The Food and Drug Administration on Jan. 14 approved two oral JAK-1 inhibitors for patients with moderate-to-severe atopic dermatitis (AD) — upadacitinib and abrocitinib — making them the first oral JAK inhibitors available for this indication in the United States.
“It’s big news because a few years ago we didn’t have any systemic treatments that are safer than the classical immunosuppressants like cyclosporine and methotrexate,” Emma Guttman-Yassky, MD, PhD, Waldman professor and system chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York, told this news organization commenting on upadacitinib’s approval.
“The only oral approved drug for AD up to now was oral prednisone, which has terrible safety concerns. This is the first oral medication we can offer our patients for long-term usage. “
The approval of upadacitinib (Rinvoq), marketed by AbbVie, for moderate-to-severe AD in patients ages 12 and older, comes on the heels of findings from three pivotal phase 3 studies involving more than 2,500 adults and children 12 years of age and older with moderate-to-severe AD: Measure Up 1 and 2, led by Guttman-Yassky, which evaluated upadacitinib compared with placebo, and AD UP, which compared upadacitinib along with topical corticosteroids, compared with placebo.
Across the three studies, upadacitinib — both 15 mg and 30 mg once daily monotherapy — met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance based on the Eczema Area and Severity Index 90 (EASI-90) and EASI-100.
“I always say that patients with AD need options, “Guttman-Yassky said. We need biologics. Oral medications are essential. Some people don’t like injectables. The advantage of injectables from the JAK inhibitors class is their quick onset of action. She said that many patients at her clinic continue to receive upadacitinib for more than two years. Many of these patients failed to take cyclosporine or other immunosuppressants like prednisone and methotrexate. “
She estimated that upadacitinib will be av