Lung, ENT Involvement, Steroid Use Reduced With Tavneos: ADVOCATE

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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Tavneos (avacopan) reduced respiratory, ear, nose, and throat (ENT) involvement among people with ANCA-associated vasculitis (AAV), but did not significantly outperform prednisone in its ability to do so, according to a substudy of the larger Phase 3 ADVOCATE trial.

The treatment also significantly lowered patients’ reliance on glucocorticoid treatment over a year.

“The overall results of the ADVOCATE trial are very exciting as they indicate that patients with ANCA-associated vasculitis receiving avacopan can achieve sustained remission with minimal glucocorticoid exposure,”  Ulrich Specks, MD, a professor of medicine at the Mayo Clinic College of Medicine & Science in Rochester, Minnesota, said in a press release.

“While the results presented here for the subset of patients with lung and ENT involvement are most promising, the specific effect of avacopan on individual disease manifestations requires further study,” Specks said.

Specks presented the findings in a talk titled, “Insights from the ADVOCATE Study: Respiratory Tract Involvement in Patients with ANCA-Associated Vasculitis in a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Avacopan,” at the American Thoracic Society 2022 international conference.

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Tavneos is an oral treatment designed to block the activation of the complement system, a group of immune system proteins that contribute to the autoimmune attacks seen in AAV.

It was developed by ChemoCentryx, which funded the ADVOCATE trial (NCT02994927) and owns commercial rights to the therapy in the U.S. Kissei Pharmaceuticals holds the therapy’s marketing rights in Japan, and Vifor Pharma in nearly all other countries.

ADVOCATE sought to determine if Tavneos could be a suitable alternative to glucocorticoids as an add-on therapy in AAV. While glucocorticoids are considered a standard of care, significant side effects often accompany their use.

ADVOCATE enrolled 330 people with AAV, including 181 with granulomatosis with polyangiitis (GPA) and 149 with microscopic polyangiitis (MPA). Patients were randomly assigned to receive Tavneos or prednisone, a common glucocorticoid treatment, in combination with other standard immunomodulatory therapies (rituximab, or cyclophosphamide followed by azathioprine).

Top-line trial data showed Tavneos was as effective as prednisone at inducing disease remission after 26 weeks (about six months), and significantly outperformed the glucocorticoid in sustaining remission for up to a year. Tavneos was also superior in its ability to improve kidney function in a select group of patients who entered the trial with severe kidney disease.

The therapy’s eventual approval in the U.S., Europe, and other countries was largely supported by these findings.

Now, findings from a substudy of ADVOCATE  showed Tavneos also lowered signs of lung and ENT symptoms.

At the study’s start, 43% of patients showed signs of lung involvement, including 98 people with GPA and 45 with MPA. More specifically, 43% of people in the Tavneos group (71 people) and 44% in the prednisone group (72 people) had this symptom.

After six months of treatment with Tavneos, one person had lung involvement, and no one had it after one year. In the prednisone group, lung involvement was present in four people after six months and in three after a year.

Similarly, 45% of patients in the Tavneos group (75 people) and 42% of prednisone group (69 people) had ENT involvement at the study’s start. After a year, two people receiving Tavneos still had these symptoms and five people receiving prednisone did.

Yet, the differences in respiratory and ENT symptoms between the two groups were not significantly different.

Results also showed that Tavneos led to an 86% median reduction in overall glucocorticoid use among patients.