Safety Profile of Combined Nefecon and Sparsentan Therapy

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.*denotes previously reported. 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%)