Comparison of Alternative Primary Outcome Measures for Use in Lupus Nephritis Clinical Trials

摘要: Objective Clinical trials of therapies for lupus nephritis have used many different primary outcome measures, ranging from complete response to time end-stage renal disease. The objective this study was compare several possible using data a large, multicenter trial abatacept in nephritis, gain insight into which measure, if any, best able discern differences among treatment groups. Methods Study patients received either or placebo, on background mycophenolate mofetil and glucocorticoids. Using trial, the following measures at 24 52 weeks were compared: rate, major clinical total rate (complete plus partial response), improvement proteinuria, estimated glomerular filtration frequency failure. Time also evaluated. Results Complete that discriminated between groups sensitivities these 3 comparable. For sample sizes 50 would been sufficient demonstrate statistically significant difference control weeks. Each other control, but much larger group required determine statistical significance. Conclusion choice measure can substantially influence ability detect therapeutic benefit trials. This suggests weeks, may be most sensitive detecting regimens. Copyright © 2013 by American College Rheumatology.