2026 Annual Meeting

Overview of Lupus ABC’s Fourth Annual Meeting and Year Three Accomplishments

The Lupus Accelerating Breakthroughs Consortium (Lupus ABC) convened its fourth annual meeting on April 14-15, 2026, in Rockville, Maryland. The milestone gathering marked three years since the consortium was formed as the only public-private partnership (PPP) with the U.S. Food and Drug Administration (FDA) focused on accelerating the development of safer and more effective lupus treatments. Lupus ABC brings together individuals living with lupus and their advocates with researchers, clinicians, industry leaders, and regulators to address challenges in drug development, keeping the lived experiences and needs of those most affected central to its work.

Meeting Highlights

This year’s meeting welcomed 122 attendees, including representatives from the patient community, academia, industry, medical community, and government agencies (including the FDA). Attendance continues to grow each year, reflecting broad and growing engagement across the consortium.

An inspirational speech by LVC member Cindy Coney, M.Ed. set the stage for a productive and dynamic meeting – including a motivating keynote address by Rafid Fadul, M.D., MBA, Chief Medical Officer, Advanced Research Projects Agency for Health (ARPA-H), on the power of partnership with patients, updates from Lupus ABC working groups on the momentous progress made over the past year, and an insightful panel discussion on pediatric lupus drug development.

Plenary Session

The plenary session opened with remarks from FDA officials. Nikolay Nikolov, M.D., from the Center for Drug Evaluation and Research (CDER), conveyed that over the past three years, Lupus ABC has become a model of successful and productive collaboration, centered around people living with lupus, to address challenges in drug development and accelerate progress toward safer, more effective lupus treatments through engagement with all stakeholders. Vijay Kumar, M.D., from the Center for Biologics Evaluation and Research (CBER), expressed excitement on behalf of the FDA about participating in Lupus ABC at a pivotal moment where scientific and technological advances are accelerating the translation of new tools from the lab into meaningful benefits for patients.

Opening remarks were followed by a moving speech from LVC member Cindy Coney, M.Ed. Cindy’s message centered on the power of an “unsinkable spirit,” shaped by resilience, optimism, and purpose in the face of decades of living with lupus. She affirmed that despite the significant toll lupus can take on one’s health, daily life, and everyday moments, hope is sustained through personal meaning, community, and having a seat at the table as a representation of the patient voice. Above all, she conveyed gratitude for this community and urged the audience to remember that their work fuels hope and strength for patients and families navigating this challenging disease.

Dr. Rafid Fadul delivered a compelling keynote address on the importance of partnerships with patients. He highlighted how determined patient communities can drive transformative change and outlined how ARPA‑H is built to tackle urgent, high‑risk health challenges that traditional systems are not designed to solve. He emphasized the importance of embedding patients as partners from the outset. Dr. Fadul concluded by calling on the lupus community to help define the hardest problems and co‑design solutions, reinforcing that patients are essential architects of innovation.

Key updates followed from Barbara Mittleman, M.D. (AstraZeneca) (RC Co-Chair), Judith Mills, M.B.S. and Veronica Vargas Lupo, MBA (LVC Co-Chairs), and the co-chairs of individual working groups and projects (described in detail below).

The plenary session concluded with a panel discussion moderated by Laura Lewandowski, M.D., M.S. (Childhood Arthritis and Rheumatology Research Alliance) on the challenges and opportunities in pediatric lupus drug development. Panelists included Najat Bouchkouj, M.D. (CBER, FDA), Hermine Brunner, M.D., M.Sc., MBA (Cincinnati Children’s Hospital Medical Center), Judith Mills, M.B.S. (Person living with lupus and LVC), Suzette Peng, M.D. (CDER, FDA), Elizabeth SantaCruz (Caregiver to person living with lupus and LVC), Anam Tariq, D.O., MHS, FASN (CBER, FDA), and Sule Yavuz, M.D. (AstraZeneca). Discussion amongst this multidisciplinary panel highlighted that pediatric lupus drug development must be redesigned around the realities of children and families, underscoring flexibility, reduced burden, and trust as prerequisites for successful trial participation. LVC members emphasized the importance of trust, caregiver support, age-appropriate communication, and validating both child and caregiver voices to improve recruitment and retention. Other panelists discussed opportunities to accelerate access to therapies through earlier pediatric inclusion, leveraging extrapolation from adult data, innovative trial designs, and proactive regulatory engagement. Overall, this session reinforced that meaningful patient and caregiver input and a shared commitment to balancing safety with urgency are essential to delivering better, faster treatments and improved quality of life for children with lupus.

