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Lilly and Incyte's baricitinib successful in mid-stage dermatitis study

Published 09/14/2017, 09:34 AM
© Reuters.  Lilly and Incyte's baricitinib successful in mid-stage dermatitis study
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  • Eli Lilly (LLY) and development partner Incyte (INCY) announce positive results from a Phase 2 clinical trial assessing baricitinib, branded as OLUMIANT in Europe, in patients with moderate-to-severe atopic dermatitis (AD). The results were presented today at the European Academy of Dermatology and Venereology Annual Meeting in Geneva.
  • The data showed treatment with baricitinib, in combination with a mid-potency topical corticosteroid (TCS) significantly improved AD symptoms compared to TCS alone. Specifically, after 16 weeks' treatment, 61% of patients in the 4 mg baricitinib arm achieved at least a 50% reduction in symptoms (EASI-50) compared to 37% in the TCS arm (p<0.05). The proportion of patients achieving EASI-50 in the 2 mg baricitinib arm was 57%, but the treatment effect was not statistically valid (p=0.065).
  • At week 4, the proportions achieving EASI-50 favored baricitinib, 68% for 4 mg and 62% for 2 mg, compared to TCS alone (16%) (p<0.001), which was a more pronounced treatment effect than what was observed at week 16, although the trial participants were all treatment-resistant to begin with.
  • Baricitinib was approved in the EU in February and Japan in July for the treatment of adults with moderate-to-severe rheumatoid arthritis. The marketing application in the U.S. for RA should be refiled by the end of January.
  • Previously: FDA rejects Lilly's marketing application for RA candidate baricitinib (April 14)
  • Now read: Eli Lilly Offers Consistent Dividends, But Stock Shows Uneven Performance


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