High-dose Glucocorticoids Common for AAV Patients in Europe, But Response Is Limited, Study Reports

High-dose glucocorticoids — a type of corticosteroid hormone — are commonly prescribed as part of remission-induction therapy to people with ANCA-associated vasculitis (AAV) in Europe, a retrospective study reports.

The majority of the patients remained on glucocorticoids for over a year, but only a minority reached full remission of AAV without the clinical need for steroids.

These findings were detailed in a poster, titled “Glucocorticoids in Incident ANCA-Associated Vasculitis (AAV) Patients – A Study of Routine Clinical Practice in the EU Demonstrates Prolonged Use and Temporal Relationship to Adverse Events and Infections.” The poster was presented by Dieter Goette, from Vifor Pharma, at the 2019 ACR/ARP Annual Meeting, which took place Nov. 8-13 in Atlanta.

Treatment with high-dose glucocorticoids is currently a standard-of-care approach in disease management of people with AAV. However, this type of treatment is linked with adverse events, including infections that can cause long-term organ damage and are associated with acute morbidity and mortality.

Now, researchers at Vifor Pharma, in Switzerland, assessed how often glucocorticoids are prescribed in Europe, as well as patients’ responses and the rate of adverse events.

A retrospective analysis was performed on 929 AAV patients — 54% with granulomatosis with polyangiitis, and 46% with microscopic polyangiitis — with a mean age of 56.82 years, who were diagnosed between 2014 and 2017. The patients were from four different countries in Europe, corresponding to a total of 399 physicians.

The team observed that the severity of vasculitis varied, with the majority of patients (54%) showing moderate vasculitis all over the body (systemic). Among the rest, 12% had mild or localized vasculitis, and 34% had severe life-threatening vasculitis.

Glucocorticoids were prescribed to 83% of patients. For nearly half (49%), the treatment was given intravenously, or into the vein, followed by oral administration. Another 17% of patients received glucocorticoids either exclusively intravenously or orally.

Among the patients receiving the treatment, 43% were given a combination of cyclophosphamide and glucocorticoids, while 13% received glucocorticoids plus rituximab. Glucocorticoids alone were given to 10% of the individuals.

The analysis showed that the majority of patients took glucocorticoids for more than 12 months, but failed to respond completely to the treatment. Adverse events were frequent, occurring primarily during the first three months of treatment when the dose of glucocorticoids was the highest.

The glucocorticoids doses used were variable, changing from country to country. In the United Kingdom, the glucocorticoids doses were lower compared with other countries: after three months, 55% had a reduction in dose, while 46% were given a lower dose after six months.

After 12 months, 67% of patients had no signs of vasculitis activity, while 17% remained with localized disease, 11% had mild-to-moderate, and 6% had moderate-to-severe systemic disease.

Among those still depending on glucocorticoids after one year — a total of 61% — 34% were being treated with a dose below 5 milligrams (mg). More than half (56%) of these patients were receiving doses between 5 and 10 mgs, while 9% were given doses of 10-20 mg. Only 2% were given doses above 20 mg.

Overall, these results showed that the clinical response to glucocorticoids “is variable and only a minority of patients at 12 months have full remission of AAV without the clinical need for steroids,” the researchers said.

“New targeted therapeutic approaches are needed to address this unmet medical need in AAV,” they concluded.