Title: Long-term outcome of patients randomized in the euro-lupus nephritis trial: further evidence that a low-dose IV cyclosphosphamide induction regimen achieves good results
Authors: Houssiau, F
D'Cruz, D
Sebastiani, G
De Ramon Garrido, E
Danieli, M
Abramovicz, D
Blockmans, Daniel Engelbert
Cauli, A
Direskeneli, H
Galeazzi, M
Gül, A
Levy, Y
Petera, P
Popovic, R
Petrovic, R
Sinico, R
Cattaneo, R
Font, J
Depresseux, g
Cosyns, J
Cervera, R #
Issue Date: 2006
Publisher: Ann Rheum Dis
Host Document: vol:65 issue:64
Conference: Eular location:Amsterdam date:21-24 June 2006
Abstract: Background: In a prospective trial (ELNT), we randomly assigned 90 SLE patients with proliferative glomerulonephritis to a high-dose (HD) intravenous (IV) cyclophosphamide (CYC) regimen (6 monthly and 2 quarterly pulses; doses increased according to white blood cell count nadir) or a low-dose (LD) IV CYC regimen (6 fortnightly pulses at a fixed dose of 500 mg), each of which was followed by azathioprine (AZA). After a median of 73 months (M), we did not observe a different efficacy between the two regimens (Houssiau et al. A&R 2004; 50: 3934). The purpose of the current analysis is to further extend the follow-up and to compare long-term outcome measures.
Methods: Follow-up data were collected from all patients but 4 lost to follow-up. Survival curves were derived using the Kaplan-Meier (KM) method.
Results: After a mean (± SD) follow-up of 97 (15) M, the KM analyses indicated that there was no significantly greater cumulative probability of end-stage renal disease (ESRD; 4 in HD, 2 in LD), or death (1 in HD, 4 in LD) in patients given a LD IV CYC regimen. At follow-up, mean serum creatinine, number of red blood cells/high power field on urinalysis, 24-hour proteinuria, SLICC/ACR damage index, cumulated number of cardiovascular events, and incidence of cancer did not differ between groups. Steroids, other immunosuppressants and antihypertensive drugs were still prescribed to 71, 55 and 61% of the patients, respectively (without "between groups" differences). More than 8 years after initial therapy for lupus nephritis, 74% of LD patients had not received more than 3 g of IV CYC (i.e. the per protocol regimen) and their mean cumulative dose of IV CYC remained much lower compared to HD patients (p = 0.002). Percentages of menopaused patients did not differ but LD patients had more successful pregnancies after randomisation in the trial (p = 0.05).
Conclusion: Long-term follow-up of patients randomized in the ELNT confirms that a remission-inducing regimen of LD IV CYC followed by AZA achieves clinical results comparable to those obtained with a HD regimen. Interestingly, two thirds of LD patients did not require additional IV CYC and successful pregnancies were more common in LD patients.

SLE clinical aspects
Publication status: published
KU Leuven publication type: IMa
Appears in Collections:Laboratory for Clinical Infectious and Inflammatory Disorders
# (joint) last author

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