An open-label extension trial shows dupilumab provides similar skin clearance and itch benefit at 5 years as it had at 1 year of treatment.
Dupilumab is now supported by a half-decade’s worth of clinical evidence in the treatment a patient’s atopic dermatitis.
New late-breaking abstract data from an open-label study presented at the Revolutionizing Atopic Dermatitis (RAD) 2023 Spring Conference in Washington, DC, this weekend showed the interleukin 4 and 13 (IL-4; IL-13) inhibitor biologic provided sustained improvement in atopic dermatitis skin lesions and itch in adult patients after 5 years of treatment.
The findings from the Sanofi and Regeneron-supported phase 3 LIBERTY AD OLE trial showed comparative efficacy with dupilumab after 5 years of treatment as has been observed at 1 year of treatment, along with a positive and consistent safety profile.
Presented by study author Lisa A. Beck, MD, of the University of Rochester Medical Center’s department of dermatology, the extension assessment concluded the prespecified 5-year analysis of LIBERTY AD patients treated with dupilumab for their moderate to severe atopic dermatitis.
Beck noted that, despite the recommendation that systemic immunosuppressants be not used for long-term treatment of moderate to severe atopic dermatitis due to safety concerns, previous data from the presented open-label extension supported dupilumab’s safety and sustained efficacy at approximately 4 years.
The trial assessed a 300 mg dose of dupilumab once every 2 weeks in adult patients with moderate to severe atopic dermatitis who previously participated in dupilumab clinicals, for up to 5 years. Investigators permitted concomitant treatment for patients’ atopic dermatitis, including topical corticosteroids and calcineurin inhibitors.
For the 5-year assessment, Beck and colleagues used patients receiving a similar dupilumab regimen from the 1-year LIBERTY AD CHRONOS trial as comparison for outcomes.
Mean patient age was 39.2 years old, with a mean atopic dermatitis duration of 29.9 years. Approximately 60% of patients were male and 73.2% were White. The open-label extension reported 334 of 2677 (12.5%) patients completed 260 weeks of dupilumab.
Investigators observed that 88.9% of patients had achieved Eczema Area Severity Index (EASI) 75 at 5 years; another 76.2% achieved EASI 90. Two-thirds (66.5%) of treated patients achieved itch relief per ≥4-point reduction in Peak Pruritus Numerical Rating Scale (NRS) score at 5 years.
The rate of patients reporting ≥1 treatment-emergent adverse event (TEAE) at 5 years was consistent to those who reported ≥1 in the 1-year LIBERTY AD CHRONOS trial (85.0% vs 83.5%, respectively). The rate of severe TEAEs nearly doubled among patients who completed 5 years of dupilumab, however (10.0% vs 5.4%, respectively). Rates of TEAEs leading to dupilumab treatment discontinuation were similar at 5 years and 1 year (3.8% vs 2.9%, respectively).
The team concluded that dupilumab continued to demonstrate efficacy for moderate to severe atopic dermatitis at 5 years based on sustained improvement in patient EASI and Peak Pruritus NRS scores. Though patient drop-off from 1 year to 5 years in the open-label extension was notable, Beck noted the most common cause for treatment discontinuation was the US Food and Drug Administration (FDA) approval and commercialization of dupilumab; discontinuation due to the treatment itself was low after a half-decade.
“The improvement is in both the signs and the symptoms (of atopic dermatitis),” Beck said. “There were no adverse events that appeared to emerge.”