BEAT-Lupus clinical trial shows promise of new treatment for lupus

07 June 2021

We’ve funded the UK’s first clinical trial testing a combination of biological treatments for people with systemic lupus erythematosus (SLE), the most common form of lupus. 

The BEAT-Lupus clinical trial has found that the combination of belimumab and rituximab is safe for patients with lupus and shows promising results for its effectiveness.

The study led by Professor Mike Ehrenstein, consultant rheumatologist at University College London Hospitals has taken 6 years from initial funding to finishing the review of data from the 52 patients recruited for the trial.

Why are the results of this lupus trial important?

There’s no cure for lupus at present. 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. 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.”

So, what did the researchers do?

The development of biologic drugs like anti-TNF revolutionised the treatment of inflammatory arthritis such as rheumatoid arthritis.

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

Sherron Alexander-Bedingfield was diagnosed with lupus 14 years ago following the birth of her youngest daughter.

Here she shares what it was like taking part in the BEAT-Lupus trial:

I was willing to take part in the trial as my way of helping the understanding of lupus. It’s a silent illness that creeps up on you without knowing the full implications of what is happening. The research monitored my illness without being intrusive in my daily life. The staff worked appointments around my work schedule, and I got the benefit of specialist 1-2-1 care for 18 months.

Medical staff could see how my body reacted to the treatment. They encouraged me to listen to my body and note subtle changes that were occurring. I thought more carefully about how I was feeling in between appointments and could explain this in more detail at my next appointment."

And what did the researchers find?

  • Treating people with belimumab after rituximab caused a reduction in levels of an important antibody that is associated with disease activity in lupus.
  • The study also showed that this combination of drugs led to a threefold reduction in severe flares in patients with lupus, compared to the placebo group receiving only rituximab.

This reduction in the risk of severe flares suggests this combination of biologic drugs could be an effective treatment for people with lupus.

The treatment works by the combined action of the two biologic drugs:

  • Rituximab depletes the number B-cells that cause inflammation in the condition.
  • Belimumab targets a protein which increases the number and activity B-cells, to keep the number of inflammatory B-cells under control and therefore reduce lupus flares.

Results of the trial showed that the belimumab suppressed the number of B-cells at 52 weeks compared to the placebo group.

Positive steps for new treatment options

Professor Mike Ehrenstein “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, says:

"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."

The BEAT-Lupus trial was funded through a collaboration between Versus Arthritis and GlaxoSmithKline, with additional support from University College London Hospitals Biomedical Research Centre and the NIHR UK Musculoskeletal Translational Research Collaboration.

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