Baricitinib beneficial in head and neck AD

Conference
AAD Virtual Meeting Experience

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) [1].

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 [1]

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.

  1. Simpson EL, et al. P15059, AAD Virtual Meeting Experience, 12-14 June 2020.

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