Publication
Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: Results from the JAK1 Atopic Dermatitis Ef…
[Jan-2022] JADE REGIMEN primary manuscript.
What is it about?
JADE REGIMEN was a Phase 3 clinical trial evaluating long-term disease control in patients with moderate-to-severe atopic dermatitis (AD) who initially responded to 12 weeks of open-label abrocitinib 200 mg. Response was defined as achieving an Investigators Global Assessment (IGA) 0/1 with ≥2-point improvement and a ≥75% reduction in the Eczema Area and Severity Index score (EASI-75).
Responders were randomized into three maintenance arms for 40 weeks: continued abrocitinib 200 mg, reduced dose (100 mg), or placebo (withdrawal). Patients who experienced flare, defined as ≥50% loss of EASI response and IGA ≥2, received 12 weeks of open-label rescue therapy with abrocitinib 200 mg and medicated topical treatment.
The primary endpoint was loss of response requiring rescue medication; a key secondary endpoint was loss of IGA 0/1. Additional assessments included EASI-50/75/90 and PP-NRS-4 responses. Patient-reported outcomes, adverse events (AEs), serious AEs, discontinuations, and lab abnormalities were also monitored.
Details of these and other results, including recent post-hoc analyses of JADE REGIMEN, are provided below.
Why is it important?
JADE REGIMEN was a unique study designed to investigate the likelihood of flaring during dose reduction or withdrawal in patients aged ≥12 years with moderate-to-severe atopic dermatitis (AD) who responded to a 12-week induction therapy with abrocitinib 200 mg. Of 1233 treated patients, 798 responders entered a 40-week maintenance phase with either continued 200 mg, reduced 100 mg, or placebo.
Most patients who remained on abrocitinib maintained their response. Loss of response occurred in 16.5% (200 mg), 39.6% (100 mg), and 77.5% (placebo). Flare risk was significantly lower with abrocitinib 200 mg and 100 mg compared to placebo (p<0.0001) and also lower with 200 mg vs. 100 mg (p<0.0001). Rescue treatment with abrocitinib 200 mg plus medicated topical therapy was effective in regaining response.
These findings support continued abrocitinib 200 mg as the most effective option, however, many patients also maintained treatment response at the lower dose. During the maintenance period, treatment emergent adverse events were more frequent in the 200 mg arm. High flare rates with placebo suggest withdrawal is not recommended for most patients. Identifying predictors of sustained response may enable personalized treatment strategies.
EM-GLB-ARO-0142 | December 2025 Page published: 03-Feb-2026
