New drug for lupus nephritis! Phase III clinical success of benlysta, GlaxoSmithKline, was approved in July this year in China!

December 19, 2019 / bioin / - GSK, a British pharmaceutical giant, recently announced the positive results of the largest phase III bliss-ln study on the treatment of active lupus nephritis (LN) with benlysta (Chinese trade name: belimumab, universal name: belimumab) intravenous (IV) preparation Ln is a kind of renal inflammation caused by systemic lupus erythematosus (SLE), which can lead to end-stage renal disease The study was a two-year (104 week) randomized, double-blind, placebo-controlled, post marketing commitment study in which 448 patients were enrolled to evaluate the efficacy of bentysta (IV, 10mg / kg) combined with standard therapy (metoclopramide for induction and maintenance, or cyclophosphamide for induction, thiazolidine for maintenance, and endosterol) combined with placebo in the treatment of active ln adults Results: 1 During the screening visit, active ln was confirmed by renal biopsy and clinical active kidney disease according to the standards of international society of Nephrology / Society of renal pathology (isn / RPS) in 2003 The primary end point of the study was primary efficacy renal response (perR), defined as: glomerular filtration rate (EGFR) ≥ 60ml / min / 1.73m2, or EGFR decreased no more than 20% from before flare; urinary protein: creatinine ratio (upcr) ≥ 0.7; and it was not a treatment failure The strictest secondary end point complete renal response (CRR) was defined as EGFR less than 10% of pre flare value or within the normal range, upcr less than 0.5, and not treatment failure Ordered renal response (ORR) is defined as complete, partial and unresponsive The results showed that the study reached the primary end point: after 2 years of treatment, compared with the placebo + standard treatment group, the patients in the bentysta + standard treatment group who reached perR were statistically significantly increased (43% vs 32%, odds ratio [95% CI] = 1.55 [1.04,2.32], P = 0.0311) In addition, bentysta also showed statistical significance compared with placebo in four primary secondary endpoints: complete renal response (CRR, the strictest measurement of renal response) after two years, ordered renal response (ORR) after two years, perR after one year, time of death or renal related events In this study, the safety results of the bentysta + standard therapy group were generally comparable to those of the placebo + standard therapy group The security results are consistent with the known bentysta profile Currently, benlysta is not recommended for patients with severe active lupus nephritis (LN) because the drug has not been evaluated in these patients before Based on the positive results of the phase III study, GSK plans to promote regulatory submissions in the first half of 2020 to seek updates to prescription information The full results of the study will be published in upcoming medical conferences and peer-reviewed journals Dr Hal Barron, chief scientific officer and President of research and development of GSK, said: "lupus nephritis is one of the most common and serious complications of systemic lupus erythematosus, which occurs in up to 60% of adult patients The results of the bliss-ln study show that bentysta can make clinically significant improvements in the lives of these patients who currently have limited treatment options " Systemic lupus erythematosus (SLE) is the most common type of lupus (about 70%), which is a chronic, incurable autoimmune disease, accompanied by a series of symptoms, which fluctuate over time, including joint pain or swelling, extreme fatigue, fever of unknown cause, rash and organ damage In lupus nephritis (LN), systemic lupus erythematosus (SLE) causes renal inflammation, which can lead to end-stage renal disease Although the diagnosis and treatment of LN have improved in the past decades, it is still an indicator of poor prognosis The manifestations of LN include proteinuria, elevated serum creatinine and presence of urinary sediment Benlysta is the first specific inhibitor of B lymphocyte stimulator (BLyS), which can block the binding of soluble BLyS (a B cell survival factor) to BLyS receptor on B cell Benlysta does not directly bind to B cells, but by binding to BLyS, it can inhibit the survival of B cells (including self reactive B cells) and reduce the differentiation of B cells into plasma cells that produce immunoglobulins Benlysta can reduce the number of abnormal B lymphocytes that can aggravate the condition of lupus patients These abnormal B lymphocytes can cause the immune system to produce cells that attack blood vessels and other healthy tissues, thus causing lupus and other immune system diseases Benlysta is the first new drug approved to treat SLE in the past 50 years It has two dosage forms: intravenous injection (IV) and subcutaneous injection (SC) IV dosage form is infused once every 4 weeks, the dosage is adjusted according to body weight (10mg / kg), and the time is about 1 hour There are two forms of SC dosage form products: single dose pre filling syringe and single dose automatic syringe After training, patients can inject drugs subcutaneously by themselves This dosage form will provide an important treatment option for patients with SLE It should be noted that SC preparation is not suitable for children In the United States and the European Union, benlysta is suitable for the treatment of SLE children and adults aged ≥ 5 years old, active and positive for autoantibodies In China, benlysta was approved in July As the world's first approved biological agent for the treatment of SLE, beilitang is approved to be combined with conventional treatment in China, which is applicable to adult SLE patients with high disease activity and positive autoantibody on the basis of conventional treatment GSK announcements positive headline results in phase 3 study of bentysta in patients with lupus nephritis