FDA Clears Two JAK 1 Inhibitors for Atopic Dermatitis

The FDA okayed two Janus kinase 1 (JAK1) JAK inhibitors January 14 the for atopic dermatitis: Cibinqo and Rinvoq.

The FDA okayed two Janus kinase 1 (JAK1) JAK inhibitors January 14 the for atopic dermatitis (eczema).

AbbVie's Rinvoq (upadacitinib) treats moderate to severe atopic dermatitis (AD) in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, or when use of other pills or injections is not recommended, AbbVie said in a news release.

Pfizer’s Cibinqo (abrocitinib) treats adults living with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable, the pharma maker said in a news release.

“The reality for patients living with chronic inflammatory skin disease such as moderate-to-severe atopic dermatitis is that many experience debilitating symptoms that are not managed by current treatment options,” said Jonathan Silverberg, M.D., Ph.D., with the Department of Dermatology at The George Washington University School of Medicine and Health Sciences.

The approval of Cibinqo “will provide an important new oral option that could help those who have yet to find relief,” Silverberg added.

FDA’s approval of the medication was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. Across the trials, Cibinqo demonstrated a consistent safety profile and profound improvements in skin clearance, extent of disease, and severity, as well as rapid improvement in itch after two weeks, for some people living with AD versus placebo.

In addition, a higher proportion of subjects treated with Cibinqo in two monotherapy trials achieved improvement in itching at week 12 compared to placebo, Pfizer said.

Meanwhile, FDA’s approval of Rinvoq is supported by efficacy and safety data from one of the largest registrational Phase 3 programs for atopic dermatitis with more than 2,500 patients evaluated across three studies, AbbVie said.

Across the three atopic dermatitis pivotal studies, Rinvoq (15 mg and 30 mg, once daily) monotherapy and with topical corticosteroids met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance (EASI 90 and 100), according to AbbVie.

“In all three studies, a significant improvement in itch (Worst Pruritus NRS ≥4) was observed as early as week one, compared to placebo,” the pharma maker added.

"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, M.D., Ph.D., 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,” Guttman-Yassky said. “And 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.”