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Abrocitinib and Flares in Adults and Adolescents With Atopic Dermatitis

<ѻý class="mpt-content-deck">– Pfizer analysis covered 200- and 100-mg dosing regimens

Abrocitinib (Cibinqo) was effective in preventing flare in adolescents and adults with moderate-to-severe atopic dermatitis (AD).

The post-hoc analysis examined data from JADE REGIMEN, a trial designed to evaluate patient response to abrocitinib -- an oral, once-daily JAK inhibitor -- over 40 weeks. Specifically, the study evaluated response to continuous and reduced-dose abrocitinib regimens and response to treatment reintroduction after a disease flare. The trial ultimately included 246 adolescents and 981 adults.

Of these, large majorities of adolescents (145/246) and adults (655/981) saw improvement in the induction phase. During the study's maintenance period, far lower percentages of adolescents and adults experienced flares when taking 200 mg of abrocitinib (14.9%/16.9%) and 100 mg of abrocitinib (42.9%/38.9%) compared with placebo (75.5%/78.0%).

Abrocitinib had a similar safety profile regardless of the age group, with nausea reported in a higher number of adolescents.

In February of this year, the FDA for use in adolescents with refractory, moderate-to-severe AD whose disease is not adequately controlled with other agents or when use of other therapies is inadvisable.

John Nesnas, a medical team leader for Pfizer UK, served as a co-author of the paper, which appeared in the . (Pfizer manufactures abrocitinib and sponsored the study.) Nesnas discussed the study and its findings with the Reading Room. The exchange has been edited for length and clarity.

How would you summarize the study's key findings?

Nesnas: During the trial, both doses of abrocitinib (100 mg and 200 mg):

  • Met their primary endpoints, resulting in significantly fewer patients experiencing a loss of response requiring rescue treatment, or "flaring," compared to those randomized to placebo.
  • Met the key secondary endpoint of a larger percentage of patients maintaining an Investigator's Global Assessment (IGA) response of clear or almost clear disease relative to placebo.

A key strength of this analysis was the evaluation of efficacy, safety, and quality-of-life outcomes across different abrocitinib dosing regimens from a phase 3 study in a well-defined population of both adults and adolescents with AD.

These findings confirm the efficacy and safety profile of abrocitinib in adolescents and adults over 40 weeks of treatment. They also reinforce that treatment with abrocitinib using either induction with abrocitinib 200 mg followed by maintenance with a reduce dose, or continuous dosing with abrocitinib 200 mg, can be an effective therapeutic approach in moderate-to-severe AD.

Based on these study findings, what is your message to dermatologists managing these patient populations?

Nesnas: Many patients living with chronic inflammatory skin diseases such as moderate-to-severe AD experience debilitating symptoms. Abrocitinib is an oral option that could help both adult and adolescent patients find relief. I am encouraged by these ongoing findings that support its safety profile and efficacy.

Nesnas is an employee and stockholder of Pfizer Inc.

Primary Source

Journal of Dermatological Treatment

Source Reference:

AAD Publications Corner

AAD Publications Corner