Baricitinib ‘potential therapeutic option’ for moderate to severe atopic dermatitis

Key takeaways:

• Baricitinib 4 mg bested placebo in terms of vIGA-AD 0/1 and EASI response in patients with moderate to severe AD.
• The overall adverse event rate for treatment with baricitinib was 0.6%.

A 4 mg dose of baricitinib was associated with significant improvement over placebo in a number of efficacy parameters in patients with moderate to severe atopic dermatitis, according to a study.

“Baricitinib, an oral selective Janus kinase (JAK)1/JAK2 inhibitor, is approved in many countries for moderate-to-severe atopic dermatitis (AD) in adult patients who are candidates for systemic therapy,” Antonio Torrelo, MD, of the department of dermatology at Hospital Infantil Universitario Niño Jesús, in Madrid, Spain, and colleagues wrote.

The study included 483 patients aged 2 to younger than 18 years who were randomly assigned 1:1:1:1 to one of three dosing regimens of baricitinib — 1 mg, 2 mg or 4 mg — or placebo for 16 weeks.

At week 16, patients were assessed using the validated IGA for atopic dermatitis (vIGA-AD). A score of 0/1 with a 2-point or greater improvement at week 16 served as the primary efficacy endpoint.

Regarding secondary outcomes, the proportion of patients reaching a 75% and 90% improvement as assessed by EASI was one other efficacy measure used. Other secondary outcomes included 75% improvement in the SCORing Atopic Dermatitis, the mean change from baseline in EASI score and the proportion of patients who demonstrated a 4-point improvement according to the Itch Numeric Rating Scale for patients aged at least 10 years.

Results at 16 weeks showed that the 4 mg baricitinib dose was associated with a significant improvement over placebo in terms of vIGA-AD 0/1 with an at least 2-point improvement and all secondary endpoints (P < .05 for all). The other baricitinib doses did not reach significance in primary or secondary endpoints compared with placebo.

Results of a non-multiplicity adjusted analysis showed that the 4 mg dose also yielded significant benefit over placebo in the ability to fall asleep and reduction in use of topical corticosteroids (P < .05 for both).

Discontinuations due to adverse events occurred in 1.6% of patients in the placebo group and 0.6% of those treated with any baricitinib dose. There were similar rates of about 50% for treatment-emergent adverse events in both groups, and most were considered mild or moderate, according to the researchers.

No fatalities were reported. The researchers did not observe venous thromboembolic events, arterial thrombotic events, major adverse cardiovascular events, malignancies, gastrointestinal perforations or opportunistic infections, according to the findings.

“Study results indicate that baricitinib offers a potential therapeutic option with a favorable benefit-risk profile for pediatric patients with moderate to severe AD who are candidates for systemic therapies,” Torrelo and colleagues concluded.