FDA Approves Abrocitinib for Adults with Moderate to Severe Atopic Dermatitis

Officials with the FDA have approved abrocitinib as a once-daily oral treatment for adults with moderate to severe atopic dermatitis.

“Atopic dermatitis is so much more than just a rash, and it goes beyond the surface of the skin,” said Julie Block, president and CEO of the National Eczema Association, in a press release. “It’s a chronic condition that can both significantly disrupt patients’ daily lives and negatively impact their emotional well-being.”

According to a Pfizer press release, abrocitinib has shown proven efficacy to manage symptoms for adults who have struggled to find an effective treatment. The Janus kinase 1 (JAK1) inhibitor is approved at the recommended doses of 100 mg and 200 mg, with the 200 mg dose recommended for patients who are not responding to the 100 mg dose.

A 50 mg dose was also approved to treat moderate-to-severe atopic dermatitis in patients with moderate renal impairment, certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19, or patients who are known or suspected to be poor metabolizers of CYP2C19. The 50 mg dose may also be prescribed for patients who are not responding to the 100 mg once daily.

The FDA approval was based on results from 5 clinical trials in a program of more than 1600 patients. The safety and efficacy of abrocitinib were evaluated in 3 randomized, placebo-controlled, phase 3 trials, as well as a randomized, placebo-controlled, dose-ranging trial and an ongoing, long-term, open-label extension trial.

Across the trials, abrocitinib demonstrated a consistent safety profile and profound improvements in skin clearance, extent of disease, and severity, as well as rapid improvement in itch after 2 weeks. Furthermore, a higher proportion of subjects treated with abrocitinib in 2 monotherapy trials achieved improvement in itching at week 12 compared to placebo.

“In multiple large-scale clinical trials, Cibinqo demonstrated strong efficacy at clearing skin, improving itch, and managing the extent of severity of eczema, offering a benefit-risk profile that supports the use of this treatment in the FDA-approved patient population,” said Jonathan Silverberg, MD, PhD, MPH, in the department of dermatology at the George Washington University School of Medicine and Health Sciences, in a press release.

In the JADE MONO-1 trial, the Investigator Global Assessment (IGA) response rate at week 12 was 24% for the 100 mg dose, 44% for the 200 mg dose, and 8% in the placebo group. Furthermore, the Eczema Area and Severity Index (EASI)-75 response rate was 40%, 62%, and 12%, respectively.

The JADE MONO-2 trial found similarly encouraging results, with an IGA response rate at week 12 of 28%, 38%, and 9%, respectively. Researchers also found an EASI-75 response rate of 44%, 61%, and 10%, respectively.

The most common adverse events reported in 5% or more of patients receiving abrocitinib included nasopharyngitis (12.4% with 100 mg and 8.7% with 200 mg), nausea (6% with 100 mg and 14.5% with 200 mg), and headache (6% with 100 mg and 7.8% with 200 mg).

“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,” Silverberg said in the press release. “Today’s approval of Cibinqo will provide an important new oral option that could help those who have yet to find relief.”

REFERENCE

US FDA Approves Pfizer’s Cibinqo (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis. News release. Pfizer; January 14, 2022. Accessed January 17, 2022. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-cibinqor-abrocitinib-adults