Enhancing NIH Research on Autoimmune Disease (2022)
Chapter: Front Matter
ENHANCING
NIH RESEARCH ON
AUTOIMMUNE DISEASE
Committee for the Assessment of NIH Research
on Autoimmune Diseases
Board on Population Health and Public Health Practice
Health and Medicine Division
A Consensus Study Report of
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
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This activity was funded with federal funds from the National Institutes of Health, U.S. Department of Health and Human Services, Contract/Task Order No. HHSN263201800029I/75N98020F00006. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-68830-7
International Standard Book Number-10: 0-309-68830-2
Digital Object Identifier: https://doi.org/10.17226/26554
Library of Congress Catalog Number: 2022939055
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2022. Enhancing NIH research on autoimmune disease. Washington, DC: The National Academies Press. https://doi.org/10.17226/26554.
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COMMITTEE FOR THE ASSESSMENT OF NIH RESEARCH ON AUTOIMMUNE DISEASES
BERNARD M. ROSOF (Chair), Professor, Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
GLINDA S. COOPER, Director of Science and Research, Innocence Project1
DEIDRA C. CREWS, Professor of Medicine, Division of Nephrology, Department of Medicine, Deputy Director, Center for Health Equity, Johns Hopkins University School of Medicine
WILLIAM R. DUNCAN, Vice Provost for Research Emeritus, East Tennessee State University
DELISA FAIRWEATHER, Associate Professor of Medicine and Immunology, Director of Translational Research, Department of Cardiovascular Medicine, Mayo Clinic
SONIA FRIEDMAN, Associate Professor of Medicine, Harvard Medical School; Director of Women’s Health, Crohn’s and Colitis Center, Brigham and Women’s Hospital
LISA I. IEZZONI, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
ANDREA M. KNIGHT, Associate Professor of Pediatrics, University of Toronto; Staff Physician, Division of Rheumatology, Hospital for Sick Children, Toronto; Adjunct Assistant Professor of Pediatrics, Perelman School of Medicine, University of Pennsylvania; Faculty Scholar, PolicyLab, Children’s Hospital of Philadelphia
SCOTT M. LIEBERMAN, Associate Professor of Pediatrics, Division of Rheumatology, Allergy, and Immunology, Carver College of Medicine, University of Iowa
MICHAEL D. LOCKSHIN, Professor of Medicine, Weill Cornell Medicine, Director, Barbara Volcker Center for Women and Rheumatic Disease, Hospital for Special Surgery
JILL M. NORRIS, Professor and Chair, Department of Epidemiology, Colorado School of Public Health, University of Colorado Anschutz Medical Campus
EMILY C. SOMERS, Professor and Epidemiologist, Departments of Internal Medicine, Environmental Health Sciences and Obstetrics & Gynecology; Michigan Institute for Clinical & Health Research (MICHR) Interdisciplinary Research and Team Science Faculty Lead, University of Michigan Schools of Medicine & Public Health
___________________
1 Director of Science and Research at the Innocence Project until November 2021.
BARBARA G. VICKREY, Professor and System Chair, Department of Neurology, Icahn School of Medicine at Mount Sinai
Study Staff
ROSE MARIE MARTINEZ, Study Director (from July 2021), Senior Board Director
H. AWO OSEI-ANTO, Study Director (until July 2021)
KRISTIN E. WHITE, Associate Program Officer
DARA ROSENBERG, Research Associate (from November 2020)
LEILA MEYMAND, Senior Program Assistant (October 2020–January 2022)
GRACE READING, Senior Program Assistant (from January 2022)
MISRAK DABI, Finance Business Partner
Y. CRYSTI PARK, Administrative Assistant
Consultants
JOSEPH ALPER, Consulting Science Writer
CHRIS BAROUSSE, Consulting Researcher
NANCY DONOVAN, Consulting Advisor
CHRISTINE LAGANA RIORDAN, Senior Director of Research & Evaluation, Ripple Effect
Reviewers
This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.
