Fully human monoclonal antibody dupilumab provides long-term control of atopic dermatitis (AD) and prevents disease flares, which may help reduce the need for escalation and/or intensification of therapy, according to study findings from the phase 3 LIBERTY AD CHRONOS trial published in the Journal of the American Academy of Dermatology.
The double-blind LIBERTY AD CHRONOS trial randomly assigned patients with moderate to severe AD to either 300 mg dupilumab (n=106) or placebo (n=315), both of which were administered every 2 weeks for 52 weeks. Patients in both groups received medium-potency topical corticosteroids with their assigned therapy.
The annualized flare rate was significantly higher in patients who were treated with placebo (0.77; 95% CI, 0.63-0.93) vs dupilumab (0.17; 95% CI, 0.10-0.29). Patients treated with dupilumab plus topical corticosteroids had a 78% relative reduction in their annual flares (relative risk, 0.22; 95% CI 0.13-0.39; P <.0001). In addition, the estimated cumulative flare-free rates were greater for dupilumab-treated patients vs placebo-treated patients at 12 weeks (0.9709 vs 0.7964, respectively), 24 weeks (0.9208 vs 0.6674), and 52 weeks (0.8500 vs 0.5479).
During the 12 months prior to study enrollment, approximately 84% of patients in the dupilumab group and 77% of patients in the placebo group reported flares of their disease. The mean number of flares per patient in the dupilumab and placebo arms were 6.2 and 4.5, respectively. Of patients who experienced ≥1 flare before treatment, a higher percentage of patients in the dupilumab group were free of flares during the treatment period (84% vs 57%; P <.0001).
A limitation of this study included its potential for recall bias, as pre-treatment flares were self-reported by participants.
The investigators suggest that long-term AD disease control, either with dupilumab or another effective therapy, can reduce “the likelihood of disruptive and costly flares,” and long-term control of AD with dupilumab could be “an important treatment goal that reduces patient burden and risk of inappropriate short-term AD management with systemic corticosteroids.”
Disclosure: This clinical trial was supported by Sanofi and Regeneron Pharmaceuticals. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Merola JF, Sidbury R, Wollenberg A, et al. Dupilumab prevents flares in adults with moderate-to-severe atopic dermatitis in a 52-week randomized controlled phase 3 trial [published online May 6, 2020]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2020.05.003