ESPN 53rd Annual Meeting

ESPN 2021


 
LOW-DOSE PREDNISOLONE AT THE TIME OF AN URTI DOES NOT PREVENT RELAPSES IN STEROID SENSITIVE NEPHROTIC SYNDROME BUT MAY HAVE A HEALTH ECONOMIC BENEFIT: THE PREDNOS 2 TRIAL
MARTIN CHRISTIAN 1 NICHOLAS WEBB 2 SAMIR MEHTA 3 REBECCA WOOLLEY 3 ELIZABETH BRETTELL 3 ADAM KHAN 3 NATALIE IVES 3 NAFSIKA AFENTOU 4 EMMA FREW 4 DAVID MILFORD 5 DETLEF BOCKENHAUER 6 MOIN SALEEM 7 ANGELA HALL 8 ANIA KOZIELL 9 HEATHER MAXWELL 10 SHIVARAM HEGDE 11 HITESH PRAJAPATI 12 RODNEY GILBERT 13 CAROLINE JONES 14 KARL MCKEEVER 15 WENDY COOK 16

1- NOTTINGHAM CHILDREN’S HOSPITAL
2- ROYAL MANCHESTER CHILDREN’S HOSPITAL
3- BIRMINGHAM CLINICAL TRIALS UNIT, UNIVERSITY OF BIRMINGHAM
4- HEALTH ECONOMICS UNIT, UNIVERSITY OF BIRMINGHAM
5- BIRMINGHAM CHILDREN’S HOSPITAL
6- GREAT ORMOND STREET HOSPITAL FOR CHILDREN
7- BRISTOL ROYAL HOSPITAL FOR CHILDREN
8- LEICESTER CHILDREN’S HOSPITAL
9- EVELINA CHILDREN’S HOSPITAL, LONDON
10- ROYAL HOSPITAL FOR SICK CHILDREN, GLASGOW
11- UNIVERSITY HOSPITAL OF WALES, CARDIFF
12- LEEDS CHILDREN’S HOSPITAL
13- SOUTHAMPTON CHILDREN’S HOSPITAL
14- ALDER HEY CHILDREN’S HOSPITAL, LIVERPOOL
15- DEPARTMENT OF PAEDIATRIC NEPHROLOGY, ROYAL HOSPITAL FOR SICK CHILDREN, BELFAST, UK
16- NEPHROTIC SYNDROME TRUST (NEST)
 
Introduction:

For children with relapsing steroid sensitive nephrotic syndrome (rSSNS),previous studies have shown that giving daily low-dose prednisolone for 5-7 days during an upper respiratory tract infection (URTI) may reduce risk of relapse.It is unclear if these findings are generalisable to a large multi-ethnic population on different maintenance treatments.

Material and methods:

A randomised, double-blind, placebo-controlled trial was carried out in 122 UK paediatric units.365 children with rSSNS (7.6 ± 3.5 years) were randomised by background treatment to receive 6 days of prednisolone 15 mg/m2 or placebo at the start of an URTI. Primary outcome was incidence of first URTI-related relapse (URR) following any URTI.Secondary outcomes included measures of corticosteroid adverse effects and quality of life (QoL).Cost-effectiveness analysis used trial data and a decision-analytic model to estimate 1-year Quality-Adjusted-Life-Years (QALYs) and costs, which were then extrapolated over 16 years.

Results:

The number of patients experiencing a URR was 56 (42.7%) and 58 (44.3%) in prednisolone and placebo arms respectively (adjusted risk difference: -0.024, 95% CI: -0.14 to 0.095; P=0.7).  There was no evidence that treatment effect differed according to maintenance treatment.There were no significant differences in secondary outcomes between treatment arms.In apparent contrast, the economic evaluation found that daily prednisolone at the time of an URTI increased QALYs and decreased overall costs, a finding that was robust to sensitivity analysis.  

Conclusions:

PREDNOS 2 has shown no clinical benefit to 6 days of daily low-dose prednisolone at the start of an URTI in reducing relapse risk.The apparent conflicting economic result illustrates the cost implications associated with background treatment and the costs and reduced QoL associated with relapses when balanced against a cheap treatment.Literature in this area is sparse and more work is needed to evaluate the QoL and economic impact of SSNS relapses.