Belimumab In Prevention of LN

Exclusion Criteria

• •\-- Patients with previous kidney involvement were excluded;
• •Definition of previous kidney involvement:
• •Kidney biopsy confirmed; or
• •Active urinary sediment defined as any one of the following:
• •A. \>5 RBC/hpf in the absence of menses and infection; B. \>5 White blood cell per high powered field (WBC/hpf) in the absence of infection; or Cellular casts limited to RBC or WBC casts.
• •C. 24-hour urine protein \> 0.5g
• •Severe active lupus such as neuropsychiatric lupus or cardiac involvement were excluded from the trial;
• •Pregnancy or lactation;
• •Previous treatment with any B-lymphocyte-targeted drug (including rituximab), intravenous cyclophosphamide within 6 months of enrolment, and intravenous Ig or prednisone (\>100 mg/day) within 3 months.
• •Hepatic (ALT or AST \> 2 times upper normal limits) or renal dysfunction (creatinine clearance rate \< 60 ml/min).
• •Have a history of a primary immunodeficiency
• •Have a significant IgG deficiency (IgG level \< 400 mg/dL)
• •Have an IgA deficiency (IgA level \< 10 mg/dL)
• •Infection history:
• •* Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)
• •* Hospitalization for treatment of infection within 60 days of Day 0.
• •* Use of parenteral (IV or IM) antibiotics (anti-bacterial, antiviral, anti-Fungal, or anti-parasitic agents) within 60 days of Day 0
• •* Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb
• •* Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies
• •* Have a historically positive HIV test or test positive at screening for HIV
• •* Have any other clinically significant abnormal laboratory value in the opinion of the investigator
• •* Have any intercurrent significant medical or psychiatric illness that the investigator considers would make the candidate unsuitable for the study
• •* Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to Day 0
• •Excluded Concomitant Medications
• •Anti-B-cell therapy:
• •Wash-out of 5 therapeutic half lives after prior B-cell therapy, or until pharmacodynamic effect would be minimal (e.g., 1 year following rituximab)
• •365 days prior to belimumab:
• •Any biologic investigational agent (e.g., abetimus sodium, anti CD40L antibody, BG9588/ IDEC 131)
• •90 days prior to belimumab:
• •Intravenous cyclophosphamide
• •Subjects who receive CYC whose leukocyte count is \<2000/m3
• •30 Days Prior to belimumab (or 5 half-lives, whichever is greater) o Any non-biologic investigational agent
• •Live vaccines within 30 days prior to baseline or concurrently with belimumab