Long-term use of even low-dose glucocorticoid for remission maintenance might not be necessary.
Introduction
ANCA-associated vasculitis (shortened to AAV), is a rare group of diseases of the immune system. These diseases are linked to a type of autoantibody called ANCA. An antibody is a protein that the normal healthy immune system makes to attack foreign substances in the body, such as viruses or bacteria. In people with AAV the body makes antibodies that bind its own components – these are called autoantibodies. In AAV, the ANCA autoantibodies bind to a specific population of white blood cells called neutrophils, and then these activated neutrophils cause damage to small blood vessels. Any part of the body can be affected, but AAV most often affects a person’s kidneys, lungs, joints, nerves, and may cause bleeding in their nose and ears. AAV is very severe, and can be life-threatening if left untreated.
There are several drugs that can be used to keep AAV in remission. Remission means that the disease is under control, and there are no signs of symptoms of active disease, and no relapses. Therapy often involves a combination of high-dose glucocorticoids and either cyclophosphamide or rituximab. But some of these medicines – especially glucocorticoids – are associated with various side effects including severe infections.
What did the authors hope to find?
The authors wanted to see whether there was a difference in relapse rates between AAV patients treated with different doses of glucocorticoid.
Who was studied?
The study included 140 people with newly diagnosed AAV, either microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA).
How was the study conducted?
This was a multicentre, open-label, randomised controlled, non-inferiority clinical trial. This means that people were assigned by chance to one of two treatment groups. Using chance in this way means that the groups will be similar and allow treatments to be compared objectively. The non-inferiority part means the researchers intended to show that the reduced-dose regimen was not worse than the high-dose one. The study was not designed to see if reduced-dose was better than high-dose.
The researchers then compared the number of relapses between the two groups over a period of 2 years.
What were the main findings of the study?
The main finding was that relapse was not frequent in people treated with the reduced-dose glucocorticoid induction regimen compared to those taking the conventional high-dose regimen. When receiving rituximab maintenance therapy, relapses happened in 13% of people in the reduced-dose glucocorticoid group, compared to 8% in the high-dose glucocorticoid group.
Among patients who achieved remission, 90% taking reduced-dose glucocorticoids were able to stop the glucocorticoid treatment, compared to just 16% taking the higher dose. The authors suggest this means that for most people treated with rituximab long-term glucocorticoid maintenance is not necessary, and glucocorticoids can be stopped early on.
Serious side effects were less common in the reduced-dose group – reported in just 27.5% of people compared to 46.2% in the high-dose group.
Are these findings new?
Yes, these are new findings.
What are the limitations of this study?
One of the limitations is that most of the people taking part had MPA, not GPA. This means that the findings may not apply for people with GPA.
What do the authors plan on doing with this information?
The authors have shown that glucocorticoid maintenance therapy is not necessary for people on rituximab maintenance therapy. However, it remains unclear how long rituximab maintenance should be continued for. The authors plan to explore this in a long-term follow-up study.
What does this mean for me?
If you have AAV, you might be able to be treated with a newer strategy of reduced-dose glucocorticoids. This could help reduce the number of side effects that you might experience. However, it is very important that you do not change the dose of your medicine yourself, or stop taking it without talking to your doctor – this needs to be done carefully and gradually.
If you have any concerns about your disease or its treatment, you should talk to your doctor or a healthcare professional involved in your care.
Date prepared: June 2024
Summary based on research article published on: February 2024
From: Summary from Furuta S, et al. Reduced-dose versus high-dose glucocorticoids added to rituximab on remission induction in ANCA-associated vasculitis: predefined 2-year follow-up study. Ann Rheum Dis 2024;83:96–102. doi:10.1136/ard-2023-224343
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