Scheinberg M.A.,Clinical Research Division Hospital |
Srinivasan D.,Anthera Pharmaceuticals |
Martin R.S.,Anthera Pharmaceuticals
International Journal of Clinical Rheumatology | Year: 2014
In the last 50 years, only one drug has achieved marketing approval for treatment of systemic lupus erythematosus (SLE) by global regulatory authorities. This drug, belimumab, is a monoclonal antibody that binds to and inhibits BAFF. Blisibimod is a 'peptibody' consisting of four BAFF-binding domains fused to the Fc domain of human IgG1, and is structurally distinct from the anti-BAFF monoclonal antibodies such as belimumab and tabalumab. Compared with tabalumab and belimumab, blisibimod's binding affinity for BAFF (1 pM) is 126-250-fold higher, while its serum half-life (8-10 days) is approximately half as long. Completed Phase I and Phase II clinical trials with blisibimod provide the first evidence that subcutaneous administration of a biologic therapeutic may lead to improvements in SLE disease activity, as well as disease-associated pharmacodynamic markers, including peripheral B cells, autoantibodies and decreased complement consumption. Furthermore, the effect to significantly decrease the urinary protein:creatinine ratio suggests that blisibimod may have therapeutic potential beyond SLE in patients with mechanistically analogous autoimmune renal damage, such as lupus nephritis and IgA nephropathy. © 2014 Future Medicine Ltd.