PRESS RELEASE: Stratify Lupus
DATE: 9/5/2025
Pioneering UK clinical trial could change lives of those living with “devastating” disease
Hope is on the horizon for lupus patients who don’t respond to current treatments, as a pioneering clinical trial is due to get underway in the UK that could revolutionise treatment approaches across the globe.
Researchers at University College London Hospitals and UCL have developed a biomarker measurable in the blood of patients resistant to conventional treatments, that makes them 17 times more likely to respond to an innovative combination of drugs that are used in the NHS, but not together, for Lupus treatment.
More than 3,000 people, mainly women, are diagnosed in the UK every year with the incurable and potentially life-threatening autoimmune condition that can attack the body’s major organs. Predominantly affecting women of child-bearing age, with Afro-Caribbean women most severely impacted, it is characterised by arthritis, skin rashes, chronic fatigue and kidney problems.
Professor Michael Ehrenstein, consultant rheumatologist University College London Hospitals and Professor of Experimental Rheumatology at UCL, will lead the trial which is due to begin in Spring 2026 at 16 hospitals across the UK*. The £1.7m Stratify Lupus trial is being funded by charity Versus Arthritis and the Efficacy and Mechanism Evaluation (EME) Programme, a partnership between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC).
Professor Lucy Donaldson, Director of Research at Versus Arthritis, which funds research and provides support services to those living with arthritis and musculoskeletal conditions, believes this will be a significant advance for the treatment of a destructive condition : “This major trial holds real promise of a better future for those living with lupus, which particularly affects underserved people. Too few advances have been made in tackling the devastating disease which mainly affects women, in particular women of African and Caribbean heritage, in the prime of their lives.”
Professor Michael Ehrenstein and his team have dedicated many years to advancing lupus research, on which the latest trial will build. The team’s 2021 study BEATLupus found the combination of two advanced immune system targeting “biologic” drugs- rituximab and belimumab - was able to bring disease activity under control and significantly reduce severe flares in some, but not all, patients.
Further laboratory work and advanced analysis methods revealed the new biomarker in the blood – an antibody called IgA2 anti-dsDNA - was found in around 50% of lupus patients resistant to conventional therapy. The team tested blood samples from their own and a US trial and found those who tested positive for the biomarker were 17 times more likely to respond to the combination of rituximab and belimumab, compared to rituximab alone.
Now the team are undertaking an innovative trial where only patients positive for the biomarker will be given the drug combination. If the clinical trial, due to end in 2029, proves successful, patients may not have long to wait to access the new targeted treatment. Professor Ehrenstein said: “If the results are positive then we would apply to allow patients who are positive for the biomarker to receive the combination therapy on the NHS. Targeting the patients most likely to benefit from this treatment should make it deliverable on the NHS and improve patient access and outcomes.”
Those living with Lupus can testify to the challenges of finding treatments that work. Ayo Ogunwumiju was pregnant when she began experiencing shortness of breath, chest pains and fatigue. Initially put down to pregnancy-related complications, Ayo’s symptoms progressed and by the time her daughter reached the age of six months she was struggling to lift her baby due to intense joint pain. “I was eventually diagnosed with Lupus after being hospitalised when I lost mobility in my legs and found it difficult to breathe,” recalls Ayo who has tried many treatments over many years to bring her symptoms under control.
“It took me six years of trying different medications with horrible skin blisters which left me with scars before I was finally put on a treatment that works well for my immune system. Research like this, using a biomarker in blood to target better treatments to control people’s symptoms, would make a world of difference to patients not having to live in pain for a long period of time,” Ayo added.
In terms of achievement, a successful trial would not only improve lives of patients but herald a breakthrough in advancing research aims to deliver personalised medicine – something written into the future direction of the NHS. A potential world-first looks to be within the reach of Professor Ehrenstein and his team. He explains: “To have a positive result in a personalised medicine trial for lupus would be globally significant, not only for the biomarker and treatment combination, but also the success of this targeted approach. Everyone talks about personalised medicine, but so far this goal has not been achieved in inflammatory/autoimmune rheumatic diseases. STRATIFY lupus will be the first biomarker enrichment trial for lupus, which is a real coup for UK research.”
The trial is funded by a collaboration between the charity Versus Arthritis and a major public funder of health research, the National Institute for Health and Care Research (NIHR). Clinical trials for Lupus are notoriously difficult to complete due to the complexity of the disease and need to recruit from many different hospitals. This is where the research infrastructure provided by the NIHR helps to support these complex trials to be conducted within the NHS.
