Approximately 8% of the U.S. population is living with an autoimmune disease, and nearly 80% of those with an autoimmune disease are women. The category of autoimmune diseases includes between 80 and 150 conditions (depending on the source) that are chronic and in many cases debilitating—with no known cures. These diseases can affect almost every organ in the body and can occur at any point across the lifespan. Despite the large burden of disease, many autoimmune diseases are understudied, and treatment options are limited.
To accelerate progress in this area, in 2022, the U.S. Congress directed NIH to establish an Office of Autoimmune Disease Research within ORWH.
As described in the Consolidated Appropriations Acts, 2023 (Public Law 117-328) for the departments of Labor, Health and Human Services, and Education, and related agencies, the Office of Autoimmune Disease Research (OADR-ORWH) will:
- Coordinate development of a multi–institute and center (IC) strategic research plan;
- Identify emerging areas of innovation and research opportunity;
- Coordinate and foster collaborative research across ICs;
- Annually evaluate the NIH autoimmune disease research (ADR) portfolio;
- Provide resources to support planning, collaboration, and innovation; and
- Develop a publicly accessible central repository for ADR.
These directives—along with the findings of the National Academies of Sciences, Engineering, and Medicine (NASEM) report titled Enhancing NIH Research on Autoimmune Disease—guide the establishment of the office.
Currently, ADR expertise is housed across various NIH institutes, centers, and offices (ICOs) in alignment with their mission areas. Establishing OADR-ORWH within the NIH Office of the Director (OD) positions it well to amplify and integrate individual ICO efforts and create opportunities for collective innovation.
OADR-ORWH’s mission will echo that of the overarching mission of NIH—to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.
Autoimmune diseases occur when the body’s immune system malfunctions and mistakenly attacks the body’s healthy cells, tissues, and organs. They can affect specific organs or multiple organ systems and may result in poor quality of life, withdrawal from the labor force, and even shortened life expectancy.
Autoimmune diseases include at least 80 acute and chronic illnesses that are often disabling, such as Sjögren’s disease, systemic lupus erythematosus (SLE), antiphospholipid syndrome, rheumatoid arthritis, psoriasis, inflammatory bowel disease (IBD), celiac disease, primary biliary cholangitis, multiple sclerosis, type 1 diabetes, and autoimmune thyroid disease.
For more information, refer to the 2022 NASEM report Enhancing NIH Research on Autoimmune Disease.
Sex- and gender-specific differences in the prevalence and expression of autoimmune diseases underscore the critical importance of recognizing sex and gender as factors in health and disease at every stage of the research process—a critical part of ORWH’s mission.
The reasons underlying the higher prevalence of autoimmune diseases in women are not yet well studied or understood.[4} In addition, not all autoimmune diseases act the same; some autoimmune diseases are many times more prevalent in women, and some affect men and women at similar rates. These diseases also affect males and females differently. Type 2 diabetes, for example, is more common in men, but women are more likely to develop comorbidities, such as cardiovascular disease and end-stage kidney disease.[5}
Though the complex factors underlying these differences are not yet clear, a growing body of research has documented significant sex differences in the immune system which contribute to the sex differences observed in the symptoms, expression, treatment response, and prevalence of autoimmune diseases. For example, women tend to have a stronger immune response than men, which may contribute to improved outcomes in infectious diseases and greater vulnerability to autoimmune diseases.
Psychosocial and cultural factors can also contribute to the risk factors, diagnosis, morbidity, and treatment of autoimmune diseases. For example, gender norms related to femininity—including the perception that women are more emotional than men—have been shown to contribute to frequent misdiagnosis of autoimmune symptoms. SLE, for instance, is often misdiagnosed as hypochondria or anxiety in women, leading to delays in diagnosis and treatment. (See the citations in Understanding Influences of Sex and Gender in Health and Disease.)
These examples underscore the critical importance of recognizing sex and gender as factors in health and disease at every stage of the research process—a critical part of ORWH’s mission.
Learn more about the influences of sex and gender in health and disease.
Learn more about sex differences in immunology with Module 1 of ORWH’s Bench to Bedside course. (Registration is free and open to the public.)
4 Fairweather D, Frisancho-Kiss S, Rose NR. Sex differences in autoimmune disease from a pathological perspective. Am J Pathol. 2008 Sep;173(3):600-9. doi: 10.2353/ajpath.2008.071008. Epub 2008 Aug 7. PMID: 18688037; PMCID: PMC2527069.
5 Shepard. B. D. (2019). Sex differences in diabetes and kidney disease: Mechanisms and consequences. American Journal of Physiology-Renal Physiology, 317(2), F456–F462. https://doi.org/10.1152/ajprenal.00249.2019
6 vom Steeg, L. G., & Klein, S. L. (2016). SeXX matters in infectious disease pathogenesis. PLOS Pathogens, 12(2), e1005374. https://doi.org/10.1371/journal.ppat.1005374
Chen, N., Zhou, M., Dong, X., Qu, J., Gong, F., Han, Y., et al. (2020). Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: A descriptive study. The Lancet, 395(10223), 507–513. https://doi.org/10.1016/s0140-6736(20)30211-7
Ngo, S. T., Steyn, F. J., & McCombe, P. A. (2014). Gender differences in autoimmune disease. Frontiers in Neuroendocrinology, 35(3), 347–369. https://doi.org/10.1016/j.yfrne.2014.04.004
The direction to establish OADR-ORWH stemmed from recommendations from the NASEM report Enhancing NIH Research on Autoimmune Disease, which identified a need for greater coordination across NIH regarding autoimmune disease research. The report recommended that an Office of Autoimmune Disease Research be established within OD, and Congress selected ORWH to establish this office in because autoimmune diseases disproportionately affect women.
