Methylprednisolone reduces risk of major kidney outcomes for patients with IgA nephropathy
Steroids can reduce the risk of major kidney outcomes and kidney failure in patients with high-risk IgA nephropathy, according to data presented at ASN Kidney Week.
“The incidence of serious adverse events, particularly serious infections, is increased, but this was seen mainly with full-dose therapy, suggesting that the reduced dose may offer the best balance of risk vs. benefit in the future,” Vlado Perkovic, MBBS, PhD, of The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia, said during the virtual meeting.
The Therapeutic Evaluation of Steroids in IgA Nephropathy Global (TESTING) study assessed the effects of oral methylprednisolone compared with placebo on major kidney outcomes and safety in patients with IgA nephropathy. In the investigator-initiated, double-blind randomized trial, researchers studied 503 patients with IgA nephropathy, proteinuria greater than or equal to 1 g/day and eGFR 20 mL/min/1.73 m2 to 120 mL/min/1.73 m2, following 3 or more months of optimized background care, including renin-angiotensin system blockade.
Mean age was 38 years. Mean eGFR was 61.5 mL/min/1.73 m2 and mean proteinuria was 2.46 g/day. Overall, 257 patients received methylprednisolone and 246 received placebo. This included 262 patients who received a full-dose methylprednisolone (0.6 mg/kg/day -0.8 mg/kg/day, maximum 48 mg/day, for 2 months then weaning by 8 mg/day/month) or matching placebo, and 241 patients who received a reduced dose of methylprednisolone of 0.4 mg/kg/day, maximum 32 mg/day, weaning by 4 mg/day/month or matching placebo. Due to serious infections in the methylprednisolone cohort, researchers reduced the dose of methylprednisolone and Pneumocystis jirovecii prophylaxis was added. Average patient follow-up was 4.2 years.
Perkovic said for patients with high-risk IgA nephropathy, a 6- to 9-month course of oral methylprednisolone reduced the risk of the major kidney outcomes, which was composite of 40% eGFR decline or kidney failure, by 47% and kidney failure by 41%. The reduction in risk was seen with both doses of methylprednisolone.
“The kidney protective effect was consistent across prespecified subgroups, including the full- and the reduced-dose regimens,” he said.
Serious adverse events were more frequent with methylprednisolone vs. placebo, he said, for patients who received the full-dose therapy (22 vs. four patients) compared with the reduced dose (six vs. three).
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