Kidney Week

Abstract: FR-PO866

Results from a Real-World Case Series of Patients with IgAN Who Received at Least 9 Months of Tarpeyo

Session Information

• IgA Nephropathy: Clinical, Outcomes, and Therapeutics
  October 25, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Ngai, Christopher, Calliditas Therapeutics AB, New York, New York, United States

Christopher Ngai

• Pesce, Giancarlo, Certara Inc, Princeton, New Jersey, United States

Giancarlo Pesce, MSc, PhD

• Zaidi, Sarah, Certara Inc, Princeton, New Jersey, United States

Sarah Zaidi

• Petiot, Nadia, Certara Inc, Princeton, New Jersey, United States

Nadia Petiot, MSc

• Tolouian, Ramin, Calliditas Therapeutics AB, New York, New York, United States

Ramin Tolouian, MD

• Madison, Terri, Calliditas Therapeutics AB, New York, New York, United States

Terri Madison, PhD, MPH

Background

Tarpeyo, a targeted-release formulation of budesonide, is currently the only FDA-approved treatment for IgA nephropathy (IgAN) to significantly reduce the loss of kidney function. This research evaluated safety and effectiveness outcomes in a cohort of Asian-American patients who received ≥ 9 months of Tarpeyo in a real-world setting.

Methods

Patients with IgAN who received Tarpeyo for ≥9 consecutive months at the Chinatown Kidney Care (CKC) practice (NY, USA) before Nov 30 2023 (data abstraction cutoff) were included in this retrospective analysis. Data were abstracted from patient-level electronic medical records.

Results

For the 30 patients meeting eligibility criteria, the mean age was 46 years, 57% were male, and 100% were Asian-American. Patients received Tarpeyo for an average 11.7 months and were followed-up for an average 14.6 months since Tarpeyo initiation. On average, eGFR was 68.4 mL/min/1.73m² at Tarpeyo initiation, which was 6.7 mL/min/1.73m² lower than when first seen at CKC (annual decrease until Tarpeyo initiation: 0.6 mL/min/1.73m²). After Tarpeyo initiation, eGFR increased by average 3.6 mL/min/1.73m² in 9 months [Figure]. Overall, adverse events (AEs) were observed in 2 patients; both were mild and resolved. In one patient the AE resulted in a dose reduction. Preliminary results for a subgroup of patients treated for > 9 months (n=23, mean Tarpeyo treatment duration=12.5 months) showed continued preservation of kidney function without an increase in incidence of serious AEs.

Conclusion

Results from this case series demonstrated that real-world use of Tarpeyo was well-tolerated and can reduce loss of kidney function in patients who receive ≥9 months of treatment.

Fig. eGFR distribution in IgAN patients before and after Tarpeyo initiation

Funding

• Commercial Support – Calliditas Therapeutics AB