Prospective 96-week study to evaluate efficacy and safety of tacrolimus and glucocorticoid against mycophenolate and glucocorticoid as continuous induction-maintenance treatment for Class III/IV without or with Class V lupus nephritis
In brief
Tacrolimus and mycophenolate produced similar remission rates at 96 weeks
In a randomized trial of 130 patients with lupus nephritis, sustained renal response at 96 weeks occurred in 58.5% receiving tacrolimus and 69.2% receiving mycophenolate, with no significant difference between treatments. Overall adverse event rates were equal, but the types differed: serious treatment-related events and severe infections were more frequent with mycophenolate, while acute kidney injury and tremors were more frequent with tacrolimus.
- Journal
- Kidney international (Q1)
- Published
- 28 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Desmond Y H Yap, Sandra V Navarra, Zhaohui Ni, Yingyos Avihingsanon, Soo Kun Lim, Hui Zhi, et al.
- PMID
- 42805336
- DOI
- 10.1016/j.kint.2026.08.026
Why clinicians should know about it
- Picked for Rheumatology (paper of the day, 29 September 2026): Tacrolimus vs MMF in lupus nephritis: efficacy and safety
Abstract
INTRODUCTION: We conducted a prospective Asian multicenter randomized controlled trial to evaluate the efficacy and safety of tacrolimus (TAC) and glucocorticoid (GC), against standard-of-care mycophenolate (MMF) and GC, as continuous induction-maintenance therapy for active lupus nephritis (LN) (ClinicalTrials.gov ID: NCT02630628). METHODS: One Hundred thirty biopsy-proven patients with Class III/IV without or with Class V LN were randomized to receive GC (intravenous methylprednisolone for three days then oral prednisolone) with either TAC (target trough level 6 - 8ng/mL) or MMF (1g twice a day) for 96 weeks. Primary endpoint was Sustained Renal Response (SRR) at week 96, defined as proteinuria reduction over 50% and estimated glomerular filtration rate no less than 60mL/min per 1.73m2, and no disease flare or rescue therapies. Secondary endpoints included rates of Complete Renal Remission (CRR) and Partial Renal Remission (PRR) at week 96, SRR at week 48, and adverse events (AE). RESULTS: TAC and MMF groups (65 patients each) showed no significant difference in the rates of SRR (58.5% vs 69.2% respectively) and CRR (55.4% vs 63.1% respectively) at week 96. SRR rates for TAC and MMF groups were 63.1% vs 66.2% at week 48, respectively. Overall, AE rates did not differ between TAC and MMF groups (80.0% in both). Acute kidney injury and tremors were more frequent in TAC group, while leucopoenia was more frequent in MMF group. Three deaths occurred, all in the MMF group. Treatment-related serious adverse events (SAE) and infection resulting in SAE were significantly more frequent in the MMF group. CONCLUSIONS: Dual immunosuppressive regimen with TAC and GC showed no difference in efficacy but different safety profile compared with MMF and GC over 96 weeks, when used as continuous induction-maintenance treatment for LN.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.