Q: What is lupus and how does it impact patients’ lives?
A: Systemic lupus erythematosus (SLE), or lupus, is a chronic immune-mediated disease that results from the immune system attacking multiple organs in the body. Lupus patients often experience difficulty in receiving a diagnosis as signs and symptoms can be protean in nature and often mimic those of other diseases. Patients most often complain of skin rashes, joint pain and/or constitutional symptoms such as fever, fatigue and ‘brain fog.’ Additionally, up to 60 percent of patients will develop significant kidney disease, known as lupus nephritis, which can lead to end-stage renal failure and potentially death.
The impact of lupus extends beyond physical symptoms, impacting patients’ mental health and emotional wellbeing, as well as their quality of life and work productivity. Due to the variable nature of lupus manifestations and timing of disease flares, patients often experience anxiety and depression and can find it challenging to conduct daily activities and to remain active within the workforce.
Currently, treatment options are limited, with patients being mostly prescribed antimalarials and steroids as standard therapies. However, steroids are not always able to fully address symptoms, and prolonged steroid use can result in further complications in patients that are already dealing with a difficult disease. Patients need new treatment options that decrease symptoms, prevent flares, and reduce steroid use, while not causing adverse effects.
Q: What challenges have researchers faced in developing treatments for lupus?
A: In lupus clinical trials, it has historically been difficult to show efficacy with new drugs for a number of reasons. The disease is heterogeneous, meaning symptoms can vary widely from patient to patient, and the underlying disease pathways can be different across the lupus patient population. Patients with lupus also experience flares, with intervening periods of lower disease activity or inactive disease. This fluctuating course of the condition can result in high placebo responses that can mask effects of agents in clinical studies. Additionally, endpoints that have been used have been found to be variable across trials and have lower reproducibility from study to study than in other diseases, such as rheumatoid arthritis.
Given these challenges, Bristol Myers Squibb, together with the broader lupus community, has been focused on identifying biomarkers to better understand each patient’s disease and its course, and predict response to treatments in individual patients. We are also part of the industry’s effort to develop new clinical trial endpoints in partnership with the lupus community, including patients and clinicians, which are more consistent across trials and have the potential to show meaningful disease improvements with effective agents.
Q: Understanding that lupus can be difficult to treat, how is Bristol Myers Squibb taking a unique approach to research?
A: Bristol Myers Squibb is committed to pursuing innovative approaches to offering personalized medicine options for lupus patients. Given the heterogeneity of lupus, we understand that one therapy targeting a single pathway is unlikely to be effective for every patient. Our researchers are exploring multiple targets for drug development in lupus that may lead to effective therapies across the lupus population. The exploration of disease pathways and novel biomarkers help further our understanding of the disease biology, advance potential treatment options, and provide hope of long-lasting relief for lupus patients.
Q: Why does Bristol Myers Squibb have the potential to make meaningful contributions to the field and advance care for patients?
A: At Bristol Myers Squibb, our efforts in discovering and developing medicines for immune-mediated diseases are grounded in the understanding of the disease biology and varying nature of diseases from person to person. We began our lupus research almost a decade ago and have leveraged our translational medicine capabilities, experience with clinical studies in lupus, and rich heritage in precision medicine to get us to where we are today – with three advanced assets currently being studied as potential treatments for lupus, with additional assets in the pipeline.
We also partner with the advocacy and patient community to advance research. One example of this is our sponsorship of the inaugural Lupus Research Alliance (LRA) LRA-BMS Accelerator Award, which provides a collective total of 3 million dollars to support ten cutting-edge lupus research projects over two years. These research projects focus on understanding the underlying causes of systemic and cutaneous lupus, unraveling its complexity and identifying novel biomarkers. In addition, we are an active member of the LRA Lupus Industry Council (LIC), an academic-industry collaboration, to further research and development in lupus.
Q: What would you like the lupus community to know about Bristol Myers Squibb’s research efforts?
A: We continue to evaluate each and every day how we can better advance research and ultimately transform patients’ lives through science along every aspect of the drug development continuum. One example of this is our commitment to increasing clinical trial diversity. Lupus disproportionately affects African American and Hispanic patient populations above others. We’re committed to ensuring that our clinical trials in lupus accurately reflect the populations impacted, and we remain committed to ensuring that diversity and inclusion play a central role in the research efforts in lupus and other diseases.
Q: On a personal note, what is it about your work that most motivates you?
A: I am constantly motivated by the patients we’re working to treat. As both a physician and a scientist, it is gratifying to see our hypotheses bearing fruit and validating our research efforts, while transforming the lives of patients. For a disease like lupus that has been wrought with challenges and setbacks in drug development, I am constantly motivated by patients suffering from this disabling and incurable disease to persevere and bring forward new treatments for them.