Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial

Abstract

Sanofi and Regeneron Pharmaceuticals Inc.

▼Dupilumab for atopic dermatitis

“…The overall rates of adverse effects were similar with dupilumab and placebo (88% vs. 84%, respectively) with 4% versus 5% classified as severe 26. Discontinuation due to adverse effects was higher among patients treated with placebo (8%) than with dupilumab (2%).…”

“…After 52 weeks of treatment, the incidence of herpetic skin infections was similar (7% with dupilumab vs. 8% with placebo); however, patients treated with dupilumab reported a higher incidence of localised herpes simplex infections (6% vs. 3%) 26. All herpes viral infections resolved by the end of the study 14…”

“…Two trials assessed short-term use (16 weeks) as monotherapy (SOLO1 and SOLO2) 25. The CHRONOS study included concomitant topical corticosteroids and lasted 52 weeks 26. However, the primary efficacy outcome was assessed at week 16.…”

“…Only one trial evaluated the long-term efficacy of dupilumab (52 weeks) as a secondary outcome 26. No data on disease-free period, maintenance of remission or rebound effects after treatment discontinuation are available.…”

Atopic Dermatitis: Collegium Internationale Allergologicum (CIA) Update 2019

“…The application of 300 mg dupilumab qw or q2w results in rapid improvement of clinical signs and symptoms; among patients with moderate to severe AD, up to 85% reach EASI-50, 44–51% reach EASI-75, and 30–36% achieve EASI-90 after 16 weeks, while the frequency of pruritus decreases by 40–60% [147, 148]. Dupilumab has a sustained effect over 1 year and a tolerable safety profile, with conjunctivitis as a noteworthy adverse event occurring in 14–19% of patients [149]. Recent published phase 2 studies have demonstrated that the monoclonal antibodies that block IL-13 (lebrikizu­mab and tralokinumab) are effective in patients with moderate to severe AD [150, 151].…”