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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
Open accessAbstract
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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“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]
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“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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Metadata
- 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)
- 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
- hybrid
- doi.org
- 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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