Abstract: SA-OR050
Prospective Randomized Controlled 96-week Study to Evaluate the Efficacy and Safety of Tacrolimus and Glucocorticoid as Continuous Induction-Maintenance Treatment for Class III/IV±V Lupus Nephritis
Session Information
- Glomerular Targeted Therapies: The New Era
November 08, 2025 | Location: Room 310A, Convention Center
Abstract Time: 05:10 PM - 05:20 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Chan, Tak Mao Daniel, Department of Medicine, The University of Hong Kong, Hong Kong SAR, Hong Kong
- Yap, Yat Hin Desmond, Department of Medicine, The University of Hong Kong, Hong Kong SAR, Hong Kong
- Ni, Zhaohui, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
- Avihingsanon, Yingyos, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand
- Lim, Soo Kun, Department of Medicine, University Malaya Medical Centre, Kuala Lumpur, Malaysia
- Jiang, Na Ginna, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
- Chen, Wei, Department of Nephrology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
- Li, Chao, Department of Nephrology, Peking Union Medical College Hospital, Beijing, China
- Zhi, Hui Helen, School of Public Health, The University of Hong Kong, Hong Kong SAR, Hong Kong
- Yung, Susan, Department of Medicine, The University of Hong Kong, Hong Kong SAR, Hong Kong
- Chan, Wing Suet Catherine, Department of Medicine, The University of Hong Kong, Hong Kong SAR, Hong Kong
- Takeuchi, Tsutomu, Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
- Navarra, Sandra V., Department of Medicine, University of Santo Tomas, Manila, Philippines
Background
Tacrolimus (TAC) and glucocorticoid as continuous induction-maintenance therapy for lupus nephritis (LN) has never been investigated. We conducted a prospective randomized open-label multicenter study to evaluate its efficacy and safety against standard-of-care mycophenolate (MMF) and glucocorticoid dual immunosuppression in Asian patients with active severe LN.
Methods
Patients with biopsy-proven Class III/IV±V LN were randomized to receive pulse methylprednisolone (500mg/500mg/150mg) for 3 days followed by oral prednisolone (0.7mg/kg/day, then taper) in combination with either TAC (initial dose 2mg bid; target trough level 6-8ng/mL) or MMF (1g bid), then followed for 96 weeks. Primary endpoint was sustained renal response (SRR) [defined as proteinuria reduced by >50% compared with baseline and 24h urine protein <1g and serum creatinine not higher than 15% above baseline and no disease flare or rescue therapies] at Week 96. Secondary endpoints included complete renal response rates (CR), adverse events, and time-to-renal related adverse events/death.
Results
130 patients were randomized (65 in each group). TAC and MMF treatment groups showed similar rates of SRR (58.5% vs 69.2%, OR 0.62; 95% CI 0.29-1.29; p=0.2) and CR (55.4% vs 63.1%, OR 0.72; p=0.36) at Week 96. SRR rates for TAC and MMF groups were 53.8% vs 52.3% at Week 24, and 63.1% vs 66.2% at Week 48 respectively. Time-to-renal related adverse events/death were similar in both groups (HR 0.70; 95% CI 0.37-1.35; p=0.29). Overall adverse event rates were 69.2% and 70.8% in TAC and MMF groups respectively (p=1.00), while serious adverse events were more frequent in the MMF group (12.3% vs 30.8%, p=0.02). Acute kidney injury (16.9% vs 3.1%) and tremor (16.9% vs 0%) were more frequent in TAC-treated patients, while leucopoenia (1.5% vs 12.3%) was more frequent in the MMF group. Three patients in the MMF group died.
Conclusion
Immunosuppressive regimen with TAC combined with glucocorticoid showed comparable efficacy as MMF with glucocorticoid, as induction-maintenance treatment for LN over 96 weeks, with similar overall adverse event rate but a different safety profile.
Funding
- Private Foundation Support