Climb to the top again! The world's largest lupus nephritis III study was published. EULAR 2020.

Compared with the traditional treatment, baileyumab combined with standard therapy can significantly improve the renal response of patients with lupus nephritis, with good safety.on June 3-6, 2020, the European rheumatism academic year meeting held by the European Union Against Rheumatism (EULAR) was held online.in this annual meeting, the largest bliss-ln study of lupus nephritis was first presented in today's theme report, and became one of the most remarkable academic focuses, and the research results are encouraging.following the remarkable achievements of three global multicenter phase III clinical trials bliss-52, bliss-76 and Northeast Asia studies, baileyumab has conquered the dangerous peak of lupus nephritis again: up to now, the world's largest active lupus nephritis randomized, controlled, 104 week phase III clinical trial (bliss-ln) has reached the primary endpoint and all secondary endpoints. Background: kidney is the most frequently involved organ in systemic lupus erythematosus (SLE), and lupus nephritis (LN) is one of the most serious complications of SLE, and 70% of SLE patients are accompanied by lupus nephritis.to control renal injury as soon as possible, protect renal function and improve long-term survival rate of human and kidney are the treatment objectives of LN.despite the progress of medicine, the proportion of patients with lupus nephritis progressing to end-stage renal disease (ESRD) in 15 years is still more than 40%.in a post-mortem analysis of a global multicenter phase III bliss-52 / 76 study, it was found that belizumab can improve renal parameters in lupus patients with baseline renal involvement.▎ Objective: To evaluate the efficacy and safety of baileyumab for injection combined with standard therapy in patients with active lupus nephritis.▎ methods: bliss-ln (GSK study bel14054, nct01639339) was a randomized, double-blind, controlled, 104 week global multicenter phase III clinical study.patients with LN (III, IV, V or III + V or IV + V) confirmed by recent renal biopsy and requiring induction therapy were included in the study.448 patients with LN were randomly divided into "baileyumab 10mg / kg + standard treatment group" or "placebo + standard treatment group" at 1:1.▎ primary end point: perR at 104 weeks (defined as urinary protein creatinine ratio upcr ≤ 0.7; and EGFR reduction ≤ 20% before recurrence or ≥ 60 ml / min / 1.73 m2; and no rescue treatment).▎ key secondary end point: complete response rate (CRR) at 104 weeks (defined as upcr & lt; 0.5; And EGFR reduction ≤ 10% before recurrence or ≥ 90 mL / min / 1.73m2; and no rescue treatment); 52 weeks perR; lead to death or to the time of kidney related events (ESRD / double increase of serum creatinine / renal deterioration / failure of renal related treatment); overall renal remission (ORR) after two years.▎ other end points: including the duration of perR / CRR, the change of perR and CRR with time, sledai-s2k & lt; 4 points at 104 weeks, proteinuria and EGFR changes with time, safety, etc.▎ results: at 104 weeks, more patients in the "baileyumab + standard treatment group" reached the primary end point perR [43.0% vs. 32.3%, or 1.55, 95% CI (1.04, 2.32), P = 0.0311].more patients in the baileyumab group reached the key secondary endpoint, and the differences were statistically significant.compared with the placebo + standard treatment group, patients treated with baileyumab had a higher proportion of achieving and maintaining perR and CRR, and the baileyumab treatment group significantly reduced the risk of kidney related events within 104 weeks. at the end point of safety, baileyumab was comparable to placebo group. Table 1: primary end point and key secondary efficacy endpoint results conclusion bliss-ln study is the largest clinical study of lupus nephritis so far, The efficacy and safety data of baileyumab have been confirmed in active lupus nephritis population. Compared with the traditional treatment, baileyumab combined with standard treatment can significantly improve the renal response of patients with lupus nephritis, with good safety. love me, please show me!