Date: 2017-09-14
Type of
information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the European Academy of Dermatology and Venereology (EADV) Annual Meeting
Company: Eli Lilly (USA - IN) Incyte Corporation (USA - DE)
Product: baricitinib (LY3009104)
Action
mechanism:
- kinase inhibitor/tyrosine kinase inhibitor/janus kinase inhibitor. Baricitinib is a once daily, oral, selective JAK1 and JAK2 inhibitor. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions. Baricitinib demonstrates approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than JAK 3 in kinase assays.
- In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
- Baricitinib was approved in February 2017 for the treatment of adults with moderate-to-severe-active rheumatoid arthritis in the European Union.
Disease: moderate-to-severe atopic dermatitis
Therapeutic
area: Dermatological diseases - Inflammatory diseases
Country:
Trial
details:
Latest
news:
- • On September 14, 2017, Eli Lilly and Incyte announced new safety and efficacy data from a Phase 2 study of baricitinib in people with moderate-to-severe atopic dermatitis. The results showed that baricitinib in combination with a mid-potency topical corticosteroid significantly improved the signs and symptoms of atopic dermatitis compared to topical corticosteroid alone. The results were presented in an oral presentation at the European Academy of Dermatology and Venereology (EADV) Annual Meeting.
After 16 weeks of treatment, 61 percent of patients treated with 4-mg of baricitinib in combination with topical corticosteroid (n=38) achieved a 50 percent or greater reduction in their overall disease severity as measured by the Eczema Area and Severity Index (EASI-50), compared to 37 percent of patients treated with topical corticosteroid alone (n=49), (p<0.05). Among patients treated with 2-mg of baricitinib in combination with topical corticosteroid (n=37), 57 percent achieved EASI-50, although these results were not statistically different compared to treatment with topical corticosteroid alone (p=0.065). At four weeks, 68 percent of patients treated with 4-mg baricitinib in combination with topical corticosteroid and 62 percent of patients treated with 2-mg of baricitinib in combination with TCS achieved EASI-50, compared to 16 percent of patients treated with TCS alone (p<0.001).
During the treatment period, treatment-emergent adverse events (TEAE) occurred in 49 percent of patients treated with topical corticosteroid, 46 percent and 71 percent of the 2-mg and 4-mg baricitinib in combination with topical corticosteroid groups, respectively. The most common TEAEs in the 4-mg baricitinib in combination with topical corticosteroid group were upper respiratory tract infections and nasopharyngitis, headache, and increases in asymptomatic laboratory changes, namely increases in creatine phosphokinase.
Based on these data, Eli Lilly plans to initiate a Phase 3 clinical program for atopic dermatitis later this year.
Is
general: Yes
