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A phase III trial examined the maintenance of abrocitinib-elicited response with continuous abrocitinib therapy, dose reduction or withdrawal, and response to therapy reintroduction after the flare.
The findings from JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN study showed that most people suffering from moderate-to-severe atopic dermatitis who initially respond to abrocitinib maintain response with reduced dosing. Also, abrocitinib + topical therapy effectively recaptures response following flaring.
A phase III trial examined the maintenance of
abrocitinib-elicited response with continuous abrocitinib therapy, dose
reduction or withdrawal, and response to therapy reintroduction after the
flare.
Subjects with atopic dermatitis who responded to
open-label abrocitinib 200 mg monotherapy for twelve weeks were randomized to
abrocitinib (100 or 200 mg) or placebo for about forty weeks. Rescue treatment
(abrocitinib 200 mg+ topical therapy) was given to people experiencing flares. The
loss of response requiring rescue medication during the maintenance period was the major
outcome.
Out of 1233 people, 798 responders to induction (64.7%) were randomly allocated. Table 1 shows the flare probability in the study groups during maintenance. Among people with flare in the study groups, the percentage of people regaining investigator global assessment (IGA) 0/1 response and eczema area and severity index (EASI) response with rescue treatment is shown in Table 1.
During maintenance, 54% and 63.2% of subjects receiving
abrocitinib 100 and 200 mg, respectively, reported adverse events.
Induction therapy with abrocitinib
is effective in atopic dermatitis patients. Most responders continuing
abrocitinib therapy didn't flare. Rescue therapy with the combination of
abrocitinib and topical therapy effectively recaptured the responses.
The Journal of the American Academy of Dermatology
Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: Results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial
Andrew Blauvelt et al.
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