Baricitinib: a possible treatment option for children with AD?

Children treated with various baricitinib dosages for atopic dermatitis showed significant amelioration with high dose in the BREEZE-AD-PEDS study.

Patients had a history of inadequate or intolerant response to topical treatment

In the phase 3 BREEZE-AD-PEDS trial (NCT03952559), 483 patients aged 2 to <18 years were randomised to 4 study arms, receiving baricitinib either at a low, medium, or high dose, or placebo1. Dose regimens were adjusted to <10 years or 10 to <18 years, with daily 0.5 mg/1 mg, 1 mg/2 mg, or 2 mg/4 mg baricitinib. A vIGA of clear or almost clear (0/1) score with at least 2-point improvement from baseline, marked the primary endpoint at week 16. To be included, the patient needed to have moderate-to-severe AD with a history of inadequate response or intolerance of topical treatment plus a disease duration of at least 6 or 12 months, depending on age.   

Dr Antonio Torrelo (Hospital Infantil Universitario Niño Jesús, Spain) underlined that the 4 study arms were similar with regard to age, gender, race, and geographical region. The mean age was around 12 years and the mean duration of AD was at least 9 years. Participants with vIGA 4 made up between 37.5% and 39.3% of the participants, all other participants had vIGA 3.

A favourable benefit-risk profile for children between 2 and 18 years

In the high-dose baricitinib group, 41.7% reached the primary endpoint at week 16, significantly more than on placebo (16.4%; P<0.001). For the secondary endpoints of Eczema Area and Severity Index (EASI)75 and EASI90, significance was similarly present in the high dose arm, with rates of 52.6% and 30% responders, respectively (P<0.01). Dr Torrelo further highlighted that 35.5% of the children on 2 mg/4 mg of baricitinib had an ≥ 4-point reduction in the itch numeric rating scale (P<0.05).

Any treatment-emergent adverse event happened in 50% of the low dose and placebo group, 52.5% in the medium arm, and 50.8% in the high dose arm. “The severity was low, mild, or moderate in most of the cases and severe adverse effects were reported very seldom,” Dr Torrelo stated. Most common were headache, acne, abdominal pain, and nasopharyngitis. “But you can see again that these adverse effects were similarly seen in all 4 groups,” Dr Torrelo stressed.

In summary, baricitinib was assessed as a potential therapeutic option with a favourable benefit-risk profile for children between 2 and 18 years, who have moderate-to-severe atopic dermatitis, and who are candidates for systemic therapy.

  1. Torello A. Efficacy and safety of baricitinib in a phase 3, randomised, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe atopic dermatitis. D3T01.1E, EADV Congress 2022, Milan, Italy, 7–10 September.