For individuals with atopic dermatitis, dupilumab significantly improved symptoms such as itching, pain, sleep disturbances, anxiety and depression, and quality of life when compared to placebo, according to a study published in the Journal of Dermatological Treatment.
Researchers examined pooled data from 2 phase 3 studies, LIBERTY AD SOLO 1 (ClinicalTrials.gov Identifier: NCT02277743) and SOLO 2 (ClinicalTrials.gov Identifier: NCT02277769), to assess patient-reported outcomes and disease status, as well as the effectiveness of treatment. SOLO 1 and SOLO 2 both used a randomized, placebo-controlled, double-blind design, with participants receiving either subcutaneous placebo treatment once weekly for 16 weeks or dupilumab 300 mg once weekly or every 2 weeks. Reported outcomes included symptoms of pruritus, assessment of pain levels, sleep disturbances, symptoms of atopic dermatitis, anxiety and depression symptoms, health-related quality of life, global assessment of disease status, treatment effectiveness, and treatment safety.
Of the 1379 patients included in the clinical trials, 462 were in the cohort receiving dupilumab once weekly, 457 were in the cohort receiving dupilumab every 2 weeks, and 460 were in the placebo cohort. In regards to pruritus, Peak Pruritus Numerical Rating Scale scores improved by 3 points or higher with active treatment by week 16 in 50.3% of patients in the once weekly cohort and 48.8% of patients in the cohort receiving dupilumab every 2 weeks, vs 15% in the placebo cohort. Pruritus Categorical Scale improved to “absent of or mild” pruritus in 51.9% of those in the cohort receiving dupilumab every 2 weeks and 53.7% of those in the cohort receiving dupilumab once weekly; among the placebo cohort, these scores improved by 19.3% (P <.0001, for both dupilumab cohorts).
By week 16, 62.0% to 62.2% of dupilumab-treated cohorts reported no pain or discomfort vs 39.2% of the placebo cohort. Between 43.5% and 51.2% of those in the dupilumab-treated cohorts reported the absence of sleep disturbances vs 17.6% of members taking the placebo (P <.0001). Overall, more patients reported having no atopic dermatitis symptoms when treated with dupilumab than with placebo (P <.0001), and more patients reported improved anxiety and depression symptoms when treated with dupilumab than with placebo (P <.0001). In addition, more patients reported minimal impact of atopic dermatitis on quality of life when treated with dupilumab than with placebo (P <.0001), and more patients reported sustained improvement in disease status when treated with dupilumab than with placebo (P <.0001).
A limitation of this study is that the P values were not specified before the pooled data analysis.
The researchers concluded that their “data expand upon previous reports by showing that dupilumab improves [atopic dermatitis] in multiple dimensions important to the patient and highlight the importance of [patient-reported outcomes] in assessing the efficacy of treatments for [atopic dermatitis].”
This study was funded by Sanofi and Regeneron Pharmaceuticals and several authors report multiple associations with pharmaceutical companies. Please see the original reference for a full list of authors’ disclosures.
Cork MJ, Eckert L, Simpson EL, et al. Dupilumab improves patient-reported symptoms of atopic dermatitis, symptoms of anxiety and depression, and health-related quality of life in moderate-to-severe atopic dermatitis: analysis of pooled data from the randomized trials SOLO 1 and SOLO 2 [published online June 9, 2019]. J Dermatolog Treat. doi: 10.1080/09546634.2019.1612836