Led by Eric Morand, M.D., Ph.D. (Monash University), this project aims to develop a new outcome assessment designed specifically to measure responses to treatment in clinical trials that are meaningful to patients and clinicians. Current SLE trial assessments have limitations, including that they are adapted from pre-existing disease activity measures (not fit-for-purpose for measuring treatment response), may lack sensitivity to change, may lack a strong evidence base for thresholds/weighting, have limited validation, and often rely on complex and obscure endpoints. These limitations of existing efficacy outcomes measures represent a critical gap in the lupus drug development landscape and have contributed to clinical trial failures in the past. The working group undertook a multi-step process to address these limitations, including a two-stage modified Delphi process to identify which domains to prioritize within the measurement. The results of this effort were published in Lupus Science and Medicine in March 2025.

The final stages of TRM-SLE development will address domain measures and response definitions, as well as integrate the domains into a finalized measurement instrument. The TRM-SLE will then be subjected to a series of validation studies to support its use as a primary outcome measure in registrational clinical trials for SLE.

Established in January 2024 and currently led by Benjamin Chong, M.D. (University of Texas Southwestern Medical Center) and Eduardo Vianna, Ph.D., MBA (EMD Serono), this Working Group is focused on the use of CLASI as a primary outcome measure and for cutaneous lupus erythematosus (CLE) in clinical trials.

In the first phase of this working group’s efforts, the group worked to align among members and with FDA standards for the acceptability of using CLASI as an outcome measure for CLE in clinical trials. With an unprecedented opportunity to have an open dialogue with the FDA on its concerns with the use of CLASI, the working group compiled published and unpublished data to address these concerns. These efforts led to unanimous consensus that CLASI is an acceptable tool for assessing CLE skin disease activity as a primary outcome measure in clinical trials – published in January 2026 in Nature Reviews Rheumatology.

The CLASI WG is currently focused on determining the threshold of CLASI activity (CLASI-A) improvement that is deemed clinically meaningful in trials, defining the minimum CLASI-A score needed for inclusion, and determining the range of CLASI-A scores that represent low CLE disease activity. The working group is compiling and analyzing data to address these topics and will also lead an effort to expand an ongoing prospective observational study that will contribute additional data to this effort.

CLASI Working Group Roster

This working group was originally launched in March 2024 as the Chimeric Antigen Receptor (CAR) T cell therapy WG (led by Elena Hsieh, M.D., and James Chung, M.D., Ph.D.). The WG aimed to address outstanding questions on the use of CAR T cell therapy in lupus, integrating perspectives from key stakeholders, including the FDA’s Center for Biologics Evaluation and Research, into a position paper on key considerations for advancing CAR T cell therapies for lupus, published in October 2025 in RMD Open.

The next phase of the working group (led by Jonathan Hogan, M.D. (Cabaletta), and Maximilian Kӧnig, M.D. (Johns Hopkins), has expanded the scope beyond CAR T cell therapy to all immune cell-engaging therapies with the potential to achieve durable treatment-free remission in lupus. The working group has three interconnected subprojects:

1. Dashboard Subgroup: This subgroup, led by Aimee Payne, M.D., Ph.D. (Columbia), and Cindy Coney, M.Ed. (Lupus Voices Council), will develop a clinical trial dashboard to collect and organize publicly available information from ongoing or finished immune resetting therapy trials. The dashboard will provide a comprehensive landscape of information to patients, physicians, and other professionals, helping to inform decision-making across the board. It will also lay the groundwork for capturing critical information that could otherwise be lost as companies inevitably pull out of the lupus cell therapy or immune cell engager space.

2. Consensus Definitions Subgroup: This subgroup, led by Ronald van Vollenhoven, M.D., Ph.D. (UMC Amsterdam), and Sule Yavuz, M.D. (AstraZeneca), will develop increased consensus on common terms and concepts currently in use or circulating in the field (e.g., treatment-free remission, durable, severity, immune reset, etc.). The group will harmonize and collaborate with other ongoing initiatives that are engaged in similar work to bring together insights and to improve alignment on key definitions.

3. Phenotyping Subgroup: This subgroup, led by Alfred Kim, M.D., Ph.D. (Washington University in St Louis), and Paul Brunetta, M.D. (HingeBio), will work to define and standardize measurements of the clinical, immunological, and laboratory features that may be correlative features of “immune reset” and that may be indicative of better long-term outcomes for lupus patients.

Immune Reset Working Group Roster

Lupus ABC convened an in-person meeting in October 2024 to determine the current state of lupus PROs and identify the potential focus of a Lupus ABC working group on this topic. The meeting summary was published in December 2025 in Lupus Science & Medicine. Based on the input from this meeting and from the Lupus ABC governing bodies, two PRO-focused WGs were launched in 2025:

PRO Measures Working Group: This working group, led by Zahi Touma, M.D., Ph.D. (University of Toronto), Elektra Papadopoulos, M.D., MPH (AbbVie), and Veronica Vargas Lupo, MBA (Lupus Voices Council), is focused on identifying domains of SLE important to patients and selecting outcome measures best suited to capture these domains.

PRO Measures Working Group Roster

PRO Trial Data Working Group: Chaired by Patti Katz, Ph.D. (UCSF), Daanish Ashraf, Pharm.D. (Biogen), and Brian Ung, Pharm.D., (Lupus Voices Council), the PRO Trial Data working group is focused on harnessing existing PRO measurement data from lupus clinical trials to examine the performance of PRO measures in trial settings, relative to clinical outcomes, and to develop recommendations for their use in lupus clinical trials.

PRO Trial Data Working Group Roster