OR WAIT null SECS
Findings from the ongoing LIBERTY AD OLE trial show the sustained long-term effect of the biologic therapy for eczema.
Long-term dupilumab is associated with sustained skin clearance over 4 years in a majority of treated patients with moderate to severe atopic dermatitis, according to new research.
In data presented at the Society of Dermatology Physician Assistants (SDPA) 2022 Annual Meeting in Miami, FL last week, the interleukin 4 and 13 (IL-4; IL-13) inhibitor from Sanofi and Regeneron was associated with achievement of Eczema Area Severity Index scores of 50 (EASI) in 95% of patients receiving the drug over the span of 204 months.
The findings from the ongoing phase 3 LIBERTY AD OLE open-label extension trial additionally highlight dupilumab’s sustained efficacy in improved itch, as well as consistent safety profiles from previous clinical trials, over 4 years.
Led by Andrew Blauvelt, MD, MBA, president of the Oregon Medical Research Center, investigators sought to assess the efficacy of dupilumab in patients with moderate to severe atopic dermatitis for up to 4 years in the ongoing phase 3 open-label trial.
Patients from parent dupilumab studies were invited for trial re-entry for up to 5 years, transitioned from 300 mg every week to 300 mg every other week in 2019 to align with the US Food and Drug Administration’s (FDA’s) approved drug regimen. Patients were additionally allowed to continue concomitant treatments for their atopic dermatitis, including topical corticosteroids and calcineurin inhibitors.
The assessment presented at SDPA 2022 included 2677 total enrolled patients—352 (13.1%) of whom completed up to week 204. Another 240 (9.0%) reported treatment duration >204 weeks. Mean patient age was 39.2 years old, with a mean eczema duration of 29.9 years. Another 60.2% of patients were male; 72.3% were White. Mean EASI at the open-label extension baseline was 16.4—compared to 32.8 at baseline of the parent clinical trials. Mean IGA scores were 2.7 and 3.49, respectively.
Blauvelt and colleagues observed another rapid decline in mean EASI among patients in the open-label extension, followed by a steadier decline and an eventual plateau. Mean EASI among patients receiving treatment at week 204 was 2.5, indicating only mild disease. Another 95% of patients had achieved EASI 50 scores at week 204; 91% accomplished EASI 75 and 76% achieved EASI 90.
Itch symptoms, per mean Peak Pruritus Numerical Rating Scale (PP-NRS) scores, similarly followed a trend of rapid decline shortly after the beginning of the open-label extension, before steadying out over week. Mean score at week 204 was 2.1—a significant decrease from the open-label baseline mean of 5.0. Another 79% of patients achieved a >4-point reduction in PP-NRS from baseline to week 204.
Regarding safety, investigators observed ≥1 treatment-emergent adverse events (TEAEs) in 84.9% of patients in the open-label extension. Another 9.8% experienced a severe TEAE, and 3.7% discontinued the trial due to TEAEs. When compared to outcomes from the 52-week CHRONOS trial safety data, the LIBERTY AD OLE dupilumab arm reported similar rates of adverse events and outcomes.
Investigators concluded with optimism on the latest outcomes regarding long-term adult atopic dermatitis treatment with the beneficial biologic therapy.
“In this ongoing open-label study, dupilumab demonstrated robust and sustained efficacy with progressive improvement of AD signs and symptoms (including skin lesions and pruritus) in adults with moderate-to-severe AD who completed up to 4 years of treatment,” they wrote. “The safety profile was consistent with the known safety profile observed in dupilumab controlled studies.”