Therapy Areas: Inflammatory Diseases
US FDA Approves Adbry as the First and Only Treatment Specifically Targeting IL-13 for Adults with Moderate-to-Severe Atopic Dermatitis
3 January 2022 - - The US Food and Drug Administration has approved Adbry (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable, US-based Leo Pharma Inc said.

Adbry can be used with or without topical corticosteroids.

Adbry is the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.

The approval of Adbry is based on safety and efficacy results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included nearly 2,000 adult patients with moderate-to-severe atopic dermatitis.

Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose-finding trial, and a vaccine response trial.

In all three pivotal trials, Adbry 300 mg every other week alone or with topical corticosteroids as needed met the primary endpoints at Week 16 as measured by an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and/or at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75), and the secondary endpoint of reduction of weekly average Worst Daily Pruritus NRS of ≥ 4 points on the 11-point itch NRS.

In clinical trials, the safety of Adbry was well established with an overall frequency of adverse events comparable with placebo.

The most common adverse events (incidence ≥1% and greater than placebo) were upper respiratory tract infections (mainly reported as common cold), conjunctivitis, injection site reactions, and eosinophilia.

Adbry will be available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week.

Adbry can be used with or without TCS. 1 A dosage of 300 mg every four weeks may be considered for patients below 100 kg who achieve clear or almost clear skin after 16 weeks of treatment.

The FDA approval marks the fifth global regulatory approval for tralokinumab in 2021. Tralokinumab is marketed outside of the US under the tradename Adtralza and is currently approved in the European Union, Great Britain, Canada and the United Arab Emirates.

ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab trials Nos. 1 and 2) were randomized, double-blind, placebo-controlled, multinational 52-week trials, which included 802 and 794 adult patients, respectively, to evaluate the efficacy and safety of Adbry (300 mg every other week) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.

At Week 16, for the ECZTRA 1 and 2 monotherapy trials, respectively, 16% and 21% of patients treated with Adbry 300 mg every other week achieved clear or almost clear skin (IGA 0/1) vs 7% and 9% with placebo.

At Week 16, for ECZTRA 1 and 2, respectively, 25% and 33% of patients treated with Adbry 300 mg every other week achieved an improvement of 75% or more in the Eczema Area and Severity Index score (EASI-75) vs 13% and 10% with placebo.

Additionally, at Week 16, for ECZTRA 1 and 2, respectively, 20% and 25% of patients treated with Adbry 300 mg every other week achieved a reduction of ≥ 4 points in the weekly average Worst Daily Pruritus NRS vs 10% and 9% with placebo.

At 52 weeks, 51% and 60% of patients who responded at Week 16 maintained IGA 0/1 response with Adbry 300 mg every other week in ECZTRA 1 and 2, respectively.

At 52 weeks, 60% and 57% of patients who responded at Week 16 maintained EASI-75 response with Adbry 300 mg every other week in ECZTRA 1 and 2, respectively.

ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week trial, which included 380 adult patients, to evaluate the efficacy and safety of Adbry (300 mg) in combination with TCS as needed in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

In the ECZTRA 3 Adbry plus TCS as needed combination trial:

At Week 16, 38% of patients treated with Adbry 300 mg every other week plus TCS achieved clear or almost clear skin (IGA 0/1) vs 27% with placebo plus TCS.

At Week 16, 56% of patients treated with Adbry 300 mg every other week plus TCS achieved an improvement of 75% or more in the Eczema Area and Severity Index score (EASI-75) vs 37% with placebo plus TCS.

Further, at Week 16, 46% of patients treated with Adbry 300 mg every other week plus TCS achieved a reduction of ≥4 points in the weekly average Worst Daily Pruritus NRS vs 35% with placebo plus TCS.

At 32 weeks, 89% and 92% of patients who responded at Week 16 maintained response (IGA 0/1 and EASI-75, respectively) with Adbry 300 mg every other week.

Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.

Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.

Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.

Adbry (tralokinumab-ldrm) is a human monoclonal antibody developed to specifically neutralize the IL-13 cytokine, which plays a key role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.

Adbry specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).
Login
Username:

Password: