Table 2:
Definition of key efficacy measures.
| Outcome measure | Definition | References |
|---|---|---|
| Partial renal remission | PRR is defined as relevant improvement of 2 LN-RV* with the remaining LN-RV being at least stable. | [22,34] |
| Complete renal remission | CRR is the presence of all 3 LN-RVs within normal range. | [22,34] |
| Lupus nephritis flare | A LN flare is the reproducible+ presence of 1 or more of the following (a-d) that is at least partially due to renal inflammation from LN per the treating physician. a. Newly abnormal GFR plus increase in hematuria by at least 2 categories (normal: 0 to 5 RBC/HPF (normal), 6 to 10 RBC/HPF, 11 to 25 RBC/HPF, 26 to 50 RBC/HPF, >50 RBC/HPF) OR new gross hematuria (>50 RBC/HPF). b. Abnormal GFR that decreased by >10% plus increase in hematuria by at least 2 categories (normal: 0 to 5 RBC/HPF (normal), 6 to 10 RBC/HPF, 11 to 25 RBC/HPF, 26 to 50 RBC/HPF, >50 RBC/HPF) OR new gross hematuria (>50 RBC/HPF). c. Persistent increase of UPCR to >0.5, after CRR d. Persistent doubling of UPCR with values >1.0, after PRR |
[22,34] |
Note: PRR-partial renal response; LN-RV-lupus nephritis core response variables; CRR-complete renal response; GFR-glomerular filtration rate; RBC/HPF-red blood cell per high-power field; UPCR-urine protein to creatinine ratio.
*
LN-RVs are the upper limit of normal (ULN) or lower limit of normal (LLN) of the following:
Urine protein to creatinine ratio (ULN: 0.2), estimated GFR (LLN: 95 ml/min/1.73m2) and glomerular hematuria (ULN:0)
+
Reproducibility means presence on >2 subsequent time points >1 week apart.