Avacopan in granulomatosis with polyangiitis and microscopic polyangiitis: a profile of its use

Declarations Funding The preparation of this review was not supported by any external funding. Authorship and conflict of interest S. M. Hoy is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content. Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability Not applicable. Additional information about this Adis Drug Review can be found here. Abstract Avacopan (TAVNEOS®), a first-in-class, small molecule, selective antagonist of the complement fragment 5a receptor (C5aR), is an effective and glucocorticoid-sparing treatment option with a manageable tolerability profile for granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). It is administered orally in combination with standard therapy (e.g. rituximab, cyclophosphamide, glucocorticoids). In a 52-week, multinational phase 3 study in patients (most of whom were adults) with GPA and MPA, the avacopan regimen was non-inferior, but not superior, to the tapered prednisone regimen in achieving remission at week 26, and superior to the prednisone regimen in sustaining remission at week 52. It may also have beneficial effects on relapse rates, glucocorticoid-induced toxicity, kidney function and health-related quality of life. In this study, overall infections (a major driver of early mortality in this patient population), serious infections and serious opportunistic infections were less frequent with avacopan than tapered prednisone. © Springer Nature Switzerland AG 2022