Rituximab Efficacy Investigated for Relapsing ANCA-Associated Vasculitis
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SAN DIEGO – Rituximab, taken along with glucocorticoids, effectively re-induces remission in patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), according to results presented at the 2017 ACR/ARHP Annual Meeting, held November 3-8.
RITAZAREM (ClinicalTrials.gov: NCT01697267) is an ongoing randomized controlled trial that compares the efficacy of rituximab with azathioprine as maintenance therapy after induction of remission with rituximab and glucocorticoids for relapsing AAV.
In the trial, 188 patients with granulomatosis with polyangiitis or microscopic polyangiitis were selected to receive rituximab 4 x 375 mg/m2 along with a glucocorticoid dosed at either 1 mg/kg/d or 0.5 mg/kg/d (56 participants vs 132 participants, respectively), reduced to 10/mg/d by month 4. Patients who achieved remission by month 4 were then randomly assigned to receive either a repeat dose of rituximab 1 g every 4 months or azathioprine 2 mg/kg/d for a treatment period of 24 months.
In total, 165 of 181 (91.2%) patients achieved remission while 11 (6%) did not. Of the 11 participants who did not achieve remission, 9 were receiving the lower dose of glucocorticoid.
Five (2.8%) patients died during the induction phase; causes of death included pneumonia, cerebrovascular accident, alveolar hemorrhage or respiratory failure, and colon cancer. Thirty of the participants experienced a total of 53 severe adverse events, 15 of which were severe infections.
“Data from the first phase of RITAZAREM … demonstrates that rituximab, in conjunction with glucocorticoids, is highly effective at re-inducing remission in patients with AAV [that has] relapsed,” concluded the researchers.
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Smith R, Jones R, Specks U, et al. Rituximab as re-induction therapy in relapsing ANCA-associated vasculitis. Presented at: ACR/ARHP Annual Meeting; November 3-8, 2017; San Diego, CA. Abstract 18L.