Continuing long-term low-dose prednisone may help avoid relapse in people with Lupus.
Systemic lupus erythematosus (often called Lupus or SLE) is an autoimmune disease. It typically starts in women between the ages of 15 and 45. Lupus symptoms can vary from patient to patient. People with Lupus are often very tired, have joint pain, and their skin may be sensitive to sunlight. Lupus is caused by hyperactive immune cells and the subsequent production of autoantibodies. An antibody is a protein that the immune system makes to attack foreign substances in the body, such as viruses or bacteria. In autoimmune diseases, the body makes antibodies that attack its own tissues. These are called autoantibodies.
Lupus is often treated with a class of medicines called steroids (or cortisone). Steroids can help prevent the autoimmune inflammation that causes the disease. Like a lot of medicines, steroids have side effects. These can build up if steroids are taken for a long period of time, or at high doses.
What did the authors hope to find?
The authors wanted to find out whether people with Lupus whose disease has been in remission (inactive, with no symptoms – described in the paper title as ‘quiescent’) for at least a year could stop taking their steroid medicine without their Lupus becoming active again (often called a relapse).
Who was studied?
The study looked at 124 people whose Lupus had been inactive for at least one year. Everyone included was treated at the same clinic in France, and was on a stable treatment regimen for at least one year that included a low dose (5 mg) of a steroid called prednisone.
How was the study conducted?
This was a randomised open-label study. This means that patients were assigned by chance to one of two treatment groups – either to carry on taking their steroid, or to withdraw (stop) the treatment for 12 months. Using chance in this way means that the groups will be similar and the results can be compared. During the trial, both the patients and their doctors knew which group they were in. People in both groups were allowed to carry on taking any other non-steroid medicines they were on.
What were the main findings of the review?
The authors found that people who stayed on treatment were much less likely to have a disease flare than people who stopped taking their steroid medicine. Over the year of the study, 27% of people in the withdrawal group had a flare, compared to only 7% in the group who had carried on taking their low-dose steroid. Nevertheless, three-quarters of people experienced success after withdrawing steroids.
Are these findings new?
Yes. This is the first scientific evidence that maintenance treatment with long-term, low-dose steroid medicine can help prevent relapse in people with Lupus.
What are the limitations of the study?
The study had a several limitations. The open-label and single-centre design could have affected the results. This is because there could have been a bias caused by people knowing which treatment group they were in, or something that is done differently at that clinic. Also, the steroid was withdrawn quite abruptly, and it is possible that slower tapering would work better. The people included might also not be representative of everyone with Lupus due to their ethnicity or disease history.
What do the authors plan on doing with this information?
The authors want to search for risk factors for relapse so they can determine before or early after withdrawal who may need continuation of therapy and who can be successfully withdrawn from this treatment.
What does this mean for me?
If you have Lupus, you may need to keep taking low doses of steroid medicines even if your disease is inactive. It is very important that you do not suddenly decide to stop or change your dose yourself.
If you have any concerns about your disease or its treatment, you should speak to your doctor.
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Date prepared: February 2020
Summary based on research article published on: 18 December 2019
From: Mathian A, et al. Withdrawal of low-dose prednisone in SLE patients with a clinically quiescent disease for more than 1 year: a randomised clinical trial. Ann Rheum Dis 2020;79:339–346. doi:10.1136/annrheumdis-2019-216303
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