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Rituximab may not be superior to standard treatment in inducing remission in eosinophilic granulomatosis with polyangiitis
1. In this randomized controlled trial, rituximab was not superior to standard treatment in inducing remission in patients with eosinophilic granulomatosis with polyangiitis.
2. Adverse event rates were similar between the two groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Eosinophilic granulomatosis with polyangiitis is a rare systemic small vessel vasculitis with presence of antineutrophil cytoplasmic antibodies (ANCAs). Uncontrolled studies have suggested that rituximab may be effective in treating EGPA, although this has not been adequately evaluated in controlled trials. This study aimed to assess the efficacy of rituximab with glucocorticoids in inducing remission in patients with EGPA compared with the standard treatment strategy involving glucocorticoids with or without cyclophosphamide. Remission was induced among a greater percentage of patients who received rituximab, although this result was not statistically significant. This lack of difference was consistent after stratification and sensitivity analyses. The rituximab and standard treatment groups had a similar median time to remission as well as similar remission durations. Relapse also occurred in similar proportions of patients on the two different treatment regimens. The generalizability of this study was limited by its design as a superiority rather than non-inferiority trial, limited sample size, and relatively short follow-up period. Nevertheless, these results suggested that rituximab was not superior to the conventional strategy in inducing remission in EGPA.
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In-Depth [randomized controlled trial]: This study aimed to evaluate the efficacy of rituximab plus glucocorticoids in inducing remission in patients with EGPA compared with the conventional treatment strategy. Patients were eligible if they were aged 18 years or above, had newly diagnosed or relapsing EGPA regardless of ANCA status, had active disease defined as a Birmingham Vasculitis Activity Score (BVAS) of 3 or greater (out of 63), and had initiated or increased glucocorticoids at a dose of 1 mg/kg per day or less within the previous 21 days. Patients were excluded if they had received rituximab within the previous 12 months. The primary outcome was the percentage of patients who achieved remission, defined as absence of active disease corresponding to a BVAS of 0, at 180 days after randomization. The study included data for 105 patients, with 52 patients receiving rituximab and 53 receiving the conventional strategy. At 180 days, 33 patients (63.5%) in the rituximab group and 32 (60.4%) in the conventional strategy group achieved remission, yielding a relative risk of 1.05 (95% CI, 0.78 to 1.42, p = 0.75). Adjusting for stratification factors (newly diagnosed or relapsed disease, disease severity, and ANCA status) yielded a relative risk of 1.08 (95% CI, 0.80 to 1.45); sensitivity analysis with the 103 patients who had complete data yielded a relative adjusted risk of 1.14 (95% CI, 0.85 to 1.53). At 360 days, 31 patients (59.6%) in the rituximab group and 34 (64.2%) in the conventional strategy group achieved remission, yielding a relative risk of 0.93 (95% CI, 0.69 to 1.26, p = 0.63). Duration of remission was analyzed for the 81 patients who achieved a BVAS of 0 during follow-up, with the mean duration being 48.5 ± 6.51 weeks in the rituximab group and 49.1 ± 7.42 weeks in the conventional strategy group (p = 0.41). Relapse was reported for 10 patients (19.2%) in the rituximab group and 10 (18.9%) in the conventional strategy group, including 4 patients with a major relapse in each group. This yielded a hazard ratio for any relapse of 1.25 (95% CI, 0.50 to 3.11, p = 0.63) and for major relapse of 1.57 (95% CI, 0.33 to 7.37, p = 0.32). Quality of life, disability, and disease sequelae scores were all similar between the two groups. Both groups reported 29 adverse events; 18 patients (35%) in the rituximab group and 22 (42%) in the conventional strategy group had at least 1 serious adverse event. Overall, rituximab was found to not be superior to the conventional strategy in inducing remission among patients with EGPA.
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