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The treatment difference of 1.8 percentage points (1-sided 97.5% CI, −13.7 to ∞) between the groups met the noninferiority criterion ( P = .003 for noninferiority). At 6 months, 49 of 69 patients (71.0%) in the reduced-dose group and 45 of 65 patients (69.2%) in the high-dose group achieved remission with the protocolized treatments. Results Among 140 patients who were randomized (median age, 73 years 81 women ), 134 (95.7%) completed the trial. There were 8 secondary efficacy outcomes and 6 secondary safety outcomes, including serious adverse events and infections. Main Outcomes and Measures The primary end point was the remission rate at 6 months, and the prespecified noninferiority margin was −20 percentage points.
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Interventions Patients were randomized to receive reduced-dose prednisolone (0.5 mg/kg/d) plus rituximab (375 mg/m 2/wk, 4 doses) (n = 70) or high-dose prednisolone (1 mg/kg/d) plus rituximab (n = 70). A total of 140 patients with newly diagnosed ANCA-associated vasculitis without severe glomerulonephritis or alveolar hemorrhage were enrolled between November 2014 and June 2019 at 21 hospitals in Japan. Objective To compare efficacy and adverse events between a reduced-dose glucocorticoid plus rituximab regimen and the standard high-dose glucocorticoid plus rituximab regimen in remission induction of ANCA-associated vasculitis.ĭesign, Setting, and Participants This was a phase 4, multicenter, open-label, randomized, noninferiority trial.
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Although these regimens have high remission rates, they are associated with considerable adverse events presumably due to high-dose glucocorticoids. Importance The current standard induction therapy for antineutrophil cytoplasm antibody (ANCA)–associated vasculitis is the combination of high-dose glucocorticoids and cyclophosphamide or rituximab. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.