Blisibimod will go on to the next stage of clinical development for use in people with SLE.
INTRODUCTION
Systemic lupus erythematosus (SLE) is an autoimmune disease. It typically affects women between the ages of 15 and 45. 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 very tired and have joint pain and rashes that are sensitive to sunlight. SLE can also lead to pain and swelling in internal organs such as the kidneys. Blisibimod is a new drug called a biologic. It works by interfering with an immune pathway, and reducing B cell counts. 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 main objective was to see whether blisibimod was safe and effective for patients with SLE, and to work out the best dose and frequency to achieve good outcomes with minimal side effects.
WHO WAS STUDIED?
The study included 547 patients who had moderate or severe SLE for more than 6 months and had been receiving another medicine for more than 2 months. All patients were positive for one or both types of autoantibodies (anti-nuclear or anti-double-stranded DNA) which are markers for the disease.
HOW WAS THE STUDY CONDUCTED?
This was a randomised, placebo-controlled trial, which means that patients were assigned by chance to receive either blisibimod (the active medicine) or placebo (a dummy that has no active medicine in it) on top of the medicine they were already taking for their SLE. 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. As this was a study to work out the best dose of the drug, each main drug group was split into three smaller groups to receive different doses at different frequencies. During the treatment neither patients nor their doctors knew which group they were in.
WHAT WERE THE MAIN FINDINGS OF THE STUDY?
The study found that some doses of blisibimod gave a benefit over placebo, particularly higher doses given weekly and in a subgroup of patients with severe disease. A dose of 200 mg given once a week was found to be the best and most convenient option. The authors saw that there were improvements in the numbers of autoimmune biomarkers in the blisibimod group. There were also reductions in the amount of protein found in the urine of patients taking blisibimod, which suggests that the drug improves kidney function. Blisibimod was found to be generally well tolerated, with side effects and infections similar to those in the placebo group. The most common side effect seen in the blisibimod group was a reaction at the injection site, but these were typically mild.
ARE THESE FINDINGS NEW?
Yes, this is the first study to show a significant improvement in disease activity with blisibimod in patients with SLE. This is also the first time that a subcutaneously injected biologic drug has been shown to work in patients with SLE, although intravenous infusions of belimumab – another new biologic dug – have previously had good results.
HOW RELIABLE ARE THE FINDINGS?
There are some limitations in the study design. Although the treatment was blinded, knowledge of visit frequency (e.g. every 1 or 4 weeks) or dose volume may have biased scoring or decisions. Also, a smaller number of patients in the blisibimod treatment group were receiving background immunosuppressive medication compared with placebo. There were also some statistical limitations because of the number of small groups involved.
WHAT DO THE AUTHORS PLAN ON DOING WITH THE INFORMATION?
More studies are underway to investigate blisibimod in people with SLE as well as people with some types of autoimmune nephropathy (kidney disease).
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 summary prepared: September 2015
Summary based on research article published on: 19th April 2014
From: Furie, RA. et al. A phase 2, randomised, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus, the PEARL-SC study. Ann Rheum Dis 2015;74:1667–75. doi:10.1136/annrheumdis-2013-205144LaySummary
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