Tacrolimus versus mycophenolate in lupus nephritis: similar response, different harms

Design

Prospective multicentre randomised controlled trial

Population

130 Asian patients with class III/IV ± V lupus nephritis

Primary outcome

Sustained renal response at week 96

Effect

58.5% v 69.2% (tacrolimus v MMF), not significant; serious infections more frequent with MMF

A randomised trial across Asian centres, published in Kidney International on 28 September, assigned 130 patients with biopsy-proven class III or IV lupus nephritis, with or without class V, to glucocorticoids plus either tacrolimus (trough 6–8 ng/mL) or mycophenolate mofetil (1 g twice daily), continued as induction and maintenance for 96 weeks.

Sustained renal response at 96 weeks was 58.5% with tacrolimus and 69.2% with mycophenolate, and complete remission 55.4% v 63.1%; neither difference was significant. Overall adverse events were the same (80%). The harms differed: acute kidney injury and tremor were more frequent with tacrolimus; leucopenia, treatment-related serious adverse events and serious infections were more frequent with mycophenolate, and all three deaths occurred in that arm.

The trial was small and not designed to prove equivalence, and the numerically lower response with tacrolimus should not be dismissed. Mycophenolate-based regimens remain standard in major guidelines, which have not changed on this trial. But because the data come from Asian patients, they are directly relevant to Indian practice, and they support tacrolimus as a reasonable alternative where mycophenolate is poorly tolerated or infection risk is a particular concern, with close monitoring of creatinine and trough levels.

• Mycophenolate-based therapy remains the guideline standard for class III/IV lupus nephritis.
• Consider tacrolimus with glucocorticoids where mycophenolate is poorly tolerated or infection risk is high.
• Monitor creatinine and tacrolimus troughs (6–8 ng/mL in this trial) for kidney injury.
• On mycophenolate, watch white cell counts and infection closely.

Why it matters

It gives randomised, Asian data for choosing between two immunosuppressants on safety rather than efficacy alone.

Don't overread it

The trial was small and not designed to show equivalence; the lower response with tacrolimus may be real.

The statistics, in plain English

With 65 patients per arm, a difference of 10 percentage points in response (58.5% v 69.2%) was not statistically significant, but the trial was too small to rule out a real difference of that size. 'No significant difference' is not the same as 'equally effective'.

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