The Food and Drug Administration (FDA) has approved Adbry (tralokinumab-ldrm) for the treatment of moderate to severe atopic dermatitis in adults 18 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Adbry is a fully human, immunoglobulin (Ig) G4 monoclonal antibody that specifically binds to the interleukin-13 (IL-13) cytokine with high affinity and prevents its interaction with subsequent downstream signaling.
The approval was based on data from 3 pivotal, randomized, double-blind, placebo-controlled phase 3 (ECZTRA 1-3) trials that evaluated the safety and efficacy of Adbry in 1934 adults with moderate to severe AD. ECZTRA 1 (ClinicalTrials.gov Identifier: NCT03131648) and ECZTRA 2 (ClinicalTrials.gov Identifier: NCT03160885) assessed Adbry as monotherapy for 52 weeks. ECZTRA 3 (ClinicalTrials.gov Identifier: NCT03363854) assessed Adbry in combination with topical corticosteroids in adults for 32 weeks.
In all 3 trials, patients were randomly assigned to receive Adbry 600mg subcutaneously on Day 0, then 300mg every other week or placebo for 16 weeks. The primary endpoints for all trials were an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) at week 16 and at least a 75% improvement in the Eczema Area and Severity Index (EASI) score at week 16. Key secondary endpoint was the reduction of weekly average Worst Daily Pruritus Numeric Rating Scale (NRS) of at least 4 points on the 11-point itch NRS.
Results from all 3 trials showed that a significantly greater proportion of patients treated with Adbry met the primary and secondary endpoints at week 16 compared with placebo. The proportion of patients who achieved an IGA score of 0 or 1 at week 16:
- ECZTRA 1: 16% vs 7% for placebo (difference from placebo 9%; 95% CI, 4-13);
- ECZTRA 2: 21% vs 9% for placebo (difference from placebo 12%; 95% CI, 7-17);
- ECZTRA 3: 38% vs 27% for placebo (difference from placebo 11%; 95% CI, 1-21).
The proportion of patients who achieved EASI-75 at week 16:
- ECZTRA 1: 25% vs 13% for placebo (difference from placebo 12%; 95% CI, 6-18);
- ECZTRA 2: 33% vs 10% for placebo (difference from placebo 22%; 95% CI, 17-28);
- ECZTRA 3: 56% vs 37% for placebo (difference from placebo 20%; 95% CI, 9-30).
The proportion of patients who achieved at least a 4-point reduction in the weekly average Worst Daily Pruritus NRS at week 16:
- ECZTRA 1: 20% vs 10% for placebo (difference from placebo 10%; 95% CI, 4-15);
- ECZTRA 2: 25% vs 9% for placebo (difference from placebo 16%; 95% CI, 11-21);
- ECZTRA 3: 46% vs 35% for placebo (difference from placebo 11%; 95% CI, 1-22).
As for safety, the most common adverse reactions (incidence at least 1% and greater than placebo) for Adbry are upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.
“For people living with atopic dermatitis, the experience goes beyond the skin, often impacting important psychosocial aspects of their life,” said Julie Block, President and CEO of the National Eczema Association. “It’s exciting to see a new targeted therapeutic option for adult patients living with moderate-to-severe atopic dermatitis. Therapeutic advances like this provide much needed hope for those who may have spent years struggling to find an effective therapy to alleviate the burden of this disease.”
Adbry is supplied as a 150mg/mL injection in a single-dose prefilled syringe with needle guard, and is expected to be available by February 2022.
- LEO Pharma announces FDA approval of Adbry™ (tralokinumab-ldrm) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis. News release. LEO Pharma. Accessed December 28, 2021. https://www.businesswire.com/news/home/20211227005159/en/LEO-Pharma-announces-FDA-approval-of-Adbry%E2%84%A2-tralokinumab-ldrm-as-the-first-and-only-treatment-specifically-targeting-IL-13-for-adults-with-moderate-to-severe-atopic-dermatitis
- Adbry. Package insert. LEO Pharma; 2021. Accessed December 28, 2021. https://www.leo-pharma.us/Files/Billeder/US%20Website%20Product%20PIs/AdbryPI.pdf