Avacopan (Tavneos®) shows promise in improving remission rates in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) while maintaining a favorable adverse effect profile compared with other approved medications, according to a systematic review of the literature published in the Annals of Pharmacotherapy.

In the phase 3 ADVOCATE trial, the 26-week remission rates were 72.3% in the avacopan group and 70.1% in the placebo group. The 52-week remission rates were 65.7% and 54.9% in the avacopan and placebo groups, respectively.

Moreover, data from the phase 2 CLEAR trial showed an improvement of 50% or greater in Birmingham Vasculitis Activity Score in 86.4% of avacopan-treated patients and 70% of prednisone-treated patients.

“Glucocorticoids in combination with cyclophosphamide, azathioprine, and/or rituximab have been a mainstay of ANCA-associated vasculitis treatment. However, short- and long-term medication related adverse effects risk negative outcomes for patients,” the study authors said. “Avacopan may provide equivalent to better treatment with fewer side effects due to a reduction, if not elimination, of glucocorticoids.”

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The proportions of adverse events and serious adverse events were similar between the experimental and control groups in the ADVOCATE trial.

In the CLEAR trial, serious adverse events occurred in 13.64% of patients who received avacopan plus 20 mg of prednisone, 36.36% of patients receiving avacopan alone, and 17.39% of patients given a placebo.

The ADVOCATE trial enrolled 331 patients with AAV. One group received 30 mg of avacopan twice daily plus cyclophosphamide/azathioprine or rituximab and a prednisone-matching placebo (experimental group), and the other group was given an avacopan-matching placebo twice daily plus cyclophosphamide/azathioprine or rituximab and a 20-week taper of oral prednisone (control group).

The CLEAR trial enrolled 67 patients with AAV who received 30 mg of avacopan twice daily, 30 mg of avacopan twice daily plus 20 mg of prednisone daily, or placebo twice daily plus 60 mg of prednisone daily.

Avacopan is a selective antagonist of the complement C5a receptor C5aR1 that was recently approved by the US Food and Drug Administration as an add-on treatment for severe, active AAV.


Alihosseini C, Kopelman H, Zaino M, Feldman SR. Avacopan for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Ann Pharmacother. Published online March 28, 2023. doi:10.1177/10600280231161592