Baricitinib superior to placebo in reducing rheumatoid arthritis disease activity in second Phase 3 study
Posted: 23 February 2015 | European Pharmaceutical Review
Eli Lilly and Company (LLY) and Incyte Corporation (INCY) today announce that the investigational medicine baricitinib demonstrated a statistically significant improvement compared to placebo in a second consecutive Phase 3 trial in rheumatoid arthritis (RA). The RA-BUILD study included patients with moderately-to-severely active rheumatoid arthritis who had an inadequate response to, or were intolerant of, at least one conventional disease-modifying antirheumatic drug (cDMARD). The study met its primary endpoint of an improved ACR20 response rate compared to placebo after 12 weeks of treatment.
“We are encouraged that baricitinib demonstrated statistically significant improvement in rheumatoid arthritis disease activity compared to placebo, now in a second pivotal study,” said David Ricks, Lilly senior vice president, and president of Lilly Bio-Medicines.
Part of an extensive Phase 3 program testing baricitinib in more than 3,000 patients at different stages along the RA treatment continuum, the RA-BUILD study enrolled 684 patients with rheumatoid arthritis who previously had an inadequate response to, or were intolerant of, at least one cDMARD and had not received a biologic disease-modifying antirheumatic drug (bDMARD). Patients received either one of two doses of once-daily baricitinib or placebo, in addition to their background therapy.
“Despite treatment advances, many people with RA continue to experience active disease, including pain, joint stiffness, disability and progressive joint damage,” said Rich Levy, M.D., chief drug development and medical officer, Incyte Corporation. “These results suggest that baricitinib could provide an additional treatment option for patients who are not responding to conventional drugs.”
In RA-BUILD, the incidence of treatment-emergent adverse events and serious adverse events with baricitinib treatment, including serious infections, was similar to placebo. There were no opportunistic infections or gastrointestinal perforations in the study. A single case of tuberculosis was reported in a patient receiving baricitinib. The most common adverse events observed were consistent with previous studies of baricitinib in RA. Discontinuation rates due to adverse events were similar between treatment groups. A large majority of patients completing this 6-month trial opted to participate in a long-term extension study.
Lilly and Incyte announced top-line results from the first Phase 3 trial of baricitinib, RA-BEACON, which also met its primary endpoint, in December 2014 and plan to present detailed data from both RA-BEACON and RA-BUILD at scientific meetings in 2015.
