Abstract: SA-PO0808
Safety Profile of Combined Nefecon and Sparsentan Therapy
Session Information
- Glomerular Management: Real-World Lessons and Emerging Therapies
November 08, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Wang, Jingyu, Peking University First Hospital Department of Nephrology, Beijing, China
- Shi, Sufang, Peking University First Hospital Department of Nephrology, Beijing, China
- Lv, Jicheng, Peking University First Hospital Department of Nephrology, Beijing, China
- Zhang, Yuemiao, Peking University First Hospital Department of Nephrology, Beijing, China
- Zhang, Hong, Peking University First Hospital Department of Nephrology, Beijing, China
Background
To date, there have been no safety reports on the combination of Nefecon and Sparsentan.
Methods
Data on Nefecon, alone or in combination with Sparsentan, were extracted from the FDA Adverse Event Reporting System. Disproportionality analysis was performed to identify potential adverse reactions (AEs).
Results
After combination with sparsentan, the AE spectrum associated with Nefecon decreased from 32 signals to 5 signals (Figure 1a, b). Subgroup-specific signals by sex and age (male, female, younger, and middle-aged to elderly patients) are presented in Figures 1c–f. Similarly, following combination with Nefecon, the sparsentan's AE spectrum narrowed from 43 signals to 7 signals (Figure 1e, f), with subgroup-specific signals shown in Figures 2g–i for males, females, younger, and middle-aged to elderly patients.
Conclusion
This is the first safety analysis of combined targeted therapy for IgAN. Our findings show that compared to monotherapy, combined use of Nefecon and sparsentan reduces the spectrum of AEs.
Table 1
| Cohort 1 (N=2678) | Cohort 2 (N=52) | Cohort 3 (N=948) | Cohort 4 (N=59) | |
| Gender | ||||
| Female | 1172 (43.8%) | 26 (50.0%) | 436 (46.0%) | 26 (44.1%) |
| Male | 1506 (56.2%) | 26 (50.0%) | 510 (53.8%) | 33 (55.9%) |
| Age (yr) | ||||
| 18-44 | 1074 (40.1%) | 28 (53.8%) | 389 (41.0%) | 16 (27.1%) |
| ≥45 | 1604 (59.9%) | 24 (46.2%) | 559 (59.0%) | 43 (72.9%) |
| Outcomes | ||||
| Death | 22 (0.8%) | 0 (0%) | 6 (0.6%) | 0 (0%) |
| Life-threatening | 8 (0.3%) | 1 (1.9%) | 0 (0%) | 0 (0%) |
| Hospitalization | 231 (8.6%) | 3 (5.8%) | 75 (7.9%) | 8 (13.6%) |
| Other serious outcome | 256 (9.6%) | 4 (7.7%) | 135 (14.2%) | 12 (20.3%) |
| Unknown | 2161 (80.7%) | 44 (84.6%) | 732 (77.2%) | 39 (66.1%) |
| Reported countries | ||||
| US | 2677 (100.0%) | 52 (100%) | 923 (97.4%) | 59 (100%) |
| Other | 1 (0.0%) | 0 (0%) | 25 (2.6%) | 0 (0%) |
*denotes previously reported.