Eli Lilly, Incyte's baricitinib hits main goal of Phase III rheumatoid arthritis study

Eli Lilly and Incyte announced Tuesday that a late-stage study of the experimental drug baricitinib in patients with rheumatoid arthritis (RA) met its primary endpoint of improved ACR20 response compared to placebo after 12 weeks of treatment. Baricitinib is a once-daily oral drug that selectively inhibits JAK1 and JAK2.

The RA-BEACON trial included 527 subjects with moderately-to-severely active RA who previously failed one or more tumour necrosis factor inhibitors and who were taking stable doses of conventional disease-modifying anti-rheumatic drug (DMARD) therapy. Patients in the study were randomised to treatment with one or two doses of once-daily baricitinib or placebo in addition to standard background DMARD therapy.

The proportion of baricitinib-treated patients who exhibited an ACR20 response was not disclosed. Eli Lilly spokeswoman Celeste Stanley stated that these data, as well as the percentages of patients who exhibited an ACR50 or ACR70 response, will be made public in 2015.

According to the drugmakers, the incidence of serious adverse events was similar between the baricitinib and placebo arms, although baricitinib therapy was associated with a higher rate of treatment-emergent adverse events versus placebo. Discontinuation rates were not different between the study arms. The companies indicated that data from the study will be presented at a future scientific meeting, while the results of other ongoing late-stage studies of the drug will be shared in various disclosures next year.

Eli Lilly obtained global rights to develop and commercialise baricitinib for inflammatory and autoimmune conditions as part of a collaboration forged with Incyte in 2009. Analysts estimate that the therapy may generate $673 million in revenue for Eli Lilly by 2020.

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