* First and only biologic approved in
The NMPA approval is based on data from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) phase III trial, which showed that over two years, belimumab added to standard therapy increased renal response rates and helped to reduce the risk of worsening of kidney disease in patients with active LN compared to standard of care alone.
Professor
The BLISS-LN phase III trial is the largest and longest trial conducted in active LN, involving 448 adult patients. The trial met its primary endpoint, demonstrating that a statistically significant and clinically meaningful greater number of patients achieved Primary Efficacy Renal Response (PERR) at two years (or 104 weeks) when treated with belimumab plus standard of care compared to placebo plus standard of care in adults with active LN (43% vs 32%, odds ratio (95% CI) 1.55 (1.04, 2.32), p=0.0311). Statistical significance compared to placebo across all four major secondary endpoints was achieved, including complete renal response at week 104 and time to renal-related event or death. The adverse reactions observed in BLISS-LN were consistent with the known safety profile of belimumab administered intravenously plus standard of care in patients with SLE.
Belimumab is also approved in
About the BLISS-LN trial
BLISS-LN is a phase III, 104-week, randomised, double-blind, placebo-controlled, post-approval commitment trial to evaluate the efficacy and safety of intravenous (IV) belimumab 10mg/kg plus standard of care (mycophenolate mofetil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids) compared to placebo plus standard of care in adult patients with active LN. Active LN was confirmed by renal biopsy during screening visit using the 2003
About lupus
The most common form of lupus is SLE, a chronic, incurable, autoimmune disease. It is difficult to diagnose and even more challenging to treat. The condition is associated with a range of debilitating symptoms that can fluctuate over time, including painful or swollen joints, extreme fatigue, unexplained fever, and skin rashes. In LN, SLE causes inflammation (swelling or scarring) of the small blood vessels that filter wastes in the kidney (glomeruli) and sometimes the kidneys by attacking them like they would attack a disease.[ii] LN can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. Despite improvements in diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis.[iii],[iv] Manifestations of LN include proteinuria, elevated serum creatinine levels, and urinary sediment. Approximately 20% of patients with LN progress to end-stage kidney disease within ten years of diagnosis.[v]
About Benlysta (belimumab)
Benlysta (belimumab), a B-lymphocyte stimulator (BLyS) specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. Belimumab does not bind to B cells directly or directly deplete B cell populations. By binding BLyS, belimumab inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
In
Benlysta China Indication
Benlysta, combined with standard therapy, is indicated as therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high disease activity (e.g., positive anti-dsDNA and low complement, SELENA-SLEDAI score>=8) despite standard therapy.
Benlysta, combined with standard therapy, is indicated in adult patients with active lupus nephritis.
IMPORTANT SAFETY INFORMATION
The following Important Safety Information is based on the China Product Information. Please consult the full Product Information for all the labelled safety information for Benlysta (belimumab).
Contraindications:
Hypersensitivity to belimumab or any excipients.
Warnings and precautions:
Benlysta has not been studied in patients with severe active central nervous system lupus, hypogammaglobulinaemia (IgG
.
(C) 2022 M2 COMMUNICATIONS, source