We thank the following individuals for their review of this report:
ANNE E. BURKE, Johns Hopkins University School of Medicine
HERMINE I. BRUNNER, Cincinnati Children’s Hospital Medical Center
DAVID A. HAFLER, Yale University
JUDITH A. JAMES, Oklahoma Medical Research Foundation, University of Oklahoma Health Sciences Center
SUE JINKS-ROBERTSON, Duke University
FREDERICK W. MILLER, National Institutes of Health
GARY W. MILLER, Columbia University Mailman School of Public Health
DAVID S. PISETSKY, Duke University & Durham VA Medical Center
D. BRENT POLK, University of California San Diego
MARIAN REWERS, Barbara Davis Center for Diabetes, University of Colorado School of Medicine
TERRY J. SMITH, University of Michigan Medical School
ROBERT B. WALLACE, The University of Iowa
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by BETTY A. DIAMOND, The Feinstein Institute for Medical Research, and ALAN I. LESHNER, American Association for the Advancement of Science (AAAS). They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.
Preface
As a practicing gastroenterologist, I treated patients who had Crohn’s disease and ulcerative colitis. Both are inflammatory bowel diseases (IBD) and among the most common autoimmune diseases. Over the last two decades, we have made progress in diagnosing IBD, but we have not yet identified biomarkers that enable us to screen for it. We have made revolutionary advances in targeting pharmaceutical therapies to manage IBD, but these options are still limited, many patients have refractory disease, and the therapies themselves may have significant side effects. There is currently no cure for IBD, so for much of their lives, patients may be at risk for developing additional autoimmune diseases as well as complications such as cancer, infections, and maternal/fetal complications. During the course of this study, I was also reminded that we do not have reliable U.S. incidence and prevalence data for IBD.
A goal of autoimmune disease research is to empower physicians to more accurately diagnose, treat, minimize, and ideally, cure disease. There is a critical research gap in personalized medicine, for example, the ability to measure a combination of individual genetics, serologies, phenotypes, and biological mechanisms that predict response to a specific therapy. Side effects and eventual failures, over time, of current medications dictate a need for continuing research into disease pathogenesis and candidate therapeutics.
Congressional legislation has often assisted in focusing National Institutes of Health (NIH) efforts to meet urgent demands related to the health
and welfare of U.S. citizens. In 2019 Congress called for NIH to contract with the National Academies of Sciences, Engineering, and Medicine to identify and review NIH’s research efforts in the broad area of autoimmune diseases with a particular emphasis on the risk factors, diagnostic tools, barriers to diagnosis, treatments, and prospects for cure. Given the complexity of autoimmune diseases and the fact that they encompass many conditions, the committee’s expertise included clinicians and researchers in numerous specialties that focus on autoimmune diseases as well as epidemiologists, health disparities researchers, and persons familiar with NIH’s research administration processes.
NIH has conducted research that has contributed significantly to the advances in care of autoimmune disease, and it is important to continue to translate research knowledge into more precise diagnostic criteria and clinical interventions to achieve the best outcomes and benefit the lives of our patients. Progress in medical research requires visionary strategic thinking, the ability to meet constant challenges in disease prevention and therapeutics, new findings in genetics, coordination, and interdisciplinary guidance.
The recommendations of the committee in Chapter 7 are preceded by a thoughtful analysis of Institute and Center (IC) autoimmune disease research activity along with the committee findings and conclusions. The number and complexity of these diseases requires a concerted strategic effort that leverages the many research activities that occur across ICs. The committee identifies opportunities and options for enhancing autoimmune disease research at NIH. The committee’s recommendations provide a basis for developing a strategy with metrics that yield data that can be reviewed periodically. It is our hope that a subsequent review would show advancement in autoimmune disease research and improvements in outcomes.
On behalf of the committee, I would like express our thanks for the responsiveness of NIH’s ICs and Offices in aiding the committee to gather information. A special thanks to Lisa Begg (Office of the Director/Office of Research on Women’s Health), Susan Cooper (National Institute of Allergy and Infectious Diseases [NIAID]), and Ellen Goldmuntz (NIAID) for their guidance and support.
I would also like to thank the committee members for their tremendous commitment and hard work, all the more meaningful in view of increased responsibilities both in their practices and their lives as a result of the pandemic, and the need to meet and work together virtually.
