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Background <p>Avacopan is effective in ANCA-associated vasculitis (AAV) in randomized trials, and real-world studies have supported its clinical effectiveness. However, treatment-emergent adverse events (TEAEs) often lead to discontinuation, and data beyond 1 year remain limited.</p> Methods <p>We retrospectively studied 40 adults with newly diagnosed or relapsing AAV treated with avacopan. Patients were classified into continuation (<i>n</i> = 23) and discontinuation (<i>n</i> = 17) groups according to discontinuation due to avacopan-related TEAEs.</p> Results <p>During a median follow-up of 29 months (interquartile range 26–32), avacopan-related TEAEs occurred in 21 patients (52.5%) at a median of 1.4 months following initiation; all patients in the discontinuation group stopped avacopan because of TEAEs. Clinical remission (BVAS = 0 and no glucocorticoid use) was achieved in 47.5%, 62.5%, and 87.2% of patients at 6, 12, and 24 months, respectively. Five patients (21.7%) in the continuation group remained in remission on avacopan monotherapy for a median of 24 months after withdrawing all other immunosuppressive agents.</p> Conclusions <p>In this retrospective single-center cohort, clinical outcomes beyond 1 year appeared broadly comparable between patients who continued avacopan and those who discontinued it early because of TEAEs. Further prospective studies are needed to define the optimal use, patient selection, and duration of avacopan therapy in AAV.</p> Clinical trial number <p>Not applicable.</p>

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Real-world outcomes of avacopan beyond the first year in antineutrophil cytoplasmic antibody-associated vasculitis: a retrospective cohort study

  • 期刊论文

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  • 发表日期：

    2026年5月19日

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  • Makoto Yamaguchi,
  • Hirokazu Sugiyama,
  • Hiroshi Kinashi,
  • Kentaro Imai,
  • Keisuke Kamiya,
  • Takayuki Katsuno,
  • Takahiro Imaizumi,
  • Shogo Banno,
  • Yasuhiko Ito,
  • Takuji Ishimoto

摘要

Background

Avacopan is effective in ANCA-associated vasculitis (AAV) in randomized trials, and real-world studies have supported its clinical effectiveness. However, treatment-emergent adverse events (TEAEs) often lead to discontinuation, and data beyond 1 year remain limited.

Methods

We retrospectively studied 40 adults with newly diagnosed or relapsing AAV treated with avacopan. Patients were classified into continuation (n = 23) and discontinuation (n = 17) groups according to discontinuation due to avacopan-related TEAEs.

Results

During a median follow-up of 29 months (interquartile range 26–32), avacopan-related TEAEs occurred in 21 patients (52.5%) at a median of 1.4 months following initiation; all patients in the discontinuation group stopped avacopan because of TEAEs. Clinical remission (BVAS = 0 and no glucocorticoid use) was achieved in 47.5%, 62.5%, and 87.2% of patients at 6, 12, and 24 months, respectively. Five patients (21.7%) in the continuation group remained in remission on avacopan monotherapy for a median of 24 months after withdrawing all other immunosuppressive agents.

Conclusions

In this retrospective single-center cohort, clinical outcomes beyond 1 year appeared broadly comparable between patients who continued avacopan and those who discontinued it early because of TEAEs. Further prospective studies are needed to define the optimal use, patient selection, and duration of avacopan therapy in AAV.

Clinical trial number

Not applicable.