Drugs Xagena
Eli Lilly has announced today that it will discontinue the phase 3 rheumatoid arthritis 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 rheumatoid arthritis 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 rheumatoid arthritis program. All ongoing phase 2 and phase 3 rheumatoid arthritis studies will be stopped.
BAFF ( B cell activating factor ) 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 ( MAb ) that inhibits both membrane-bound and soluble B cell activating factor ( BAFF ). ( Xagena )
Source: Eli Lilly, 2013
XagenaMedicine_2013
