Interim data support the long-term safety and efficacy profile of Adbry™ (tralokinumab-ldrm) for up to 3.5 years in adult patients with moderate-to-severe atopic dermatitis (AD). Results were shared as a poster presentation at the American Academy of Dermatology (AAD) 2022 Annual Meeting.

Adbry, a high-affinity human monoclonal antibody, was approved 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.

The 3.5-year interim safety analysis in more than 1,400 patients from the ECZTEND long-term, open-label extension trial showed that the overall safety profile of Adbry 300mg 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 300mg 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 three years. 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,” says 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.”

“At LEO Pharma, it is our mission to help people living with debilitating dermatological conditions, and we are gratified to see such encouraging data emerge from the ongoing ECZTEND long-term extension trial,” says Adriana Guana, Vice President, Medical Strategy and Scientific Affairs, LEO Pharma Inc. United States. “The latest analysis shows that the safety and efficacy profile of Adbry, administered at the dose indicated on our label, are sustained long-term and we look forward to additional data readouts from ECZTEND.”