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Kidney Week

Abstract: TH-PO607

Patient-Reported Outcomes in Adults with FSGS: Sparsentan vs. Irbesartan

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

  • Ayoub, Isabelle, The Ohio State University Wexner Medical Center, 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
  • Gong, Wu, Travere Therapeutics Inc, San Diego, California, United States
  • Preciado, Priscila, Travere Therapeutics Inc, San Diego, California, United States
  • Komers, Radko, Travere Therapeutics Inc, San Diego, California, United States
  • Inrig, Jula K., Travere Therapeutics Inc, San Diego, California, United States
  • Rheault, Michelle N., University of Minnesota Medical School, Minneapolis, Minnesota, United States
  • Trachtman, Howard, University of Michigan, Ann Arbor, Michigan, United States
Background

In the randomized, phase 3 DUPLEX trial (NCT03493685), sparsentan (SPAR), a dual endothelin and angiotensin II receptor antagonist (DEARA), demonstrated a greater sustained antiproteinuric effect compared with irbesartan (IRB), with a favorable safety profile similar to IRB in patients with FSGS. This analysis aimed to evaluate the effect of SPAR compared with IRB on patient-reported outcomes (PROs) in adults with FSGS.

Methods

In the DUPLEX trial, the Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire was administered to adults at baseline and every 12 weeks. Least squares mean changes from baseline in physical component summary, mental component summary, bodily pain, and kidney-targeted subscales were estimated using mixed models for repeated measures. A prespecified threshold change of 5 points was considered clinically meaningful.

Results

Burden of kidney disease scores were clinically meaningfully improved compared with baseline in the SPAR group but not in the IRB group (Figure). Least squares mean changes from baseline scores were stable, if not improved, throughout the 2-year treatment period for SPAR with the exception of mental component summary, which appeared slightly worsened at some timepoints compared with baseline and with IRB.

Conclusion

For adult patients with FSGS, our analysis of PROs from the DUPLEX trial suggests that health-related quality of life was relatively stable over the 2-year treatment period and comparable between SPAR and maximized angiotensin II receptor inhibition with IRB. Further work is needed to better understand the association between PROs and clinical endpoints in FSGS.

Funding

  • Commercial Support – Travere Therapeutics