Systematic Review of Trial Design and End Points in Lupus Nephritis

Introduction: Advances in our understanding of immune dysregulation in lupus nephritis (LN) are driving a surge in the development of targeted pharmaceutical agents for a disease that continues to carry a high rate of morbidity and mortality. Although meaningful progress is being made in the management of LN, the substantial heterogeneity in critical elements of trial design and reporting that exists across contemporary LN trials hampers our ability to fairly compare the efficacy of new therapies. Methods: In this review, we comprehensively summarized and compared end points, various aspects of methodology (including glucocorticoid usage and eligibility criteria), actual trial population, and results reporting across studies published in the last 2 decades. We assessed 15 phase 2/3, interventional, randomized controlled trials (RCTs), of which 4 demonstrated the superiority of the investigational agent over standard therapy. Results: ), differences in definitions of active disease, high variability in kidney function, and glucocorticoid-based definitions of treatment response. Conclusion: Based on the findings of this review, we suggest a set of expert-posited guidelines to help in standardizing future studies in LN.