Extended initial prednisolone therapy did not alter nephrotic syndrome course in children
Click Here to Manage Email Alerts
Prolonged initial prednisolone therapy does not significantly alter the disease course in young children with nephrotic syndrome, according to a speaker at ASN Kidney Week.
“The chief question that this open-label randomized trial was designed to address was whether extending the duration of initial therapy of steroid-sensitive nephrotic syndrome (NS) in young children is associated with a reduced tendency to relapse in the subsequent 1 year,” Aditi Sinha, from All India Institute of Medical Sciences, in New Delhi, Delhi, India, said.
Past studies have suggested that prolonged (>2 months to 3 months) initial corticosteroid therapy has no role in NS, but the subgroup analysis in two studies implies an association with reduced frequency of subsequent relapses in children older than 4 to 6 years of age, according to Sinha and colleagues.
In this multicenter open-label trial, 207 consecutive patients (1-4 years of age) were enrolled at onset of idiopathic NS between 2015 and 2019. Patients received 6-week daily and 6-week alternate day (AD) initial prednisone therapy, then were randomized (1:1) to either tapering prednisone on AD for 12 weeks or no therapy at all. All relapses were treated with prednisone until remission, then on AD for 4 weeks.
Among the 207 patients, 172 were randomized and those with prolonged therapy (age, 33±11 months; boys, 70%; hypertension, 37%; eGFR, 75 mL/min per 1.73 m² to 178 mL/min per 1.73 m²; microscopic hematuria, n=10.5) shared similar baseline characteristics with those with standard therapy (age, 35±10 months; boys, 66%; hypertension, 43%; eGFR, 77 mL/min per 1.73 m² to 190 mL/min per 1.73 m²; microscopic hematuria, n=13.9).
The number of relapses between patients receiving prolonged therapy vs. patients receiving standard therapy were not significantly significant at 12 months or 24 months.
“Overall, to conclude, therapy with prednisone for 6 months compared to 3 months was associated with similar proportions of patients and sustained remission at 1-year follow- up. The time to relapse was comparable and was extended by 3 months, the same duration as extended therapy. The proportion of patients with frequent relapses at 1-year and 2-year follow-ups appeared to be similar. The cumulative prednisone exposure, while higher in the extended therapy length at 3 months, was similar at 1-year and 2-year follow-ups; and adverse rates and infections were comparable,” Sinha said. “There are certain analyses that remain to be done.”
Collapse
Sinha A, et al. Paper FR-OR62. Presented at: ASN Kidney Week; Nov. 4-7, 2021 (virtual meeting).
Read more about
Click Here to Manage Email Alerts