Date: 26 April 2018
The UK’s first clinical trial testing a biological combination treatment for patients with the chronic autoimmune disease, systemic lupus erythematosus (SLE), has successfully met its 50 per cent recruitment target.
The BEAT-Lupus study, supported by the NIHR Joint and Related Inflammatory Diseases Translational Research Collaboration, has recruited its 25th patient out of a target of 50.
Systemic Lupus Erythematosus (SLE) is an autoimmune disease that occurs when a person’s antibodies, produced by immune B cells, mistakenly attack the body’s own cells.
This attack causes severe inflammation, with a range of problems including fatigue, rashes, hair loss, arthritis, kidney involvement and blood disorders. Long-term complications in SLE can include early onset heart attacks, strokes and kidney failure.
There is currently no cure for SLE and existing treatments only help with managing the symptoms. Rituximab is a biological therapy that is used to reduce inflammation and improve the symptoms of SLE. However, it has been observed that it can lead to an increase in B-cell activating factor (BAFF), which is believed to cause “flares” of inflammation after the treatment cycle is complete.
The BEAT-Lupus study will treat SLE patients with rituximab and the BAFF-inhibiting drug, belimumab, in order to attain preliminary results about whether this combination of drugs prevents the development of inflammatory flares and improves the overall efficacy of rituximab treatment.
Professor Mike Ehrenstein is a consultant rheumatologist treating patients with SLE at University College London Hospitals and is the Chief Investigator for this nationwide study.
He said: “The development of new treatments for lupus has been frustratingly slow with few clinical trials for this debilitating disease in the UK over the last decade. Thanks to the dedication of the lupus teams at participating hospitals we are delighted to have hit this patient recruitment target and hope to complete recruitment by the end of this year.”
BEAT-Lupus, a randomised Phase II clinical trial, is funded by Arthritis Research UK in partnership with the UCL Hospitals NIHR Biomedical Research Centre and GSK, and will recruit 50 patients from 16 lupus specialist centres across the UK.
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