Blisibimod was initially developed by
Amgen, with
Phase I trials demonstrating comparable safety between the blisibimod and
placebo treatments.[1] It was subsequently acquired by Anthera Pharmaceuticals,[13] who in 2010 initiated a global
Phase II study called PEARL-SC to investigate the efficacy, safety, and tolerability of blisibimod in subjects with systemic lupus erythematosus.[2][14] The PEARL-SC study, completed in April 2012, yielded data that has been published.[15] Blisibimod is currently being tested in a Phase 3 study, CHABLIS-SC1, for systemic lupus erythematosus, and a Phase 2 study, BRIGHT-SC, for
IgA nephropathy.
^
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^Petri M, Stohl W, Chatham W, McCune WJ, Chevrier M, Ryel J, et al. (August 2008). "Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus". Arthritis and Rheumatism. 58 (8): 2453–2459.
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^
abFabris M, Grimaldi F, Villalta D, Picierno A, Fabro C, Bolzan M, et al. (January 2010). "BLyS and April serum levels in patients with autoimmune thyroid diseases". Autoimmunity Reviews. 9 (3): 165–169.
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^Navarra SV, Guzmán RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, et al. (February 2011). "Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial". Lancet. 377 (9767): 721–731.
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^Clinical trial number NCT01162681 for "PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus" at
ClinicalTrials.gov
^Furie RA, Leon G, Thomas M, Petri MA, Chu AD, Hislop C, et al. (September 2015). "A phase 2, randomised, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus, the PEARL-SC study". Annals of the Rheumatic Diseases. 74 (9): 1667–1675.
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