Oct. 02, 2014

Foundation Responds to Eli Lilly and Company’s Release of Data from Clinical Trial of Tabalumab

Sandra C. Raymond, President & CEO of the Lupus Foundation of America, issued the following statement in response to Eli Lilly and Company’s announcement of the results of two Phase III clinical trials of tabalumab, a biologic agent studied for the treatment of lupus.  Unfortunately, the trials did not show favorable results and the company is terminating these studies. The halting of the studies was not based on safety concerns. The statement follows:

Although the topline results of these trials were not favorable, the evidence we do see supports further examination of these data. The results underscore that the pathway this drug targets (B-cell) is known to be critical in the development of lupus.

The federal government and the pharmaceutical industry are the largest funders of medical research to develop new treatments for chronic diseases such as lupus. It is imperative that federal agencies, especially the U.S. Food and Drug Administration (FDA), make lupus a higher priority and focus on how lupus clinical trials are designed and conducted or patients will continue to suffer.

While the FDA has named lupus as an important disease in their Critical Path Initiative, it has yet to allow a lupus development program that keeps pace with 21st century medicine.  They must use their existing authorities to allow innovative trial design in lupus. Present FDA guidelines to test potential new drugs for lupus do not allow us to truly understand the reasons for failures in lupus clinical trials. We don’t know whether it is the investigational drug, the design of the clinical trial or other factors that cause trials to be unsuccessful.

Despite results announced today, there are many reasons for people with lupus to be hopeful due to the outstanding interest and investment by pharmaceutical and biotech industries to develop new treatments for lupus.  We are also encouraged that several promising treatments remain in the near-term pipeline.

The Lupus Foundation of America is leading game-changing research initiatives to improve outcomes and create a clear path forward to advance the science and medicine of lupus. Our national lupus research program is tackling the tough issues with a focus on accelerating the pace of lupus drug development that may lead to an arsenal of new, safe and more tolerable treatments.

For example, our Collective Data Analysis Initiative (CDAI) is analyzing data from past lupus clinical trials to gain insight on how other drugs that participants are allowed to take during lupus clinical trials (background medications) might mask the effectiveness of potential new treatments.  Data from the Foundation’s CDAI will help to improve design of future trials.

Additionally, we are currently developing a more accurate and efficient way to measure patient progress, suitable for use in future lupus clinical trials as well as in clinical practice. The LFA-REAL™ (Lupus Foundation of America Rapid Evaluation of Activity in Lupus) system is a first-of-its-kind evaluation tool that addresses both the needs and concerns of clinicians and people with lupus.

The Lupus Foundation of America also is a leading partner with the National Institutes of Health’s Accelerated Medicines Program (AMP) which is focusing significant resources to expand the understanding of lupus and other diseases.  The AMP project ultimately will open additional pathways for developing new therapies for this unpredictable and devastating disease.

We remain committed to improving the quality of life for people with lupus. We look forward to continued progress in the fight to end lupus so people no longer have to suffer from its brutal impact. We invite you to learn more about our national lupus research program at lupus.org/research.

Read Eli Lilly and Company announcement.


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