BACKGROUND/PURPOSE: Clinical trials in lupus nephritis have often been designed to demonstrate renal response (or remission) followingtherapy based on categorical remission endpoints (often no remission, partial and complete) derived from laboratory measures of renalfunction and activity. The clinical relevance of these remission categories has been questioned. The primary objective of this study(WEUKBRE6068) was to compare long-term renal survival in patients with complete (CR), partial (PR) or no remission, as defined bycriteria used in the Aspreva Lupus Management Study (ALMS) (NCT00377637) and Belimumab International Lupus Nephritis Study(BLISS-LN) (NCT01639339) with the modification of excluding urinary sediments (mBLISS-LN and mALMS), assessed at 24 monthsfollowing positive lupus nephritis biopsy.
METHODS: A retrospective analysis of the prospective Hopkins Lupus Cohort was conducted. Eligible patients had systemic lupuserythematosus (SLE) per revised American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics(SLICC) criteria plus biopsy record of ISN class III, IV, V or mixed lupus glomerulonephritis. The primary endpoint was renal survival(survival without end-stage renal disease (ESRD) or mortality). The primary exposure was remission status (CR, PR or no remission) bymBLISS-LN and mALMS criteria at 24 months post biopsy date. Survival analysis (Kaplan-Meier plots with log-rank test and CoxProportional Hazards regression) was used to describe subsequent event rates and assess the association between renal survival andremission status at 24 months.
RESULTS: We identified 176 SLE patients with lupus nephritis. At 24 months post biopsy date, more patients met mALMS remissioncriteria (CR = 59.1%, PR = 30.1%) than met mBLISS-LN criteria (CR = 40.9%, PR = 16.5%). During subsequent follow-up, 18 patientsdeveloped ESRD or died. The Kaplan-Meier plots suggested patients with no remission at 24 months post biopsy date were more likelythan those with PR or CR to develop the outcome by both mALMS (p=0.0038) (Figure 1) and mBLISS-LN (p=0.0097) (Figure 2)criteria. Based on Cox regression models adjusted for key confounders, those in CR by both mBLISS-LN (HR 0.254, p=0.0176) andmALMS criteria (HR 0.228,p=0.0246) were significantly less likely to experience ESRD/mortality than those not in remission.Similarly, those in PR were less likely to experience ESRD/mortality (mBLISS-LN HR 0.141, p=0.0599; mALMS HR 0.575,p=0.3727)
CONCLUSION: Renal remission status at 24 months following lupus nephritis is associated with long-term renal survival.
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