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Combination therapy study for lupus underway at UCLH

Doctors at UCLH are trialling a biological combination treatment for patients with the disabling condition lupus.

The experimental drug, called belimumab, could act as a huge breakthrough if it proves effective.

A team led by consultant rheumatologist Professor Mike Ehrenstein will treat lupus patients with belimumab, which works by targeting a naturally occurring protein believed to play a role in the production of antibodies which attack and destroy the body's own healthy tissues, in addition to a standard therapy called rituximab.

Rituximab is a ‘B cell depletion’ therapy that is used to reduce inflammation and improve the symptoms of lupus. 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 team anticipate that this combined treatment approach will prevent the lupus from coming back after rituximab therapy. At present however they do not know whether giving belimumab is any better than simply having B cell depletion therapy alone.

The 50 patients the team intend to enrol on the trial have systemic lupus erythematosus (SLE), an incurable autoimmune condition which affects the whole body. The immune system, which should be fighting disease, instead attacks healthy tissue. SLE is estimated to affect five million people worldwide and can lead to serious damage to organs such as the kidneys and the heart.

Half of the trial patients will receive belimumab and half will receive a placebo. Both treatments will be given by intravenous infusion; the placebo treatment will look the same as belimumab but will not contain an active drug.

SLE symptoms vary between patients, but the most common are joint and muscle pain, rashes and fatigue. There is currently no cure for SLE and existing treatments only help with managing the symptoms.

BEAT-Lupus aims to recruit 50 patients from participating lupus specialist centres across the UK and is funded by the University College London Hospitals Biomedical Research Centre, Arthritis Research and GSK.

The trial is sponsored by the Comprehensive Clinical Trials Unit (CCTU) at UCL. For further information about the trial contact the CCTU Clinical Trial Manager: ctu.beatlupus@ucl.ac.uk