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Introduction <p>Preserving kidney function and limiting renal flares are important treatment goals for patients with lupus nephritis (LN). The relationship between renal flares and health-related quality of life (HRQOL) was assessed in patients with LN receiving standard therapy in the LUNAR phase&#xa0;3 clinical trial.</p> Methods <p>A post hoc analysis was conducted on data collected from patients with biopsy-confirmed class&#xa0;III/IV ± V LN randomized to the control arm of the phase&#xa0;3 LUNAR (NCT00282347) trial. Relationships between renal flare(s) (estimated glomerular filtration rate decrease &gt; 20% and urine-to-creatinine ratio [UPCR] &gt; 1&#xa0;g/g; increase in UPCR &gt; 1 if UPCR &lt; 0.2&#xa0;g/g or UPCR &gt; 2 if UPCR ≥ 0.2&#xa0;g/g; or receipt of rescue therapy compared with week&#xa0;16 when steroid tapering occurred) and mean change in HRQOL score across eight 36-Item Short Form Health Survey (SF-36) domains and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) were assessed using multivariate analysis of covariance (ANCOVA) modeling.</p> Results <p>Among 72 patients receiving standard therapy, renal flare occurred in 24 patients (33%) (flare rate 3.18 per 1000 person days). Domain-specific mean SF-36 HRQOL scores and FACIT-Fatigue scores improved over time among study participants receiving standard therapy. Multivariate analyses identified a significant impact of experiencing one or more renal flares on mean change in FACIT-Fatigue score as well as the following SF-36 domains: physical functioning, role physical, bodily pain, vitality, and social functioning.</p> Conclusions <p>Renal flares in patients with LN significantly impact their HRQOL as measured by the SF-36 and the FACIT-Fatigue, highlighting the importance of preserving kidney function from the patient perspective among those with LN.</p>

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Renal Flares and Health-Related Quality of Life Among Patients with Lupus Nephritis: A Post Hoc Analysis of Control Arm Data from the LUNAR Phase 3 Clinical Trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月28日

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  • Seitaro Yoshida,
  • Christophe Toukam Tchakoute,
  • Huiyan Ashley Mao,
  • Gene Wallenstein,
  • Jorge A. Ross Terres,
  • Lisa Lindsay

摘要

Introduction

Preserving kidney function and limiting renal flares are important treatment goals for patients with lupus nephritis (LN). The relationship between renal flares and health-related quality of life (HRQOL) was assessed in patients with LN receiving standard therapy in the LUNAR phase 3 clinical trial.

Methods

A post hoc analysis was conducted on data collected from patients with biopsy-confirmed class III/IV ± V LN randomized to the control arm of the phase 3 LUNAR (NCT00282347) trial. Relationships between renal flare(s) (estimated glomerular filtration rate decrease > 20% and urine-to-creatinine ratio [UPCR] > 1 g/g; increase in UPCR > 1 if UPCR < 0.2 g/g or UPCR > 2 if UPCR ≥ 0.2 g/g; or receipt of rescue therapy compared with week 16 when steroid tapering occurred) and mean change in HRQOL score across eight 36-Item Short Form Health Survey (SF-36) domains and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) were assessed using multivariate analysis of covariance (ANCOVA) modeling.

Results

Among 72 patients receiving standard therapy, renal flare occurred in 24 patients (33%) (flare rate 3.18 per 1000 person days). Domain-specific mean SF-36 HRQOL scores and FACIT-Fatigue scores improved over time among study participants receiving standard therapy. Multivariate analyses identified a significant impact of experiencing one or more renal flares on mean change in FACIT-Fatigue score as well as the following SF-36 domains: physical functioning, role physical, bodily pain, vitality, and social functioning.

Conclusions

Renal flares in patients with LN significantly impact their HRQOL as measured by the SF-36 and the FACIT-Fatigue, highlighting the importance of preserving kidney function from the patient perspective among those with LN.