Baricitinib possible therapeutic option for children with AD

Baricitinib led to clear or almost clear skin in over 40% of participants in the BREEZE-AD-PEDS trial. Children and adolescents with atopic dermatitis (AD) were treated at different dosages of the JAK inhibitor and the high-dose group met the primary endpoint at week 16.

Baricitinib, a JAK inhibitor, has been approved in several countries for the treatment of AD in adult patients and its efficacy has been proven in different studies. “Therefore, it is mandatory to know if this drug is also effective in children and adolescents,” stated Dr Antonio Torrelo Fernández (Hospital Infantil Universitario Niño Jesús, Spain) [1]. The phase 3, randomised, placebo-controlled BREEZE-AD-PEDS trial (NCT03952559) randomised 483 patients aged 2 to 18 years to receive baricitinib either at a low, medium, or high dose, or placebo. Dose regimens were adjusted for participants aged <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 validated Investigator’s Global Assessment (vIGA) score of clear or almost clear skin (0/1) with at least 2 points improvement from baseline marked the primary endpoint at week 16. To be included, patients 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 Torrelo Fernández underlined that the 4 study arms were similar in 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.

In the high-dose baricitinib group, 41.7% reached the primary endpoint at week 16, significantly more than the placebo group (16.4%; P<0.001; see Figure). For the secondary endpoints Eczema Area and Severity Index (EASI)-75 and EASI-90, significant difference was similarly present in the high-dose arm, with 52.6% and 30% responders, respectively (P<0.01). Dr Torrelo Fernández further highlighted that 35.5% of the patients on 2 mg/4 mg of baricitinib had a ≥4-point reduction in the itch numeric rating scale (P<0.05). Dr Torrelo Fernández stated that the vIGA results were consistent in subgroups according to age <10 or ≥10 years and across 3 different weight groups. Of note, there was a very high study adherence with 96.7% of participants completing week 16.

Figure: Percentage responders with vIGA-AD(0/1) with ≥2 points improvement [1]

*, P<0.05; **, P<0.01; ***, P<0.001; †, statistically significant with multiplicity adjustment; NRI, non-responder imputation.

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

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

1. Torello F. 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.

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Posted on 5 November, 20225 November, 2022