Changing the Standard of Care for Lupus Treatment: Q&A with Albert T. Roy

As the CEO of the Lupus Research Alliance, Albert T. Roy oversee’s the organization’s efforts to fund Lupus research. According to the alliance, recent breakthroughs and develops have breathed new life into treating the disease.

While previous therapies focused primarily on treating symptoms and depended on effective but potentially damaging steroids, newer therapies have the potential to reset the immune system. For patients, this provides treatment options that provide a better patient experience.

Roy spoke with Pharmaceutical Executive about that state of funding for Lupus research, recent treatment developments, and a potential shift in the standard of care.

Pharmaceutical Executive: Why is lupus underfunded relative to its disease burden?
Albert T. Roy: Lupus has long been underfunded in part because of its complexity and heterogeneity, which can make drug development risky.As a result, lupus was often deprioritized relative to diseases with clearer biology and clearer regulatory pathways, despite affecting millions globally and disproportionately impacting women and communities of color.

That imbalance is increasingly recognized, and there has been greater sustained interest and investment in lupus drug development, given recent regulatory successes in systemic lupus erythematosus (SLE) and lupus nephritis, as well as the emergence of cell therapies for treating B-cell-mediated autoimmune diseases, such as lupus.

Recent progress in lupus has shown what’s possible when funding aligns with urgency—and why continued investment is critical.

PE: What is the current status of the lupus treatment landscape?
Roy: The lupus treatment landscape is more dynamic today than at any point in history. After decades with limited options, four therapies have now been approved since 2011, with multiple late‑stage programs and regulatory designations signaling continued momentum. Major pharmaceutical companies are re‑entering the field with serious commitment, recognizing both unmet need and scientific opportunity.

At the same time, we remain early on the journey. No single therapy works for everyone, and sustained drug-free remission is not yet the norm. But for the first time, the field has depth, choice, and a credible path forward.

PE: For new treatments, what evidence is needed to shift the standard of care?
Roy: To shift the standard of care, new treatments must demonstrate not only efficacy but also meaningful advantages over existing approaches. That includes durability of response, steroid-sparing effects, improved quality of life, and acceptable long‑term safety. Increasingly, trials are being designed to answer those questions.

Equally important is embracing clinical trials as standard of care. For patients speaking with their provider about treatment options, clinical trials should be a part of initial conversations. They cannot remain a last-resort option.

PE: How is the treatment paradigm being redefined?
Roy: The paradigm is shifting from chronic disease management toward targeted intervention and, potentially, immune reset. Instead of broadly suppressing immune activity, newer therapies are becoming more targeted and less immunosuppressive. This approach aligns with the broader move toward precision medicine and recognizes lupus as an umbrella diagnosis with multiple biological subtypes.

This redefinition also reframes patient expectations—from lifelong symptom suppression to the possibility of deeper, sustained disease control. That psychological shift is just as important as the scientific one.

PE: Will steroids be replaced as a common treatment for lupus?
Roy: Steroids will likely remain part of lupus care, but their use in a front-line and chronic clinical setting is clearly being challenged, which is a positive development for lupus patients. The goal is not elimination, but minimization. As more therapies demonstrate their ability to control disease while enabling steroid tapering, reliance on chronic prednisone should continue to decline.

Importantly, this shift is already being tested in clinical trials, where steroid tapering is being incorporated into study design. That intentionality reflects a shared commitment across the field to protect patients from long‑term steroid harm while delivering better outcomes.