On behalf of the committee, I would like to express our thanks and appreciation to the National Academies leadership and staff: Rose Marie
Martinez, Senior Director of the Board on Population Health and Public Health Practice, and acting Study Director; Kristin White, Associate Program Officer; Dara Rosenberg, Research Associate; and Grace Reading, Senior Program Assistant. I would also like to thank former staff members Awo Osei-Anto, Senior Program Officer and Leila Meymand, Senior Program Assistant for their contributions to the study process.
Bernard M. Rosof, M.D., Chair, Committee on the Assessment of NIH Research on Autoimmune Diseases
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Summary and Research Implications
4 CROSSCUTTING ISSUES IN AUTOIMMUNE DISEASES
Commonalities Across Autoimmune Diseases
Maximizing Advances in Technology
Summary and Research Implications
PART II
5 NIH AUTOIMMUNE DISEASE RESEARCH EFFORTS
NIH Overview and Organizational Structure
Congressional Actions and NIH Autoimmune Disease Research
Current Coordination of Autoimmune Disease Research at NIH
6 ANALYSIS OF INSTITUTE AND CENTER AUTOIMMUNE DISEASE RESEARCH ACTIVITY
Characteristics of Research Activities Supported by ICs
Research Grants by Autoimmune Disease
Research Focus of Funded Grants
NIH Autoimmune Disease Research: Indicators of Accomplishments
7 OPPORTUNITIES AND OPTIONS FOR ENHANCING RESEARCH AT NIH
A COMMITTEE MEMBER BIOGRAPHIES
D EPIDEMIOLOGY: SELECT DISEASES
E MISSION STATEMENTS OF NIH’S INSTITUTES AND CENTERS
F NIH OFFICE OF AUTOIMMUNE DISEASE RESEARCH ACT OF 1999
G ANALYSIS OF THE NIH AUTOIMMUNE DISEASE RESEARCH GRANT PORTFOLIO: METHODOLOGY
H TOPIC ANALYSIS OF NIH AUTOIMMUNE DISEASE RESEARCH GRANT ABSTRACTS
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Acknowledgments
The committee and staff are grateful for the support of the National Academies of Sciences, Engineering, and Medicine’s Health and Medicine Division (HMD) staff who contributed to producing this report. The committee and staff thank Tina Seliber, Lauren Shern, Leslie Sim, and Taryn Young in the HMD Executive Office; Anne Marie Houppert, Christopher Lao-Scott, and Rebecca Morgan in the National Academies Research Center; Sadaf Faraz, Devona Overton, and Marguerite Romatelli in the Office of the Chief Communications Officer; Stephanie Miceli in the Office of News and Public Information; Julie Eubank in the Office of Congressional and Government Affairs; and Mandy Enriquez, Thomas Holland, Dempsey Price, and Alejandro Velazquez in the Office of Conference Management.
The committee’s work was enhanced by the systematic analysis of Christine Lagana Riordan and her team from Ripple Effect, as well as the technical advice provided by Nancy Donovan who served as a consultant to the project. The committee thanks Chris Barousse for her assistance in conducting topic modeling of research grants. The committee thanks Joseph Alper for his editorial assistance in the production of this report. The committee also thanks Aimee Mead for her assistance in reviewing the report.
The committee thanks all the speakers and moderators who participated in committee meetings, as well as others who provided information, input, and assistance. They include the following: James M. Anderson, Karyl S. Barron, Lisa Begg, Jane Buckner, Stephanie Burrows, Susan
Cooper, Mary K. Crow, Cindy Danielson, Sanjoy Dutta, Julia Gichimu, Ellen Goldmuntz, Brian Haugen, Caren Heller, Deborah Hodge, Michael C. Humble, Judith A. James, Calvin Johnson, Daniel Kastner, Alex Keenan, Ruth Kirby, Virginia Ladd, Nicholas LaRocca, Jessica Lobo, Marie Mancini, James McNamara, Sara Myers, John O’Shea, Mark Pedersen, Nishadi Rajapakse, Lisa G. Rider, Judy Riggie, Pamela L. Schwartzberg, Lisa Spain, Yaron Tomer, Ursula Utz, Emily von Scheven, and Victoria P. Werth.
