ESPN 51th Annual Meeting

ESPN 2018


 
Short versus long courses of prednisone for the treatment of relapses of steroid sensitive nephrotic syndrome. Results of the PROPINE study.
ANTONIO GARGIULO 1 MARINA VIVARELLI 1 CARMINE PECORARO 2 MARCO PENNESI 3 ANDREA PASINI 5 ALBERTO EDEFONTI 4 PAOLA ROMAGNANI 6 SILVIO MARINGHINI 7 BRUNO GIANOGLIO 8 GIOVANNI MONTINI 4 LUISA MURER 9 GIANMARCO GHIGGERI 10 LAURA MASSELLA 1 FRANCESCO EMMA 1

1- BAMBINO GESù PEDIATRIC HOSPITAL AND RESEARCH CENTER IRCCS ROME, ITALY
2- PEDIATRIC NEPHROLOGY UNIT, SANTOBONO - PAUSILLIPON HOSPITAL, NAPLES, ITALY
3- INSTITUTE FOR MATERNAL AND CHILD HEALTH, IRCCS BURLO GAROFOLO, TRIESTE, ITALY
4- PEDIATRIC NEPHROLOGY, DIALYSIS, AND TRANSPLANT UNIT, FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO MILAN, ITALY
5- NEPHROLOGY AND DIALYSIS UNIT, DEPARTMENT OF PEDIATRICS, AZIENDA OSPEDALIERO UNIVERSITARIA, POLICLINICO SANTORSOLA-MALPIGHI, BOLOGNA, ITALY
6- NEPHROLOGY AND DIALYSIS UNIT, MEYER CHILDRENS HOSPITAL, FLORENCE, ITALY
7- PEDIATRIC NEPHROLOGY UNIT, CHILDRENS HOSPITAL G. DI CRISTINA, A.R.N.A.S. CIVICO, PALERMO, ITALY
8- CITY OF THE HEALTH AND THE SCIENCE OF TURIN HEALTH AGENCY, REGINA MARGHERITA CHILDRENS HOSPITAL, TURIN, ITALY
9- PEDIATRIC NEPHROLOGY, DIALYSIS AND TRANSPLANT UNIT, DEPARTMENT OF PEDIATRICS, UNIVERSITY HOSPITAL OF PADUA, PADUA, ITALY
10- DIVISION OF NEPHROLOGY, DIALYSIS, TRANSPLANTATION, AND LABORATORY ON PATHOPHYSIOLOGY OF UREMIA, ISTITUTO G. GASLINI, GENOA, ITALY
 
Introduction:

Corticosteroids remain the mainstay of treatment of childhood steroid sensitive nephrotic syndrome (SSNS). Despite side effects being mostly caused by repeated courses of prednisone (PDN), most studies have focused on the initial episode. Few have tested optimal protocols for the treatment of relapses. To this end, we have designed the PROPINE study (EudraCT: 2012-004326-16), a multicentric, open-label, prospective, randomized, controlled trial, performed between 2013 and 2017 in 10 Italian pediatric nephrology units.

Material and methods:

A total of 126 SSNS patients aged 3-17 years who had not received in the previous year steroid-sparing medications and had experienced at least one relapse were enrolled in the study. Upon relapse, patients were randomized to receive, starting from day 5 post-remission, a 4 week course of PDN at a dose of 40 mg/m2 on alternate days (short arm) or a 8 weeks progressive tapering schedule (long arm) with the same cumulative dose of PDN. Patients were monitored for 12 months or until relapse. Families were provided with cell phones to report daily urinary dipstick results and adverse events, using an ad hoc application, and with an oscillometric monitor to report weekly blood pressure values.

Results:

Overall, 79 patients relapsed during the observational phase of the study and were randomized to one of the two arms. By Kaplan-Meier analysis, the probability of remission at 12 months was 35±8% in the short arm and 31±8% in the long arm (p=0.315). In an ancillary study, 33 patients underwent a second course of treatment in the arm opposite to their initial randomization. The median time to relapse was 3.4 and 3.5 months in the short and long arms, respectively (p=0.315). No differences in side effects and blood pressure control between the two groups were observed during both primary and ancillary studies.

Conclusions:

Diluting the same cumulative dose of PDN over a longer period of time offered no benefits in preventing relapses of SSNS.