The JAK inhibitor was previously approved only for the treatment of adults aged 18 years and older.

The US FDA has approved a supplemental New Drug Application (sNDA) for CIBINQO (abrocitinib, Pfizer). This move expands the drug's indication to include adolescents (12 to < 18 years) with refractory, moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. 

CIBINQO was previously approved only for the treatment of adults 18 years of age and older.

“This is a big win for adolescents with AD that are in dire need for additional systemic medications, including oral medications, that are able to provide fast relief to patients after only a few days of daily use,” says Emma Guttman-Yassky, MD, PhD, Waldman professor and system chair of dermatology in the Kimberly and Eric J. Waldman department of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, in an interview with DermWire. She also serves as director of the Center of Excellence in Eczema and the Laboratory of Inflammatory Skin Diseases at Mount Sinai.

“[CIBINQO] also provides an additional efficacious treatment to those adolescents who are afraid of injections as well as those that want to have the flexibility of intermittent use of a systemic drug upon exacerbations of their disease,” she says.

This drug is now the third systemic approved for adolescents and the second oral medication, she says. “We need to remember that there is a very large population of adolescents with moderate to severe AD,” she emphasizes.

Peter Lio, MD, a clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine in Chicago, agrees. "This adds another important tool in our toolkit for adolescents with uncontrolled moderate to severe AD," he says. "At the same time, it helps round out the general therapeutic options by putting it on the same footing as the other major member of this class of medications, which I think can be helpful for both patients and clinicians."

“This is a meaningful advancement for the many adolescents across the US who are affected by the persistent itching and discomfort that accompanies uncontrolled moderate to severe atopic dermatitis,” says Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital in San Diego, in a news release. “The extended indication of CIBINQO offers potential relief for young atopic dermatitis patients in need and their families.”

The CIBINQO prescribing information was updated to include data from JADE TEEN, a phase 3, randomized, placebo-controlled clinical trial. JADE TEEN, which supported the expanded indication, evaluated both the 100- and 200-mg doses of CIBINQO versus placebo in adolescents who were 12 to less than 18 years of age with moderate to severe AD while also on background therapy with topical medications. The trial evaluated measures of improvement in skin clearance, itch, disease extent, and severity, including the Investigator Global Assessment (IGA), Peak Pruritus Numerical Rating Scale (PP-NRS), and Eczema Area and Severity Index (EASI).

“Moderate to severe atopic dermatitis can have debilitating physical and emotional impacts on adolescents,” adds Angela Hwang, chief commercial officer, president, global biopharmaceuticals business, Pfizer. “As an efficacious once-daily pill, we believe that CIBINQO offers an important new treatment option for adolescents burdened by uncontrolled symptoms of atopic dermatitis. Encouraged by an increasing uptake in the adult population, we look forward to bringing this important new oral medicine to adolescents who have yet to find relief from this inflammatory skin condition with current options.”

Data from the robust clinical trial program included in the prescribing information now stem from five randomized, placebo-controlled clinical trials and a long-term extension study with more than 1,600 patients treated with CIBINQO. Across the trials to date, 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 2 weeks, for some people living with AD versus placebo, including adolescents.

Across trials, the most common adverse events reported in 1% or more of patients treated with CIBINQO for up to 16 weeks included nasopharyngitis (12.4% with CIBINQO 100 mg, 8.7% with CIBINQO 200 mg, and 7.9% with placebo), nausea (6%, 14.5%, and 2.1%, respectively), and headache (6%, 7.8%, and 3.5%, respectively).

More on the JADE TEEN Clinical Trial

JADE TEEN: A randomized, double-blind, placebo-controlled, parallel group study. A total of 285 individuals who were 12 to less than 18 years of age with moderate to severe AD were randomly assigned to receive once-daily abrocitinib 200 mg, abrocitinib 100 mg, or placebo for 12 weeks while also on background topical therapy. Eligible individuals completing the 12-week treatment period of the study had the option to enter a long-term extension study, B7451015. The trial assessed the coprimary endpoints of IGA 0 or 1 and EASI-75 responses at week 12.
Select findings from JADE TEEN are as follows:

• IGA 0 or 1 response rate (week 12): 39% with CIBINQO 100 mg, 46% with CIBINQO 200 mg, and 24% with placebo
• EASI-75 response rate (week 12): 64%, 71%, and 41%, respectively
• Proportion of participants achieving PP-NRS at least a 4-point decrease from baseline (week 2): 13%, 25%, and 8%, respectively
• Safety profile seen in JADE TEEN consistent with the pivotal trials and findings for the adult population