielle BaumDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.
Patricia GilleaudeauLaboratory for Investigative Dermatology, The Rockefeller University, New York, New York.
Mary Sullivan-WhalenLaboratory for Investigative Dermatology, The Rockefeller University, New York, New York.
Sharon RoseDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.
Shelbi Jim OnDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.
Xuan LiLaboratory for Investigative Dermatology, The Rockefeller University, New York, New York.
Judilyn Fuentes-DuculanLaboratory for Investigative Dermatology, The Rockefeller University, New York, New York.
Yeriel EstradaDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.
Sandra GarcetLaboratory for Investigative Dermatology, The Rockefeller University, New York, New York.
Claudia Traidl-HoffmannInstitute of Environmental Medicine, University Center for Health Sciences at the Klinikum Augsburg, Technical University Munich and Helmholtz Zentrum München - German Research Center for Environmental Health, Augsburg, Germany; Christine Kühne - Center for Allergy Research and Education, Davos, Switzerland.
James G KruegerLaboratory for Investigative Dermatology, The Rockefeller University, New York, New York.
Mark G LebwohlDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.
Icahn School of Medicine at Mount Sinai · USRockefeller University · USCK-CARE · CHUniversity Hospital Augsburg · DE

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
A Study of ILV-94 (Anti-22 Antibody) Administered via IV in Atopic DermatitisUM1AR063917 · NIAMS · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI GUTTMAN, EMMA · 2013 to 2017
$2.8M
NCATS NIH HHS UL1 TR001866NIAMS NIH HHS UM1 AR063917
6 · The paper itself

Abstract

backgroundInterleukin 22 promotes epidermal hyperplasia and inhibits skin barrier function.

objectiveEvaluate interleukin 22 blockade in adults with moderate-to-severe atopic dermatitis (AD).

methodsWe performed a randomized, double-blind, placebo-controlled trial with intravenous fezakinumab monotherapy every 2 weeks for 10 weeks, with follow-up assessments until 20 weeks. The change in SCOring AD (SCORAD) score from baseline at 12 weeks served as the primary end point.

resultsAt 12 weeks, the mean declines in SCORAD for the entire study population were 13.8 ± 2.7 in the fezakinumab arm and 8.0 ± 3.1 in the placebo arm (P = .134). In the severe AD patient subset (with a baseline SCORAD of ≥50), SCORAD decline was significantly stronger in the drug-treated patients than placebo-treated patients at 12 weeks (21.6 ± 3.8 vs 9.6 ± 4.2, P = .029) and 20 weeks (27.4 ± 3.9 vs 11.5 ± 5.1, P = .010). At 12 weeks, improvements in body surface area involvement in the entire population were significantly stronger in the drug-treated than placebo-treated patients (12.4% ± 2.4 vs 6.2% ± 2.7; P = .009), and in the severe AD subset, the decline in Investigator Global Assessment was significantly higher in the drug-treated than placebo-treated patients (0.7 ± 0.2 vs 0.3 ± 0.1; P = .034). All scores showed progressive improvements after last dosing (10 weeks) until end of study (20 weeks). Common adverse events were upper respiratory tract infections. LIMITATIONS: The limited sample size and lack of assessment with Eczema Area and Severity Index and a pruritus numerical rating scale were limiting factors. Significance was primarily obtained in severe AD.

conclusionFezakinumab was well-tolerated, with sustained clinical improvements after last drug dosing.

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDermatitis, AtopicDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHumansInfusions, IntravenousInterleukin-22InterleukinsMaleMiddle AgedSeverity of Illness IndexAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedfezakinumabInterleukin-22Interleukinsatopic dermatitisfezakinumabIL-22moderate-to-severe ADplacebo-controlled trial

Identifiers

PMID29353025
PMCPMC8711034
OpenAlexW2783616522

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.