Eli Lilly and Company and Incyte Corporation have announced detailed data from the fourth Phase 3 study of baricitinib, RA-BEAM, at the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) annual meeting in San Francisco. The findings demonstrated statistical superiority for investigational therapy baricitinib over adalimumab after 12 weeks based on several critical measures of rheumatoid arthritis (RA) disease activity, including ACR20, ACR50 and ACR70 response rates - composite scores that represent at least a 20 percent, 50 percent and 70 percent improvement in multiple measures of RA disease activity.

Improvements in the mean number of swollen and tender joints and a reduction in pain were seen as early as week one for baricitinib versus placebo. At 52 weeks, baricitinib significantly improved all seven components of the ACR composite score compared to adalimumab, including reducing the number of tender and swollen joints, reducing patients' pain, and improving physical function.

Patient-reported outcomes, including degree of tiredness and the severity and duration of morning joint stiffness, assessed daily for the first 12 weeks of the study, were all significantly improved with baricitinib compared to adalimumab.

At week 52, structural changes in the joints, as measured by changes in the modified Total Sharp Score, were significantly improved for both baricitinib and adalimumab compared with placebo.

Lilly and Incyte previously announced that the study met its primary objective of demonstrating superiority for baricitinib versus placebo based on ACR20 response rate after 12 weeks of treatment.

"Rheumatoid arthritis is a lifelong condition, but it can be managed with treatment to help control symptoms, including joint inflammation and fatigue, to slow the progression of the disease and improve a patient's quality of life," said Peter Taylor, M.A., Ph.D., F.R.C.P., study author and Norman Collisson chair of Musculoskeletal Sciences in the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford. "These findings suggest that the once-daily oral drug baricitinib, if approved, could provide another treatment option for those with insufficient response to current therapy."

RA-BEAM was a 52-week trial of 1,305 patients who had active, moderate to severe RA, despite ongoing treatment with methotrexate. Patients were randomized to placebo once daily (n=488), baricitinib 4 mg once daily (n=487), or adalimumab 40 mg biweekly (n=330). All patients received background methotrexate. At week 24, patients taking placebo were crossed over to baricitinib.

"This is the first Phase 3 study showing that a once daily, oral treatment significantly improved clinical outcomes compared with injectable adalimumab for patients with active RA who were also receiving treatment with methotrexate," said Dr Greg van Wyk, Senior Medical Director, Lilly UK. "Lilly is committed to improving outcomes for patients living with this chronic condition."

Serious adverse event rates were similar for baricitinib compared with placebo and lower for adalimumab, while serious infection rates were similar across groups*. There were no cases of gastrointestinal perforations. One event of tuberculosis was reported, in the adalimumab group. Four deaths occurred, one in the placebo arm, two in the baricitinib arm and one in the adalimumab arm. Two potential opportunistic infections occurred in the baricitinib arm; neither were considered serious. Temporary interruptions in treatment due to adverse events occurred with similar frequency across treatment groups.

Lilly and Incyte announced top-line results in December 2014 for the first Phase 3 trial of baricitinib, RA-BEACON, in February 2015 for the second, RA-BUILD, in September 2015 for the third, RA-BEGIN and in October 2015 for the fourth, RA-BEAM. The companies will also share detailed results from the RA-BEGIN study at the American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting this year, and plan to submit additional detailed data from all four studies for presentation in scientific meetings and publication in peer-reviewed journals in 2016.

Detailed data from the long-term extension study, RA-BEYOND, will also be submitted for presentation in scientific meetings and publication in peer-reviewed journals in 2016.

About Baricitinib

Baricitinib is the only once-daily, oral, selective JAK1 and JAK2 inhibitor currently in late- stage clinical studies for inflammatory and autoimmune diseases.

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialisation of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

About Baricitinib Phase 3 Trials

Lilly and Incyte conducted four Phase 3 clinical trials of baricitinib in patients with moderately- to-severely active rheumatoid arthritis to support regulatory submission in most countries. The clinical trial program includes a wide range of patients including those who are methotrexate naïve, inadequate responders to methotrexate, inadequate responders to conventional disease- modifying anti-rheumatic drugs, or inadequate responders to TNF inhibitors. Patients completing any of the five Phase 3 studies can enroll in a long-term extension study. For additional information on this clinical trial program, please visit www.clinicaltrials.gov.