Abstract: TH-PO999
Impact of Sparsentan on Quality of Life (QoL) in Focal Segmental Glomerulosclerosis (FSGS) Patients in DUET: An Interim Analysis
Session Information
- Glomerular Diseases: Minimal Change Disease, FSGS, IgAN
November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
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 Dimension | SPAR:SPAR | IRB: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±SD | 49±8 | 49±9 | 49±9 | 49±9 | 50±7 | 50±7 | 53±5 | 53±6 |
| MCS, mean±SD | 50±10 | 50±9 | 52±10 | 52±9 | 50±11 | 50±10 | 52±6 | 50±7 |
Funding
- Commercial Support – Retrophin, Inc., San Diego, CA