AbbVie announced that it has submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for RINVOQ (upadacitinib) for the treatment of adults and adolescents with moderate to severe atopic dermatitis.
The atopic dermatitis indication applications to the FDA and EMA are supported by data from three pivotal Phase 3 studies. RINVOQ was studied without topical corticosteroids (TCS) in Measure Up 1 and Measure Up 2 and with TCS in AD Up. In all three studies, RINVOQ demonstrated significant improvement in skin clearance and reduction in itch in adults and adolescents with moderate to severe atopic dermatitis compared to placebo. RINVOQ met the co-primary endpoints including at least a 75 per cent improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16. Additionally, more patients treated with either dose of upadacitinib experienced a clinically meaningful reduction in itch, defined as improvement in Worst Pruritus Numerical Rating Scale (NRS)≥4. The safety profile of RINVOQ was consistent across the three pivotal Phase 3 studies in atopic dermatitis. No new safety risks of RINVOQ were observed in these studies compared to the safety profile observed in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis receiving RINVOQ.
"While there have been advancements in care, patients with moderate to severe atopic dermatitis continue to experience relentless itch and skin symptoms that can impact their everyday lives," said Michael Severino, M.D., vice chairman and president, AbbVie. "These submissions are an important step forward in our commitment to providing an additional treatment option for those who struggle with this debilitating and often underappreciated disease."
Atopic dermatitis is characterized by a cycle of itching and scratching that leads to cracked, scaly, oozing skin, which intensifies with worsening disease severity. Between 20 to 46 per cent of adults with atopic dermatitis have moderate to severe disease. The range of symptoms pose significant physical, psychological and economic burden on individuals impacted by the disease.