Dupilumab Reduces Atopic Dermatitis Flares

Atopic dermatitis is a serious condition that has been reported to affect between 30% and 50% of people who are HIV positive vs ≤20% of those who are HIV negative.2 The condition has been associated with elevated immunoglobulin E levels, eosinophilia, and possible Th1-Th2 imbalances.2,12 Because nearly all patients with AIDS demonstrate Th1-Th2 imbalances, they are at particularly high risk for atopic dermatitis.2 Patients generally present with chronic, red, thick, lichenified plaques and severe, incessant pruritus that can have an impact on daily function and sleep and reduce quality of life significantly.13 Isolated pruritic papules are sometimes observed. The hands, face, and eyelids, and areas of the body with large skin folds are most often affected; however, inflammatory flare-ups can affect the entire body and might necessitate hospitalization.13

Atopic dermatitis is a serious condition that has been reported to affect between 30% and 50% of people who are HIV positive vs ≤20% of those who are HIV negative.2 The condition has been associated with elevated immunoglobulin E levels, eosinophilia, and possible Th1-Th2 imbalances.2,12 Because nearly all patients with AIDS demonstrate Th1-Th2 imbalances, they are at particularly high risk for atopic dermatitis.2

Patients generally present with chronic, red, thick, lichenified plaques and severe, incessant pruritus that can have an impact on daily function and sleep and reduce quality of life significantly.13 Isolated pruritic papules are sometimes observed. The hands, face, and eyelids, and areas of the body with large skin folds are most often affected; however, inflammatory flare-ups can affect the entire body and might necessitate hospitalization.13

Dupilumab provides long-term control of AD and prevents disease flares, which may help reduce the need for escalation and/or intensification of therapy.

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.

Reference

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