Led by Eric Morand, MD, PhD, this project aims to develop a new treatment response measure for SLE. The project was already in progress with strong support from the global community. Because of its promising potential, Lupus ABC became a partner to provide further support to bolster its success. A representative from the Center for Drug Evaluation and Research (CDER) has been appointed to the steering committee to offer regulatory insights. Additionally, members of the Lupus Voices Council (LVC) serve on both the steering committee and the patient advisory board to provide additional patient perspectives.

Established in January 2024, this Working Group (WG) is dedicated to refining CLASI to align with FDA standards for use as an outcome measure for cutaneous lupus in clinical trials. Comprised of members from the LVC, leading figures from academia, industry, and the FDA/CDER, the WG has identified the main concerns with the use of CLASI and is compiling published and unpublished data to address them. The WG is co-chaired by Denesh Chitkara, MD (EMD Serono) and Benjamin Chong, MD (University of Texas Southwestern Medical Center).

Launched in March 2024, this WG was established to address outstanding questions on the use of CAR-T Cell therapy in lupus. The very near-term goal of the project is to develop a position paper on the key considerations to advance CAR-T cell therapies for lupus. The longer-term objectives will be defined later in 2024 and may include areas such as other CAR approaches, CAR design, or a biomarker-based project. The WG is comprised of experts from FDA/CBER, academia, industry, and members of the LVC. The WG is co-chaired by James Chung, MD, PhD (Kyverna Therapeutics) and Elena Hsieh, MD (University of Colorado).

Before a WG is launched on this topic, a planning committee, chaired by Patti Katz, Ph.D., is organizing a meeting on lupus PROs. Scheduled for October 2024, the meeting aims to bring together PRO experts to discuss the state of lupus PROs and establish a strategic roadmap for future working group efforts.