The British Journal of Rheumatology, Vol 37, 217-221, Copyright © 1998 by British Society for Rheumatology
LW Fu, LY Yang, WP Chen and CY Lin
Cyclosporin A (CsA) was introduced in recent years for the treatment of
lupus nephritis in patients with steroid resistance or in those with severe
corticosteroid toxicity. Our previous study on paediatric patients showed
that Neoral (a new microemulsion formulation) had better bioavailability
than CsA capsules. To evaluate the clinical efficacy of Neoral in children
with lupus nephritis compared with conventional therapy, we performed an
open randomized study on 40 children, ranging from 9 to 14 yr old, with
class III-V lupus nephritis and heavy proteinuria. They were randomly
assigned to either Neoral (5 mg/kg/day), administered q.12.h, or
prednisolone (2 mg/kg/day) plus cyclophosphamide (2 mg/kg/day) for 1 yr.
Both groups showed a significant decrease in proteinuria (Neoral: 4.62 +/-
1.93 to 0.35 +/- 0.29 g/day, P < 0.05; prednisolone plus
cyclophosphamide: 4.52 +/- 1.86 to 0.62 +/- 0.21 g/day, P < 0.01). The
CH50 haemolytic assay titre decreased after 1 yr of Neoral treatment (26.5
+/- 0.9 to 21.4 +/- 2.2 U/ml, P < 0.05). Serum C3 and
anti-double-stranded (ds) DNA antibody levels also fell with Neoral (C3:
86.2 +/- 6.8 to 76.3 +/- 4.5 mg/dl; anti-ds DNA antibodies: 14.1 +/- 3.2 to
8.2 +/- 1.4 IU/ml, P < 0.05). The Neoral group had a significant
increase in growth rate over the prednisolone plus cyclophosphamide group
(8.2 +/- 1.1 cm/yr vs 2.7 +/- 0.6 cm/yr, P < 0.01) with improvement of
growth status. During the study period, patients tolerated Neoral well with
no significant changes in renal function, liver function or lipid profile.
Our study implies that Neoral appears to be effective in suppressing
proteinuria. Neoral should be regarded as being adjunctive therapy, perhaps
with a steroid-sparing effect, in paediatric lupus nephritis. However, its
long-term use awaits further studies.
ORIGINAL PAPERS
Clinical efficacy of cyclosporin a neoral in the treatment of paediatric lupus nephritis with heavy proteinuria
Department of Pediatrics, Veterans General Hospital-Taipei, Taiwan, ROC.
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