Abrocitinib Shows Positive Efficacy, Safety Results in Phase 3 Atopic Dermatitis Study
Abrocitinib showed improvements in skin clearance and itch relief in patients aged 12 years and older with moderate-to-severe atopic dermatitis.
Treatment with abrocitinib, an investigational oral Janus kinase (JAK) 1 inhibitor, resulted in skin clearance and itch relief in patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD), according to a phase 3 study.
The JAK pathways are believed to play an important role in inflammatory processes, as they are involved in signaling for more than 50 cytokines and growth factors, many of which drive immune-mediated conditions, according to Pfizer.
Furthermore, inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD, including interleukin (IL)-4, IL-13. IL-31, and interferon gamma.
The study, named JADE MONO-1, included 387 patients who received either abrocitinib 200 mg, abrocitinib 100 mg, or a placebo. Patients who completed the 12-week treatment period had the option to enter a long-term extension study. Those who discontinued treatment or were ineligible for the long-term extension study entered a 4-week follow-up period.
According to the results, both doses of abrocitinib significantly improved the Investigator Global Assessment (IGA) and Eczema Area and Severity Index (EASI)-75 dose response outcomes compared with placebo.
By week 12, the percentage of patients achieving IGA scores of clear (0) or almost (1) skin and 2-point or greater improvement to baseline for abrocitinib 200 mg, 100 mg, and placebo improved by 43.8%, 23.7%, and 7.9%, respectively. The percentage of patients who achieved EASI-75 response rates for 200 mg and 100 mg were 62.7% and 39.7%, respectively, compared with 11.8% for placebo.
For key secondary endpoints, 57.2% and 37.7% of patients who received 200 mg and 100 mg, respectively, achieved a 4-point or larger reduction in itch severity measured with pruritis numerical rating scale, compared with 15.3% on placebo. Additionally, 38.6%, 18.6%, and 5.3% of patients achieved EASI-90 with abrocitinib 200 mg, 100 mg, and placebo, respectively.
The percentage changes from baseline in the SCORing Atopic Dermatitis response were significantly greater at all time points in both treatment arms compared with placebo, according to the study.
Safety data demonstrated that both doses of abrocitinib were well tolerated and consistent with the companion JADE MONO-2 study. The most common treatment-emergent adverse events in the study were short-lasting nausea, headache, and nasopharyngitis.
“There is a critical need for additional treatment options for patients living with moderate-to-severe atopic dermatitis,” Michael Corbo, PhD, chief development officer, Inflammation & Immunology, Pfizer Global Product Development, said in a statement. “We are pleased by these findings, which together with the recently reported positive top-line results from our second phase 3 trial, encourage us that, if approved, abrocitinib may provide the first oral, once-daily treatment option for these patients.”
The results of the JADE MONO-1 study were presented as a late-breaking abstract at the European Academy of Dermatology and Venereology taking place October 9 to 13, 2019, in Madrid, Spain.
Abrocitinib received breakthrough therapy designation from the FDA for the treatment of AD in February 2018.
Pfizer Presents Positive Phase 3 Data at the 28th Congress of the European Academy of Dermatology and Venereology for Abrocitinib in Moderate to Severe Atopic Dermatitis [news release]. Pfizer’s website. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_presents_positive_phase_3_data_at_the_28th_congress_of_the_european_academy_of_dermatology_and_venereology_for_abrocitinib_in_moderate_to_severe_atopic_dermatitis. Accessed October 14, 2019.