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 health-related quality of life (HRQOL) in adults with FSGS.
METHOD: 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 patient-reported outcomes (PRO) suggests that HRQOL 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 PRO and clinical endpoints in FSGS.
