Baricitinib demonstrates superiority to placebo for RA disease activity reduction

Eli Lilly and Company and partner developer, Incyte Corp., announced that patients with rheumatoid responded to treatment with baricitinib compared with placebo in a second phase 3 study.

The study comprised 684 patients with rheumatoid arthritis (RA) who previously did not respond to conventional disease-modifying anti-rheumatic drugs (DMARDs) and had not received a biologic DMARD. The patients were part of a larger trial of more than 3,000 patients at different stages of the disease. Patients received one of two doses of baricitinib once daily or placebo in addition to their background therapy. After 12 weeks, the study met its primary endpoint of American College of Rheumatology 20% improvement in disease activity criteria, according to a press release.

“We are encouraged that baricitinib demonstrated statistically significant improvement in rheumatoid arthritis disease activity compared with placebo, now in a second pivotal study,” David A. Ricks, Lilly senior vice president and president of Lilly Bio-Medicines, said in the release.

The incidence of adverse effects were reported to be similar to placebo, with no opportunistic infections or gastric perforations present in those who were treated with baricitinib.

“Despite treatment advances, many people with RA continue to experience active disease, including pain, joint stiffness, disability and progressive joint damage,” Richard S. Levy, MD, chief drug development and medical officer for Incyte Corporation, said in the release. “These results suggest that baricitinib could provide an additional treatment option for patients who are not responding to conventional drugs.”

The companies plan to present more detailed data from the two studies, RA-BEACON and RA-BUILD, at conferences later in the year, according to the release.

Reference: www.lilly.com.