On January 14, the Food and Drug Administration approved two oral JAK-1 inhibitors for patients with moderate to severe atopic dermatitis – upadacitinib and abrocitinib – making them the first oral JAK inhibitors available for this indication in the United States.
“This is great news because a few years ago we had no systemic treatment that was safer than classic immunosuppressants like cyclosporine and methotrexate,” said Emma Guttman-Yassky, MD, PhD, Waldman Professor and Chair. of the Dermatology System at the Icahn School. of Medicine at Mount Sinai in New York, told this news agency commenting on the approval of upadacitinib.
“The only approved oral drug for AD so far has been oral prednisone, which has terrible safety issues. It’s essentially the first oral drug we can provide to our patients for long-term use.”
Approval of upadacitinib (Rinvoq), marketed by AbbVie, for moderate to severe AD in patients aged 12 years and older, follows results from three pivotal Phase 3 studies involving more than 2,500 adults and children 12-year-olds 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 with corticosteroids topical versus placebo.
In all three studies, upadacitinib – both 15 mg and 30 mg once daily as monotherapy – achieved 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 AD patients need options,” Guttman-Yassky said. “We need biologics. We need oral medications. Not everyone likes injectables. The plus of the class of JAK inhibitors in general is the rapid onset of action.” Many patients at her clinic are still on upadacitinib more than two years later “and are super happy,” she said. “Many of them failed on cyclosporine and other immunosuppressants such as methotrexate and prednisone.”
She estimated that upadacitinib will be available by March and predicted that health insurance companies will find cost-effective coverage “because it sets a new bar 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-scale clinical trial program of more than 1,600 patients. The recommended doses are 100 mg and 200 mg, with the 200 mg dose being recommended for patients who do not respond 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, major adverse cardiovascular events and thrombosis.
Guttman-Yassky served as a principal investigator for AbbVie and received consulting fees from the company.
This story originally appeared on MDedge.com, part of the Medscape Professional Network.