Efficacy and safety of fezakinumab (an anti-IL-22 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by conventional treatments - A randomized, double-blind, phase 2a trial.
J Am Acad Dermatol. 2018 Jan 15;:
Authors: Guttman-Yassky E, Brunner PM, Neumann AU, Khattri S, Pavel AB, Malik K, Singer GK, 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 JG, Lebwohl MG
Abstract
BACKGROUND: IL-22 promotes epidermal hyperplasia and inhibits skin barrier function.
OBJECTIVE: Evaluate IL-22 blockade in adults with moderate-to-severe atopic dermatitis (AD).
METHODS: Randomized, double-blind, placebo-controlled trial with intravenous fezakinumab monotherapy every 2wks for 10wks, with follow-up assessments until 20wks. SCORAD change from baseline at 12wks served as primary endpoint.
RESULTS: At 12wks, mean SCORAD decline was 13·8±2·7 (fezakinumab) vs. 8·0±3·1 (placebo) for the entire population (p=0·134). In severe patients (baseline SCORAD≥50), SCORAD decline was significantly stronger in drug vs. placebo at 12wks (21·6±3·8 vs. 9·6±4·2, p=0.029) and 20wks (27·4±3·9 vs. 11·5±5·1, p=0·010). At 12wks, improvements were significantly stronger in drug vs. placebo (12·4%±2·4 vs. 6·2%±2·7; p=0·009) for BSA in the entire population, and for IGA in severe patients (0·7±0·2 vs. 0·3±0·1; p=0·034). All scores showed progressive improvements after last dosing (10wks) until end of study (20wks). Common adverse events were upper respiratory tract infections.
LIMITATIONS: Limited sample size, lack of EASI and numerical rating scale (NRS) pruritus assessments; significance primarily obtained in severe AD.
CONCLUSION: Fezakinumab was well-tolerated, with sustained clinical improvements after last drug dosing.
PMID: 29353025 [PubMed - as supplied by publisher]
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