The manufacturer of upadacitinib has submitted applications to the FDA and European Medicines Agency to have the drug approved as a treatment for adults and adolescents with moderate to severe atopic dermatitis.
The applications follow the results of three phase 3 studies of upadacitinib. In the Measure Up 1 and Measure Up 2 trials, upadacitinib was studied without topical corticosteroids. The AD Up trial included upadacitinib and topical corticosteroids.
According to a release from the manufacturer, those trials showed upadacitinib provided significant improvement in skin clearance and a reduction in itch compared to placebo.
Upadacitinib met the trial’s co-primary endpoints, which included at least a 75% improvement in the Eczema Area Severity Index from baseline.
The release from the manufacturer also noted that patients treated with upadacitinib experienced a clinically meaningful reduction in itch, which was defined as an improvement in the Worst Pruritus Numerical Rating Scale.
“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, MD, vice chairman and president, AbbVie, in the release.
Upadacitinib is currently approved by the FDA as a treatment for patients with moderate to severe rheumatoid arthritis who have an inadequate response or intolerance to methotrexate.
The safety profile of upadacitinib was consistent across all three studies. The release noted there were no new safety risks observed compared to patients who use the drug for the treatment of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.
According to the release, upadacitinib is currently being studied in phase 3 clinical trials as a treatment for several conditions, including atopic dermatitis, psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, and Crohn’s disease.
