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

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 +11 more·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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  • In patients with severe AD (SCORAD >50), fezakinumab produced a significantly greater mean decline in SCORAD than placebo.

    “encouraging results were seen in patients with severe forms (SCORAD >50) where the mean decline in SCORAD was significantly better than in the placebo group122.”

    From Atopic dermatitis: an expanding therapeutic pipeline for a complex disease (2022) · cites this paper as [122]

  • In the entire fezakinumab study population, there was no significant difference in change in SCORAD from baseline as the primary end point.

    “When considering the entire study population, there was no significant difference in the change of SCORAD compared with baseline as the primary end point.”

    From Atopic dermatitis: an expanding therapeutic pipeline for a complex disease (2022) · cites this paper as [122]

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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 › Physiology › 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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