LEO Pharma A/S, a global leader in medical dermatology, today announced that American Journal of Clinical Dermatology published 32-week results from a post-hoc analysis of the Phase 3 ECZTRA 3 clinical trial (NCT03363854) in atopic dermatitis (AD).
The analysis showed treatment with Adbry™ (tralokinumab-ldrm) plus topical corticosteroids (TCS) as needed demonstrated improvements in extent and severity of AD, sleep interference, and quality of life over 32 weeks in adults with moderate-to-severe AD.
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, one of the drivers of AD signs and symptoms.
A prespecified analysis focusing on patients who achieved a response at Week 16 has been reported elsewhere. To reflect clinical practice, this post-hoc analysis pooled all patients treated with Adbry every other week (Q2W) in the initial treatment period irrespective of the response achieved at Week 16 and the dosing regimen (Q2W or every four weeks [Q4W]) received beyond Week 16.
The post-hoc analysis found treatment with Adbry plus TCS as needed provided improvements in extent and severity of AD and in sleep interference and quality of life measures over 32 weeks.