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Breakthrough in new lupus treatment
Many of you will know that to date there have never been any drugs that have formally been licenced for the treatment of lupus in
Over the last 5 years the pharmaceutical industry has taken a great interest in SLE with large scale multinational trials costing millions of dollars. While some of these trials have shown some promise, none of the trials have shown a major benefit over the current treatments - perhaps a testament to the effectiveness of steroids and immune suppressing agents such as Azathioprine.
It is therefore very exciting to hear of a positive study carried out by Human Genome Sciences using a drug called Belimumab (trade name Benlysta).
This drug works by reducing the ability of B Cells in the immune system to produce lupus antibodies. Antibodies produced by B cells include anti DNA antibodies which are associated with active lupus, especially kidney disease. In the largest ever clinical trial including 865 patients in 90 clinics around the World, Belimumab showed a significantly better treatment response compared to the placebo treated patients - all patients received the current standard of care. Belimumab was given as an intravenous drip and was well tolerated - the overall rates of side effects were similar between the treatment and placebo groups. The Lupus Clinical trials unit at
One further large study of Belimumab is due to publish its trial results later this year and the company hopes to submit the trial results to the regulatory authorities in the USA and Europe to seek a licence for Benylsta to treat lupus patients in the next 1 to 2 years.
Although Belimumab is not a cure for lupus, physicians in the lupus community consider this to be a major advance in the treatment of patients with moderately severe lupus who have not responded to standard treatments. Dr David D'Cruz.
For more information: www.hgsi.com/belimumab.html
Update January 2010
Since the previous article highlighting the success of a new treatment for lupus called BENLYSTA, further successful results have been announced by Human Genome Sciences and GlaxoSmith Kline.
A second larger study of over 800 patients was recently reported confirming the earlier results of the BLISS-52 study. This new study, known as BLISS-76, showed a significant improvement in patients' disease activity when given in addition to the patients usual care of steroids and immune suppressing treatments. As with the earlier study, the drug was well tolerated with no serious side effects compared to the placebo (dummy drug) treatment group.
The drug is a highly specific monoclonal antibody that targets B Cells in the immune system which are the main antibody producing cells. In simple terms, reducing the number of antibodies leads to improvements in lupus activity.
The drug is given by an intravenous drip infusion rather than as a tablet. Now that these two trials, which together have included 1,700 patients, have shown benefit, the company is preparing to apply for a licence to use the treatment in lupus patients. If successful this will be the first drug ever to be formally approved by the USA & European authorities to treat lupus since 1958. However, these applications do take a considerable time and it is likely that the drug will not be widely available until early next year.
Dr David D'Cruz January 2010.
February 2010
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