Drugs Xagena
The European Commission has approved Adtralza ( Tralokinumab ) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.
Tralokinumab is a human IgG4l antibody targeting IL-13, a pleiotropic T helper type 2 cytokine associated with atopic dermatitis and other inflammatory disorders.
The antibody interferes with IL-13-mediated signaling by blocking its interactions with both IL-13 receptor α1 and IL-13 receptor α2.
The approval is supported by data from three phase 3 studies, ECZTRA 1, ECZTRA 2, and ECZTRA 3.
The randomized, double-blind, placebo-controlled, multinational, 52-week ECZTRA 1 and ECZTRA 2 trials evaluated the safety and efficacy of Tralokinumab ( 300 mg SC [ subcutaneous ] ) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.
ECZTRA 3 was a double-blind, randomized, placebo-controlled, multinational 32-week study of 380 patients that evaluated the safety and efficacy of Tralokinumab ( 300 mg SC ) in combination with topical corticosteroid in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.
The results of the three phase 3 studies were published in the British Journal of Dermatology.
The primary outcome measures for the studies included an Investigator’s Global Assessment ( IGA ) of 0 or 1 and 75% improvement in Eczema Area and Severity Index ( EASI 75 ) at week 16.
At this time point in the ECZTRA 1 and ECZTRA 2 studies, 15.8% and 22.2% of patients who received Tralokinumab achieved an IGA score of 0/1 versus 7.1% and 10.9% of patients who received placebo, respectively.
More patients who received Tralokinumab also achieved EASI 75 compared to those who received placebo ( 25.0% vs 12.7% and 33.2% vs. 11.4% in ECZTRA 1 and ECZTRA 2, respectively ).
In the ECZTRA 3 study, which included use of topical corticosteroid, 38.9% patients who received Tralokinumab achieved IGA 0/1 vs 26.2% of those who received placebo.
EASI 75 was achieved in 56.0% patients who received Tralokinumab versus 35.7% of those who received placebo. ( Xagena )
Source: Leo Pharma, 2021
XagenaMedicine_2021
