Fall Clinical Dermatology 2020: Lilly + Incyte provide positive new data for baricitinib in adult patients with alopecia areata.

Eli Lilly and Company and Incyte announced new data for baricitinib ( Olumiant) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020 . The data underscore Lilly's commitment to providing medicines for dermatologic diseases that have high unmet need, including alopecia areata (AA). AA is an autoimmune disorder that can cause unpredictable hair loss on the scalp, face and other areas of the body. Data from the Phase II portion of BRAVE-AA1 , an ongoing Phase II/III study evaluating the safety and efficacy of baricitinib in adult patients with AA will be shared. The study included adult patients with a current episode of AA lasting for 6 months to 8 years with a Severity of Alopecia Tool (SALT) score greater than 50 (i.e. who had greater than 50% scalp hair loss) and no spontaneous improvement over six months prior to screening. In the Phase II portion, patients were randomized to oral baricitinib 1-mg, 2-mg, 4-mg or placebo once daily, in order to identify up to two doses for the Phase III portion. Interim analyses were conducted after patients completed 12 and 36 weeks of treatment, the latter for the primary endpoint of the Phase II part of the study. At Week 36, the proportion of patients achieving the primary endpoint of SALT less than 20 defined as having 20% or less of scalp hair loss and considered as clinically meaningful improvement, was significantly greater in baricitinib 2-mg (33.3%, p=0.016), and 4-mg (51.9%, p=0.001) groups compared to placebo (3.6%). Based on the interim results of the Phase II part of the study, the Phase III portion of BRAVE-AA1 and an additional Phase III trial (BRAVE-AA2) were initiated and are ongoing to assess the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo. The proportion of adult patients achieving no hair loss or limited hair loss on the patient-reported outcomes (PRO) for scalp hair assessment were significantly greater in the 2-mg and 4-mg groups compared to placebo (p<0.05) by week 36. similarly, patients receiving the 4-mg dose of baricitinib improved growth of eyebrows and eyelashes as assessed by the clinician-reported outcome and pro measures (p><0.05 versus placebo). in the phase ii portion, the most common adverse event was upper respiratory tract infection which occurred in 17.9%, 11.1% and 22.2% of patients in placebo, 2-mg and 4-mg groups, respectively. no serious adverse events, deaths, thrombotic events or new safety concerns were reported.>