People more likely to respond to rituximab treatment can be selected, making the treatment more focused and cost effective.
Sjögren’s syndrome is an autoimmune disease. It typically affects the saliva and tear glands, causing dry mouth and eyes. Other parts of the body may also be drier than normal, and the disease can make you feel tired and physically exhausted. Sjögren’s syndrome is mainly diagnosed in women between the ages of 40 and 60. People with Sjögren’s syndrome have a high risk of developing a type of cancer called lymphoma.
Rituximab belongs to a group of drugs known as biologics. Rituximab targets B cells in the immune system, helping to restore the immune balance. Rituximab has been shown to reduce symptoms in people with Sjögren’s syndrome, but it is not known who would most benefit from treatment.
WHAT DID THE AUTHORS HOPE TO FIND?
The authors hoped to find out whether treatment with rituximab caused any changes in a major salivary gland called the parotid. They also wanted to be able to identify specific characteristics that might help to predict which people with Sjögren’s syndrome might respond to rituximab treatment.
WHO WAS STUDIED?
The study looked at 25 people with well-established Sjögren’s syndrome seen at Sjögren’s expertise centrum in the Netherlands.
HOW WAS THE STUDY CONDUCTED?
This was a double-blind, placebo-controlled trial, which means that patients were assigned by chance to one of two treatment groups to receive placebo (dummy drug) or rituximab. 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. During the treatment neither the patients nor their doctors knew which group they were in. To minimise any side effects of the drug infusions, everyone received pre-medication before the infusion was given, and oral steroids for 5 days afterwards.
A biopsy of the parotid gland was taken before treatment and again 12 weeks after treatment. These two samples were then analysed for each person to work out the type and number of inflammatory cells (for example, B cells) and whether there were any specific characteristics to indicate that the salivary gland was being destroyed by the disease. Finally, each person’s disease activity was assessed.
WHAT WERE THE MAIN FINDINGS?
The main finding of the study was that treatment with rituximab decreased the inflammation in the parotid salivary gland. There was no change in inflammation in people treated with placebo. The study also found that people who had a good response to treatment with rituximab were those who had a higher number of inflammatory cells in their first biopsy.
ARE THESE FINDINGS NEW?
Yes, this is original research, and the first time that such results have been published.
ARE THERE ANY LIMITATIONS?
This study looked at a small sample of people. Additionally, the people included had high disease activity, with inflamed salivary glands and a positive blood test for Sjögren’s syndrome. This might mean that the results cannot be generalised to other types of the disease. However, the authors are very confident that the results are reliable. Although the number of patients seems relatively small, the authors did a statistical analysis that con- firmed the findings. Additionally, the people included had well-established Sjögren’s syndrome and characteristic parotid gland biopsies.
WHAT DO THE AUTHORS PLAN ON DOING WITH THIS INFORMATION?
There are no similar studies planned for the time being. However, the authors are currently investigating abatacept, another type of medication which may be beneficial for Sjögren’s syndrome. It is hoped that they will be able to determine who is most likely to respond to treatment with abatacept, and that these results will be published soon.
WHAT DOES THIS MEAN FOR ME?
People with Sjögren’s syndrome show wide variety of symptoms, and come from a variety of genetic backgrounds, which makes it difficult to have one type of treatment that will work predictably for everyone. This study showed that the pre-treatment number of inflammatory cells in the salivary gland may help doctors to predict how people will respond to treatment with rituximab. If you have Sjögren’s syndrome, this research might help your doctor to select the right treatment for you – often called personalised medicine.
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Date prepared: November 2016
Summary based on research article published on: 12 January 2016
From: Delli, K. et al. Towards personalised treatment in primary Sjögren’s syndrome: baseline parotid histopathology predicts responsiveness to rituximab treatment. Ann Rheum Dis 2016;75:1933–8.
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