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FDA批准Tralokinumab用于治疗中度至重度特应性皮炎成人患者
Introduction: The fully human IgG4 monoclonal antibody Tralokinumab can significantly improve the patient's severity index score in the treatment of adult patients with moderate to severe atopic dermatitis (AD).
On December 28, 2021, the U.S. Food and Drug Administration (FDA) approved tralokinumab for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) whose disease is not well controlled by topical prescription therapies or where these therapies are not advisable.
Tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of inflammation underlying AD. Tralokinumab is developed by LEO Pharma as a single-dose (150 mg) prefilled syringe with needle guard for administration by subcutaneous injection.
(Source: Internet)
In the two pivotal Phase 3 ECZTRA 1 and ECZTRA 2 trials, tralokinumab monotherapy was superior to placebo on all primary and secondary endpoints at week 16. For example, in the ECZTRA 1 and ECZTRA 2 trials, 16% and 21% of subjects (tralokinumab 300 mg every other week) achieved clear or nearly clear skin (IGA 0/1) at week 16, respectively, compared with only 7% and 9% of patients in the placebo group.
Additionally, in both trials, 25% and 33% of subjects receiving tralokinumab 300 mg every other week experienced at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75), compared with 13% and 10%, respectively, of the placebo group. At week 52, 51% and 60% of subjects (responsive to tralokinumab at week 16) maintained IGA 0/1 response.
Finally, EASI-75 responses were maintained in 60% and 57% of subjects, respectively, who responded at week 16 with tralokinumab.
In the third pivotal ECZTRA 3 trial, investigators evaluated the efficacy and safety of tralokinumab (300 mg) in combination with topical corticosteroids (TCS) in patients with moderate to severe atopic dermatitis requiring systemic therapy. At week 16, 38% of patients treated with tralokinumab (300 mg every other week) plus TCS achieved clear or nearly clear skin (IGA 0/1), compared with 27% of patients in the placebo plus TCS group. Additionally, 56% of patients in the tralokinumab combination group experienced at least a 75% improvement in EASI-75, compared with 37% of patients in the placebo group. At week 32, 89% and 92% of patients in the tralokinumab combination group (who had a response at week 16 on tralokinumab) maintained their responses at GA 0/1 and EASI-75, respectively.
Tralokinumab is expected to be available in February 2022.
References:
https://www.mdedge.com/dermatology/article/250288/atopic-dermatitis/fda-gives-nod-tralokinumab-adults-moderate-severe-ad
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