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New Study Highlights Evidence Gaps and Under-Representation in Lupus Nephritis Clinical Trials
In a new study published in Lupus Science & Medicine, researchers reviewed randomized clinical trials (RCTs) to assess therapies for initial management of lupus nephritis (LN), focusing on their design with study populations and outcomes, examining the results and identifying gaps that should be addressed in the future.
Researchers reviewed 61 RCTs published between January 2000 to February 2024 which included 124 treatment groups and involved 7,058 study participants. Each RCT group was evaluated separately and was categorized based on treatment regimen, to include mycophenolic acid analogues, mycophenolate mofetil (MMF), cyclophosphamide (CYC), calcineurin inhibitors (CNI), belimumab (Benlysta), B-cell depleting therapies, and other biologic treatments. Nearly 90% of all RCT participants were female. Asian was the most represented race (55.2%), followed by White (28.4%), while Black (7.2%) and other racial groups (9.2%) were under-represented.
The study emphasizes the importance and need for greater diversity and inclusion of under-represented populations in clinical trials, particularly Black individuals, who are more severely impacted by lupus nephritis. It also underscores the importance of using consistent and standardized study designs. Learn more about participating in clinical trials.