FDA Approves Upadacitinib for Patients 12 Years and Older with Moderate to Severe Atopic Dermatitis

Upadacitinib is now indicated for children 12 years and older, and can be used as a monotherapy or with topical corticosteroids.

Today, AbbVie announced that the US Food and Drug Administration (FDA) approved upadacitinib ( RINVOQ®) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years and older who are unresponsive to previous treatment and are not well controlled with other pills or injections.

The medicine is initiated in 15 mg doses once daily in adults and children 12 years of age and older weighing at least 40 kg. Doses can be increased to 30 mg in patients who do not achieve an adequate response.

Previous data on upadacitinib from phase 3b of the Heads Up study was reported on last summer, in which the safety and efficacy of the medicine were compared to dupilumab in adults with moderate to severe atopic dermatitis.

Of the patients treated with upadacitinib, 71% achieved EASI 75 at week 16 compared to 61% of those treated with dupilumab.

The newest FDA approval for children 12 years and older was supported by efficacy and safety data from one of the largest phase 3 programs for atopic dermatitis.

More than 2500 patients were evaluated across 3 different studies, with approximately 52% of all patients having prior exposure to systemic atopic dermatitis treatment.

The studies evaluated upadacitinib as a monotherapy (Measure Up 1 and 2) and with topical corticosteroids (AD Up) compared to placebo.

At week 16 of the studies, upadacitinib monotherapy and with topical corticosteroids met all primary and secondary endpoints, with some patients achieving higher levels of skin clearance in the Eczema Area and Severity Index (EASI 90 and 100).

Additionally, the safety profile of the medicine in patients with atopic dermatitis was similar to the safety profile observed in patients with rheumatoid arthritis, with adverse reactions including eczema herpeticum being observed.

"Despite available therapies, many people with moderate to severe atopic dermatitis are caught in an endless cycle of itching and scratching," said Emma Guttman-Yassky, MD, PhD, Waldman Professor and System Chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City.

"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. And as an oral pill with 2 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."