Dupilumab Sustains Atopic Dermatitis Efficacy at 5 Years

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 Sustains Atopic Dermatitis Efficacy at 5 Years

Lisa A. Beck, MD

Credit: University of Rochester

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.”

References

  1. Beck LA, et al. Long-term efficacy of dupilumab in adults with moderate-to-severe atopic dermatitis: results from an open-label extension trial up to 5 years. Paper presented at: Revolutionizing Atopic Dermatitis 2023 Spring Conference; April 29 – May 1, 2023; Washington, DC. Accessed April 30, 2023.
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