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Kidney Week

Abstract: SA-PO0659

Real-World Reasons for Discontinuation of Targeted-Release Budesonide in IgAN

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

  • Vadpey, Omid, University of California San Francisco, San Francisco, California, United States
  • Vaidya, Neha Vijay, University of California San Francisco, San Francisco, California, United States
  • Zeng, Billy, University of California San Francisco, San Francisco, California, United States
  • Sam, Ramin, University of California San Francisco, San Francisco, California, United States
  • Carlos, Christopher Anthony, University of California San Francisco, San Francisco, California, United States
  • Khairallah, Pascale, University of California San Francisco, San Francisco, California, United States
  • Nwosu, Uchenna A., University of California San Francisco, San Francisco, California, United States
  • Sarathy, Harini, University of California San Francisco, San Francisco, California, United States
  • Hsu, Raymond K., University of California San Francisco, San Francisco, California, United States
Background

Targeted-release (TR) budesonide is approved in the US to treat IgAN. In NeFlgArd, the standard duration of TR budesonide was 9 months. In real world practice, there is likely significant variability in duration of treatment and reasons for TR budesonide discontinuation. We report real-world experience from two academic centers.

Methods

Adults with biopsy-proven IgAN who initiated and stopped TR budesonide were included. Baseline characteristics including demographics, comorbidities, prior immunosuppression, concurrent therapies were captured. Longitudinal assessments of eGFR and UPCR were added. Based on chart review and discussion with treatment team, we ascertained start/stop dates, and reasons for discontinuation for each course of TR budesonide.

Results

13 patients treated with TR budesonide in 16 discreet courses of therapy were included (3 had repeated courses). Mean age was 44 years. 70% female; 80% Asian; 81% with HTN. Mean SCr was 1.9mg/dL; mean eGFR 46±28 mL/min/1.73m2. Median UPCR was 2.0g/g (IQR 1.1,2.5). Background therapies: 81% RAS-blocker, 69% SGLT2-inhibitor, 13% sparsentan. 50% received prior immunosuppression. Mean UPCR reduction was 10±77% at time of TR-budesonide discontinuation. Median annualized eGFR slope was -1.9 mL/min/1.73m2 (IQR -13.3,3.2). Mean duration of TR budesonide treatment was 10.6±5.2 months. 5 (31%) of 16 courses of TR budesonide lasted <9 months, while 4 (25%) lasted >12 months. Of 16 courses of therapy, only 3 (19%) were stopped routinely after 9+ months of therapy. 56% experienced lack of efficacy and 44% experienced side effects that contributed to therapy discontinuation(Fig).

Conclusion

In our small but growing cohort, lack of efficacy in either proteinuria reduction or eGFR stabilization was a major reason for TR-budesonide discontinuation. Side effects that would not be considered major adverse events in clinical trials such as minor weight gain and moon facies also contributed to stopping therapy.