title: Blisibimod for treatment of systemic lupus erythematosus: with trials you become wiser.
abstract: BACKGROUND
  Blisibimod is a potent and selective inhibitor of B cell activating factor (BAFF), a mediator of differentiation, maturation and survival of B cells. It has a unique tetravalent, 'peptibody' structure and resulting high potency, and is currently in clinical evaluation for the treatment of SLE. The importance of BAFF in the pathogenesis of systemic lupus erythematosus (SLE) is under intense investigation. The anti BAFF monoclonal antibody belimumab was approved by the FDA for the treatment of SLE.
  
  
  METHODS
  The general properties of blisibimod are reviewed including pharmacokinetic and pharmacodynamic properties in patients with SLE, efficacy and safety in the phase 2 PEARL-SC and open-label extension trials, and the focus in the ongoing phase 3 trial (CHABLIS-SC1) on the hypothesized 'responder' population. In addition, the rationale for evaluating blisibimod in patients with IgA nephropathy, a common nephritic disease for which there is no approved therapy, is presented.
  
  
  CONCLUSIONS
  Blisibimod's unique tetravalent, peptibody structure and resulting high potency, and the deliberate focus of the Phase 3 clinical development program on the 'responder populations' identified in completed trials in SLE raise the possibility that blisibimod will become an important medication for treatment of SLE and IgA nephropathy.
authors.affiliation: a Clinical Research Center Hospital Abreu Sodre , Rheumatology Hospital Albert Einstein , São Paulo , Brazil.
authors.forename: Morton A
authors.initials: MA
authors.lastname: Scheinberg
authors.affiliation: b Clinical Development , Anthera Pharmaceuticals Inc , Hayward , CA , USA.
authors.forename: Colin M
authors.initials: CM
authors.lastname: Hislop
authors.affiliation: b Clinical Development , Anthera Pharmaceuticals Inc , Hayward , CA , USA.
authors.forename: Renee S
authors.initials: RS
authors.lastname: Martin
mesh_terms: D053264:B-Cell Activating Factor / Q000037:antagonists & inhibitors; D002986:Clinical Trials as Topic; D005922:Glomerulonephritis, IGA / Q000188:drug therapy; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D011993:Recombinant Fusion Proteins / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: C573858:AMG623 peptibody; D053264:B-Cell Activating Factor; D011993:Recombinant Fusion Proteins
keywords: B lymphocyte; BAFF; IgA nephropathy; systemic lupus erythematosus