New analyses of BREEZE-AD5 phase III clinical trial data and an extended safety analysis for Olumiant across multiple trials for atopic dermatitis.

Through new analyses of BREEZE-AD5 Phase III clinical trial data and an extended safety analysis across multiple trials , Eli Lilly and Company and Incyte's Olumiant (baricitinib) 2-mg tablet taken once daily showed improvement in key measured treatment outcomes compared to placebo, and helped further characterize the long-term safety profile in adults with moderate to severe atopic dermatitis (AD). In one BREEZE-AD5 analysis, Olumiant provided concurrent improvements in the severity and extent of AD, other key symptoms and quality of life as early as one week, as measured by percent change from baseline compared to placebo. In a separate BREEZE-AD5 analysis, adults with AD on 10-50% of their bodies at baseline who were treated with Olumiant showed significant improvements in the severity and extent of disease compared to placebo. In the integrated safety analysis of eight AD studies of Olumiant, there were no increases in rates for treatment-emergent adverse events, serious adverse events or serious infections with long-term Olumiant therapy compared to the placebo-controlled period. These results are being presented virtually at the American Academy of Dermatology's Virtual Meeting Experience (AAD VMX), April 23-25, 2021. Olumiant 2-mg Concurrently Improved Extent, Severity and Key Symptoms of AD in as Early as One Week : In a post-hoc analysis of BREEZE-AD5, patients treated with Olumiant 2-mg showed statistically significant and concurrent improvements in the extent and severity of AD, as well as key symptoms such as itch, nighttime awakenings due to itch, skin discomfort and pain, and quality of life, as early as one week as measured by percent change from baseline compared to placebo. Patients taking OLumiant had statistically significant improvements from baseline (p<0.05) across all measures compared to placebo at one week and four weeks: skin measures : eczema area and severity index (easi), which is a validated, clinical scoring system measuring the extent and severity of ad: i. at one week: 25.3% for olumiant vs. 7.2% for placebo. ii. at four weeks: 50.9% for olumiant vs. 24.0% for placebo key symptoms : itch numeric rating scale (nrs) : i. at one week: 13.5% for olumiant vs. -0.2% for placebo. ii. at four weeks: 29.0% for olumiant vs. 12.5% for placebo. skin pain nrs (skin discomfort and pain) : i. at one week: 12.0% for olumiant vs. 2.6% for placebo ii.at four weeks: 27.6% for olumiant vs. 13.6% for placebo. ad sleep scale (adss) item 2 (number of nighttime awakenings due to itch) : i. at one week: 20.9% for olumiant vs. 3.9% for placebo. ii. at four weeks: 37.6% for olumiant vs. 14.1% for placebo. .composite outcomes , including quality of life : dermatology life quality index (dlqi) : i. at one week: 27.2% for olumiant vs. 12.9% for placebo ii. at four weeks: 40.4% for olumiant vs. 17.5% for placebo. patient oriented eczema measure (poem) : i. at one week: 18.0% for olumiant vs. 6.7% for placebo. ii. at four weeks: 29.3% for olumiant vs. 10.8% for placebo.>