#ACR19 Lupus Research Highlights: The Future is Bright!
The global lupus community came together with tremendous enthusiasm at the just concluded American College of Rheumatology Annual Meeting 2019 (#ACR19). Close to 16,000 attendees from more than 100 countries gathered to share the latest advancements in the field, from basic science and clinical practice updates to clinical and translational research discoveries. The commitment to developing new therapies and finding a cure was evident.
In addition to presenting two programs focused on disease management, and funding many of the research studies featured at this year’s meeting, the Lupus Foundation of America and its Inside Lupus Research team was there covering every angle and has highlights to share.
Several potential lupus therapies are showing promise, meeting clinical trial goals (“endpoints”) and/or revealing new insights prompting further investigation. The list is longer than ever before, with some potential treatments further along in development than others.
Anifrolumab is meeting efficacy endpoints against placebo including overall disease activity, skin disease and oral corticosteroid tapering. AstraZeneca is planning to file for approval of anifrolumab in the second half of 2020. Janssen Biotech, Inc.’s Stelara® has shown a sustained clinical benefit on disease activity management at one-year and a reduction in the rate of severe flares. Additionally, Gazyva® (obinutuzumab), in combination with standard of care, showed that it more than doubles the percentage of people with lupus nephritis achieving complete renal response. Genentech plans to initiate enrollment in a Phase III study in early 2020.
Meanwhile, RemeGen’s Telitacicept was well tolerated in people with lupus in a phase 2b trial, meeting its primary endpoint to reduce disease activity, and Pfizer’s Tofacitnib (XELGANZ®) performed well in participants with mild-to-moderate disease activity, though more long-term studies are needed. And, while it didn’t meet its targeted endpoint, UCB and Biogen Inc.’s Dapirolizumab Pegol showed consistent improvements in disease activity across doses. The potential benefit of the treatment warrants investigation in a larger study.
New insights related to already known therapies were also featured. Yielding new understanding regarding its mechanism of action, Hydroxychloroquine (HCQ) reduced risk of cardiovascular events in people with lupus. And, GSK’s BENLYSTA demonstrated benefits among African-Americans with lupus and high disease activity, resulting in reduced disease activity and SLEDAI renal (kidney) scores. BENLYSTA was also shown to improve disease activity in those with lupus at six and 12 months.
From gene mutation and precision medicine to microbiome investigation and machine learning, applications used in other fields are increasingly being used throughout lupus research. New tools and approaches are helping to classify people with lupus at the molecular level and strengthen our understanding of the disease at the earliest stage when development can be potentially stopped.
Many studies are targeting and including genetic data in clinical trials research. For example, the Accelerating Medicines Partnership (AMP) is exploring gene expression in single kidney cells using RNA sequencing to assess genetic differences among similar cell types in lupus nephritis research. The Lupus Foundation of America funds this innovative five-year initiative focused on speeding up the pace of drug development for lupus and other complex diseases.
Approaches such as single cell imaging to provide insights on lupus nephritis pathogenesis, regenerative therapy to address lupus complications in vital organs and immunosuppressive medications to lower cardiovascular risk also stirred great discussion. Currently the Foundation for NIH, AMPs organizational partner, is looking at ways to move ahead with a sixth year of funding for this important program.
Empowering people with lupus
Disparity and access were prevalent topics, as research underscores that women are disproportionately affected by the disease, particularly among under-served populations, including African-American, Hispanic and Asian/Pacific Islander communities. Yet, because men represent a relatively small portion of the lupus population, they may face unique issues that fly under the radar. A first-of-its kind study shared at this year’s meeting reported that nearly half of men with lupus experience some degree of sexual dysfunction, which was closely associated with their quality of life.
The Lupus Foundation of America presented research on two evidence-based, online self-management education programs aimed at increasing access to health information – Take Charge and Strategies to Embrace Living with Lupus Fearlessly (SELF). Both programs are designed for people with lupus to enhance disease management skills, communications with physicians, treatment adherence and quality of life. The Take Charge program is available, here. The Foundation’s SELF program is undergoing pilot testing at this time. More information on how to access this program will be available soon.
Lupus Foundation of America: impact in action
In addition to the education and self-management efforts, a number of this year’s stand-out studies were made possible, in part, by Lupus Foundation of America research grants. A few are highlighted for you below:
2018 Gary S. Gilkeson Career Development Award (CDA) winner Dr. Joyce Chang presented her research on noninvasive measures of heart health in kids and teens with lupus, while Erik Anderson, recipient of this year’s CDA, presented his findings on the impact of depression and cognitive dysfunction in lupus and how to potentially treat these symptoms. And, 2019 Finzi Fellow Erica Moore shared data demonstrating a link between lupus and neurological/psychiatric disorders like depression and anxiety.
Additionally, the LFA LIFELINE grant, a program that enables critical lupus studies to continue uninterrupted while undergoing review at NIH, helped carry Dr. Jill Buyon’s research over the finish line. As a result, Dr. Buyon presented significant data this year, finding that taking hydroxychloroquine (Plaquenil®) during pregnancy demonstrates reductions in the recurrence rate of congenital heart block, a potentially life-threatening fetal disorder.
Exploring all aspects of the disease.Researchers are examining every piece of the lupus puzzle, including age, disease stage, co-occurring illnesses and lifestyle factors. A pivotal study, reported the effects of age, smoking and medications on cancer risk in lupus. Age was a risk factor for cancer overall, and females have a lower risk than males for cancers overall including lung cancer.
Hair chemical use as a predictor for lupus; body mass index at diagnosis to predict future disease activity; sleep quality related to lupus therapies; perceived stress; cognitive improvement in lupus; and psychosocial factors were also discussed, exemplifying the diversity of clinical research underway.
Lupus warriors stand united. Tremendous accomplishments have taken place over the last year and progress is being made toward developing new treatments. The push to improve upon study protocol development as well as create new classification criteria to better understand and improve upon the clinical trial process itself took center stage.
We are excited at the energy enveloping the lupus community with many innovative and anticipated studies forthcoming. To keep your finger on the pulse of lupus research, follow the Lupus Foundation of America’s Inside Lupus Research for breaking news and important updates.
The future is bright!