Drugs Xagena
Adbry ( Tralokinumab-ldrm; Tralokinumab ) is a biologic drug approved by the FDA ( Food and Drug Administration ) for adults ( 18+ years ) with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies used on the skin ( topical therapies ) or when those therapies are not advisable.
Moderate to severe atopic dermatitis is generally determined by skin involvement and severity of symptoms such as itch and rash that cannot be controlled by topical medications alone.
However, atopic dermatitis can be considered moderate or severe if the disease has a significant negative impact on quality of life, even if the body surface affected is more limited.
Adbry works by blocking a type of protein called interleukin-13, or IL-13, from binding to its cell surface receptors ( IL-13R alpha 1 and IL-13R alpha 2 ).
IL-13 can be produced by many cells of the immune system and has been found to contribute to the inflammatory processes and decreased barrier functions in atopic dermatitis.
Adbry is taken by subcutaneous ( s.c. ) injection. Adbry is not available as a pill or a cream.
Like other biologics for atopic dermatitis, Adbry is an antibody with a unique protein structure, and must be given by injection.
The recommended dosage of Adbry is an initial 600 mg dose ( given as four 150mg injections ) followed by 300mg ( given as two 150 mg injections ) once every other week.
A dosage of 300 mg once every 4 weeks may be considered for patients weighing less than 100 kg who achieve clear or almost clear skin after 16 weeks of treatment.
In the ECZTRA 1 and 2 monotherapy clinical trials for Adbry after 16 weeks on Adbry1:
15.8 and 22.2% of patients had an IGA ( Investigator Global Assessment ) score of clear to almost clear ( IGA 0 or 1 ) versus 7.1 and 10.9% on placebo;
25.0 and 33.2% of patients achieved an EASI-75 ( Eczema Area and Severity Index ) versus 12.7% and 11.4% on placebo.
Reductions in daily worst itch rating and improved sleep and quality of life were also observed with Adbry vs placebo.
Patients reported these effects of Adbry versus placebo after 1-2 weeks.
The majority of patients who saw benefit from Adbry at 16 weeks maintained their response at 52 weeks with continued Adbry dosing.
In clinical trials, the most common side effects reported were upper respiratory infections, conjunctivitis, injection-site reactions, and eosinophilia.
The majority of side effects were mild to moderate in severity, with many resolving by the end of the initial 16-week treatment period. ( Xagena )
Source: FDA, 2021
XagenaMedicine_2021
