Abstract: SA-PO0640
Efficacy and Safety of Nefecon in Chinese Patients with IgAN: Real-World Evidence
Session Information
- Glomerular Diseases: Clinical, Outcomes, and Therapeutics Research - Other
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Li, Xiaomei, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Chen, Shulin, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Fei, Yang, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Wang, Niansong, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Fan, Ying, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
Background
Nefecon is a targeted-release budesonide formulation that acts on gut mucosal immunity, representing an etiology-based therapy. Its efficacy in reducing proteinuria and slowing renal function decline, established in the global phase III NEFIGARD trial, has led to its inclusion as a first-line treatment in the 2024 KDIGO guidelines. Since its approval in China, Nefecon has been in clinical use for over a year. Nevertheless, real-world evidence, particularly for progressive or high-risk patients requiring intensive intervention, remains limited.
Methods
We conducted a single-center observational study of biopsy-proven primary IgAN patients treated with Nefecon for >12 weeks at Shanghai Sixth People's Hospital from Oct 2024 to May 2026. Patients were grouped as Nefecon monotherapy group (Nefecon) or Nefecon plus other immunosuppressants group (Nefecon+IS). Baseline and follow-up characteristics were recorded. Renal biopsy specimens were scored using the Oxford MEST-C classfication.
Results
Sixty-two patients [median age 37 years; 53.2% male; baseline proteinuria 1.44 g/d; eGFR 74.96mL/min/1.73 m2; RAASi use 74.2%, SGLT2i use 50%] were included: 35 cases in Nefecon and 27 cases in Nefecon + IS group. The median duration of Nefecon therapy was 51.6 [35.2, 58.2] weeks (33 individuals more than 36 weeks). The proportions of the Oxford classification types M1, E1, S1, T1/2, and C1/2 are 77.42%, 67.74%, 54.84%, 24.19%/8.06%, and 24.19%/4.84% respectively. The Nefecon+IS group indicated more severe disease activity than Nefecon: endocapillary hypercellularity (75.56% vs 57.14% ) and cellular/fibrocellular crescents (38.15% vs 14.29%). Overall, proteinuria decreased by 36.17% after 9 months of Nefecon treatment (27.08% in Nefecon group and 43.56% in Nefecon + IS group; both p < 0.001), while eGFR changed stable (7.56% in Nefecon group, P=0.107; 4.29% in Nefecon + IS group, P=0.366). The adverse events were relatively minor.
Conclusion
Nefecon was associated with stable renal function and proteinuria reduction in IgAN patients. Combination with immunosuppressive therapy was used in patients with more active kidney pathological injury and showed more significant benefits.