General Information

Adbry (tralokinumab-ldrm) is an interleukin-13 antagonist.

Adbry is specifically indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Adbry is supplied as an injection for subcutaneous administration. Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with Adbry.

The recommended dosage of Adbry is: An initial dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered every other week. After 16 weeks of treatment, for patients with body weight below 100 kg who achieve clear or almost clear skin, a dosage of 300 mg every 4 weeks may be considered.

Mechanism of Action

Adbry (tralokinumab-ldrm) is a human IgG4 monoclonal antibody that specifically binds to human interleukin13 (IL-13) and inhibits its interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL13Rα2). IL-13 is a naturally occurring cytokine of the Type 2 immune response. Tralokinumab-ldrm inhibits the bioactivity of IL-13 by blocking IL-13 interaction with IL-13Rα1/IL-4Rα receptor complex. Tralokinumab-ldrm inhibits IL-13-induced responses including the release of proinflammatory cytokines, chemokines and IgE.

Clinical Trial Results

The FDA approved Adbry based on data from three phase 3 trials, ECZTRA 1, ECZTRA 2 and ECZTRA 3.

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. The primary endpoints were Investigator's Global Assessment (IGA) score of 0 or 1 at week 16 and ≥ 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16. Patients achieving an IGA score of 0 or 1 and/or EASI 75 with tralokinumab at week 16 were rerandomized to tralokinumab Q2W or every 4 weeks or placebo, for 36 weeks. Data https://pubmed.ncbi.nlm.nih.gov/33000465/ showed the following: at week 16, more patients who received tralokinumab versus placebo achieved an IGA score of 0 or 1: 15·8% vs. 7·1% in ECZTRA 1 and 22·2% vs. 10·9% in ECZTRA and EASI 75: 25·0% vs. 12·7% and 33·2% vs. 11·4%.

ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, placebo plus TCS controlled trial. Patients were randomized 2:1 to subcutaneous tralokinumab 300 mg or placebo every 2 weeks (Q2W) with TCS as needed over 16 weeks. Patients who achieved an Investigator’s Global Assessment (IGA) score of 0/1 and/or 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16 with tralokinumab were rerandomized 1:1 to tralokinumab Q2W or every 4 weeks (Q4W), with TCS as needed, for another 16 weeks. At week 16, more patients treated with tralokinumab than with placebo achieved IGA 0/1: 38·9% vs. 26·2% and EASI 75: 56·0% vs. 35·7%. Of the patients who were tralokinumab responders at week 16, 89·6% and 92·5% of those treated with tralokinumab Q2W and 77·6% and 90·8% treated with tralokinumab Q4W maintained an IGA 0/1 and EASI 75 response at week 32, respectively. Among patients who did not achieve IGA 0/1 and EASI 75 with tralokinumab Q2W at 16 weeks, 30·5% and 55·8% achieved these endpoints, respectively, at week 32.