Lupus Voices Council Meeting and Research Committee Meeting

The LVC and RC each held closed meetings as part of the Lupus ABC annual meeting, focused primarily on reviewing selected proposals submitted in response to the Lupus ABC request for proposal (RFP). Applicants presented their proposals, followed by a moderated discussion and vote to rank them for support. These sessions were led by their respective Co-Chairs – LVC Co-Chairs Judith N. Mills, M.B.S. and Veronica Vargas Lupo, MBA, and RC Co-Chairs Barbara Mittleman, M.D. (AstraZeneca) and Gary Koretzky, M.D., Ph.D. (Weill Cornell Medicine).

The RC meeting also included a presentation from Patti Katz, Ph.D. (University of California San Francisco), who sought feedback from members on specific aspects of the Patient Reported Outcomes (PRO) Trial Data project.

The RC meeting concluded with discussions on the next phase of Lupus ABC, covering the future needs to prioritize projects, re-examine the RC charter, and explore alternative funding options.

Year Three Project Updates

During the plenary session, the co-chairs of the Lupus ABC working groups/projects presented updates on their progress over the past year, as well as their next steps and future goals.

Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Working Group

Benjamin Chong, M.D. (University of Texas Southwestern) provided an update on the CLASI working group. Over the past two years, the CLASI working group has worked collaboratively to align on a standardized outcome measure for cutaneous lupus erythematosus (CLE) clinical trials. Through a structured review of decades of published and unpublished evidence and ongoing dialogue with the FDA to address specific regulatory questions, the group reached consensus that CLASI is a viable outcome measure for CLE clinical trials. Importantly, this effort culminated in the FDA’s acknowledgement of CLASI as a reasonable outcome measure to assess drug efficacy in CLE clinical trials, representing a critical milestone for advancing therapeutic development in cutaneous lupus. This process and its outcomes were recently published in Nature Reviews Rheumatology.

Building on this progress, the working group is now focused on defining what constitutes clinically meaningful improvement in CLASI activity scores for use in clinical trials as an endpoint. Using a combination of real-world observational data and clinical trial datasets, the group will determine if changes in CLASI activity scores correlate with key patient‑reported and physician‑reported outcomes. These findings will help to inform practical and clinically relevant thresholds for improvement, supporting more consistent interpretation of treatment effects in CLE trials.

PRO Measures Working Group

Zahi Touma, M.D., Ph.D. (University of Toronto) presented an update on the PRO Measures working group. Dr. Touma outlined the working group’s primary goals, which are to identify which PRO domains should be measured consistently in clinical trials and select appropriate validated instruments for each domain. The end goal is to define a standardized core outcome set to improve consistency and interpretability across studies.

To achieve this, the group began with an initial list of 25 potential domains, identified from the Lupus ABC PRO meeting held in 2024, work done with the American College of Rheumatology by Dr. Patti Katz, and work done by the OMERACT SLE working group. Through a structured, consensus‑driven process using clear definitions, lay language summaries, surveys, and repeated virtual discussions, the group narrowed this list to seven core domains that achieved at least 70% agreement for inclusion in all clinical trials. These domains include physical function, pain intensity, fatigue, cognitive symptoms, depression, tolerability, and patient overall assessment of lupus symptoms. The project’s next steps involve broader stakeholder validation through large‑scale surveys and rigorous evaluation of candidate PRO instruments, with the ultimate goal of establishing a widely accepted, psychometrically sound core PRO domain and instrument set for lupus clinical trials.

PRO Trial Data Working Group

Daanish Ashraf, Pharm.D. (Biogen) presented an update on the PRO Trial Data working group, on behalf of fellow Co-Chairs Dr. Patti Katz and Brian Ung, Pharm.D. (LVC). Dr. Ashraf described how the working group was established to leverage existing PRO data from lupus clinical trials to better understand how these measures perform in real-world trial settings. Its objectives are to assess the psychometric performance and responsiveness of PRO instruments and, in coordination with the PRO Measures working group, develop evidence‑based recommendations for PRO use in lupus clinical trials.

