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Long-term outcome of a randomised controlled trial comparing tacrolimus with mycophenolate mofetil as induction therapy for active lupus nephritis
  1. Chi Chiu Mok1,
  2. Ling Yin Ho1,
  3. Shirley King Yee Ying2,
  4. Man Chi Leung3,
  5. Chi Hung To1,
  6. Woon Leung Ng3
  1. 1 Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong
  2. 2 Department of Medicine, Princess Margaret Hospital, Hong Kong, China
  3. 3 Medicine, United Christian Hospital, Hong Kong, Hong Kong
  1. Correspondence to Dr Chi Chiu Mok, Medicine, Tuen Mun Hospital, Hong Kong SAR, Hong Kong; ccmok2005{at}


Objectives To report the 10-year outcome of lupus nephritis (LN) treated with mycophenolate mofetil (MMF) or tacrolimus (TAC) induction in a randomised controlled trial.

Methods Patients with active LN were treated with MMF or TAC combined with high-dose prednisolone. Responders were switched to azathioprine (AZA) at month 6. Clinical outcomes at 10 years (renal flares, renal function decline and mortality) were assessed. Factors affecting prognosis were studied by Cox regression. Urine protein-to-creatinine ratio (uPCr) and estimated glomerular filtration rate (eGFR) at different time points were evaluated for their prediction of a poor prognosis by receiver operating characteristic (ROC) analysis.

Results 150 patients were studied (age 35.5±12.8 years). Complete renal response rate was similar between MMF (59%) and TAC-treated patients (62%; p=0.71). AZA maintenance was given to 79% patients. After 118.2±42 months, proteinuric and nephritic renal flares occurred in 34% and 37% of the MMF, and 53% and 30% of the TAC groups of patients, respectively (p=0.49). The cumulative incidence of a composite outcome of ↓eGFR ≥30%, chronic kidney disease stage 4/5 or death at 10 years was 33% in both groups (p=0.90). Factors independently associated with a poor renal prognosis were first-time LN (HR 0.12 (0.031 to 0.39); p=0.01), eGFR (HR 0.98 (0.96 to 0.99); p=0.008) and no response at month 6 (HR 5.18 (1.40 to 19.1); p=0.01). ROC analysis revealed an uPCr >0.75 and eGFR of <80 mL/min at month 18 best predicted a poor renal prognosis.

Conclusions Long-term data confirmed non-inferiority of TAC to MMF as induction therapy of LN. An uPCr≤0.75 and eGFR of ≥80 mL/min at month 18 best predicted a favourable 10-year outcome and may be suitable targets for induction/consolidation therapy.

Trial registration number NCT00371319.

  • systemic lupus erythematosus
  • lupus nephritis
  • outcomes research
  • treatment

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  • Handling editor Josef S Smolen

  • Contributors CCM: study design, patients’ assessment, data collection and analysis. LYH, SKY, MCL, CHT and WLN: patients’ assessment and follow-up, data collection.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Patient consent for publication Not required.

  • Ethics approval The study protocol was approved by the Research & Ethics Committee of Tuen Mun Hospital, which consists of lay persons from the public as the core members.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.