Slide 1: PROTECT Subgroup Analysis: Sparsentan vs Irbesartan in IgAN With Proteinuria Above and Below 1 g/g
FR-OR57 PROTECT Subgroup Analysis: Sparsentan Provides Clinical Benefits vs Irbesartan in Patients With IgA Nephropathy With Proteinuria Above and Below 1 g/g To obtain a PDF of this poster, please scan the Quick Response (QR) Laura Kooienga,1 Hernán Trimarchi,2 Jürgen Floege,3 code. No Priscila Pre
Slide 2: Disclosures
DISCLOSURES • LK is a principal investigator for studies sponsored by Akebia Therapeutics, AstraZeneca, Boehringer Ingelheim, Cara Therapeutics, Chinook Therapeutics, CSL Behring, Galderma, Mineralys Therapeutics, Inc., Novartis, Omeros, Otsuka Pharmaceuticals, Reata Pharmaceuticals, Travere Therape
Slide 3: Introduction: Background
INTRODUCTION Background • Sparsentan (SPAR) is a non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist (DEARA)1 approved in the US and EU for adults with IgAN2,3 Sparsentan targets glomerular injury and slows kidney function decline1,2 EFFECTS: Anti-inflammatory4-7*
Slide 4: Introduction: Background (continued) and Objective
INTRODUCTION Background (continued) • In the pivotal Phase 3 PROTECT trial, SPAR showed sustained proteinuria reduction and better kidney function preservation vs the maximum labeled dose of irbesartan (IRB)1 • In patients with IgAN, reduced proteinuria is associated with improved kidney survival2 •
Slide 5: Methods: PROTECT Trial Design
METHODS PROTECT Trial Design (NCT03762850) Maximized ACEi/ARB Double-blind treatment • ≥12 weeks prior to screening Titrated to maximum labeled dose* • ≥50% maximum approved dose 110 weeks, randomized 1:1 Randomized (1:1) and SPAR received study drug 200 mg/day (N=404) 400 mg/day at week 2 • Adult
Slide 6: Patient Demographics and Baseline Characteristics Were Well Balanced
RESULTS Patient Demographics and Baseline Characteristics Were Well Balanced Between Treatment Arms Baseline UPCR <1.0 g/g Baseline UPCR ≥1.0 g/g (n=145) (n=259) SPAR IRB SPAR IRB Baseline characteristics (n=77) (n=68) (n=125) (n=134) Age at informed consent, mean (SD), 46.2 (12.31) 47.2 (12.21) 46.
Slide 7: SPAR Showed Rapid and Sustained Reductions in Proteinuria Through Week 110
RESULTS SPAR Showed Rapid and Sustained Reductions in Proteinuria Through Week 110, Superior to Maximum Labeled Dose IRB, Regardless of Baseline UPCR Level 50 50 Baseline UPCR <1.0 g/g Baseline UPCR ≥1.0 g/g 40 40 Least-squares mean change from baseline in UPCR (95% CI), % 30 IRB 30 20 13.9% 20 10 1
Slide 8: Absolute Change in eGFR Lower With SPAR vs IRB
RESULTS Absolute Change in eGFR From Baseline to Week 110 Was Lower With SPAR vs Maximum Labeled Dose IRB, Regardless of Baseline UPCR Level Overall population1 Baseline UPCR <1.0 g/g Baseline UPCR ≥1.0 g/g SPAR IRB SPAR IRB SPAR IRB 0 Least-squares mean change from –5.8 –9.5 –4.1 –6.0 –7.1 –11.3 ba
Slide 9: Complete Proteinuria Remission Achieved Earlier and More Frequently With SPAR
RESULTS Complete Proteinuria Remission (<0.3 g/day) Was Achieved Earlier and More Frequently With SPAR vs IRB Regardless of Baseline UPCR Level 0.50 Baseline UPCR <1.0 g/g 0.50 Baseline UPCR ≥1.0 g/g 0.45 0.45 Relative risk (95% CI) Relative risk (95% CI) Probability of achieving 0.40 2.47 (1.30-4.7
Slide 10: SPAR Was Well-Tolerated With Consistent Safety Profile
RESULTS SPAR Was Well-Tolerated With a Consistent Safety Profile Across Baseline Proteinuria Subgroups, Comparable to Maximum Labeled Dose IRB Baseline UPCR <1.0 g/g Baseline UPCR ≥1.0 g/g (n=145) (n=259) SPAR IRB SPAR IRB (n=77) (n=68) (n=125) (n=134) Patients with any TEAE, n (%) 69 (90) 58 (85) 1
Slide 11: Conclusions
CONCLUSIONS Rapid, superior proteinuria reduction was observed, and complete proteinuria remission was achieved earlier and more frequently with sparsentan vs maximum labeled dose irbesartan, regardless of baseline UPCR level Treatment with sparsentan showed greater kidney function preservation vs m
Slide 12: Acknowledgments
ACKNOWLEDGMENTS • This study was funded by Travere Therapeutics, Inc. • Medical writing assistance and editorial support were provided under the direction of the authors by Lise Barnard, PhD, and Chris Edwards, PhD, CMPP, of Nucleus Global, an Inizio company, in accordance with Good Publication Prac
Slide 13: Questions?
Questions?