Eli Lilly has announced that it will discontinue the phase 3 rheumatoid arthritis ( RA ) program for Tabalumab, an anti-BAFF ( B cell activating factor ) monoclonal antibody, due to lack of efficacy. The decision was not based on safety concerns.
The Tabalumab phase 3 program for systemic lupus erythematosus, ILLUMINATE, is ongoing and will continue as planned.
In December 2012, Lilly discontinued the phase 3 RA registration study FLEX-M for lack of treatment effect. FLEX-M was investigating Tabalumab in patients with moderate-to-severe rheumatoid arthritis 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 rheumatoid arthritis 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 2 and Phase 3 RA studies will be stopped.
BAFF is a cytokine that promotes B cell survival, proliferation and activation. In the presence of excess BAFF, B cells, including autoreactive B cells, are not appropriately eliminated by the immune system and may therefore contribute to the development of rheumatoid arthritis by producing autoantibodies and proinflammatory cytokines and helping autoreactive T cells. BAFF exists in both membrane-bound and soluble forms.
Tabalumab is a human immunoglobulin G subclass 4 ( IgG4 ) monoclonal antibody that inhibits both membrane-bound and soluble B cell activating factor. ( Xagena )
Source: Lilly, 2013