Results from head-to-head, phase 3 atopic dermatitis clinical trial of systemic treatments

Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial

• Reich K, Thyssen JP, Blauvelt A, Eyerich K, Soong W, Rice ZP, et al. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial. The Lancet. 2022;400(10348):273–282.

What is JADE DARE?

As more systemic treatments are available for moderate-to-severe atopic dermatitis, determining how these agents should be sequenced in clinical practice is important.

The JADE DARE study is the first:

• head-to-head clinical trial for evaluating the efficacy and safety of abrocitinib 200 mg per day versus dupilumab
• comparison of new systemic treatments for moderate-to-severe atopic dermatitis in people on background topical therapy

Watch contributing author Professor Jacob Thyssen discuss the rationale for conducting the JADE DARE study

Randomisation, procedures, and outcomes in JADE DARE

JADE DARE was a 26-week, randomised, double-blind, double-dummy, active-controlled, parallel-treatment, phase 3 trial in people on background topical therapy (Figure 1).

In this video clip, JADE DARE investigator Professor Jacob Thyssen summarises the methods used in the study

Figure 1. Randomisation, procedures, and outcomes in JADE DARE. Dupilumab-matching placebo was administered by subcutaneous injection every 2 weeks (Day 1 to Week 26). Abrocitinib-matching placebo was administered once per day from Day 1 to Week 26.

Primary outcomes: PP-NRS4 and EASI-90

Between June 2020 to December 2020, 940 patients were screened and 727 were enrolled (n=362, abrocitinib group; n=365, dupilumab group).

Watch study author Professor Jacob Thyssen review the primary outcomes in JADE DARE, and if they were met

PP-NRS4 response (Week 2) was higher in the abrocitinib group than in the dupilumab group

Figure 2. Proportion of patients reaching a 4 point or higher improvement from baseline in PP-NRS (Week 2) (Adapted). *P=0.0008. †P<0.0001.

EASI-90 (Week 4) was higher in the abrocitinib group than in the dupilumab group

Figure 3. Proportion of patients reaching a 90% or higher improvement from baseline in EASI-90 (Week 4) (Adapted). *P=0.0008. †P<0.0001.

Treatment tolerability

Few patients had adverse events that were serious, severe, or led to study discontinuation in either treatment group. Only 2–3% of patients in each treatment group reported serious or severe TEAEs, or TEAEs leading to discontinuation. Overall, TEAEs were reported by 268 (74%) of 362 patients in the abrocitinib group, and by 239 (65%) of 365 patients in the dupilumab group.

Clinical implications of JADE DARE

In this video, JADE DARE author Professor Jacob Thyssen outlines the implications of the study for clinical practice

What factors should be considered before initiating JAK-inhibitors for atopic dermatitis? Learn Professor Jacob Thyssen’s advice in this video.

Oral abrocitinib 200 mg per day provides therapeutic benefits versus dupilumab for people with moderate-to-severe atopic dermatitis, who need systemic treatment

Watch Dr Brett King discuss the Phase III JADE programme, and efficacy results regarding abrocitinib for atopic dermatitis

Abbreviations: EASI-90, Eczema Area Severity Index; PP-NRS, Peak Pruritus Numerical Rating Scale; QD, once per day; Q2WK, every two weeks; TEAE, treatment-emergent adverse events.