Case study: Strategic collaboration breaks ground in lupus clinical research in the UK
The UK Musculoskeletal Translational Research Collaboration and the charity Versus Arthritis brought together the NIHR University College London Hospitals (UCLH) Biomedical Research Centre (BRC) and pharma company GlaxoSmithKline (GSK) on testing a novel combination of biologics for systemic lupus erythematosus (SLE).
There remains no cure at present for lupus, and current therapies have shown varying degrees of success, and are often associated with numerous side effects.
The development of new treatments for lupus has been slow, with few interventional clinical trials conducted in the UK during the last decade in part because of challenges with patient recruitment.
While the biologic drug rituximab has shown some benefit for people with lupus, inflammation can flare up again after treatment and other biologic options like belimumab are not widely used in the UK.
While BEAT-Lupus was a small study with just 52 patients, it was the first academic-led interventional double-blind trial completed in lupus in the UK for about 20 years.
“We came up with the idea to give a combination of belimumab and rituximab to see if we could reduce the number of flares after using rituximab alone.
It was crucial to involve all of the stakeholders to maximise our chances of meeting the recruitment targets and the UK MSK TRC was perfectly placed to support and coordinate with this. Ultimately, the strong collaborative approach across the UK MSK TRC sites, allowed us to reach our target”, says Professor Mike Ehrenstein, Principal Investigator of the BEAT-Lupus study.
The trial discovered that combining the two treatments leads to a reduction in antibody levels associated with disease activity. Results also demonstrated a reduction in severe flares.
The power of academic, industry and charity collaboration
When Versus Arthritis developed the “First in Disease” funding call in close collaboration with NIHR, the specific aim was to encourage engagement with industry.
Professor Mike Ehrenstein and his team at NIHR UCLH BRC, one of the centres members of the UK MSK TRC, approached GSK to partner to supply belimumab for the study as part of their application to the funding call for clinical trials of investigational drugs to treat arthritis and other rheumatic diseases.
“Our goal was to increase visibility and access to our research landscape for experimental arthritis trials to pharma, and also provide financial support for collaborative trials between industry and academia.
And BEAT-Lupus was the only one out of a dozen applications that actually ran to delivery” says Dr. Sarah Rudkin, Head of Research Strategy at Versus Arthritis.
The other crucial element of the work was that the research agenda was also aligned with GSK’s strategic interest in bringing the science forward in this disease.
“GSK is committed to improving the lives of patients living with lupus. Benlysta (belimumab), approved in 2011, is the first biologic treatment approved for SLE in more than 50 years. Supporting the BEAT-Lupus project was aligned with our goal of exploring ways to optimise the efficacy of Benlysta leading to improved patient outcomes” says Dr. Holly Quasny, Scientific Director at GSK.
“The collaboration with GSK and Versus Arthritis aligned around our goals, research agenda and focused on patient benefit which was absolutely crucial. It demonstrates the way for future collaboration, where NIHR through the UK MSK TRC, industry, research funders and patients can together determine the priorities for clinical trials for lupus patients”, says Professor Ehrenstein.
Harnessing UK-wide expertise to overcome the challenge with multi-sites studies
The UK MSK TRC was crucial from the outset of BEAT-Lupus, providing the resource to support coordination, set up sites and identify sub-sites. It was also key in publicising the trial which included producing a video to recruit patients to time and target.
“The UK MSK TRC provides the interface between the strong academic input that multi-centre intervention studies require and an industry partner, in addition to ensuring the patient’s voice is heard, through the partnership with Versus Arthritis” says Professor Ehrenstein.
Having an established network of multidisciplinary professionals from across the UK meant BEAT-Lupus was delivered at a scale and pace that would not be achievable otherwise.
“The UK MSK TRC was the mechanism that facilitated conversations with pharma, attracting collaborations for clinical study groups. It is an excellent vehicle to support study design and delivery in experimental medicine that addresses musculoskeletal diseases” says Dr. Rudkin.
“The operational support provided by the UK MSK TRC for setting up the study in an effective manner, especially for a multi-centre study, was invaluable and allowed for the results of BEAT-Lupus to be reported in a timely fashion” adds Dr. Quasny.