Eli lilly

Eli Lilly and Company has announced the termination of one of three Phase III rheumatoid arthritis (RA) registration studies, FLEX-M, for tabalumab.

The anti-BAFF monoclonal antibody failed to meet the efficacy expectations in an interim futility analysis of the multicentre, randomised, double-blind study.

Lilly autoimmune product development vice president Dr Eiry Roberts said the study results were unexpected compared to earlier results from Phase II clinical studies of tabalumab.

"We remain committed to patients with rheumatoid arthritis and lupus and will move rapidly to evaluate the impact of these data on the overall tabalumab clinical development programme," Roberts said.

"Beyond tabalumab, Lilly will continue to develop additional treatment options for patients with autoimmune diseases."

A planned interim futility analysis of FLEX-M evaluating tabalumab to treat RA patients with inadequate response to methotrexate therapy formed the basis for the termination of the trial, which was not due to safety concerns.

FLEX-M was designed to support tabalumab registration as a potential treatment for RA, including an evaluation of its effect on structural progression.

According to Eli Lilly, patients presently enrolled in other tabalumab RA studies will continue treatment and the evaluation of the candidate in two other Phase III RA registration studies, an open-label extension study and several other smaller studies will continue.

Lilly is keeping the enrolment of the new patients on hold until additional analysis from other ongoing RA studies is completed in early 2013.

Image: Eli Lilly has discontinued one of three Phase III rheumatoid arthritis registration studies for tabalumab. Photo: Courtesy of Guanaco152003.