FDA approves Rinvoq for atopic dermatitis

The FDA approved Rinvoq, a selective JAK inhibitor, for the treatment of moderate to severe atopic dermatitis among patients aged 12 years and older, according to a press release.

Supported by safety and efficacy results across three atopic dermatitis studies, Rinvoq (upadacitinib, AbbVie) 15 mg and 30 mg once daily monotherapy, or in conjunction with topical corticosteroids, met all primary and secondary endpoints at week 16. Some patients achieved higher levels of skin clearance as measured by the eczema area and severity index. Researchers also observed improvements in itch as early as week 1 compared with placebo.

Safety profile analysis yielded results similar to those observed among patients with rheumatoid arthritis; specific adverse reactions included eczema herpeticum/Kaposi’s varicelliform eruption, allergic reaction, tears in the stomach or intestines and changes in laboratory test results.

“Despite available therapies, many people with moderate to severe atopic dermatitis are caught in an endless cycle of itching and scratching,” Emma Guttman-Yassky, MD, PhD, of the Icahn School of Medicine at Mount Sinai, said in the release. “In clinical trials, upadacitinib showed a robust response across skin and itch symptoms that may help evolve treatment goals for those who have not achieved adequate control of their disease. As an oral pill with two dose strengths, upadacitinib is a welcome addition to the toolbox of clinicians who are striving to make a significant difference for their patients with moderate to severe atopic dermatitis.”