A lupus diagnosis means a lifelong battle with inflammation, be it in the skin, joints, blood cells, brain, kidney, or heart and, at present, there is no cure to the chronic illness. Both the sites and sponsors Inato works with are diligently striving to develop effective treatments for lupus.
Lupus affects nearly five million people worldwide and, at present, there is no cure to the chronic illness. A lupus diagnosis means a lifelong battle with inflammation, be it in the skin, joints, blood cells, brain, kidney, or heart. With possible causes and triggers still unknown, researchers are fighting to seek out solutions for unanswered questions and developing a treatment that could minimize the chronic suffering accompanied with this diagnosis.
Recent research has uncovered broader information across all areas of lupus. Included in the new findings are FDA approved drugs developed to treat the autoimmune disease. Aurinia’s drug, Lupkynis, was approved in January of 2021 for the treatment of lupus nephritis, a potentially life threatening manifestation of systemic lupus erythematosus (SLE) that affects approximately half of Americans with SLE. Lupkynis launched the first FDA approved oral medication for lupus nephritis and has been the first in several recent announcements rapidly altering how the disease is treated. Following not far behind was AstraZeneca’s Saphnelo, approved by the FDA in August of 2021 to treat adults with SLE. Lupkynis and Saphnelo were groundbreaking developments in the realm of lupus research being the first two lupus treatments to be approved by the FDA since 2011.
With lupus manifesting in a number of forms and consisting of several subtypes, endeavors to uncover more about the disease are underway. As of 2022, BMS awaits an FDA decision for a new drug developed to address plaque psoriasis; they report emerging data suggesting it could be effective in treating systemic lupus erythematosus as well. Additional efforts to better understand lupus have reported evidence that the incurable disease could be caused by a gene called TLR7. With knowledge of a gene to point to the causes behind lupus, this finding could be crucial in accelerating further developments for effective treatments, redefining the experience of chronic sufferers.
Recent studies have also unearthed the drastic racial and ethnic disparities amongst those suffering from lupus. Lupus, being nine times more likely to affect women than men, was found to be most prevalent in Black women with Hispanic women being the second most affected demographic. Given that Black women make up only 14% of lupus trial participants, a significant shift in diversity recruitment is needed in lupus research.
Inato works closely with community-based research sites with access to historically underrepresented populations. In a recent Phase II Systemic Lupus trial, our team recommended several sites to the sponsor with excellent diversity capabilities. One Nevada-based research site reported that 75% of their patient population was African American with 90% of their research team identifying as African American as well. Across all of the Inato sites recommended for this trial, 80% had received a diversity medal through our inclusive research program, verifying that each site had access to a diverse patient population. These sites also consistently reported research teams with racial and ethnic breakdowns reflecting the populations they worked with, including one site that confirmed they not only had a research team representing their patient population, but had members of their staff who could communicate with patients speaking Hindi, Punjabi, Parhari, and Spanish.
In a second Phase II Systemic Lupus trial posted to our online platform, 60% of the sites selected by the sponsor reported an activation timeline of four weeks or less. The set of qualified sites volunteered from locations across the globe, including South Africa, Spain, Poland, and Colombia with nearly half having previously overenrolled in similar lupus trials. Both the sites and sponsors we work with in lupus trials are diligently striving to develop effective treatments for lupus. We are proud to showcase the outstanding sites in our network and the substantial work being done to end the suffering that too often accompanies those living with lupus.