New data from a pooled analysis of phase 3 trials demonstrated substantial efficacy of JAK-inhibition with baricitinib for head and neck lesions in atopic dermatitis (AD) .
The oral JAK1/JAK2 inhibitor baricitinib has already proven its efficacy versus placebo in treating moderate-to-severe AD in the identical, double-blind, randomised, controlled, phase 3 BREEZE-AD1 and BREEZE-AD2 trials. Patients with AD often experience affection of head and neck as particularly inconvenient, resulting in a negative impact on their quality of life. Yet, AD in these locations is difficult to treat.
Thus, pooled data from over 1,200 patients in BREEZE-AD1 and BREEZE-AD2 was used to assess efficacy of baricitinib on head and neck AD. The trial included adult patients with a history of moderate-to-severe AD for ≥12 months. They all had inadequate response to at least 1 topical treatment within the last 6 months or had shown intolerance to this therapy. Depending on earlier use of topical or systemic treatment, there was a washout period of 2-4 weeks prior to the trial. Topical steroids were only allowed as rescue therapy. Median age of the participants was 33 years, 38% were female, and 98.1% of the study participants had head and/or neck involvement.
Figure: EASI 50/75 response rates in the intention-to-treat population 
BARI, baricitinib; EASI, Eczema Area and Severity Index; PBO, placebo.
*P<0.05, **P<0.01, ***P<0.001 versus placebo.
Patients were randomised to 4 groups 2:1:1:1 receiving either placebo, or baricitinib at doses of 1 mg (BARI 1 mg), 2 mg (BARI 2 mg), or 4 mg (BARI 4 mg) per day over 16 weeks. Percentage change in Eczema Area and Severity Index (EASI) (in the intention-to-treat population) and EASI 50 and EASI 75 responders were assessed by mixed model repeated measure and logistic regression (See Figure). At baseline, the mean EASI subscore for head/neck was 31.7, head/neck EASI for erythema 2.3.
The investigators found significant amelioration rates in the head/neck area compared with placebo already after 1 week with 5.3% (placebo), 18.2% (BARI 2 mg), and 23.0% (BARI 4 mg). Corresponding improvement for the overall EASI were 8.9%, 24.1%, and 28.6% (P<0.001 for each BARI group vs placebo). At week 16, an improvement of the EASI by 50% (EASI 50) for head/neck was reached by 25.6% and 31.9% In the BARI 2 mg and BARI 4 mg groups versus 13.8% in the placebo group (P<0.001 for both dosages of baricitinib). An EASI 75 head/neck erythema response could be observed as early as week 2 in the BARI 2 mg and BARI 4 mg groups with significant test results compared with placebo (P≤0.05). There was no new or unexpected safety profile. All in all, baricitinib was effective in reducing the severity of AD involvement in the head and neck region.
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- Simpson EL, et al. P15059, AAD Virtual Meeting Experience, 12-14 June 2020.