As one of the 14 cross-cutting offices in OD’s Division of Program Coordination, Planning, and Strategic Initiatives, ORWH is experienced and skilled at coordinating across NIH to create pathways for collaboration, foster collective innovation, and mobilize multidisciplinary efforts to advance the health of women. As a part of ORWH, OADR-ORWH will be able to leverage this existing expertise, infrastructure, and position to inform and amplify its efforts.
ORWH is currently working to establish OADR-ORWH and lay the strategic and programmatic groundwork for future activities. In addition to meeting the immediate needs of staffing and infrastructure, OADR-ORWH is working with NIH leadership, other ICOs, researchers, clinicians, patient advocacy groups, and the general public to ensure that plans for the new office build upon congressional directives, synergize with other NIH efforts, address gaps in autoimmune disease research, and serve patients with autoimmune disorders.
As part of this development process, OADR-ORWH is establishing the NIH-wide Coordinating Committee for Autoimmune Disease Research, which will provide a structured forum to leverage the autoimmune disease research expertise housed across different ICOs and offer a streamlined process for expanding collaboration across NIH.
OADR-ORWH has already coordinated the release of multiple funding opportunities related to autoimmune disease research. (See “Funding Opportunities” below.)
Per NIH standard practice, OADR-ORWH will develop a strategic plan for autoimmune disease research at NIH. Once preparatory efforts are complete, OADR-ORWH plans to release a request for information (RFI) to solicit public input to inform the strategic plan.
ADR is conducted by multiple ICOs at NIH, with particular focus from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Neurological Disorders and Stroke, and the National Heart, Lung, and Blood Institute. The ICOs support research on different aspects of autoimmune disease based on their mission areas and expertise. For example, the National Eye Institute supports basic, translational, and clinical studies of the causes and mechanisms of autoimmune diseases of the eye. The National Institute of Environment Health Sciences invests in research investigating environmental triggers of disease. The National Cancer Institute supports research investigating the link between cancer and the immune system. The National Human Genome Research Institute supports research that explores genetic influences on the development of autoimmune and inflammatory diseases.
NIH-funded research across ICOs has helped advance knowledge of the basic mechanisms of the immune system, illuminate important sex differences in the immune system and immune response, and speed the development of treatments. For example, NIH-supported basic research on the immune system in the 1990s led to the development of Janus kinase (JAK) inhibitors—a class of drugs routinely used to treat a wide range of autoimmune disorders. To date, eight JAK inhibitors have been approved by the Food and Drug Administration (FDA) for treating a range of disorders. (Learn more about the impact of NIH research.)
One example of existing ICO collaborative efforts for ADR is the Accelerating Medicines Partnership® Autoimmune and Immune-Mediated Diseases (AMP® AIM). Launched in 2021, this program seeks to deepen our understanding of the cellular and molecular interactions that lead to inflammation and autoimmune diseases. This program is a collaboration among NIH, FDA, nonprofit organizations, and biopharmaceutical companies. Other examples of NIH-supported programs include the Autoimmunity Centers of Excellence (ACE) program and the Immune Tolerance Network.
As recommended by NASEM, an integrated NIH-wide approach will help advance progress in autoimmune disease research by amplifying the impact of the robust research already occurring within and across the ICOs. OADR-ORWH will provide the formal infrastructure and shared priorities to integrate and augment ICO efforts and create a more holistic foundation on which progress can be built.
Future OADR-ORWH-supported research will most likely investigate genetics, environmental exposures, biomarkers, sex influences, co-occurring autoimmune diseases, mechanistic pathways as therapeutic targets, animal models, systems biology, and translational research as they relate to various autoimmune diseases.
NIH investment in autoimmune disease research has increased over the past 5 years, reaching nearly $1 billion ($946,356,182) in fiscal year (FY) 2021.
In FY 2021 and FY 2022, 1,443 new research and administrative supplement grants listed "autoimmune disease” as the spending category. However, it is important to note that progress in our understanding of autoimmune disease research may not necessarily arise from research categorized as such. At NIH, we recognize that disease does not occur in a vacuum; disease-focused research often aligns with multiple ICO mission areas, allowing for a multidisciplinary approach.
For media inquiries, please use email@example.com.
For questions about OADR-ORWH, please reach to firstname.lastname@example.org.
NOTE: The Office of Research on Women’s Health is not accepting meeting requests at this time related to the Office of Autoimmune Disease Research, as efforts are focused on establishing the office. We look forward to engaging the community and other stakeholders in the near future.
|Status||Title||Announcement Number||Release date||Due Date(s)|
|CLOSED||Notice of Special Interest (NOSI): EXposome in Autoimmune Disease Collaborating Teams PLANning Awards (EXACT-PLAN) (Clinical Trials Not Allowed)||NOT-OD-23-112||4/14/2023||6/16/2023|
|ACTIVE||Understanding Chronic Conditions Understudied Among Women (R21 Clinical Trial Optional)||RFA-OD-23-013||3/9/2023||6/20/2024|
|ACTIVE||Understanding Chronic Conditions Understudied Among Women (R01 Clinical Trial Optional)||RFA-OD-23-014||3/8/2023||6/20/2024|