Kidney Week

Abstract: TH-PO645

How Global Are the New Lupus Nephritis Guidelines? Evidence Gaps and Underrepresented Groups

Session Information

• Lupus Nephritis: Clinical, Outcomes, and Therapeutics
  October 24, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Nordmann-Gomes, Alberto, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Ciudad de Mexico, Ciudad de México, Mexico

Alberto Nordmann-Gomes, MD

• Cojuc, Gabriel, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Gabriel Cojuc, MD

• Hernández Andrade, Adriana, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Ciudad de Mexico, Ciudad de México, Mexico

Adriana Hernández Andrade, MD

• Navarro Sanchez, Valeria, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Ciudad de Mexico, Ciudad de México, Mexico

Valeria Navarro Sanchez, MD

• Ramirez-Sandoval, Juan Carlos, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Ciudad de Mexico, Ciudad de México, Mexico

Juan Carlos Ramirez-Sandoval, MD, PhD

• Mejia-Vilet, Juan M., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Ciudad de Mexico, Ciudad de México, Mexico

Juan M. Mejia-Vilet, MD, MS, PhD

• Rovin, Brad H., The Ohio State University Wexner Medical Center, Columbus, Ohio, United States

Brad H. Rovin, MD, FASN

Background

Recent recommendations for managing lupus nephritis (LN) are based on randomized clinical trials (RCTs). However, these RCTs vary greatly in design and population characteristics. This study aimed to summarize LN RCT data to identify evidence gaps and underrepresented populations.

Methods

We performed a literature review using MEDLINE, CENTRAL, Scopus, and Web of Science to identify all LN RCTs evaluating pharmacologic interventions performed between January 2000 and February 2024. The collected information included variables of study design, selection criteria, studied populations, and study outcomes. Data is summarized by descriptive statistics.

Results

The search strategy identified 1,335 studies of which 71 were selected, with a total population of 8,281 participants. Cyclophosphamide-based regimens were studied in 39 (31.4%) treatment arms, mycophenolic acid analogs (MPAA) in 33 (26.6%), calcineurin inhibitors (CNI) plus standard of care (SoC) in 6 (4.8%), and belimumab plus SoC in 1 (0.8%). The majority of RCTs were multicenter (n=36, 59%), of which 19 (31.1%) were multinational. Most studies were performed in East Asia and the Pacific region (54.1%), followed by North America (24.6%), Europe and Central Asia (26.2%), and Latin America and the Caribbean (22.9%). Tacrolimus plus SoC was exclusively evaluated in Asia while other interventions such as oral cyclophosphamide and belimumab did not include patients from Africa and South Asia. Globally, 86.5% of participants were female. Most participants (55.2%) were Asian, followed by white (28.4%), and only 7.2% were black. ISN/RPS LN classes II and V were evaluated in <10% of RCTs. The definition of the primary efficacy outcome was not standardized among RCTs and only 29 (47.5%) reported severe adverse events. Most guideline-recommended regimens have not been compared against each other.

Conclusion

In light of new recommendations for the management of LN, we make a call to broaden inclusion of underrepresented populations, improve and homogenize study design, and assess unexplored treatment comparisons.