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Abstract: TH-PO999

Impact of Sparsentan on Quality of Life (QoL) in Focal Segmental Glomerulosclerosis (FSGS) Patients in DUET: An Interim Analysis

Session Information

Category: Glomerular Diseases

  • 1203 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Trachtman, Howard, NYU School of Medicine, New York, New York, United States
  • Hogan, Jonathan J., University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • Ferguson, Beatrice, Retrophin, Inc., San Diego, California, United States
  • Komers, Radko, Retrophin, Inc., San Diego, California, United States
Background

FSGS has been shown to impair patients’ (pts) QoL. DUET, a phase 2, randomized, active-control study, examined QoL in pts with FSGS.

Methods

In the 8-week randomized double-blind treatment period (DB), pts received sparsentan (SPAR) or irbesartan (IRB), after which all randomized pts who continued in an open-label extension received SPAR (SPAR:SPAR or IRB:SPAR, respectively). The SF-36 questionnaire was administered to adults at baseline (BL), Week 8, Week 48 and Week 144. Norm-based scoring was used for the physical (PCS) and mental (MCS) component scores (mean±SD).

Results

Seventy-three patients were randomized to SPAR and 36 to IRB with a mean baseline UP/C of 3.61 and 3.12 g/g, respectively, and median eGFR of 73.4 and 65.1 mL/min/1.73 m2, respectively. There were no clinically meaningful differences between the SPAR and IRB groups in the cross-sectional PCS or MCS at BL and Week 8. The mean change from BL to Week 8 between the SPAR and IRB groups for PCS (p=0.5103) and MCS (p=0.8725) did not differ. Importantly, there were no meaningful changes over time during the open-label extension in PCS or MCS from BL to Week 48, or Week 144 both in SPAR:SPAR and IRB:SPAR (Table).

Conclusion

Using the SF-36, the physical and mental QoL component scores in DUET were similar in SPAR- and IRB-treated patients during the DB. QoL parameters remained stable over time (2 years) in participants electing to remain on long-term open-label treatment with SPAR regardless of original randomization to SPAR or IRB and were not adversely affected by dual blockade of the AT1 and ETA receptors.

Table. Cross-Sectional Mean±SD for PCS and MCS
SF-36 DimensionSPAR:SPARIRB:SPAR
Week 0
n=53
Week 8
n=56
Week 48
n=49
Week 144
n=32
Week 0
n=25
Week 8
n=28
Week 48
n=48
Week 144
n=19
PCS, mean±SD49±849±949±949±950±750±753±553±6
MCS, mean±SD50±1050±952±1052±950±1150±1052±650±7

Funding

  • Commercial Support