Pharmaceutical Market Europe • July/August 2026 • 16-17
ASCO 2026
In the second of our articles on lupus, PME spoke to Albert Roy, President and CEO the Lupus Research Alliance, about how current research could enable standards of care to move from suppressing the immune system to centre on targeted, disease-modifying therapies
By Albert Roy
What’s driving the shift from broad immunosuppression to precision approaches in lupus, and why now?
Albert Roy (AR): For decades, lupus treatment relied on broadly suppressing the immune system. Today, that’s changing. Advances in immunology, genetics and biomarkers are finally allowing us to understand lupus at a molecular level and identify the specific immune pathways – particularly B-cell–driven processes – that fuel inflammation and organ damage. That clarity has opened the door to more targeted therapy approaches that can intervene without depleting the entire immune system.
The timing also matters. For more than 50 years, there were virtually no breakthroughs in lupus-specific treatments – but a lot of work was happening behind the scenes that, in many ways, was driven by the research enabled by the Lupus Research Alliance. In the past five years, we have seen an unprecedented acceleration in lupus drug development, including multiple new approvals, late-stage programmes and regulatory momentum. This convergence of better science, smarter clinical trial design and renewed industry investment represents a true inflection point – one where precision medicine is no longer theoretical, but increasingly achievable for people living with lupus.
How realistic is the goal of ‘immune reset’ through B-cell–targeting therapies and what evidence supports durability?
AR: The concept of immune reset is no longer speculative – it’s emerging from early clinical data. B cells are central drivers of lupus pathogenesis and therapies that deeply deplete or eradicate pathogenic B cells aim to allow the immune system to repopulate in a healthier, non-autoreactive state. Early studies of cell-based approaches – like CAR T-cell therapy – have shown remarkable results in small numbers of patients, including sustained drug-free remission, suggesting that durable disease control may be possible.
That said, it’s still early days. While bi-specific and next-generation monoclonal antibodies are demonstrating meaningful clinical benefit and steroid-sparing effects, longer follow-up is needed to understand durability across broader populations.
The goal of immune reset is realistic, but it will require continued rigorous study to define who benefits most, how long responses last and how best to balance safety, scalability and access.
What will it take to move lupus care beyond chronic steroid use?
AR: Moving beyond chronic steroids requires both better therapies and better trial design.
Steroids are highly effective in the short term, but cause cumulative harm when used in the long term, contributing to organ damage, infections and reduced quality of life. Historically, their widespread use in clinical trials masked the true benefit of investigational therapies and slowed progress by driving up placebo rates. Today, trials are intentionally designed to require steroid tapering, allowing new treatments to demonstrate whether they can truly control the disease without reliance.
Equally important is clinician and patient confidence that newer therapies can safely minimise the use of steroids. As more treatments demonstrate steroid-sparing efficacy in trials and real-world use, practice patterns can shift. The goal is not eliminating steroids entirely, but reserving them for acute situations – while also building a treatment paradigm centred on targeted, disease-modifying therapies.
Which emerging modalities look most promising in the current pipeline?
AR: The most exciting aspect of the current pipeline is its diversity. Cellular therapies – such as autologous and allogeneic CAR-T cells, NK cells and in vivo CAR approaches – represent a fundamental shift from symptom management to potential long-term drug-free remission. At the same time, advances in immune modulation, including TYK2 inhibitors, interferon-pathway blockers, FcRn inhibitors and bispecific antibodies (T-cell engagers), are offering new ways to precisely disrupt disease-driving inflammation.
Rather than identifying a single ‘winner’, the future is likely to involve multiple complementary approaches. Lupus is profoundly heterogeneous and success will come from having a broad toolkit that allows clinicians to match the right patient to the right therapy at the right time.
Are we finally solving the clinical trial challenges that have historically slowed lupus drug development?
AR: We have made great strides, but the work is far from over.
Progress has resulted from deliberate effort. Improved trial design, clearer endpoints, steroid-taper requirements, better patient stratification and a deeper understanding of disease biology have all contributed to better outcomes. Importantly, there is growing recognition that lupus trials must reflect the real-world complexities of the disease by reflecting the concerns of people living with lupus.
Clinical research must be treated as part of standard care, not a last resort. When patients, clinicians, non-profits and industry come together with shared goals and trust, trials enrol faster, questions are answered more efficiently and meaningful therapies are brought to patients sooner.
How is the Lupus Research Alliance helping accelerate this new wave of innovation with industry?
AR: The Lupus Research Alliance plays a unique role that truly spans bench to bedside. And we make that possible as a trusted convener across science, industry, clinicians and patients.
We are investing heavily in foundational science across all our grant-making programmes – while also contributing to drug discovery through our Lupus Nexus, a first-in-kind lupus registry, biorepository and information exchange platform that drives in-depth research to further the understanding and treatment of lupus. By generating high-quality, longitudinal data and biospecimens, we help industry develop more potent and effective therapies for a complex disease.
Through our clinical affiliate, Lupus Therapeutics, we partner directly with the biopharmaceutical companies on clinical trial operations and incorporation of the patient voice throughout drug development, leveraging its Lupus Clinical Investigators Network – a consortium of leading academic medical centres across North America that is currently involved in more than 25% of all active lupus clinical trials worldwide.
And now there is Lupus Ventures, the only lupus-focused venture fund to catalyse high-risk and high-reward diagnostics and treatments to close the gap that exists between breakthrough ideas and real-world treatments.
We are proud that we are there at every part of the scientific process, each working toward a cure for lupus.
In ten years, what should success in lupus look like?
AR: Success means we continue down the path towards discoveries that allow people living with lupus to get earlier diagnosis, safer and more effective treatments and live lives defined by possibility rather than disease limitation. Clinically, it means sustained drug-free remission.
Just as importantly, success means lupus drug development is no longer stalled by risk and uncertainty. It means clinical research is integrated into the standard of care, innovation is continuous and every person with lupus has access to treatments tailored to their disease biology. That is the future we are working toward.
Find out more at lupusresearch.org/
Albert Roy is President and CEO of the Lupus Research Alliance