Tavneos (avacopan), an orally administered medication from Amgen, has shown promising effects in the treatment of ANCA-associated vasculitis (AAV) patients with active ear, nose, or throat (ENT) manifestations compared to the glucocorticoid prednisone. These claims are based on subgroup analyses derived from the Phase 3 ADVOCATE clinical trial (NCT02994927). Initial data from the study supported approving Tavneos as a treatment add-on to standard methods, including glucocorticoids.
In AAV cases, excessive activation of the immune system complement system leads to inflammation and damage to the small blood vessels. ENT engagement is common in AAV and negatively contributes to patients’ quality of life (Al-Herz et. al., 2024). Glucocorticoids often used to manage AAV — such as prednisone– offer anti-inflammatory benefits and aid in achieving remission. However, their long-term utility often results in severe and undesirable side effects, specifically weight gain, high blood pressure, insulin resistance, and mental well-being issues (Reid et. al., 1996).
Tavneos works by suppressing the activation phase of the complement cascade during AAV. Its regulatory go-ahead was partially based on data from the ADVOCATE trial, which included participants diagnoses with GPA or MPA, the most common types of AAV. Topline results demonstrated that Tavneos was as effective as pre-determined prednisone tapering schedules, combined with other standard treatments, allowing patients to achieve remission up to six months. Moreover, Tavneos was more effective than prednisone in maintaining remission periods up to one year (Amgen Announces Topline AFFIRM Results Shows Avacopan Met Primary Endpoint Significantly Reducing AAV Disease Activity, Faster Time to Remission, and Improved Quality of LIfe, 2021 [cited 20 May 2023]). Further subgroup findings from trials were presented at the European Rheumatology Association’s (ERA) 2024 summit in Vienna.
In the analyzed subgroup of 144 people with ENT involvement starting the trial, Tavneos’ effectiveness was comparable to prednisone in achieving remission at approximately six months (72%,Tavneos vs.70%, prednisone). However, as time progressed, Tavneos showed a higher rate for reaching sustained remission at one year for patients with ENT indications (62,7% vs. 51,3%). Additionally, throughout the trial, fewer Tavneos-treated trial participants experienced active ENT symptoms (21,7 vs. 36,2% upon the first month and 2,0% vs. 7,60% after a year). Furthermore, the relapse rate of ANCA-associated ENT manifestations was lower in the people taking Tavneos ( 14,9% vs, 19,7%). Moreover, Tavneos was discovered to offer greater improvements in self-reported quality of life compared prednisone (Al-Ghamdi et. all., 2024). Those on Tavneos also saw less glucocorticoids use in the first month (measured in milligram (mg) (680 ± 450 mg vs .1677 ± 792 mg) and fewer glucocorticoid-related side effects after achieving remission at six months. A similar safety profile was observed from both groups, with one death incidence in the Tavneos subset, which was due to worsened AAV (Al‐Ghamdi et. ALL., 2024). Hence, the researchers concluded that Tavoneos may be an effective treatment when managing patients with ENT aspects of GPA/MPA. Besides, the study also found minimal side effects and a positive progression in kidney disorders and quality of life for those who commenced Tavneos without glucocorticoid for the first 29 days (Imbach et. al., , 2024).
