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Comparison of combined leflunomide and low-dose corticosteroid therapy with full-dose corticosteroid monotherapy for progressive IgA nephropathy.

ABSTRACT: IgA nephropathy is the most common primary glomerulonephritis and one of the leading causes of end-stage renal disease. We performed a randomized, controlled, prospective, open-label trial to determine whether leflunomide combined with low-dose corticosteroid is safe and effective for the treatment of progressive IgA nephropathy, as compared to full-dose corticosteroid monotherapy. Biopsy-proved primary IgA nephropathy patients with an estimated glomerular filtration rate ≥ 30 ml/min/1.73m2 and proteinuria ≥1.0 g/24h were randomly assigned to receive leflunomide+low-dose corticosteroid (leflunomide group; n = 40) or full-dose corticosteroid (corticosteroids group; n = 45). The primary outcome was renal survival; secondary outcomes were proteinuria and adverse events. After 12 months of treatment and an average follow-up of 88 months, 11.1% vs. 7.5% of patients reached end-stage renal disease and 20% versus 10% of patients had a ≥ 50% increase in serum creatinine in the corticosteroids and leflunomide groups, respectively. Kaplan-Meier analysis did not reveal a between-group difference in these outcomes. Decreases in 24-hour proteinuria were similar in the two groups during the treatment period, but a more marked reduction was observed during follow-up in the leflunomide group. Although the incidence of adverse events was similar in the two groups, serious adverse events were observed only in the corticosteroid group. Thus, leflunomide combined with low-dose corticosteroid is at least as effective as corticosteroid alone for the treatment of progressive IgA nephropathy, and showed a greater reduction of proteinuria during long-term follow-up and fewer severe adverse events.

SUBMITTER: Min L

PROVIDER: S-EPMC5564655 | biostudies-other | 2017 Jul

REPOSITORIES: biostudies-other

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Project description:Rationale & objectiveStudies of immunoglobulin A nephropathy (IgAN) have suggested the therapeutic benefit of simultaneously adding tonsillectomy to corticosteroid therapy. However, the efficacy of tonsillectomy monotherapy in the absence of simultaneous use of corticosteroids is unclear.Study designPatients with IgAN treated with tonsillectomy monotherapy were analyzed retrospectively. Clinical parameters, including kidney function slope, were compared before and after tonsillectomy.Setting & participantsPatients with biopsy-proven IgAN who received tonsillectomy monotherapy at our hospital between 2007 and 2018.Results20 Japanese patients with IgAN were included in this study (mean follow-up period, 135 months from initial biopsy diagnosis to tonsillectomy). All patients had been treated with renin-angiotensin-aldosterone system inhibitors. 17 patients had a history of induction therapy with corticosteroids. Mean time to tonsillectomy from termination of corticosteroid therapy was 84 months. Hematuria, proteinuria, and clinical remission were achieved in 13 of 17 (76%), 10 of 17 (59%), and 8 of 20 (40%) patients at medians of 3.0, 6.0, and 13.5 months, respectively, after tonsillectomy. The slope of the estimated glomerular filtration rate (eGFR) increased significantly during the 81-month observation period, including the periods before and after tonsillectomy (-2.59 vs 1.05 mL/min/1.73 m2 per year; P < 0.001). The effect on eGFR slope was consistent in 11 patients with reduced GFR (eGFR < 60 mL/min/1.73 m2) at the time of tonsillectomy (-3.07 vs -0.39 mL/min/1.73 m2 per year; P < 0.001).LimitationsSmall sample size. Lack of a control (no-tonsillectomy) group due to the difficulty of setting the baseline time point (which corresponded to tonsillectomy in our sample). Potential exclusion of patients with the most severe disease who are likely to receive corticosteroids. Lack of generalizability to patients in other countries.ConclusionsTonsillectomy monotherapy may prevent kidney function decline in some patients with IgAN with kidney disease that has been progressive despite long-term application of conventional therapies.

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Comparison of combined leflunomide and low-dose corticosteroid therapy with full-dose corticosteroid monotherapy for progressive IgA nephropathy.

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