Data from two studies presented at the 2023 American Society of Nephrology Kidney Week provide further insight into the potential of budesonide delayed-release capsules (Talpeyo) in the management of primary IgA nephropathy.
The meeting will provide clinicians with two years of data from the Phase 3 NefIgArd trial and estimate the potential benefits of budesonide delayed-release capsules in this patient population as the drug’s December 2023 PDUFA deadline approaches. New insights regarding modeling studies were provided.1, 2, 3
Decline in eGFR from 2 years of NefIgArd data
After full trial results are published, lancet A 2023 Kidney Week study published in August 2023 by Richard Lafayette, M.D., founder and director of the Stanford Glomerular Disease Center, found that after two years, the effects of budesonide delayed-release capsules compared to placebo therapy The effect on eGFR reduction in patients has been described. trial. Of note, this analysis included all of his 364 patients from the study’s entire analysis set.1
The analysis showed that 21.4% of the placebo group and 11.5% of the budesonide group had an eGFR decline of 30% or more. Further analysis suggested that time to 30% reduction was significantly delayed with budesonide compared with placebo (hazard ratio) [HR]0.45; 95% confidence interval [CI]0.26-0.75]; P=.0014). The researchers also noted that a predefined supplemental analysis that included rescue medication use as an event yielded similar results (HR, 0.51).1
long-term modeling study2
Another study at Kidney Week 2023 was presented by Jonathan Barratt, MD, Mayer Professor of Nephrology at the University of Leicester, describing NefIgArd’s 2-year total eGFR slope-based modeling study aimed at predicting long-term clinical outcomes. The results are detailed. In IgA nephropathy. Given that his observed 2-year total eGFR slope was 2.78 mL/min/1.73 m2/year (95% CI, 1.39 to 4.17), the researchers concluded that the change in his 2-year total eGFR slope and designed a linear regression model to examine the treatment effect. Log HR of clinical outcomes based on a meta-analysis of over 60,000 patients with chronic kidney disease.2
Researchers matched 352 of the 364 NefIgArd patients to a cohort of 866 unique records at Leicester General Hospital. Modeling study results showed that the total slope observed with NefIgArd translated to a log HR of clinical outcome of 0.38 (95% CI, 0.21 to 0.63) compared with placebo. Further analysis suggested that the median time to clinical outcome was 9.6 years in the standard treatment group and 22.4 years in the budesonide group (median delay 12.8 years) [95% CI 4.8–27.9] Year). Additionally, the researchers highlighted that 24% of those in the budesonide group were expected to experience a clinical outcome within 10 years, compared to 52% in the standard-of-care group.2
Read our interview with Mr. Barratt to learn more about budesonide delayed-release capsules in the management of IgA nephropathy.
Disclosures related to Barrett include Cariditas Therapeutics, Alnylam Pharmaceuticals, Travele Therapeutics, Chinook Therapeutics, Novartis and others.
References:
- Lafayette RA, Christensen J, Stone AM et al. Reducing eGFR in IgA nephropathy patients treated with Nefecon or Placebo: Results from the 2-year NefIgArd Phase 3 trial. Paper presentation location: American Society of Nephrology Kidney Week 2023. November 1-5, 2023.
- Barrett J, Stone AM, Reich HN, Lafayette RA. NefIgArd’s 2-year total eGFR slope-based modeling predicts long-term clinical benefit of Nefecon in a real-world IgA nephropathy (IgAN) population. Paper presentation location: American Society of Nephrology Kidney Week 2023. November 1-5, 2023.
- Cariditas Therapeutics. The FDA has granted priority review for full approval of Tarpeyo for the treatment of IGA nephropathy. The FDA has granted priority review for full approval of his TARPEYO for the treatment of IgA nephropathy. August 18, 2023. Accessed November 4, 2023. https://www.prnewswire.com/news-releases/fda-grants-priority-review-for-full-approval-of-tarpeyo-for-the-treatment-of-iga-nephropathy-301904398.html.