The U.S. Food and Drug Administration (FDA) has expanded the approval of tralokinumab-ldrm (Adbry, LEO Pharma Inc) to include kids aged 12-17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Adbry is the first and only FDA-approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine.
An initial loading dose of 300 mg, followed by a 150 mg dose every two weeks is approved for U.S. pediatric patients aged 12-17 years.
“The approval of Adbry for pediatric patients living with moderate-to-severe atopic dermatitis expands the therapeutic options for those living with this disease who historically have had a limited selection to choose from,” says Julie Block, President and CEO of the National Eczema Association, in a news release. “Such advances in the atopic dermatitis treatment landscape provide much-needed hope for pediatric patients seeking a long-term treatment option that could work for them.”
The approval is based on data from the Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of Adbry in 289 pediatric patients aged 12-17 years with moderate-to-severe AD who were candidates for systemic therapy. A total of 98 patients received an initial dose of Adbry 300 mg followed by 150 mg every other week up to Week 16. The trial met its primary and key secondary endpoints.
- More than five times as many pediatric patients had clear or almost clear skin with Adbry compared to placebo: 21% of patients who received Adbry achieved an Investigator’s Global Assessment (IGA) score of 0 (“clear”) or 1 (“almost clear”) compared to 4% who received placebo.
- Approximately five times as many pediatric patients saw a substantial disease improvement with Adbry compared to placebo: 29% of patients who received Adbry achieved 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: 23% of patients who received Adbry achieved 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
The safety of Adbry, assessed through the initial treatment period of 16 weeks and the long-term period of 52 weeks, was comparable to the safety profile from trials in adults with atopic dermatitis. In the ECZTRA 1, 2, and ECZTRA 3 adult trials, the most common adverse events (incidence ≥1%) were upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.
“We know the symptoms associated with moderate-to-severe atopic dermatitis can have an impact on pediatric patients, which is why it’s so important to have treatment options with demonstrated efficacy in itch reduction and skin clearance,” says Amy Paller, M.D., Chair, Department of Dermatology, Feinberg School of Medicine, Northwestern University in Chicago, in a news release. She is the international coordinating investigator for ECZTRA 6. “Clinical trial results that provide this evidence are invaluable to clinicians evaluating the safety and efficacy of treatment options for their pediatric patients.
Adbry, which is marketed outside of the U.S. under the tradename Adtralza (tralokinumab), is approved for the treatment of adults and pediatric patients (12 years and above) with moderate-to-severe AD in the U.S., Canada, the European Union, the United Arab Emirates, Great Britain, and South Korea. Adtralza is approved for use in adults with moderate-to-severe AD in Saudi Arabia, Switzerland, and Japan.
