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In the meantime, you can enjoy access to all the latest news, events and resources for different therapy areas on our website.Consider BENLYSTA for your patients with non-severe renal involvement
Kidney involvement in SLE can range from mild to severe and occurs in 50%-70% of patients with lupus.1 BENLYSTA can be used in patients with renal involvement to treat SLE disease activity. It is not recommended in severe active lupus nephritis (proteinuria >6 mg over 24 hours and/or serum creatinine >2.5 mg/dL).2
Patients with non-severe renal involvement
In BLISS-IV (52/76) and BLISS-SC trials, 11% (n=1125) and 12% (n=836) of SLE patients had renal involvement, respectively.2
Patients were excluded from the BLISS trials if they had the following:3-5
Severe active lupus nephritis
- Proteinuria >6 g over 24 hours or equivalent with spot urine protein:creatinine ratio
- Serum creatinine >2.5 mg/dL
- Required haemodialysis or high-dose prednisone (>100 mg/day) within 90 days of study entry
Patients were excluded from the BLISS trials if they had the following:3-5
Severe active lupus nephritis
- Proteinuria >6 g over 24 hours or equivalent with spot urine protein:creatinine ratio
- Serum creatinine >2.5 mg/dL
- Required haemodialysis or high-dose prednisone (>100 mg/day) within 90 days of study entry
Review data from the BENLYSTA clinical trials
Adding BENLYSTA SC led to fewer patients experiencing renal flares vs. standard therapy5*
Only statistically significant for patients with baseline proteinuria >0.5 g/24 hours
The BLISS trials excluded patients with severe active lupus nephritis (proteinuria >6 mg over 24 hours and/or serum creatinine >2.5 mg/dL), and the effect of BENLYSTA therapy on renal abnormalities was not a pre-specified endpoint of these studies.2,6
Data is consistent with the results of the BLISS-52 trial, but not BLISS-76.7-8
* A renal flare was defined as the reproducible development (i.e., confirmed at the subsequent clinical visit) of ≥1 of the following 3 features:
An increase in 24-hour urinary protein to >1000 mg if baseline was <200 mg or to >2000 mg if baseline was 200-1000 mg or to more than twice a baseline value of >1000 mg
* A decrease in the glomerular filtration rate of >20%, accompanied by proteinuria (>1000 mg/24 hours), haematuria (≥4 red blood cells [RBCs]/high-power field [hpf]), and/or cellular (RBC and white blood cell) casts
New haematuria (≥11-20 RBCs/hpf) or a 2-grade increase in haematuria compared with baseline, associated with >25% dysmorphic RBCs, glomerular in origin, and accompanied by an 800-mg increase in 24-hour urinary protein level or new RBC casts.5
In patients treated with BENLYSTA 10 mg/kg vs. placebo, respectively:6
Numerically, there were more patients who showed improvement in renal involvement in patients with renal involvement at baseline (54.1% vs. 44.6%, n=177), as measured by SELENA-SLEDAI (no statistical analysis performed)
Numerically, there were more patients who showed improvement in renal involvement in patients with renal involvement at baseline (54.1% vs. 44.6%, n=177), as measured by SELENA-SLEDAI (no statistical analysis performed)
Numerically, there were more patients who showed improvement in renal involvement in patients with renal involvement at baseline (54.1% vs. 44.6%, n=177), as measured by SELENA-SLEDAI (no statistical analysis performed)
Numerically, there were more patients who showed improvement in renal involvement in patients with renal involvement at baseline (54.1% vs. 44.6%, n=177), as measured by SELENA-SLEDAI (no statistical analysis performed)
Numerically, there were more patients who showed improvement in renal involvement in patients with renal involvement at baseline (54.1% vs. 44.6%, n=177), as measured by SELENA-SLEDAI (no statistical analysis performed)
* Includes HDA and non-HDA patients.
† Renal involvement defined as including ≥1 of the following: proteinuria >0.5 g/24 hours, haematuria >5 RBCs/hpf, pyuria >5 white blood cells/hpf and heme granular/RBC casts).6
Median percent reductions in proteinuria in patients with baseline proteinuria >0.2 g/24 hours (n=643)6
Numerically, there were more patients who showed improvement in renal involvement in patients with renal involvement at baseline (54.1% vs. 44.6%, n=177), as measured by SELENA-SLEDAI (no statistical analysis performed)
Dosing guidance in renal impairment2
Mild (CrCl ≥60 and <90 mL/min) and moderate (CrCl ≥30 and <60 mL/min) renal impairment
Mild (CrCl ≥60 and <90 mL/min) and moderate (CrCl ≥30 and <60 mL/min) renal impairment
Mild (CrCl ≥60 and <90 mL/min) and moderate (CrCl ≥30 and <60 mL/min) renal impairment
Mild (CrCl ≥60 and <90 mL/min) and moderate (CrCl ≥30 and <60 mL/min) renal impairment
Severe active lupus nephritis
(Proteinuria >6 g/24 hours or equivalent using spot urine protein to creatinine ratio or serum creatinine >2.5 mg/dL)3-5
Mild (CrCl ≥60 and <90 mL/min) and moderate (CrCl ≥30 and <60 mL/min) renal impairment
BENLYSTA: Designed with your patients in mind
References
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