Publish date: 10 June 2021

A combination of two drugs could be an effective treatment for the debilitating disease lupus, according to preliminary evidence from a UCLH led trial.

The BEAT Lupus trial, principally funded by Versus Arthritis in a collaboration with GSK, and led by Professor Mike Ehrenstein, consultant rheumatologist at UCLH, found that treating people with belimumab after rituximab – both ‘biologic’ drugs that are made from substances produced by the body – caused a reduction in levels of a harmful antibody that is associated with disease activity in lupus.

The study, which took place at the NIHR UCLH Clinical Research Facility and which received seed funding from the UCLH BRC, showed that this combination of drugs led to a threefold reduction in severe flares in patients with lupus, compared to the placebo group only receiving rituximab during the 52 weeks of the trial.

It is the UK’s first clinical trial testing a combination of ‘biologic’ treatments for people with systemic lupus erythematosus (SLE), the most common form of lupus.

There is currently no cure for lupus. However, the condition can respond well to a number of drugs. The earlier treatment is started, the more effective it’s likely to be.

Treatments used for lupus vary depending on how serious it is, and which parts of the body are affected, but often includes treatment with steroids, or other drugs, which are associated with numerous side effects.

More effective treatments are needed, however, the development of new treatments for lupus is difficult, and many clinical trials have failed to complete or shown benefit. This means treatments have not changed much in recent years.

Professor Mike Ehrenstein 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.”

For lupus, the biologic drug rituximab is generally recommended to treat patients who are not responding to conventional treatments. Another biologic, belimumab is licensed to treat lupus, although this is used less frequently in the UK.

However, while rituximab shows some benefit for people with lupus, clinical trials have shown varying success, and for some people inflammation can flare up again after treatment.

The BEAT-Lupus study explored whether treating people with belimumab after they’d received rituximab could reduce the ongoing disease flares. The study compared treatment with belimumab to a group of people who received only rituximab.

Professor Mike Ehrenstein said: “Thanks to the dedication of the lupus teams at participating hospitals we are delighted to not only have completed recruitment, but also to provide preliminary evidence for a clinical benefit of the combination of rituximab and belimumab, compared to patients treated with rituximab alone. These results will need to be confirmed in a larger clinical trial.”

Dr Caroline Aylott, Head of Research Delivery at Versus Arthritis, said: “There is currently no cure for lupus, and responses to treatment can vary greatly. We're delighted that the BEAT-Lupus trial has shown encouraging results in reducing lupus activity and symptoms. The results need to be confirmed in a larger clinical trial, but the study is a positive step towards a new treatment option for people with lupus.

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