FDA approves AbbVie's JAK inhibitor Rinvoq for atopic dermatitis

The U.

Upadacitinib is a selective and reversible JAK inhibitor

The FDA approval was based on a large Phase 3 development program that evaluated 2,500 patients across 3 studies, approximately 52% of whom had previously received systemic atopic dermatitis therapy

The study showed that upadacitinib (15 mg and 30 mg orally daily) as monotherapy, and in combination with topical corticosteroids, met all primary and secondary clinical endpoints and achieved EASI 90 and EASI after 16 weeks of treatment The proportion of patients with 100 was also significantly higher

▲The specific results of 3 clinical trials (picture source: Reference [1])

In terms of safety, the data observed in the treatment groups were similar to the safety profile previously observed in patients with rheumatoid arthritis

"Despite available treatments, many patients with moderate-to-severe atopic dermatitis suffer from endless itching that requires scratching," said Emma Guttman-Yassky, professor of dermatology at Mount Sinai School of Medicine.

References:

[1] US FDA Approves RINVOQ® (upadacitinib) to Treat Adults and Children 12 Years and Older with Refractory, Moderate to Severe Atopic Dermatitis, Retrieved January 14, 2022, from https:// us-fda-approves-rinvoq-upadacitinib-to-treat-adults-and-children-12-years-and-older-with-refractory-moderate-to-severe-atopic-dermatitis-301461377.