eli lilly

Eli Lilly and Company and Incyte have reported 12-week results from a Phase 2b study of baricitinib in patients with active rheumatoid arthritis.

Baricitinib, formerly LY3009104 (INCB28050), is an orally administered selective JAK1 and JAK2 inhibitor that is JAK3-sparing.

In the Phase 2b double-blind study, 301 patients with active RA on stable doses of methotrexate were randomised to receive either placebo or one of four once-daily doses of baricitinib (1mg, 2mg, 4mg or 8mg) for 12 weeks.

The study demonstrated a statistically significant difference in the American College of Rheumatology 20 (ACR20) response between the combined 4mg and 8mg baricitinib groups (76%) compared with placebo (41%) after 12 weeks of treatment, thereby reaching the primary endpoint.

The placebo-controlled dose-ranging study reported that a statistically significant improvement was observed at the first assessment point after two weeks of treatment and was sustained through week 12.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

With the 1mg, 4mg and 8mg dose groups compared with placebo, a statistically significant difference in response for the ACR20, ACR50 and ACR70 secondary endpoints was observed.

Infections, with a similar rate observed among patients in the placebo group (12%) and patients receiving baricitinib (14%), were the most common treatment-emergent adverse event class reported.

Seven serious adverse events were reported in six patients (two events in the placebo group, four in the 2mg group and one in the 8mg group), according to the study data.

With greater changes being observed in the 8mg baricitinib group, dose-dependent changes in laboratory tests such as haemoglobin, neutrophil, serum creatinine, LDL and HDL were observed.

Image: Eli Lilly and Company’s global headquarters, in Indiana, US. Photo courtesy of: Guanaco152003.