Comparison and evaluation of lupus nephritis response criteria in lupus activity indices and clinical trials.
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with diverse manifestations. Although the approval of new therapies includes only one agent in 50 years, a number of promising new drugs are in development. Lupus nephritis is a dreaded complication of SLE as it is associated with significant morbidity and mortality. Advancing the treatment of lupus nephritis requires well-designed clinical trials and this can be challenging in SLE. The major obstacles involve identifying the correct population of patients to enroll and ensuring that a clinically appropriate and patient-centered endpoint is being measured. In this review, we will first discuss the clinical utility of endpoints chosen to represent lupus nephritis in global disease activity scales. Second, we will review completed and active trials focused on lupus nephritis and discuss the endpoints chosen. There are many important lessons to be learned from existing assessment tools and clinical trials. Reviewing these points will help ensure that future efforts will yield meaningful disease activity measures and well-designed clinical trials to advance our understanding of lupus management.
Division of Nephrology, Department of Medicine, Massachusetts General Hospital, 55 Fruit St., Boston, MA, 02114, USA. kcorapi@partners.org.
Kristin M
KM
Corapi
Division of Nephrology, Department of Medicine, University of North Carolina (UNC) Kidney Center, 7024 Burnett-Womack Building, Campus Box # 7155, Chapel Hill, NC, 27599-7155, USA. mary_dooley@med.unc.edu.
Mary Anne
MA
Dooley
Division of Nephrology, Department of Medicine, University of North Carolina (UNC) Kidney Center, 7024 Burnett-Womack Building, Campus Box # 7155, Chapel Hill, NC, 27599-7155, USA. will_pendergraft@med.unc.edu.
William F
WF
Pendergraft
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D005919:Glomerular Filtration Rate / Q000502:physiology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007677:Kidney Function Tests; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis / Q000188:drug therapy / Q000276:immunology; D008181:Lupus Nephritis / Q000188:drug therapy* / Q000503:physiopathology / Q000517:prevention & control*; D008297:Male; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D051436:Renal Insufficiency, Chronic / Q000209:etiology / Q000517:prevention & control; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents