April 20, 2018
The Lupus Research Alliance Lupus Industry Council (LIC) met a key objective with the recent publication in the medical journal Arthritis & Rheumatology reporting on a new tool to better measure the effectiveness of potential drug treatments in clinical trials.
The LIC aims to bring industry and academia together to work collaboratively, along with the Lupus Research Alliance, to address common obstacles and accelerate shared research goals related to the development of new and effective therapies for patients with lupus. One goal has been to overcome the lack of accurate measures to evaluate outcomes of clinical trials studying potential new treatments for lupus. To address this obstacle, the LIC developed a new Lupus Multivariable Lupus Outcome Score (LuMOS).
The LuMOS formula was developed by analyzing raw data of two pivotal trials that provided the basis for the approval of belimumab (Benlysta®). It tried to overcome the difficulties presented by the heterogeneity of lupus by aggregating information gathered by different variables, each measuring change in a specific component or measure of disease activity. LuMOS showed superior ability to differentiate responders (patients who show disease improvement according to specific measurements) from non-responders when compared to an existing and well-accepted outcome tool, the Systemic Lupus Erythematosus Responder Index (SRI).
“Our findings suggest that LuMOS may improve the efficiency and power of analyses in future lupus trials,” noted principal author and LIC Co-Chair Peter E. Lipsky, MD, AMPEL BioSolutions. “Better accuracy in measuring efficacy in clinical trials could speed up FDA approval of new lupus treatments. Future research is needed to refine and provide additional validation of LuMOS, especially in trials of different lupus treatments and/or different patient populations.”