To date, the group has identified a list of relevant completed Phase II and III SLE trials, catalogued the PRO measures used across these studies, and developed a consensus statistical analysis plan focused primarily on responsiveness and associations with clinical outcomes. Engagement with industry partners to enable data access is underway, with multiple sponsors already agreeing to participate through centralized or in‑house analyses aligned to the common analysis plan. Next steps include executing these analyses as data become available, aggregating findings into a trial‑agnostic meta‑analysis and integrating the results with the work of the PRO Measures working group to inform clear, practical recommendations for future lupus clinical trials.

Immune Reset Working Group

Maximilian König, M.D. (Johns Hopkins University) and Jonathan Hogan, M.D. (Cabaletta) presented an update on the Immune Reset working group. Dr. König described how the group originally started as the Chimeric Antigen Receptor (CAR) T-cell therapy working group. Recognizing that the rapidly evolving landscape now extends beyond CAR T‑cell therapies, the group expanded its scope beyond CAR T-cell therapy and was established as the Immune Reset working group for the next phase of its work in January of 2026. The working group’s objectives are to accelerate the development and approval of immune‑resetting therapies in lupus by addressing critical gaps in how emerging modalities are compared, measured, and defined. The working group is organized around three coordinated subprojects: (1) a dashboard subgroup to centralize and communicate safety and efficacy data across trials; (2) a consensus definitions subgroup to align terminology such as remission, durability, and deep B‑cell depletion across stakeholders; (3) an immune phenotyping subgroup to standardize biological measures of immune reset and long‑term response. Together, these efforts aim to improve interpretability, comparability, and shared understanding for patients, clinicians, investigators, and regulators.

Since the launch of the working group in early 2026, the dashboard subgroup has developed an initial prototype leveraging published early-phase trial safety data, with plans underway to validate datasets, engage sponsors, and expand to patient‑ and physician‑facing views that integrate interpretable efficacy measures. The phenotyping subgroup has initiated surveys and structured discussions to identify priority biomarkers and methodological standards, with the goal of producing a position paper on potential correlates of durable immune reset across modalities. The consensus definitions subgroup has conducted surveys to prioritize key concepts and is moving forward with scoping reviews and consensus development for high‑priority terms. Next steps across the working group include data validation, broader dissemination tools, development of position papers and manuscripts, and continued refinement of shared definitions and measurement frameworks to support future clinical trials of immune‑resetting therapies in lupus.

Treatment Response Measures for Systemic Lupus Erythematosus (TRM-SLE) Project

Eric Morand, M.D., Ph.D. (Monash University), provided an update on the TRM-SLE project, which aims to develop and validate a new clinical outcome assessment for use in lupus clinical trials as a measure of treatment response. Starting from a blank slate and aligned with regulatory guidance, the group developed a domain‑based, continuous outcome measure that captures clinically meaningful improvement across organ systems, enables assessment of partial and complete responses, and overcomes key limitations of existing lupus trial endpoints.

Over four years, the group completed the full instrument development process, including systematic literature reviews, global expert and patient engagement, consensus‑driven domain selection, and evidence‑based response thresholds for each domain. The multi‑domain TRM‑SLE instrument and responder definitions are now finalized, with supporting deployment manuals already shared with industry partners. Dissemination is underway through conference presentations and publications, and the instrument will be made freely available to the research community. Next steps focus on extensive validation studies using retrospective trial datasets, prospective clinical trials, and real‑world cohorts, alongside continued regulatory engagement with the FDA, European Medicines Agency, and Pharmaceutical and Medical Devices Agency. These efforts aim to confirm measurement properties, refine application guidance, and support broader adoption of TRM‑SLE in future lupus clinical trials.

Additional Year Three Accomplishments and Looking Ahead

Lupus ABC made meaningful advances during its third year and will continue to strengthen and expand these efforts in Year 4. Major accomplishments from Year 3 include:

  • Advancement of the TRM-SLE project and CLASI working group project to phase 2. 
  • Launch of three new working groups  
    • PRO Measures  
    • PRO Trial Data  
    • Immune Reset
  • Release of Lupus ABC’s first RFP in August 2025. 
  • A new partnership with the NIH Office of Autoimmune Disease Research within the Office of Research on Women’s Health. 
  • Publication of 5 manuscripts on working group activities and Lupus ABC in general:

Looking ahead to Year 4, Lupus ABC will build on its significant momentum, with each working group advancing toward concrete milestones. At least one new working group will be launched in year 4, based on the results of the review of proposals submitted in response to the Lupus ABC RFP. Finally, Lupus ABC will continue to grow and expand the number of partnerships, with outreach ongoing to patient advocacy groups and international organizations.