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Abstract: FR-PO0645

Association Between Achievement of Low-Proteinuria Thresholds and Health-Related Quality of Life in FSGS: Pooled DUET and DUPLEX Analysis

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

  • Ayoub, Isabelle, The Ohio State University, Columbus, Ohio, United States
  • Bensink, Mark Eliot, Travere Therapeutics Inc, San Diego, California, United States
  • Zhou, Xiaolei, RTI Health Solutions Research Triangle Park, Research Triangle Park, North Carolina, United States
  • Wang, Jinyi, RTI Health Solutions Research Triangle Park, Research Triangle Park, North Carolina, United States
  • Lin, Julie, Travere Therapeutics Inc, San Diego, California, United States
  • Rheault, Michelle N., Regents of the University of Minnesota, Minneapolis, Minnesota, United States
  • Trachtman, Howard, University of Michigan, Ann Arbor, Michigan, United States
Background

Building on the positive outcomes observed in DUET (NCT01613118), in DUPLEX (NCT03493685), patients with focal segmental glomerulosclerosis (FSGS) achieved low proteinuria thresholds earlier and more often with sparsentan, a dual endothelin and angiotensin II receptor antagonist (DEARA), compared to maximum labeled dose irbesartan. We performed a post hoc analysis of the association between achievement of low proteinuria thresholds and health-related quality of life (HRQoL) pooling data from DUET and DUPLEX studies.

Methods

We explored whether achieving lower proteinuria (defined by multiple thresholds) at any time during double-blind or open-label extension periods was associated with concurrent improvement in Short-Form (SF-12) HRQoL domain scores in adult patients with FSGS; odds ratios (ORs) and 95% Confidence Intervals (CIs) are reported.

Results

Of the adult patients with FSGS pooled from the two clinical studies included in the analysis (n=368), ORs across 6 of the 8 domains showed a trend indicating positive associations between achievement of low proteinuria thresholds and improvement in HRQoL (Figure). The magnitude of association was greater at lower proteinuria thresholds compared with higher thresholds particularly for Bodily Pain, Vitality and General Health Perceptions domains.

Conclusion

Achievement of low proteinuria thresholds in patients with FSGS was associated with pronounced improvements in HRQoL domains of Bodily Pain, Vitality and General Health Perceptions. These associations highlight the importance of achieving meaningful reductions in proteinuria for patients with FSGS.

Improvement in HRQoL Domain Score by Achievement of Proteinuria Threshold

Funding

  • Commercial Support – Travere Therapeutics, Inc.