1. Reduced-dose glucocorticoid plus rituximab regimen was non-inferior compared to high-dose glucocorticoid plus rituximab regimen for induction of disease remission in ANCA-associated vasculitis
Evidence Rating Level: 1 (Excellent)
Study Rundown: Antineutrophil cytoplasm antibody (ANCA)–associated vasculitis is a group of multi-system autoimmune small and medium-sized vessel vasculitides with a prevalence of 4.6-18.4 cases per 100,000 individuals worldwide. Current standard therapies for induction of ANCA-associated vasculitis include high-dose glucocorticoids plus either cyclophosphamide or rituximab, which is associated with a high mortality rate and significant adverse events. In this phase 4, open-label randomized clinical trial, 140 patients with newly diagnosed ANCA-associated vasculitis were recruited to evaluate and compare of the efficacy and potential adverse effects of reduced-dose glucocorticoid plus rituximab regimen with high-dose glucocorticoid plus rituximab regimen for induction of ANCA-associated vasculitis remission. At 6 months after initiating treatment, 71% of the patients in the reduced-dose group achieved ANCA-associated vasculitis remission, while 69.2% in the high-dose achieved disease remission. Two deaths were reported in the reduced-dose group, and there were three deaths in the high-dose group, without any statistically significant difference between the two treatment regimen groups. The study does however have limitations, primarily the cofounding that comes with an open-label trial. It was difficult to blind the effects of high-dose glucocorticoid as patients can easily notice the changes in their appearance and blood tests.
In-Depth [Randomized clinical trial]: In this randomized clinical trial with 140 patients, 70 patients were assigned to the high-dose group (high-dose glucocorticoid plus rituximab), and the other half were randomly assigned to the reduced-dose group (reduced-dose glucocorticoid plus rituximab). The difference between the two groups for achieving disease remission in 6 months was 1.8 percentage points (1-sided 97.5% Confidence Interval, -13.7 to infinity) which met the noninferiority criterion (P=0.003 for noninferiority). The main adverse event was death of patients. The difference of reported deaths in the two groups was −1.7% (95% CI, −4.7% to 8.2%, P=0.67) with no statistically significant difference.
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