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, Sharon Rose, Shelbi Jim On, Xuan Li, Judilyn Fuentes-Duculan, Yeriel Estrada, Sandra Garcet, Claudia Traidl-Hoffmann, James G. Krueger, Mark G. Lebwohl

Research output: Contribution to journalArticlepeer-review

240 Scopus citations

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.

Original languageEnglish
Pages (from-to)872-881.e6
JournalJournal of the American Academy of Dermatology
Volume78
Issue number5
DOIs
StatePublished - May 2018
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2018 American Academy of Dermatology, Inc.

Keywords

  • IL-22
  • atopic dermatitis
  • fezakinumab
  • moderate-to-severe AD
  • placebo-controlled trial

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this