Division of Rheumatology, University of Toronto Lupus Program, Schroeder Arthritis Institute, University Health Network, Toronto, Ontario, Canada.
Value Evidence and Outcomes, GSK, Brentford, UK.
Lupus Sci Med. 2024 Nov 27;11(2):e001264. doi: 10.1136/lupus-2024-001264.
To evaluate modified versions of the Belimumab International Study in Lupus Nephritis (BLISS-LN) belimumab study primary efficacy renal response (mPERR) and complete renal response (mCRR) criteria (excluding mandatory corticosteroid tapering) as predictors of real-world, long-term renal outcomes among patients with lupus nephritis (LN).
This retrospective, observational study (GSK Study 212866) used deidentified data between 1970 and 2015 from the University of Toronto Lupus Cohort from adults diagnosed with systemic lupus erythematosus and biopsy-proven Class III±V, IV±V or V LN. At 24 months postbiopsy, patients were retrospectively indexed as responders/non-responders based on mPERR (estimated glomerular filtration rate (eGFR) ≤20% below biopsy value/≥60 mL/min/1.73 m and urine protein:creatinine ratio (uPCR) ≤0.7 g/day) or mCRR (eGFR ≤10% below biopsy value/≥90 mL/min/1.73 m and uPCR ≤0.5 g/day) criteria. The association between index mPERR (primary outcome) or mCRR (secondary outcome) status and long-term (up to 25 years, until censoring or death) renal survival (no progression to end-stage kidney disease (eGFR <30 mL/min/1.73 m, dialysis or transplant) or death) was assessed.
Overall, 179 patients were included in the analysis (mPERR responders, n=128; non-mPERR responders, n=51). Most patients were female (87.2%); the mean (SD) age was 34.1 (11.3) years.Long-term renal survival was attained for 78.9% of mPERR responders and 60.8% of non-mPERR responders; achieving mPERR was associated with an increased likelihood of long-term renal survival versus not achieving mPERR (log-rank p=0.0119). Overall, 102 patients were mCRR responders, and 77 were non-mCRR responders. Long-term renal survival was attained for 80.4% of mCRR responders and 64.9% of non-mCRR responders; achieving mCRR was associated with an increased likelihood of long-term renal survival than not achieving mCRR (log-rank p=0.0259).
Achieving mPERR or mCRR was associated with improved long-term renal survival, highlighting that these statuses are suitable predictors of long-term renal outcomes in patients with LN.
评估改良版贝利尤单抗国际狼疮肾炎研究(BLISS-LN)贝利尤单抗研究主要疗效肾应答(mPERR)和完全肾应答(mCRR)标准(不包括强制性皮质类固醇逐渐减量)作为预测狼疮肾炎(LN)患者长期真实世界肾脏结局的指标。
这是一项回顾性、观察性研究(GSK 研究 212866),使用了多伦多大学狼疮队列 1970 年至 2015 年间的匿名数据,纳入了诊断为系统性红斑狼疮并经活检证实为 III±V、IV±V 或 V 级 LN 的成人患者。在活检后 24 个月,根据 mPERR(估计肾小球滤过率(eGFR)比活检值低 20%/≥60ml/min/1.73m 和尿蛋白:肌酐比值(uPCR)/≤0.7g/天)或 mCRR(eGFR 比活检值低 10%/≥90ml/min/1.73m 和 uPCR /≤0.5g/天)标准,将患者回顾性地归入应答者/非应答者。评估 mPERR(主要结局)或 mCRR(次要结局)状态与长期(最长 25 年,直至截止或死亡)肾脏存活率(无进展至终末期肾脏病(eGFR <30ml/min/1.73m、透析或移植)或死亡)之间的关联。
共有 179 例患者纳入分析(mPERR 应答者,n=128;非 mPERR 应答者,n=51)。大多数患者为女性(87.2%);平均(SD)年龄为 34.1(11.3)岁。mPERR 应答者的长期肾脏存活率为 78.9%,非 mPERR 应答者为 60.8%;与未达到 mPERR 相比,达到 mPERR 与长期肾脏存活率增加相关(对数秩检验 p=0.0119)。总体而言,102 例患者为 mCRR 应答者,77 例为非 mCRR 应答者。mCRR 应答者的长期肾脏存活率为 80.4%,非 mCRR 应答者为 64.9%;与未达到 mCRR 相比,达到 mCRR 与长期肾脏存活率增加相关(对数秩检验 p=0.0259)。
达到 mPERR 或 mCRR 与改善长期肾脏存活率相关,这突出表明这些状态是 LN 患者长期肾脏结局的合适预测指标。