FDA approves Rinvoq for atopic dermatitis patients aged 12 and upwards.- AbbVie

Rinvoq 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg. In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily.

The FDA approval is supported by efficacy and safety data from one of the largest registrational Phase III programs for atopic dermatitis with more than 2,500 patients evaluated across three studies. Approximately 52 percent of the patients had prior exposure to systemic atopic dermatitis treatment. These studies evaluated the efficacy and safety of Rinvoq monotherapy (Measure Up 1 and 2) and with topical corticosteroids (AD Up), compared to placebo, in adults and children 12 years of age and older with moderate to severe atopic dermatitis.

Overall, the safety profile observed in patients with atopic dermatitis treated with Rinvoq 15 mg or 30 mg was similar to the safety profile observed in patients with rheumatoid arthritis. Other specific adverse reactions reported in atopic dermatitis patients included eczema herpeticum/Kaposi's varicelliform eruption.