Dr James Q Del Rosso announces the expanded approval for Adbry, now approved for pediatric patients aged 12-17, discussing dosing and safety for this critical patient group

LEO Pharma Inc. has achieved a significant milestone in the treatment of pediatric patients with moderate-to-severe atopic dermatitis (AD) in the United States with the expanded approval of Adbry (tralokinumab-ldrm) by the US Food and Drug Administration (FDA). Adbry is the only FDA-approved biologic designed to target the IL-13 cytokine, a crucial factor in driving the signs and symptoms of AD. 

The Pediatric AD landscape 

Approximately 2.4 million pediatric patients aged 12-17 years in the US are living with AD, with around 1.2 million classified as having moderate-to-severe disease. The expanded approval offers a new treatment option for this critical patient group, especially for those whose disease is not adequately controlled with topical prescription therapies or when such therapies are not advisable. 

Clinical trial insights 

Adbry's approval for pediatric patients aged 12-17 years is supported by data from the Phase 3 ECZTRA 6 trial, where the efficacy and safety of Adbry were evaluated in 289 pediatric patients with moderate-to-severe AD. 

The trial results showed that over five times as many pediatric patients had clear or almost clear skin compared with placebo, with 21% of patients who received Adbry achieving an Investigator's Global Assessment (IGA) score of 0 or 1 compared to 4% who received placebo. 

Approximately five times as many pediatric patients saw a substantial improvement with Adbry compared to placebo, with 29% of patients who received Adbry achieving at least a 75% improvement in their Eczema Area and Severity Index score (EASI-75) compared to 6% who received placebo. 

More than seven times as many pediatric patients experienced significantly reduced itch with Adbry compared to placebo, with 23% of patients who received Adbry achieving at least a four-point reduction in Adolescent Worst Pruritis Numerical Rating Scale (NRS) compared to 3% with placebo. 

In ECZTRA-6, a higher proportion of pediatric patients who received Adbry achieved at least a 90% improvement in their Eczema Area and Severity Index score (EASI-90) compared to placebo. 

Safety profile 

The safety profile of Adbry during the trial was comparable to that observed in trials involving adults with AD. The most common adverse events were upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia. 

Future outlook 

Adbry is already approved for the treatment of adults with moderate-to-severe AD. The expansion of its approval for pediatric patients further solidifies its position as a valuable treatment option in the atopic dermatitis landscape.