Finally, we give special thanks to the National Institutes of Health for generously funding this project.
Acronyms and Abbreviations
| 25OHD | 25-hydroxyvitamin D |
| AARDA | American Autoimmune Related Diseases Association1 |
| ACE | Autoimmunity Centers of Excellence |
| ACF | Administration for Children and Families |
| ACL | Administration for Community Living |
| ACP | American College of Physicians |
| ACR | American College of Rheumatology |
| AD-ADRD | Alzheimer’s Diseases and Alzheimer’s Disease Related Dementias |
| ADCC | NIH Autoimmune Diseases Coordinating Committee |
| AHRQ | Agency for Healthcare Research and Quality |
| AI | artificial intelligence |
| AIDS | acquired immune deficiency syndrome |
| AIM | autoimmune and immune-mediated diseases |
| AIT | autoimmune thyroiditis |
| ALP | alkaline phophatase |
| ALPS | autoimmune lymphoproliferative syndrome |
| AMA | antimitochondrial antibodies |
| AMP® | Accelerating Medicines Partnership® |
| ANCA | antineutrophil cytoplasmic antibodies |
___________________
1 In 2021, AARDA changed its name to The Autoimmune Association.
| Anti SSA/Ro | anti Sjögren’s syndrome related antigen A autoantibodies |
| Anti SSB/La | anti Sjögren’s syndrome related antigen B autoantibodies |
| APECED | autoimmune polyendrocrinopathy candidiasis ectodermal dystrophy |
| aPL | antiphospholipid antibodies |
| APS | antiphospholipid antibody syndrome |
| APS-ACTION | Antiphospholipid Antibody Syndrome Alliance for Clinical Trials and International Networking |
| AS | ankylosing spondylitis |
| ASBT | apical sodium-dependent bile acid transport |
| ASPE | HHS Assistant Secretary for Planning and Evaluation |
| ATD | autoimmune thyroid disease |
| ATSDR | Agency for Toxic Substances and Disease Registry |
| B&F | Buildings and Facilities |
| BA | Budget Authority |
| BARDA | Biomedical Advanced Research and Development Authority |
| BPA | bisphenol A |
| BRAIN | Brain Research through Advancing Innovative Neurotechnologies Initiative |
| BRIDA | BACH2-Related Immunodeficiency and Autoimmunity |
| CAPS | catastrophic antiphospholipid syndrome |
| CAR | chimeric antigen receptor |
| CARRA | Childhood Arthritis and Rheumatology Research Alliance |
| CC | NIH Clinical Center |
| CD | Crohn’s disease |
| CD40 | cluster of differentiation 40 |
| CDC | Centers for Disease Control and Prevention |
| CeD | celiac disease |
| CHOP | Children’s Hospital of Philadelphia |
| CIT | Clinical Islet Transplantation Consortium |
| CMS | Centers for Medicare & Medicaid Services |
| CNS | central nervous system |
| COPD | chronic obstructive pulmonary disease |
| COVID-19 | coronavirus disease 2019 |
| CRD | Committee RePORTER Datasets |
| CRS | Congressional Research Service |
| cSLE | childhood-onset systemic lupus erythromatosus |
| CSR | Center for Scientific Review |
| CVD | cardiovascular disease |
| DAIDS | Division of AIDS Research |
| DAISY | Diabetes Autoimmunity Study in the Young |
| DAIT | Division of Allergy, Immunology, and Transplantation |
| DCCT/EDIC | Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications |
| DED | dry eye disease |
| DGP | deamidated gliadin peptide |
| DIPP | Type 1 Diabetes Prediction and Prevention Study |
| DNA | deoxyribonucleic acid |
| DOC | dental, oral, craniofacial |
| DPCPSI | Division of Program Coordination, Planning, and Strategic Initiatives |
| EAE | experimental autoimmune encephalomyelitis |
| EAP | Expanded Access Program |
| EBV | