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Cited by 343Dermatology and Skin DiseasesPsoriasis: Treatment and PathogenesisAsthma and respiratory diseases

The DOI matches its Crossref record; 31 of the 33 references it cites were found in a registry or an index.

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

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Guttman-Yassky, Emma, Brunner, Patrick M., Neumann, Avidan U., Khattri, Saakshi, Pavel, Ana B., Malik, Kunal, Singer, Giselle K., Baum, Danielle, Gilleaudeau, Patricia, Sullivan-Whalen, Mary, Rose, Sharon, Jim On, Shelbi, Li, Xuan, Fuentes-Duculan, Judilyn, Estrada, Yeriel, Garcet, Sandra, Traidl-Hoffmann, Claudia, Krueger, James G., Lebwohl, Mark G.·2018·Journal of the American Academy of Dermatology
DOI 10.1016/j.jaad.2018.01.016PMC PMC8711034
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Abstract

BACKGROUND: Interleukin 22 promotes epidermal hyperplasia and inhibits skin barrier function. OBJECTIVE: Evaluate interleukin 22 blockade in adults with moderate-to-severe atopic dermatitis (AD). METHODS: We 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. RESULTS: At 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. CONCLUSION: Fezakinumab was well-tolerated, with sustained clinical improvements after last drug dosing.

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Authors
Guttman-Yassky, E., Brunner, P. M., Neumann, A. U., Khattri, S., Pavel, A. B., Malik, K., Singer, G. K., Baum, D., Gilleaudeau, P., Sullivan-Whalen, M., Rose, S., Jim On, S., Li, X., Fuentes-Duculan, J., Estrada, Y., Garcet, S., Traidl-Hoffmann, C., Krueger, J. G., & Lebwohl, M. G.
Affiliations
  • Rockefeller University (US)
  • University of Zurich (CH)
  • Icahn School of Medicine at Mount Sinai (US)
ORCID
Venue
Journal of the American Academy of Dermatology
Publisher
Elsevier BV
Published
2018-05
Volume
78
Issue
5
Pages
872-881.e6
ISSN
0190-9622 (ISSN-L)
DOI
10.1016/j.jaad.2018.01.016
PMC
PMC8711034
OpenAlex
W2783616522
Cited by
343
References
33
Citations by year
2026: 20 · 2025: 31 · 2024: 35 · 2023: 40 · 2022: 38 · 2021: 46 · 2020: 49 · 2019: 50 · 2018: 33
FWCI
48.14
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of the American Academy of Dermatology (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion, other-oa)
  • Site cant be reached (submittedVersion, cc-by-nc-nd)
  • PuSH - Publication Server of Helmholtz Zentrum München (submittedVersion)
  • OPUS (Augsburg University) (submittedVersion, cc-by-nc-nd)
Funders
  • Amgen
  • Eli Lilly and Company
  • Pfizer
  • GlaxoSmithKline
  • Sanofi
  • Celgene
  • Danone
  • Regeneron Pharmaceuticals
  • Dermira
  • Glenmark Pharmaceuticals
  • Galderma
  • LEO Pharma
  • National Institutes of Health (UL1TR001866)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (UM1AR063917)
  • National Center for Advancing Translational Sciences (UL1TR0001866)
Topics
  • Health Sciences › Medicine › Dermatology › Dermatology and Skin Diseases
  • Life Sciences › Immunology and Microbiology › Immunology › Psoriasis: Treatment and Pathogenesis
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Asthma and respiratory diseases
Keywords
atopic dermatitis, moderate-to-severe atopic dermatitis, monoclonal antibody therapy, SCORAD, body surface area involvement, upper respiratory tract infection, adverse events, treatment efficacy
MeSH terms
Interleukin-22, Adult, Antibodies, Monoclonal, Dermatitis, Atopic, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Infusions, Intravenous, Interleukins, Male, Middle Aged, Severity of Illness Index, Treatment Outcome, Antibodies, Monoclonal, Humanized

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