Early use of Tavneos in AAV may prevent irreversible organ damage
Real-world study also found treatment lowered daily glucocorticoid dose
Treatment with Tavneos (avacopan) appeared to more effectively suppress organ damage — while also significantly lowering glucocorticoid dosages and associated adverse events — in people with ANCA-associated vasculitis (AAV), according to a real-world study in Japan.
The study looked at the safety and effectiveness of glucocorticoids plus rituximab or cyclophosphamide, with or without Tavneos, in inducing disease remission in AAV patients.
The results showed that individuals given Tavneos had lower scores on the Vasculitis Damage Index (VDI), a measure of accumulated organ damage, than patients receiving only the standard AAV treatments.
According to the researchers, “given that VDI scores typically increase early in AAV … early use of [Tavneos] may play a critical role in preventing irreversible organ damage.”
The study, “Avacopan is effective in inducing remission for MPA/GPA, regardless of changes in serum C5a levels: a single-center study in Japan,” was published in the journal BMC Rheumatology.
AAV is characterized by ANCAs, self-reactive antibodies that bind to immune cells called neutrophils and activate them, resulting in inflammation and damage to small blood vessels.
Tavneos is an oral therapy that’s widely approved, including in Japan, as an add-on to standard treatment for adults with the two most common types of AAV: severe and active microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA). It works by binding to the receptor of C5a, a complement system protein, thus preventing C5a from exerting its damaging effects on blood vessels. The complement system is a family of proteins that plays an important role in the immune response.
“However, there are still limited reports on [the treatment’s] efficacy and safety in real-world settings, specifically regarding its impact on the [VDI],” the researchers wrote.
Tavneos treatment lowered scores on VDI scale of organ damage
To learn more, a team of scientists from Kagawa University Hospital conducted a retrospective study of Tavneos to evaluate its efficacy in inducing disease remission in people with AAV.
Their research involved 66 patients, nearly three-quarters of whom were women, ranging in age from 68 to 81. The vast majority (72.7%) had MPA.
Among them, 14 received Tavneos together with standard AAV treatments — glucocorticoids and rituximab or cyclophosphamide — while 52 were treated with standard therapies alone.
A similar rate of disease remission was seen in both groups of patients. The two groups also had similar reductions in disease activity, as assessed with the Birmingham Vasculitis Activity Score for up to six months.
However, those treated with Tavneos experienced a significantly smaller increase in VDI scores — a finding the team deemed important.
“Approximately 80% of patients [have] an increase in at least [one] item [on the VDI scale] by [six] months,” the researchers wrote, noting these are linked to complications like high blood pressure, known as hypertension, and diabetes.
The use of [Tavneos] appeared to inhibit the increase in VDI scores in items associated with [glucorticoid] toxicity, particularly hypertension and diabetes.
Individuals given Tavneos also had a more significant reduction in the daily dose of glucocorticoids used, the data showed.
After six months of treatment, the daily dose of glucocorticoids was significantly lower in the Tavneos group (2.5 vs. 7.5 mg). The proportion of adverse events potentially related to glucocorticoids, which could include hypertension, diabetes, and serious infections, was also lower in these patients (7.1% vs. 50%). In fact, the only such adverse event reported in the Tavneos group was hypertension.
Four participants treated with Tavneos experienced drug-induced liver injury that eased after treatment discontinuation or dose reduction.
“These results align with previous clinical trial data and highlight the [glucocorticoid]-sparing potential of [Tavneos] in real-world settings,” the researchers wrote. “The use of [Tavneos] appeared to inhibit the increase in VDI scores in items associated with [glucorticoid] toxicity, particularly hypertension and diabetes.”
The blood levels of C5a, a biomarker of AAV, decreased in both groups, though the effect was only significant in people who did not receive Tavneos. Disease remission in the Tavneos group was independent of whether or not C5a levels decreased, the researchers noted.
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