Investigators from the United Kingdom conducted a multicenter, blinded, randomized trial in children ≤18 years of age with new-onset Henoch-Schönlein purpura (HSP) to determine if a 2-week course of prednisolone decreased the presence of proteinuria at 1-year follow-up, or the need for additional treatment during the 12-month study period. Children presenting to 1 of 24 participating centers in England and Wales with a diagnosis of HSP and fewer than 7 days of the characteristic rash were eligible for enrollment. Children were randomly assigned to receive either prednisolone 2 mg/kg per day (max 80 mg) for 7 days, followed by 1 mg/kg per day for 7 days (max 40 mg), or placebo for 14 days. The primary outcome was the presence of proteinuria at the 1-year follow-up, defined as urine protein to creatinine ratio (UP:UC) of >20 mg/mmol (equivalent to a pure ratio of 0.13). Secondary outcomes included the need for additional treatment (such as antihypertensives, nontrial steroids, ACE inhibitors), a renal biopsy anomaly, and side effects from the study medication.
A total of 352 children with a median age of 6 years were entered into the trial, including 181 randomized to prednisolone and 171 who received placebo. At baseline, patients randomized to the prednisolone group were more likely to have proteinuria than placebo recipients (19% and 8%, respectively). At the 12-month follow-up, proteinuria results were available for 123 prednisolone and 124 placebo patients. Fifteen percent of the patients on prednisolone versus 10% of the patients on placebo had UP:UC >20mg/mmol (OR = 1.46; P = .33). After adjusting for baseline proteinuria and the use of ACE inhibitors (which may affect proteinuria), the results were still not statistically significant. Both the need for additional treatment and side effects related to trial medication (prednisolone or placebo) were rare and did not differ significantly between the groups.
The authors conclude that routine use of steroids in unselected cases of HSP provides no beneficial effect on renal outcomes.
Dr Garber has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.
HSP is the most common small vessel vasculitis of childhood and is usually self-limited. About 34% of patients present with renal involvement, and about 5% of those develop long-term renal impairment (see related article in AAP Grand Rounds, December 2005;14:651 ). While steroids have been used anecdotally since the 1950s, little evidence supports their use in the prevention or management of HSP-associated renal disease. In 1992 a prospective trial showed that, in children with HSP and no renal involvement on presentation, significantly fewer children who received prednisone developed proteinuria compared to those who did not receive prednisone;...