Baricitinib shows long-term efficacy at two dosing levels in atopic dermatitis

Both a 4 mg and 2 mg dosing regimen of oral baricitinib yielded positive outcomes in patients with moderate to severe atopic dermatitis, according to a study.

Jonathan I. Silverberg, MD, of the department of dermatology at George Washington University School of Medicine, and colleagues highlighted the clinical efficacy of the oral selective Janus kinase inhibitor baricitinib in AD as assessed by the BREEZE-AD1 and BREEZE-AD2 studies.

However, because long-term efficacy of the drug had not been assessed in this population, the current analysis uses findings from the BREEZE-AD studies to assess outcomes through 68 weeks in full or partial responders to the drug.

Response was defined as validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 for responders and 2 for partial responders. Reaching a score of 0 or 1 at weeks 36, 52 and 68 of the analysis served as the primary endpoint, while key secondary measures included 75% or more improvement in the Eczema Area and Severity Index score and four-point or more improvement in the itch numeric rating scale (NRS) based on baseline data from the earlier studies.

Among 70 patients treated with 4 mg of the drug, 45.7% reached vIGA-AD of 0 or 1 at week 16, while 47.1% reached this outcome at week 68. Also in this treatment group, the EASI-75 endpoint was achieved by 70% of patients at week 16 and 55.7% at week 68. Itch NRS improvement of four points or greater was reported by 52.5% of patients at week 16 and 45.9% of those at week 32 in the 4 mg treatment arm.

Turning to outcomes for 54 patients treated with 2 mg baricitinib, vIGA-AD of 0 or 1 was reported in 46.3% at week 16 and 59.3% at week 68. EASI-75 was achieved in 74.1% of patients in this group at week 16 and 81.5% at week 68. Itch NRS improvement was observed in 44.2% of this group at week 16 and 39.5% at week 32.

“In this long-term double-blind extension study of two randomized clinical trials, baricitinib, 4 and 2 mg, demonstrated sustained long-term efficacy in patients with moderate to severe atopic dermatitis,” the researchers wrote. “Overall, these findings provide support that baricitinib may be a longer-term treatment option for patients with moderate to severe AD.”