LEO Pharma A/S, a global leader in medical dermatology, today announced up to 3.5-year data that further support the long-term safety and efficacy profile of Adbry™ (tralokinumab-ldrm) in adult patients with moderate-to-severe atopic dermatitis (AD). Interim results were shared as a poster presentation at the American Academy of Dermatology (AAD) 2022 Annual Meeting.1
Adbry, a high-affinity human monoclonal antibody, was approved by the U.S. Food and Drug Administration (FDA) in December 2021 for the treatment of adults with moderate-to-severe AD and is the first and only FDA-approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, a key driver of AD signs and symptoms.2,3,4
The 3.5-year interim safety analysis in more than 1,400 patients from the ECZTEND long-term, open-label extension trial (NCT03587805) showed that the overall safety profile of Adbry 300 mg every other week (Q2W) plus optional topical corticosteroids (TCS) was consistent with that observed in the parent trials of tralokinumab-ldrm, with no new safety signals emerging. The interim efficacy analysis showed Adbry 300 mg Q2W plus optional TCS demonstrated sustained improvement in extent and severity of atopic dermatitis, itch severity, and quality of life in adult patients treated with Adbry for up to 3 years.1 Patients who had enrolled in the parent trials and continued into ECZTEND were on treatment for up to 3.5 years, including up to 2.5 years in ECZTEND and up to one year in the parent trials.
“It is reassuring to see such consistent results as the ECZTEND trial continues to unfold,” said Andrew Blauvelt, MD, MBA, President of the Oregon Medical Research Center in Portland, Oregon, and lead investigator of ECZTEND. “The latest interim safety and efficacy findings are similar to earlier reports and continue to reinforce the rationale for treatment specifically targeting IL-13 in adult patients with moderate-to-severe atopic dermatitis.”
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The 3.5-year interim safety analysis included 1,442 patients from the parent trials ECZTRA 1 and 2, ECZTRA 3, ECZTRA 4, ECZTRA 5, and ECZTRA 7 who had received at least one dose of Adbry.1 Patients were eligible for ECZTEND regardless of their treatment response or whether they were treated with Adbry or placebo in the parent trials.1 From ECZTEND baseline to data cut-off (up to 2.5 years in ECZTEND), 22.9% of patients had withdrawn from the study, and discontinuation rates due to an adverse event (AE) were 2.4%.1 The most frequently reported AEs (occurring in at least 5% of participants) included viral upper respiratory tract infection (mainly reported as common cold), atopic dermatitis, upper respiratory infection, headache, and conjunctivitis. None of the conjunctivitis events were serious AEs.1 Overall, the safety profile in ECZTEND was similar to that observed with Adbry in the parent trials.1
In the cohort of 616 patients who received Adbry for up to 3 years, 85.1% achieved at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75).1 Half of the patients (50.5%) achieved an Investigator Global Assessment score of 0/1 (IGA 0/1), indicating clear or almost clear skin.1 Additionally, patients achieved improvements in itch and quality of life as measured by 60.6% of patients achieving a Worst Weekly Pruritus Numerical Rating Scale (NRS) score of ≤3 and 76.4% achieving a Dermatology Life Quality Index (DLQI) score of ≤5.1 Data reported as observed. The modified non-responder imputation and last observation carried forward analyses were also reported in the poster and results were comparable across the three analyses.