JADE DARE is the first head-to-head clinical trial designed to assess the efficacy and safety of abrocitinib 200mg per day versus dupilumab 300 mg every two weeks in adults with moderate-to-severe-atopic dermatitis. It is also the first comparative trial of a JAK inhibitor versus dupilumab for moderate to severe atopic dermatitis in patients receiving background topical therapy, which reflects real world practice.¹ 

Study design¹

Randomised, double-blind, double-dummy, active-controlled, head-to-head phase III trial that compared the efficacy and safety of Cibinqo 200 mg + TCS vs dupilumab TCS in 727 adult patient with moderate-to-severe AD.
 

*TCS includes low - to medium-potency topical corticosteriods and other medicated topicals, which were required per study protocol. Non-medicated topicals were also required. Participants with intolerable AD symptoms were eligible to receive rescue therapy after Week 4, which indcluded high-potency TCS for up to 2 weeks, systemic corticosteriods for up to 10 days, or other systemic therapy. ^1
†Patients randomised to dupilumab received a loading dose of 600mg. ¹

• PP-NRS4 response at week 2 vs dupilumab
• EASI-90 response at week 4 vs dupilumab

• EASI-90 at week 16 vs dupilumab

PP-NRS4 response defined as ≥4- point improvement from Baseline;EASI-90 response defined as ≥90% improvement from baseline.

PP-NRS4 response at week 2 vs dupilumab (primary endpoint):

• A significant greater proportion of patients treated with abrocitinib 200 mg + TCS achieved a PP-NRS4 compared to dupilumab + TCS at week 2 (48% vs 26%)¹
• The difference between the abrocitnib + TCS and dupilumab + TCS groups was 22.6% (95% confidence interval (CI) 15.8%-29.5%; P<0.0001)¹

^{Adapted from Reich K, et al. Lancet 2022;400:273-282}
Patient who withdrew from the study or used rescure therapy were considered as non-responders after that point. Intermittent imssing values were not imputed. Error bars represent 95% CIs.^1
†TCS: Includes low - to medium-potency topical corticosteriods and other medicated topicals, which were required per study protocol.¹

The figure below depicts the percentage of patients who achieved an EASI-90 response, defined as ≥90% improvement in EASI scores from baselins through week 26 for each of the treatment groups.¹
 

Figure 1 - Proportion of patient achieving EASI 90 from baseline

^{Adapted from Reich K, et al. Lancet 2022;400:273-282}
†TCS: includes low - to medium-potency topical corticosteriods and other medicated topicals, which were required per study protocol. Non-medicated topicals were also required.¹

At week 4 (primary endpoint):

• ​​​​​​A signifcantly higher proportion of patients treated with abrocitinib 200 mg + TCS achieved EASI-90 response versus dupilumab 300 mg +TCS at week 4 (29% vs 15%)¹
• The difference between groups of 14.1% (95% CI 8.2%-20.0%; P<0.0001)¹

• A significantly higher proportion of patients treated with abrocitinib 200 mg + TCS achieved EASI-90 response versus dupilumab 300 mg +TCS at week 16 (54% vs 42%)¹
• The difference between groups was 12.5% (95% CI 5.3%-19.7%), which achieved both noninferiority (lower bound of the 95% CI interval greater than -10%) and superiority  (P=0.0008)¹

a.Includes events that lead to death or serious deterioration in the participant's health, or to distress or death of a foetus or a congenital abnormality or birth defect.
b.Includes events that prevent normal everyday activites.
c.Includes events classified as acne pustular, folliculitis, acne, and dermatitis acneiform.
d.Includes events classified as allergic keratitis, conjunctival haemorrhage, conjunctivitis allergic, keratisis, noninfective conjunctivitis, ocular hyperaemia, conjunctivities, conjunctivities bacterial and conjunctivties viral.