April 15, 2019Dermatology
Congratulations to our friends and colleagues at Eli Lilly and Company.
Atopic dermatitis (AD), also known as eczema, is a chronic, non-contagious inflammatory skin condition characterized by dry, itchy skin that can weep clear fluid when scratched. People with eczema also may be particularly susceptible to bacterial, viral, and fungal skin infections. AD affects an estimated 30% of the U.S. population, mostly children and adolescents.
According to an article published in the Journal of the American Academy of Dermatology (April 2019), the efficacy and safety of baricitinib, an oral selective inhibitor of Janus kinase 1 and Janus kinase 2, were evaluated in patients with moderate-to-severe AD. Janus kinase 1 and Janus kinase 2 modulate proinflammatory cytokine signaling,
The phase 2 study was a randomized, double-blind, placebo-controlled study, with 124 patients with moderate-to-severe AD. Prior to randomization to once-daily placebo, 2 mg of baricitinib, or 4 mg of baricitinib for 16 weeks, all study subjects applied topical corticosteroids (TCSs) for 4 weeks. Use of TCSs was also permitted during the study. The primary outcome was the proportion of patients achieving at least a 50% reduction in the Eczema Area and Severity Index (EASI-50) compared with placebo.
Study results showed that at 16 weeks, significantly more patients who received baricitinib, 4 mg, achieved EASI-50 than did patients receiving placebo (61% vs 37%; P = .027). The difference between the proportion of patients receiving baricitinib, 2 or 4 mg, who achieved EASI-50 and the proportion of patients receiving placebo and achieving EASI-50 was significant as early as week 4. Baricitinib also improved pruritus and sleep loss. Treatment-emergent adverse events were reported in 24 of the patients receiving placebo (49%), 17 of those receiving 2 mg of baricitinib (46%), and 27 of those receiving 4 mg of baricitinib (71%).
According to the authors, that while baricitinib use with TCSs reduced inflammation and pruritus in patients with moderate-to-severe AD, a TCS standardization period before randomization reduced disease severity, thus limiting the ability to compare results with those of baricitinib monotherapy. The authors added that longer studies are required to confirm baricitinib's efficacy and safety in patients with AD.
As a followup, on 4 February 2019, Eli Lilly and Company and Incyte Corporation announced today that baricitinib met the primary endpoint in BREEZE-AD1 and BREEZE-AD2, two Phase 3 studies evaluating the efficacy and safety of baricitinib monotherapy for the treatment of adult patients with moderate to severe AD. In both investigational trials, compared to patients treated with placebo, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint at Week 16 defined by the Investigator's Global Assessment for AD (IGA) score of clear or almost clear (IGA 0,1). These are two of five studies that will be part of the placebo-controlled data program intended to support global registrations.