High-dose atacicept prevented disease flares, although there were some safety concerns.
Systemic lupus erythematosus (also known as SLE or lupus) is an autoimmune disease. It typically starts in women between the ages of 15 and 45, but can affect both genders. The cause of SLE is not known, and symptoms can vary from patient to patient, but it often causes B cells in the body to become hyperactive and increases the production of autoantibodies. People with SLE are often exhausted and have joint pain and rashes that are sensitive to sunlight. SLE can also lead to joint pain and swelling as well as inflammation in internal organs such as the kidneys. SLE tends to flare up from time to time. Atacicept is a new drug called a biologic. It works by interfering with two factors in the immune pathway, and blocks the stimulation of a certain kind of white blood cell. Clinical trials are still underway to work out if it will be safe and effective to use in people with SLE.
WHAT DID THE AUTHORS HOPE TO FIND?
The authors wanted to know whether it is possible to prevent SLE flares using atacicept. WHO WAS STUDIED? The study looked at almost 500 patients with SLE.
HOW WAS THE STUDY CONDUCTED?
This was a double-blind, randomised clinical trial, which means that patients were assigned by chance to one of three treatment groups to receive either atacicept at a low or high dose, or a placebo (dummy drug). 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. All patients were over the age of 16 and had previously achieved remission using steroid medicines.
WHAT WERE THE MAIN FINDINGS OF THE STUDY?
The findings showed clearly that the higher dose of atacicept was able to reduce flares. The lower dose showed improvements in blood tests, but did not prevent flares. This suggests that high doses of atacicept may help to prevent disease flares. If patients have fewer flares, they will be saved from using steroids, which can have side effects in the long term. There were some concerns over safety in the study. Two patients died in the high-dose group from infections, and so that part of the study was stopped early. However, this death rate is similar to that seen in other lupus trials, and the deaths may have been caused by the underlying disease, use of steroid medicines or delays in diagnosis and treatment.
ARE THESE FINDINGS NEW?
Yes, this is the first time that atacicept has been used to reduce SLE flares in this way. Usually, drugs for SLE are used to treat active disease flares, rather than to prevent them.
HOW RELIABLE ARE THE FINDINGS?
The findings are limited by the early stopping of the trial for the high-dose group. However, the authors are confident that the results are still reliable, and that atacicept may be useful in patients with SLE.
WHAT DO THE AUTHORS PLAN ON DOING WITH THIS INFORMATION?
Another study is underway to see if atacicept can treat active SLE.
WHAT DOES THIS MEAN FOR ME?
If you have SLE, there are limited treatment options at the moment. The data from this study will help to develop new drugs for SLE and other autoimmune diseases, which may mean that there are better options for you in the future. If you are interested in taking part in clinical trials for new medicines, you should talk to your doctor.
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Date prepared: November 2015
Summary based on research article published on: 20 June 2014.
From: Isenberg D, et al. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial). Ann Rheum Dis 2015;74:2006–15. doi:10.1136/annrheumdis-2013-20506
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