医学
内科学
狼疮性肾炎
不利影响
安慰剂
临床试验
系统性红斑狼疮
钙调神经磷酸酶
胃肠病学
移植
疾病
病理
替代医学
作者
Cristina Arriens,Y K Onno Teng,Ellen M. Ginzler,Samir Parikh,Anca Askanase,Amit Saxena,Keisha Gibson,Dawn J. Caster,Tatsuya Atsumi,Laura Lisk,Simrat Randhawa,Rashieda Gluck,Neil Solomons,Robert B. Huizinga
摘要
Objective This integrated analysis evaluates the efficacy and safety of voclosporin, a novel calcineurin inhibitor, at 23.7 mg twice daily in combination with mycophenolate mofetil (MMF) and oral glucocorticoids in lupus nephritis (LN) using pooled data from two large phase II and phase III clinical trials. The purpose was to expand the pool of patients for safety analyses and to increase power for efficacy analyses in patient subpopulations . Methods Aurinia Urinary Protein Reduction in Active Lupus with Voclosporin (AURA‐LV) (phase II) and Aurinia Renal Response in Active Lupus With Voclosporin (AURORA 1) (phase III) were randomized, placebo‐controlled, double‐blind trials with similar designs and end points comparing voclosporin to control in combination with MMF and oral glucocorticoids for the treatment of LN. The primary efficacy outcome of the integrated analysis was complete renal response (CRR) at approximately one year (Week 48 data from AURA‐LV and Week 52 from AURORA 1). Safety was assessed throughout the trials. Results Overall, 534 patients (268 voclosporin; 266 control) were included in the integrated analysis. Significantly more patients achieved a CRR at one year in the voclosporin group than in the control group (43.7% vs. 23.3%; OR 2.76; 95% CI 1.88, 4.05 P < 0.0001). The incidence of adverse events (AEs) was similar (91.4% voclosporin; 87.2% control). Most AEs were mild to moderate in severity; the most commonly reported AEs were classified as infections and infestations (62.2% voclosporin; 54.9% control) and gastrointestinal disorders (45.3% voclosporin; 35.3% placebo). No new or unexpected safety signals were detected. Conclusions This integrated analysis demonstrates the efficacy and safety of voclosporin in the treatment of LN across the diverse racial and ethnic groups studied.
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