ESPN 50th Annual Meeting

ESPN 2017


 
Standard vs. extended course prednisolone therapy for the presenting episode of steroid sensitive nephrotic syndrome: the PREDNOS study
Nicholas Webb 1 Rebecca Wooley 2 Elizabeth Brettell 2 Carol Cummins 1 Richard Trompeter 5 Emma Barsoum 1 Natalie Ives 2 On Behalf Of The PREDNOS Investigators 3

1- Royal Manchester Childrens Hospital, Manchester UK
2- Birmingham Clinical Trials Unit, University of Birmingham, UK
3- PREDNOS Investigators
4- University of Birmingham
5- Great Ormond Street Hospital, London
 
Introduction:

The optimal corticosteroid regimen for treating the presenting episode of steroid sensitive nephrotic syndrome (SSNS) remains uncertain. Previous systematic reviews indicating that >3m of prednisolone reduces risk of relapse and FRNS have not been confirmed by recent large, high quality RCTs. 

Material and methods:

237 UK children (146 male) aged 1-15y with newly presenting SSNS were randomised to receive double-blind standard course (SC: 4w 60mg/m2 then 4w 40mg/m2AD, total 2240mg/m2) or extended course (EC: 4w 60mg/m2 then 12w tapering 60mg/m2 AD to 10mg/m2 AD, total 3150mg/m2) prednisolone and followed for a minimum of 24m. The study primary end point was time to first relapse. Secondary endpoints included overall relapse rate, use of other immunosuppression, FRNS, AEs, and assessment of quality of life (PedsQL) and behaviour (Achenbach Child Behaviour Checklist (ACBC)). A comprehensive cost-effectiveness analysis (CEA) was performed. Analysis was by intention to treat.

Results:

There was no difference in time to first relapse between SC and EC regimens (Figure 1: HR 0.87 (0.65-1.17), p=0.4).

No differences were observed in the proportion experiencing relapse over 24m (SC 81% vs. EC 80%; p=0.9), developing FRNS (50% vs. 52%; p=0.8) and requiring other immunosuppression (56% vs. 54%; p=0.4). Total prednisolone dose received during the trial was 5446mg vs. 6645mg; p=0.06. SAE rates were comparable (25% vs. 17%; p=0.1) and analysis at 16w, 12m and 24m showed no significant differences in the incidence of cushingoid features, striae, hypertrichosis, cataract, acne, increased appetite, glycosuria or abdominal pain. There were no differences in PedsQL or ACBC scores. EC therapy was associated with a mean increase in generic health benefit (0.0182 additional QALYs) and cost savings (£3,194 vs. £4,915).

Conclusions:

 PREDNOS has not shown any clinical benefit associated with EC prednisolone therapy in UK children, however has shown this to be cheaper and more effective in QALY terms.