Eli Lilly to discontinue Phase III RA program based on efficacy results

Eli Lilly and Company, a pharmaceutical company, has announced that it will discontinue the Phase III rheumatoid arthritis, or RA, program for tabalumab, an anti-BAFF monoclonal antibody, due to lack of efficacy.

According to the company, the decision was not based on safety concerns. The tabalumab Phase III program for systemic lupus erythematosus, ILLUMINATE, is ongoing and will continue as planned.

In December 2012, Lilly discontinued the Phase III RA registration study FLEX-M for lack of treatment effect. FLEX-M was investigating tabalumab in patients with moderate-to-severe RA who had an inadequate response to methotrexate therapy.

Based on FLEX-M findings, an interim futility analysis was conducted of the FLEX-V study, which was investigating tabalumab for the treatment of patients with moderate-to-severe RA who had an inadequate response to one or more tumor necrosis factor (TNF) inhibitors.

Based on the outcomes of these two separate interim futility analyses, Lilly has decided to discontinue development of tabalumab in the current RA program. All ongoing Phase II and Phase III RA studies will be stopped.

"While we are obviously disappointed by these results in rheumatoid arthritis, we continue to believe that tabalumab could have significant potential for patients in other disease areas," said Eiry Roberts, M.D., vice president of autoimmune product development at Lilly. "Autoimmune disorders are highly individualized. We believe that targeting BAFF with a molecule such as tabalumab may still represent an important advance for patients, and therefore we will continue the ongoing Phase III tabalumab lupus program."