Abrocitinib and Upadacitinib Approved for Atopic Dermatitis

The US Food and Drug Administration has approved both abrocitinib and upadacitinib, Janus kinase 1 (JAK1) inhibitors, for treatment of refractory, moderate-to-severe atopic dermatitis (AD) among patients whose disease is not adequately controlled with other systemic therapies, such as biologics, or when use of those therapies is inadvisable. Abrocitinib is approved for adults, while upadacitinib is approved for adults and children 12 years and older.

Both therapies are oral, once-daily pills. Abrocitinib was approved at the recommended dose of 100 mg, with the option of 200 mg recommended for patients who do not respond to the 100 mg dose. A 50 mg dose of abrocitinib is also approved for the treatment of moderate-to-severe AD among patients with moderate renal failure, certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19, or patients who are known or suspected to be poor metabolizers of CYP2C19. Upadacitinib was approved for two dose strengths as well, 15 mg for initiation, and a 30 mg option for those who do not achieve adequate responses.

Across multiple large-scale clinical trials, both abrocitinib and upadacitinib demonstrated a consistent safety profile and improvements in skin clearance and itch, when compared to placebo.

—Allison Casey

References:

1. US FDA approves Pfizer’s CIBINQO (abrocitinib) for adults with moderate-to-severe atopic dermatitis. News release. Pfizer. January 14, 2022.
2. US FDA approves RINVOQ (upadacitinib) to treat adults and children 12 years and older with refractory, moderate to severe atopic dermatitis. News release. AbbVie. January 14, 2022.