Travere Therapeutics, Inc. · NASDAQ:TVTX
Travere Therapeutics — 61st European Renal Association (ERA) Congress 2024
17 slides from Travere Therapeutics's conference presentation, May 2024
Slide 1: Matching-Adjusted Indirect Comparisons of eGFR Slopes in the PROTECT Study (poster)
Matching-Adjusted Indirect Comparisons of eGFR Slopes in the PROTECT Study With UK RaDaR IgA Nephropathy Population and the Control Arm of NefIgArd To obtain a PDF of this presentation, please scan the QR code. W. Gong1, U. Diva1, M. Bensink1, X. Chai2, Y. Xie3, S. Gao4, B. Hendry1, A. Mercer5, Z. Z
Slide 2: Matching-Adjusted Indirect Comparisons of eGFR Slopes in the PROTECT Study
Matching-Adjusted Indirect Comparisons of eGFR Slopes in the PROTECT Study with UK RaDaR IgA Nephropathy Population and the Control Arm of NefIgArd W. Gong1, U. Diva1, M. Bensink1, X. Chai2, Y. Xie2, S. Gao2, B. Hendry1, A. Mercer3, Z. Zhou2, B. Rovin4, J. Barratt5 1Travere Therapeutics, San Diego,
Slide 3: Background
Background • Immunoglobulin A (IgA) nephropathy is an immune complex-mediated glomerulonephritis, attributed to IgA deposition in the glomerular mesangium, leading to progressive loss of renal function and increased risk of kidney failure1 • PROTECT (NCT03762850) is a randomized, multicenter, double
Slide 4: Introduction
INTRODUCTION • The active control design of PROTECT warrants an understanding of PROTECT results relative to delivery of SOC treatment for IgAN in other clinical settings • In the absence of head-to-head randomized trials, this study aimed to compare 2-year eGFR total slope outcomes between the 2 ar
Slide 5: Method: Data source and study outcome
METHOD Data source • The following data were utilized in this study: • Individual patient-level data from the sparsentan (N=202) and irbesartan (N=202) arms of the PROTECT trial (NCT03762850) in patients with IgA nephropathy2 • Published aggregate data of a subset of patients with IgA nephropathy in
Slide 6: Method: Statistical analysis
METHOD Statistical analysis • Patients in the sparsentan or irbesartan arms of the PROTECT trial were weighted to match key baseline effect modifiers and prognostic factors of patients from RaDaR or patients from the control arm of the NefIgArd trial, respectively • Matching weights were estimated u
Slide 7: Sparsentan and irbesartan vs SoC in RaDaR: Patient characteristics
RESULTS Sparsentan and irbesartan vs SoC in RaDaR Patient characteristics • In contrast to patients in RaDaR, participants in the PROTECT trial had older age, a lower percentage of White patients, a higher percentage of Asian patients, lower systolic blood pressure (SBP), lower eGFR, lower urine pro
Slide 8: Table 1. Baseline patient characteristics vs RaDaR SoC cohort
RESULTS Table 1. Baseline patient characteristics of sparsentan and irbesartan arms from the PROTECT trial vs. the SoC cohort from RaDaR Irbesartan Sparsentan Before matching After matching Before matching After matching SoC from RaDaR Summary Difference Summary Difference Summary Difference Summary
Slide 9: Sparsentan and irbesartan vs SoC in RaDaR: Two-year eGFR total slope
RESULTS Sparsentan and irbesartan vs SoC in RaDaR Two-year eGFR total slope • After matching, patients treated with maximally titrated irbesartan in the PROTECT trial demonstrated a significantly reduced annual rate of kidney function decline (-4.2 ml/min/1.73m2) compared to those receiving SoC in a
Slide 10: Figure 2. Comparisons of 2-year eGFR total slope in PROTECT and RaDaR
RESULTS Figure 2. Comparisons of 2-year eGFR total slope in PROTECT and RaDaR Sparsentan in PROTECT Real-world SoC in RaDaR A Irbesartan in PROTECT Real-world SoC in RaDaR B -0.5 -0.5 Annualized 2-year eGFR total slope, -1.5 Annualized 2-year eGFR total slope, -1.5 ml/min/1.73m2 per year (SE) ml/min
Slide 11: Sparsentan and irbesartan vs SoC in NefIgArd: Patient characteristics
RESULTS Sparsentan and irbesartan vs SoC in NefIgArd Patient characteristics • In contrast to patients in NefIgArd, participants in the PROTECT trial had older age, higher blood pressures, lower eGFR, lower urine protein, a higher percentage of baseline diabetes, and a longer duration of time since
Slide 12: Table 2. Baseline patient characteristics vs NefIgArd SoC arm
RESULTS Table 2. Baseline patient characteristics of sparsentan and irbesartan arms from the PROTECT trial vs. the SoC arm from the NefIgArd Trial Irbesartan Sparsentan Before matching After matching Before matching After matching SoC from NefIgArd Summary Difference Summary Difference Summary Diffe
Slide 13: Sparsentan and irbesartan vs SoC in NefIgArd: Two-year eGFR total slope
RESULTS Sparsentan and irbesartan vs SoC in NefIgArd Two-year eGFR total slope • After matching, similar results were observed when compared to SoC delivered in the clinical trial setting (NefIgArd) • Patients treated with maximally titrated irbesartan in the PROTECT trial demonstrated a significant
Slide 14: Figure 3. Comparisons of 2-year eGFR total slope in PROTECT and NefIgArd
RESULTS Figure 3. Comparisons of 2-year eGFR total slope in PROTECT and NefIgArd control arm RES A Irbesartan in PROTECT Optimized and stable RASi SOC in NefIgArd B Sparsentan in PROTECT Optimized and stable RASi SOC in NefIgArd ULTS -0.5 -0.5 Annualized 2-year eGFR total slope, Annualized 2-year eG
Slide 15: Limitations
LIMITATIONS • Similar to other indirect treatment comparisons, MAICs operate under the exchangeability of patients assumption, a premise that is difficult to definitively verify • Only baseline factors consistently reported across datasets could be aligned; results may be impacted by unreported or u
Slide 16: Conclusions
CONCLUSIONS • In PROTECT, maximally tolerated IRB was associated with a slower rate of kidney function decline than real-world SOC treatment in RaDaR and physician-defined, optimized SOC in NefIgArd • In PROTECT, SPAR was associated with a slower rate of kidney function decline than maximally tolera
Slide 17: References
REFERENCES 1. Barratt J, et al. Natural history of IgA nephropathy: Analysis of a UK National RaDaR IgA nephropathy cohort. J Am Soc Nephrol. 2021;32:S494. 2. Rovin BH, et al. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a random
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