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Azathioprine versus mycophenolate mofetil for long-term immunosuppression in lupus nephritis: results from the
Frédéric A Houssiau1, David D'Cruz, Shirish Sangle
1Rheumatology Department, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Saint-Luc University Hospital, Brussels 1200, Belgium. frederic.houssiau@uclouvain.be
Background:
Long-term immunosuppressive treatment does not efficiently prevent relapses of lupus nephritis (LN). This investigator-initiated randomised trial tested whether mycophenolate mofetil (MMF) was superior to azathioprine (AZA) as maintenance treatment.
Methods:
A total of 105 patients with lupus with proliferative LN were included. All received three daily intravenous pulses of 750 mg methylprednisolone, followed by oral glucocorticoids and six fortnightly cyclophosphamide intravenous pulses of 500 mg. Based on randomisation performed at baseline, AZA (target dose: 2 mg/kg/day) or MMF (target dose: 2 g/day) was given at week 12. Analyses were by intent to treat. Time to renal flare was the primary end point. Mean (SD) follow-up of the intent-to-treat population was 48 (14) months.
Results:
The baseline clinical, biological and pathological characteristics of patients allocated to AZA or MMF did not differ. Renal flares were observed in 13 (25%) AZA-treated and 10 (19%) MMF-treated patients. Time to renal flare, to severe systemic flare, to benign flare and to renal remission did not statistically differ. Over a 3-year period, 24 h proteinuria, serum creatinine, serum albumin, serum C3, haemoglobin and global disease activity scores improved similarly in both groups. Doubling of serum creatinine occurred in four AZA-treated and three MMF-treated patients. Adverse events did not differ between the groups except for haematological cytopenias, which were statistically more frequent in the AZA group (p=0.03) but led only one patient to drop out.
Conclusions:
Fewer renal flares were observed in patients receiving MMF but the difference did not reach statistical significance.
Insights
Mycophenolate mofetil (MMF) showed a trend toward fewer renal flares than azathioprine (AZA) in lupus nephritis (LN) maintenance therapy, but the difference was not statistically significant. Both treatments demonstrated similar efficacy and safety profiles for lupus nephritis patients.
Area of Science:
- Nephrology
- Rheumatology
- Immunology
Background:
- Long-term immunosuppressive therapy often fails to prevent lupus nephritis (LN) relapses.
- Investigator-initiated randomized trial to compare mycophenolate mofetil (MMF) and azathioprine (AZA) for maintenance treatment in LN.
Purpose of the Study:
- To determine if mycophenolate mofetil (MMF) is superior to azathioprine (AZA) in preventing renal flares in patients with lupus nephritis (LN).
Main Methods:
- 105 patients with proliferative lupus nephritis (LN) received induction therapy (methylprednisolone, cyclophosphamide).
- Patients were randomized to receive either azathioprine (AZA) or mycophenolate mofetil (MMF) as maintenance therapy starting at week 12.
- Primary endpoint was time to renal flare, with a mean follow-up of 48 months.
Main Results:
- Renal flares occurred in 25% of AZA-treated and 19% of MMF-treated patients; this difference was not statistically significant.
- Time to renal flare, severe systemic flare, benign flare, and renal remission did not differ significantly between groups.
- Adverse events were similar, except for more frequent hematological cytopenias in the AZA group (p=0.03).
Conclusions:
- Mycophenolate mofetil (MMF) demonstrated a trend towards fewer renal flares compared to azathioprine (AZA) in lupus nephritis (LN) maintenance, though not statistically significant.
- Both MMF and AZA showed comparable efficacy and safety profiles for long-term lupus nephritis management.
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