Abstract: SA-PO0824
Beyond Nine Months: Real-World Efficacy and Safety of Extended Nefecon Therapy in IgAN
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
- Ling, Xia, Everest Medicines Ltd, Shanghai, Shanghai, China
- Cheng, Ming, Shanghai Changzheng Hospital, Shanghai, Shanghai, China
- Ao Ieong, Chi Wa, Kiang Wu Hospital, Macau, Macao
- Yichi, Zhang, Hangzhou First People's Hospital, Hangzhou, Zhejiang, China
- Ming, Yang, Shanghai Fourth People's Hospital, Shanghai, Shanghai, China
- Shi, Xuexue, Hangzhou First People's Hospital, Hangzhou, Zhejiang, China
- Ning, Zhao, Hangzhou First People's Hospital, Hangzhou, Zhejiang, China
- Han, Shuai, Shanghai Pudong New Area People's Hospital, Shanghai, Shanghai, China
- Yang, Xiu, Hangzhou First People's Hospital, Hangzhou, Zhejiang, China
Background
IgA nephropathy (IgAN) is a major cause of ESRD in Asia, with ~60% of Chinese patients progressing within 15 years. Nefecon, a targeted-release budesonide, showed short-term efficacy in the 9-month NefIgArd trial. This study assessed the real-world efficacy and safety of 12-month Nefecon treatment in IgAN patients.
Methods
This retrospective study included 12 IgAN patients treated with Nefecon 16 mg/day for 12 months and 72 matched controls receiving conventional therapy (supportive care with or without steroids/immunosuppressants). Propensity score matching (1:3) was performed based on age, sex, serum creatinine, eGFR, and 24h urine protein. Key outcomes were 24h urine protein and eGFR slope. Adverse events were recorded.
Results
After matching, 12 Nefecon-treated patients and 36 controls were analyzed. Median 24h urine protein significantly decreased in both groups: Nefecon (1016 [490, 1296] to 114 [96, 139] mg, p=0.037) vs. control (1074 [663, 1597] to 291 [167, 589] mg, p<0.001), with lower proteinuria in the Nefecon group at 12 months (p=0.01). eGFR slope favored Nefecon (5.4 [1.6, 11.6] vs. -3.4 [-12.9, 8.2] mL/min/1.73m2/year, p=0.032). No serious infections were observed in the Nefecon group. Mild adverse events included changes in bowel habits, sleep disturbance, and menstrual irregularities.
Conclusion
Twelve-month Nefecon therapy significantly reduced proteinuria and stabilized renal function compared to conventional therapy in real-world IgAN patients. Its targeted delivery offered a more favorable safety profile, supporting the benefit of extended treatment duration beyond 9 months.
Clinical characteristics of the Nefecon group and control group after PSM
| Control group(N=36) | Nefecon group(N=12) | p-value | |
| Male, n (%) | 0.47 (0.51) | 0.58 (0.51) | 0.524 |
| Age, years | 40 [33, 53] | 40 [36, 45] | 0.291 |
| Baseline SCr, μmol/L | 113.2 (38.1) | 127.8 (48.6) | 0.358 |
| Baseline eGFR, ml/min/1.73 m2 | 76.4 (32.2) | 62.3 (23.5) | 0.117 |
| Baseline 24-hour urine total protein, mg | 1074 [663, 1597] | 1016 [490, 1296] | 0.44 |