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Adult patients with moderate-to-severe atopic dermatitis reported incremental improvement of their condition in a new extension trial study presented at EADV.
Data from a recent open-label extension trial suggested that weekly doses of the monoclonal antibody dupilumab showed durable efficacy and continued incremental improvement in adult patients with moderate-to-severe atopic dermatitis.
Improvements of atopic dermatitis signs and symptoms were recorded for up to 172 weeks with minimal disease activity and continuous long-term control.
The study was led by Marjolein de Bruin-Weller, MD, University Medical Center, Utrecht, Netherlands, and was presented at the European Academy of Dermatology and Venereology (EADV) 30th Congress.
In the presentation, Bruin-Weller noted that moderate-to-sever atopic dermatitis has often been poorly controlled by current topical therapies, and the long-term use of systemic immunosuppressants for this patient population are limited due to safety concerns.
However, data from the LIBERTY AD OLE study, and open-label extension study, demonstrated the acceptable safety and sustained efficacy of dupilumab in adult patients for up to 148 weeks.
In the extension trial, Bruin-Weller and colleagues assessed the long-term safety and efficacy of the biologic in adult patients with moderate-to-severe atopic dermatitis for up to 172 weeks.
The investigators enrolled 2677 participants for their study.
Patients were adults 18 years and older with moderate-to-severe atopic dermatitis who had previously participated in any dupilumab study in the past.
Roughly 60% of the participant group were male, and 72% of all participants were Caucasian.
Initial treatment lasted 3 years, but protocol amendments in June 2017 and January 2018 allowed for patient re-entry and treatment extension for up to 5 years in certain countries.
Each patient was treated with 300 mg of dupilumab weekly for up to 172 weeks, with the data cutoff set to November 2019.
Eczema Area and Severity Index (EASI) scores were assessed in each patient, as well as Peak Pruritus Numerical Rating Scale (PP-NRS) scores that were used to evaluate itch in patients.
Concomitant treatments for atopic dermatitis, such as topical calcineurin inhibitors were permitted during the study.
All analyses in the study were based on available data 2.5 years after the last patient was enrolled into the study.
The investigators found that the mean EASI and weekly average PP-NRS scores remained consistently below 7 and 4 from Week 8 and Week 2, respectively. They added that it reflected minimal disease activity and continuous long-term control in patients with moderate-to-severe atopic dermatitis.
Safety data recorded during the study were consistent with the established safety profile of dupilumab.
A Kaplan-Meier analysis of time to treatment discontinuation also found that patients treated with dupilumab showed a higher survival probability compared to those treated with cyclosporine and methotrexate.
“This 18-month interim analysis from the EUROSTAD study highlights the current medical trends of systemic treatments for the management of moderate-to-severe atopic dermatitis,” the team wrote.