Julie E Davidson1,2, Qinggong Fu1,2, Beulah Ji3,4, Sapna Rao1,2, David Roth1,2, Laurence S Magder1,2, Michelle Petri1,2. 1. From the Real World Evidence and Clinical Development, GlaxoSmithKline R&D, Stockley Park, Uxbridge, UK; GlaxoSmithKline R&D, Upper Providence, Pennsylvania, and Research Triangle Park, North Carolina; the Department of Epidemiology and Public Health, University of Maryland; Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. 2. J.E. Davidson*, PhD, MPH, Real World Evidence, GlaxoSmithKline R&D; Q. Fu, PhD, Real World Evidence, GlaxoSmithKline R&D; B. Ji, MD, Clinical Development, GlaxoSmithKline R&D; S. Rao, MS, Real World Evidence, GlaxoSmithKline R&D; D. Roth, MD, Clinical Development, GlaxoSmithKline R&D; L.S. Magder, PhD, Department of Epidemiology and Public Health, University of Maryland; M. Petri, MD, Division of Rheumatology, Johns Hopkins University School of Medicine. 3. From the Real World Evidence and Clinical Development, GlaxoSmithKline R&D, Stockley Park, Uxbridge, UK; GlaxoSmithKline R&D, Upper Providence, Pennsylvania, and Research Triangle Park, North Carolina; the Department of Epidemiology and Public Health, University of Maryland; Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. Beulah.N.Ji@gsk.com. 4. J.E. Davidson*, PhD, MPH, Real World Evidence, GlaxoSmithKline R&D; Q. Fu, PhD, Real World Evidence, GlaxoSmithKline R&D; B. Ji, MD, Clinical Development, GlaxoSmithKline R&D; S. Rao, MS, Real World Evidence, GlaxoSmithKline R&D; D. Roth, MD, Clinical Development, GlaxoSmithKline R&D; L.S. Magder, PhD, Department of Epidemiology and Public Health, University of Maryland; M. Petri, MD, Division of Rheumatology, Johns Hopkins University School of Medicine. Beulah.N.Ji@gsk.com.
Abstract
OBJECTIVE: This observational study was a retrospective analysis of prospectively collected Hopkins Lupus Cohort data to compare longterm renal survival in patients with lupus nephritis (LN) who achieved complete (CR), partial (PR), or no remission following standard-of-care LN induction therapy. METHODS: Eligible patients with biopsy-proven LN (revised American College of Rheumatology or Systemic Lupus Collaborating Clinics criteria) were identified and categorized into ordinal (CR, PR, or no remission) or binary (response or no response) renal remission categories at 24 months post-diagnosis [modified Aspreva Lupus Management Study (mALMS) and modified Belimumab International Lupus Nephritis Study (mBLISS-LN) criteria]. The primary endpoint was longterm renal survival [without endstage renal disease (ESRD) or death]. RESULTS: In total, 176 patients met the inclusion criteria. At Month 24 postbiopsy, more patients met mALMS remission criteria (CR = 59.1%, PR = 30.1%) than mBLISS-LN criteria (CR = 40.9%, PR = 16.5%). During subsequent followup, 18 patients developed ESRD or died. Kaplan-Meier plots suggested patients with no remission at Month 24 were more likely than those with PR or CR to develop the outcome using either mALMS (p = 0.0038) and mBLISS-LN (p = 0.0097) criteria for remission. Based on Cox regression models adjusted for key confounders, those in CR according to the mBLISS-LN (HR 0.254, 95% CI 0.082-0.787; p = 0.0176) and mALMS criteria (HR 0.228, 95% CI 0.063-0.828; p = 0.0246) were significantly less likely to experience ESRD/mortality than those not in remission. CONCLUSION: Renal remission status at 24 months following LN diagnosis is a significant predictor of longterm renal survival, and a clinically relevant endpoint.
OBJECTIVE: This observational study was a retrospective analysis of prospectively collected Hopkins Lupus Cohort data to compare longterm renal survival in patients with lupus nephritis (LN) who achieved complete (CR), partial (PR), or no remission following standard-of-care LN induction therapy. METHODS: Eligible patients with biopsy-proven LN (revised American College of Rheumatology or Systemic Lupus Collaborating Clinics criteria) were identified and categorized into ordinal (CR, PR, or no remission) or binary (response or no response) renal remission categories at 24 months post-diagnosis [modified Aspreva Lupus Management Study (mALMS) and modified Belimumab International Lupus Nephritis Study (mBLISS-LN) criteria]. The primary endpoint was longterm renal survival [without endstage renal disease (ESRD) or death]. RESULTS: In total, 176 patients met the inclusion criteria. At Month 24 postbiopsy, more patients met mALMS remission criteria (CR = 59.1%, PR = 30.1%) than mBLISS-LN criteria (CR = 40.9%, PR = 16.5%). During subsequent followup, 18 patients developed ESRD or died. Kaplan-Meier plots suggested patients with no remission at Month 24 were more likely than those with PR or CR to develop the outcome using either mALMS (p = 0.0038) and mBLISS-LN (p = 0.0097) criteria for remission. Based on Cox regression models adjusted for key confounders, those in CR according to the mBLISS-LN (HR 0.254, 95% CI 0.082-0.787; p = 0.0176) and mALMS criteria (HR 0.228, 95% CI 0.063-0.828; p = 0.0246) were significantly less likely to experience ESRD/mortality than those not in remission. CONCLUSION: Renal remission status at 24 months following LN diagnosis is a significant predictor of longterm renal survival, and a clinically relevant endpoint.
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