Table 3.
Categorization of renal and extra-renal disease courses between two consecutive assessments (Visit-1 and Visit-2) as used in the Standardized Steroid dosing Regimen (SSR)
| Renal courses | Extra-renal course$ | |
|---|---|---|
| Induction therapy (weeks 1–26) | Maintenance therapy (after week 27) | |
| LN* - Active worse#: | LN flare after PRR or CRR¶: | Active - Much worse: |
| Worsening of ≥ 1 LN-RV† | Worsening (persistent¥ & substantial) of ≥1 LN-RV | Δ SLEDAI score: ≥ +8 |
| LN - Active stable: | LN worse# after PRR or CRR: | Active - Mild-moderate worse |
| Neither Active Worse nor Active Improved | Worsening of ≥ 1 LN-RV | Δ SLEDAI score: +4 to +7 |
| LN - Active improved: | PRR stable: | Active - stable: |
| Improvement of ≥1 LN-RV with the remaining LN-RV(s) not being worse | PRR with changes of LN-RVs not qualifying for being worse or improved | Δ SLEDAI score: ± 3 |
| PRR‡: | PRR improved: | Active - Improved: |
| Clinically relevant improvement of ≥2 LN-RVs with the remaining LN-RV not being worse | PPR with improvement of ≥ 1 LN-RV with the remaining LN-RV(s) not being worse | Δ SLEDAI score: ≤- 4 |
| LN - Inactive: | CRR: | Inactive: |
| All LN-RVs are within normal range | All LN-RVs are within normal range | Absolute SLEDAI score: ≤ 2 |
Lupus Nephritis
All “worsening” is considered to be due to LN
Lupus nephritis response variables, i.e., Urine protein creatinine ratio (UPCR), hematuria, estimated glomerular filtration rate (eGFR). Normal values for the LN-RVs are always considered as “improved” for the purpose of the course definitions (for details please see Figure 2)
Partial renal remission assesses the change between baseline and week 26 and can only be measured starting week 26 of induction therapy
Complete renal remission
Worsening of 1 or more LN-RVs on >2 subsequent time points >1 week(s) apart as follows: Newly abnormal eGFR or abnormal eGFR that decreased by >10%; Persistent increase of UPCR to >0.5, after CRR; Persistent doubling of UPCR with values >1.0, after PRR; Newly active or worsening by 2 categories of urine RBCs.
Based on changes in the score of the SLE disease activity index, version 2K. For item definitions please see: Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002;29(2):288–91.