The 10-year follow-up data of the Euro-Lupus Nephritis Trial comparing low-dose versus high-dose intravenous cyclophosphamide.

OBJECTIVE: To update the follow-up of the Euro-Lupus Nephritis Trial (ELNT), a randomized prospective trial comparing low-dose (LD) versus high-dose (HD) intravenous (IV) cyclophosphamide (CY) followed by azathioprine (AZA) as treatment for proliferative lupus nephritis. PATIENTS AND METHODS: Data regarding survival and kidney function were prospectively collected during a 10-year period for the 90 patients randomized in the ELNT, except in 6 lost to follow-up. RESULTS: Death, sustained doubling of serum creatinine and end-stage renal disease rates did not differ between the LD and HD group (11% vs 4%, 14% vs 11% and 5% vs 9%, respectively) nor did mean serum creatinine, 24-h proteinuria and damage score at last follow-up. Most patients in both groups were still treated with glucocorticoids, other immunosuppressants and blood pressure lowering drugs. We confirm, after 10 years of follow-up, the positive predictive value for a good outcome of an early drop in proteinuria in response to initial immunosuppressive therapy. CONCLUSION: Our data confirm that a LD IVCY regimen followed by AZA - the "Euro-Lupus regimen" - achieves good clinical results in the very long-term.