Advancing Lupus Research Through Patient-First, Data-Driven Design

Lupus affects young women at crucial stages of their lives, and meaningful advances in treatment have been slow to emerge.^1,2 In 2025, Biogen took an important step forward in lupus research by completing enrollment (“last patient in”) for the TOPAZ-1 and TOPAZ-2 Phase 3 trials evaluating an investigational drug for systemic lupus erythematosus (SLE).

What makes this milestone so significant is not only the successful enrollment, but who enrolled. The clinical trials included participants who reflect the U.S. patient populations living with lupus. A chronic autoimmune disease, lupus disproportionately impacts young women, particularly women of color.^3,4,5,6,7,8 It is twice as common in Black, African American, Hispanic and Latino communities compared to their white counterparts.⁹

“Achieving this milestone in such a competitive and complex lupus trial landscape was far from inevitable. It reflects years of partnership and unwavering commitment from our teams and our clinical trial communities. Seeing this level of representation and scientific integrity come together is meaningful,” said Kate Wilson, Biogen’s Head of Global Clinical Trial Access and Representation. 

Designing clinical trials around real lives

In the U.S., about 90% of people living with lupus are women, with most experiencing initial symptoms between ages 15 and 55^3,4,10 a period in life when many are building careers and considering having children.^7,11 Participating in clinical trials can be challenging, especially with many facing barriers like unpredictable work schedules, transportation needs and childcare responsibilities.¹²

Biogen’s recruitment strategy for the TOPAZ trials was developed with these realities at the center. We brought in insights from advocacy groups and clinical trial sites to conduct outreach where lupus is most prevalent. Sites were intentionally selected through an inclusive and patient-centered approach, prioritizing locations that featured representative and multilingual staff and extended office hours. We also provided services and reimbursement for common participation barriers, such as transportation and childcare assistance. 

Most importantly, patient and caregiver insights shaped trial structure in efforts to help make participation more manageable for individuals living with lupus. 

Using technology to simplify 

Advanced analytics and AI-enabled medical record review helped sites identify eligible participants earlier and more accurately, reducing administrative burden while shortening the time it takes for patients to confirm eligibility. These tools streamlined the experience, enabling patients to participate without added complexity.

Building a more inclusive clinical pipeline 

This approach is now being applied across Biogen’s clinical pipeline, including an additional lupus study focused on cutaneous lupus erythematosus. By strengthening the scientific foundation of our clinical programs and ensuring that study populations reflect those most affected, this work can help generate more meaningful and applicable data. Ultimately, these efforts support the development of medicines that have the potential to make a meaningful difference and are designed with the needs of the intended patient communities at the center. 

“‘Last patient in’ shows what’s possible when science, commitment and purpose align. With leadership support and teams fully engaged, we can advance clinical trials that are both rigorous and truly representative,” Kate said.

Looking ahead, we remain committed to representative research, embedding best practices across our pipeline, including in immunology, where every patient perspective creates meaningful outcomes.