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 approved for this indication in the US United States are available.
“This is big news because a few years ago we didn’t have any systemic treatments that were safer than the classic immunosuppressants like cyclosporine and methotrexate,” Emma Guttman-Yassky, MD, PhD, Waldman Professor and Chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York, told this news organization, commenting on the approval of upadacitinib.
“The only orally approved drug for AD until now has been oral prednisone, which has terrible safety concerns. This is essentially the first oral medication that we can offer long-term use to our patients.”
The approval of upadacitinib (Rinvoq), marketed by AbbVie, for moderate-to-severe AD in patients 12 years and older follows findings from three pivotal Phase 3 studies that enrolled more than 2,500 adults and children 12 years and older People with moderate to severe AD: Measure Up 1 and 2 led by Guttman-Yassky, which evaluated upadacitinib versus placebo, and AD UP, which compared upadacitinib plus topical corticosteroids to placebo.
In all three studies, upadacitinib — both 15 mg and 30 mg once daily as monotherapy — met all primary and secondary endpoints at week 16, with some patients experiencing greater levels of skin clearance based on the Eczema Area and Severity Index 90 (EASI-90). reached. and EASI-100.
“I always say patients with Alzheimer’s need options,” Guttman-Yassky said. “We need biologics. We need oral medication. Not everyone likes injections. The plus of the JAK inhibitor class in general is the rapid onset of action.” Many patients at her clinic continue on upadacitinib more than two years later “and are super happy,” she said. “Many of them failed on ciclosporin and other immunosuppressants like methotrexate and prednisone.”
She estimated upadacitinib will be available by March and predicted that health plans would see the coverage as cost-effective “because it sets new standards for effectiveness and because many patients have failed other treatments.”
Abrocitinib (Cibinqo), marketed by Pfizer, has been approved for adults with moderate to severe AD. The approval was based on the results of five clinical trials from a large clinical trials program involving more than 1,600 patients. The recommended doses are 100 mg and 200 mg, with the 200 mg dose being recommended for patients not responding to the 100 mg dose.
The labeling of abrocitinib and upadacitinib includes a boxed warning for JAK inhibitors regarding the risk of serious infections, mortality, malignancy, serious cardiovascular adverse events and thrombosis.
Guttman-Yassky served as the principal investigator for AbbVie and has received consulting fees from the company.
This story originally appeared on MDedge.com, part of the Medscape Professional Network.