AAV relapse rates did not significantly differ between individually tailored and fixed schedule rituximab regimens.
Granulomatosis is a medical term for a disease where granulomas – or clusters of certain cell types – are formed. This can happen in immune or inflammatory diseases. People can have with granulomatosis with polyangiitis (also known as Wegener’s granulomatosis, or shortened to GPA) or granulomatosis with microscopic polyangiitis (shortened to MPA). GPA is a rare condition in which the blood vessels become inflamed. It mainly affects the ears, nose, sinuses, kidneys and lungs. Anyone can get GPA, but it is most common in middle-aged or older people. MPA is similar, but there are subtle differences in the underlying inflammation.People with GPA or MPA can also have ANCA-associated vasculitis (shortened to AAV), which affects the small blood vessels.
Rituximab is one of a class of drugs called the biologics that was developed for use in autoimmune diseases. Rituximab targets B cells in the immune system, helping to restore the immune balance.
What did the authors hope to find?
The authors wanted to find out whether an individually tailored rituximab treatment would be suitable for people with AAV. They also hoped to find out if there are any markers in the blood that could be used to predict whether people would go on to have relapses in the future.
Who was studied?
The study looked at 117 people with GPA, and 45 people with MPA at 59 clinics in France. Everyone had already received treatment for their condition and was in remission.
How was the study conducted?
This was an open-label, randomised control trial, which means that patients were assigned by chance to one of two treatment groups. Using chance in this way means that the groups will be similar and will allow the variable or treatment under investigation to be compared objectively. Because it was open-label, both the people in the study and their doctors knew which treatment group they were in.
The first group received rituximab at the start of the study. Over the next 18 months they were controlled every 3 months and treated again only when the levels of markers certain markers in their blood rose above an agreed level. This was the individually tailored treatment. People in the control group received rituximab on the first day of the study, again after 2 weeks, and then at 6, 12 and 18 months. The study measured how many people’s disease got worse again over this time in each group.
What were the main findings of the study?
In the tailored group, over the course of the study, people received an average of 3 rituximab treatments, compared to 5 treatments in the control arms. The authors found that 17% of people in the tailored group had a relapse during the study, compared to 10% of people in the control group. Overall, serious side effects were reported in 32% of people in the tailored group, compared to 38% in the control group.
Whether people had ANCA antibodies or circulating CD19+ B-cells in their blood was not linked to whether they went on to have a relapse, but this information could be used to reduce the number of rituximab infusions that people need to have. The authors concluded that rituximab is the best treatment to maintain AAV remission.
Are these findings new?
Yes – this trial is the first study to test a tailored strategy to maintain remission in AAV.
What are the limitations of the study?
The main limitation of this study was is that everyone knew which treatment group they were in, which can sometimes cause bias in study results. However, all relapses were assessed by an independent Adjudication Committee, who were unaware of the treatment groups. Another limitation is that the blood samples were tested in each individual clinic, rather than in a central laboratory. This means there could be some differences in how the tests were done.
What do the authors plan on doing with this information?
The authors think that rituximab treatment should be recommended for all people with AAV. Another study is ongoing to work out the optimal duration of maintenance treatment.
What does this mean for me?
If you have AAV. these results suggest that there could be better treatment options in the future that are tailored to your individual needs. If you have any questions or concerns about your disease or its treatment, you should speak to your doctor.
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Date prepared: August 2018
Summary based on research article published on: 12 July 2018
From: Charles, P. et al. Comparison of Individually Tailored vs. Fixed-Schedule Rituximab Regimen to Maintain
ANCA-Associated–Vasculitis Remission: Results of a Multicenter, Randomized–Controlled, Phase 3 Trial (MAINRITSAN2).
Ann Rheum Dis 2018;77:1143–1149. doi: 10.1136/annrheumdis-2017- 212878
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