Randomised, double-blind, placebo-controlled trial to

determine whether steroids reduce the incidence and

severity of nephropathy in Henoch-Schnlein Purpura
(HSP)
Jan Dudley, Graham Smith, Anne Llewelyn-Edwards, Kate Bayliss, Katie
Pike, Jane Tizard

David Anggara P

Supervisor:
Dr. Ganung Harsono SpA (K)
Dr diah Lintang K., SpA MKes
INTRODUCTIONBATAS

Henoch-Schnlein Purpura (HSP) is

the commonest small vessel
vasculitis of childhood

Renal involvement in HSP affects

20%70% of patients with the
incidence of severe long-term
morbidity/mortality being less than
OBJECTIVE BATAS

The benefit early treatment with prednisolone

on the development of renal disease in
pediatric HSP
METHODS BATAS
Study multi-centre, blinded, parallel group, randomised (centre-
design stratified, allocation ratio 1 : 1) and placebo-controlled
trial
Subjects Inclusion:
Children under 18 years of age presenting to one of the
24 participating secondary care centres in England and
Wales with a diagnosis of HSP (HSP), based on the
American College of Rheumatology criteria
Exclusion:
Interventio Prednisolone 2 mg/kg/day (max 80 mg) for 7 days,
n followed by 1 mg/kg/day for 7 days (max 40 mg) or
BATAS
placebo for 14 days.
Outcome Primary
o Proteinuria after 12 month
o The need for additional treatment ; (hypertension,
renal biopsy anomaly and need for treatment of renal
disease) in the 12-month study period
Secondary
Presence of symptoms of possible trial medication-
induced toxicity; defined as the reporting of
hypertension, abdominal pain, nausea and/or vomiting
or adverse events before the end of the 4-week visit.
Randomiza Centre-stratified block randomisation
tion
Follow-up 4 weeks, 3 months and 12 months
Statistical Chi-square test or Fishers exact test
FLOWCHART
RESULT
There was no significant difference in the proportion of patients with
UP: UC >20 mg/mmol at 12 months between the treatment groups
DISCUSSION
The advantages of this
study:
1) The largest sample
with prospective
study
2) Randomised
3) Placebo-controlled
trial

) Provides the best

evidence about the
role of steroid in HSP
Intervension
Prednisolone 2 mg/kg for 1 week followed by a weaning dose over the second
week followed a year
Conclusion
There are no difference in the incidence of renal involvement at 1 year

Intervension
Prednisolone 1 mg/kg/day for 2 weeks followed by a weaning dose over 2 weeks
followed 6 months
Conclusion
1. Prednisolone did not prevent the development of nephritis
Conclusion:
Urine and blood pressure abnormalities 8 years after
HSP are associated with nephritis at its onset. Early
prednisone treatment does not affect the
outcome and should not be routinely used
 Steroids did reduce the risk of developing persistent renal disease

there was no evidence of benefit of early short-term steroids in the

prevention or treatment of HSPN 612 months following presentation
CONCLUSION
There is no beneficial effect of routine steroids in HSP
APPRAISAL
THANK YOU