The NIHR’s research infrastructure enables complex trials within the NHS. The UK Musculoskeletal Translational Research Collaboration (UK MSK-TRC), a joint initiative between the NIHR and Versus Arthritis, plays a key role in providing essential support for recruitment, visibility, and as an interface for industry and academic collaborations, as demonstrated in the BEAT-Lupus trial. Professor Ehrenstein will again work closely with the UK MSK-TRC to support the STRATIFY-Lupus trial, recognising the NIHR’s role in uniting the research community and the vital contributions of principal investigators and their teams at lupus specialist centres across the UK.
Professor John Simpson, NIHR Director of the EME Programme, said: "This innovative trial heralds an important shift towards specifically delivering treatments tailored to patients who are most likely to benefit. This raises the real potential to open up future effective treatment options for people with systemic lupus erythematosus, many of whom have limited effective treatment options. It has been a pleasure to partner strategically with Versus Arthritis to make this important trial happen.”
Preparations for set up at the 16 trial sites* will being in June, with patient recruitment through lupus centres to commence in the first quarter of 2026. The trial is scheduled to complete in 2029, with analysis completed by the end of that year.
The trial, and supporting studies, have been aided by Lupus UK, UCLH/UCL Joint Research Office, and GlaxoSmithKline.
ENDS
Notes to editors
For further information please contact Natalie Stephenson, Versus Arthritis Press Office by emailing press@versusarthritis.org or calling 0300 7900456.
*list participating sites in the notes to editors for potential regionalisation/added regional media interest
About Versus Arthritis
Versus Arthritis is the largest arthritis charity and the biggest dedicated charitable investor of arthritis research in the UK, changing lives through research, campaigning and support.
The impact of arthritis can be huge, affecting the ability to learn, work, care for family, move free from pain and live independently. Together with researchers, healthcare professionals, policymakers, supporters and volunteers, Versus Arthritis works tirelessly to make sure everyone with arthritis has access to the treatments and support they need to live the life they choose, with real hope of a cure in the future.
Find out more at: www.versusarthritis.org | Twitter/X | Instagram | Facebook | LinkedIn
About The National Institute for Health and Care Research (NIHR):
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
- Funding high quality, timely research that benefits the NHS, public health and social care;
- Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
- Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
- Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
- Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.
About the Medical Research Council
The UKRI Medical Research Council is at the forefront of scientific discovery to improve human health. Founded in 1913, the MRC now invests in some of the best medical research in the world across every area of health. Thirty-three MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of therapeutic antibodies leading to some of the most successful drugs developed. Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. The Medical Research Council is part of UK Research and Innovation. www.mrc.ukri.org
Professor Ehrenstein bio
Michael Ehrenstein is Professor of Experimental Rheumatology at University College London (UCL) and Honorary Consultant Rheumatologist at University College London Hospitals. Michael studied medicine and later trained in Rheumatology at The Middlesex Hospital. He was awarded a PhD at UCL on the pathogenesis of autoimmune rheumatic disease under the supervision of David Isenberg. He was awarded an MRC Clinician Scientist Fellowship to work at the Laboratory of Molecular Biology in Cambridge with Dr Michael Neuberger.
The objective of his research group is to use targeted therapy as a molecular scalpel to understand the pathogenesis of systemic lupus erythematosus (SLE) and rheumatoid arthritis, with respect to loss of immune tolerance and ongoing inflammation, to develop novel (and safer) therapies and improve existing therapies, and to target therapies to patients most likely to benefit through biomarker identification.
He was chief investigator for the BEAT-LUPUS trial which arose from experimental medicine studies looking at the immune consequences of B cell depletion in patients with SLE, and was one of the first trials to test combination biologic therapy (rituximab followed by belimumab) for patients with SLE.
Case study
Ayo’s story of life with lupus can be supplied on request.
References
BEAT Lupus 2021
Effectiveness of Belimumab After Rituximab in Systemic Lupus
Erythematosus : A Randomized Controlled Trial - PubMed
BEAT-Lupus clinical trial shows promise of new treatment for lupus
Strategic collaboration breaks ground in lupus clinical research in the UK | NIHR
Biomarker discovery
Lupus
Lupus (systemic lupus erythematosus, SLE) is a condition where the immune system, which is the body’s natural self-defence system, attacks the body. Lupus commonly affects the joints, causing arthritis with inflammation, swelling, stiffness, pain, and damage. It can also attack other organs including the skin, kidneys, lungs, and nervous system.
It is most commonly diagnosed in women between the ages of 15 and 44. More than 3,000 people are diagnosed with Lupus in the UK every year.
Source: State of MSK 2024