麻豆传媒

In study participants with moderate-to-severe atopic dermatitis (AD), abrocitinib helped alleviate flaring at the 12-week and 1-year marks. Further, abrocitinib maintained effectiveness at the 1-year mark even after the dosage was reduced. As a result, experts suggested that an induction-maintenance approach with abrocitinib could hold promise for the sometimes difficult-to-treat AD population.

The study findings appeared recently in the . The study was funded by Pfizer, which manufactures abrocitinib. In January, the FDA approved abrocitinib -- a Janus kinase 1 selective inhibitor -- for use in adults with moderate-to-severe AD whose disease is not adequately controlled with other drugs.

In the study, patients (n=1,233) with moderate-to-severe AD completed a 12-week induction period to determine response to 200 mg of abrocitinib monotherapy. Patients (n=798) who responded to the drug were randomly assigned to receive either 200 mg of abrocitinib, 100 mg of abrocitinib, or placebo for a 40-week maintenance period.

The probability of flares during the maintenance phase was 18.9%, 42.6%, and 80.9%, respectively, for abrocitinib 200 mg, abrocitinib 100 mg, and placebo.

Hernan Valdez, MD, vice president and medicine team leader for Pfizer Dermatology, served as a coauthor of the report. He recently discussed the study and its findings with the Reading Room. The exchange has been edited for length and clarity.

What was the study's key objective?

Valdez: The heterogeneous disease course of moderate-to-severe AD, treatment interruption due to poor adherence, or changes in disease factors all require dosing flexibility. However, there is limited evidence to guide intermittent or flexible dosing regimens for these patients.

Abrocitinib is a JAK1 selective inhibitor for the treatment of moderate-to-severe AD with inadequate response to topical therapy.

This was an induction, randomized withdrawal, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of abrocitinib in patients 12 years of age and older with moderate-to-severe AD.

What were your key findings?

Valdez: Both doses of abrocitinib resulted in significantly fewer patients experiencing either flaring or a loss of response that required rescue treatment.

Importantly, the study also showed that for patients who flared and required rescue treatment, most recaptured response with abrocitinib 200 mg and topical therapy.

What should clinicians be aware of regarding the effectiveness of abrocitinib?

Valdez: Across trials, abrocitinib has demonstrated a favorable risk-benefit profile and achieved profound improvements in skin clearance, extent of disease, and disease severity, as well as rapid improvement in itching after 2 weeks in some patients.

The observations from this report support continuous abrocitinib 200 mg monotherapy as the most effective option for maintaining disease control. However, for most patients with moderate-to-severe AD, an induction-maintenance approach with abrocitinib 200 mg followed by 100 mg may be viable, given that the majority of patients receiving reduced-dose abrocitinib maintenance did not flare for at least 40 weeks.

How might these findings potentially affect clinical practice?

Valdez: AD is more than "just a rash." It can be debilitating, it can disrupt patients' daily lives, and it can negatively affect their emotional well-being.

For people living with this chronic inflammatory condition, there have been few new treatment options over the last decade.

The recent regulatory approval of abrocitinib in the U.S., European Union, Great Britain, Japan, Korea, the United Arab Emirates, Norway, Iceland, and Singapore make us hopeful that abrocitinib may help reduce the burden of flares for patients.