Lupus Industry Council (LIC)
The mission of the Lupus Research Alliance Lupus Industry Council (LIC) is to bring industry and academia together in the pre-competitive space to collaboratively address common impediments and accelerate the shared goals of developing new and improved therapies for patients with lupus.
The guiding principles of the LIC are to:
- Create opportunities for industry to come together with the Lupus Research Alliance and academia to address shared goals
- Provide a forum for open discussion of issues related to basic/clinical research, patient care, and patient/provider education
- Foster collaboration between industry, the Lupus Research Alliance, and academia to identify and address common challenges in basic/clinical research, patient care and patient/provider education.
LIC Projects (link to another page the below projects)
Drivers of Response for SRI and BICLA in SLE Clinical Trials
One of the key challenges in SLE clinical trials are primary endpoints, SRI-4 and BILAG. They do not always provide similar answers within a trial and the factors that drive response for SRI-4 and BICLA are not well understood. To address this problem with SLE trial endpoints, the LRA LIC established a Working Group with two key goals (1) create a better understanding of the factors that drive response and non-response for SRI-4 and BICLA, and (2) determine the concordance and discordance between SRI-4 and BICLA at the individual patient level.
Lupus Nephritis Biomarker Study
PIs: David Pisetsky, MD, PhD (Duke University), Brad Rovin, MD (Ohio State University), Will Pendergraft, MD, PhD (University of North Carolina), and Peter Lipsky, MD (AMPEL BioSolutions)
The goal of this project is to identify and validate biomarkers of prognosis, treatment response, and histopathology in lupus nephritis that can contribute to the development of new therapeutics.A phase 0 imaging study (the DIVINE trial) is currently underway.
Determinants of ANA Expression in Patients with Lupus Project
PIs: David Pisetsky, MD, PhD (Duke University), Peter Lipsky, MD (AMPEL BioSolutions) and Brad Rovin, MD (Ohio State University)
This study assessed the expression of antinuclear antibodies (ANA) among patients with Systemic Lupus Erythematosus (SLE), focusing on the frequency of ANA negativity in patients with established disease.
The findings were published in the Annals of Rheumatic Diseases in February 2018 and a related letter was published in Arthritis & Rheumatology.
LIC-OMERACT Partnership to Advance SLE Outcome Measures
Project’s Executive Committee: Michal Abrahamowicz, PhD (McGill University ), John Esdaile, MD (Arthritis Research Centre of Canada), Peter Lipsky, MD (AMPEL BioSolutions), Rosalind-Ramsey-Goldman, MD (Northwestern University), Lee Simon, MD (SDG LLC Consulting), Vibeke Strand, MD (Stanford University)
The long-term objective of the project is to propose and then validate new outcome measure(s) for trials of new treatments in SLE by developing Multi-dimensional Response Indices (MRI) with better ‘responsiveness to change’ than the conventional outcome measures, such as SRI used in recent SLE trials. Better responsiveness to change, if confirmed by the rigorous analyses, will imply that use of MRI will increase both (a) the probability of demonstrating statistically significant benefits of new, effective treatments, and (b) the estimated treatment benefits.
The results of the development and validation of a novel lupus outcome measure called Lupus Multivariable Outcome Score (LuMOS) were presented at the 2017 ACR meeting. The further validation of this instrument, using data sets from additional trials, is ongoing.
The following companies are currently members of the LIC:
- Aurinia Pharmaceuticals Inc.
- Bristol-Myers Squibb
- Boehringer Ingelheim
- Eli Lilly and Company
- EMD Serono
- Equillium, Inc.
- Idorsia Pharmaceuticals
- Janssen Research & Development, LLC
- Pfizer Inc.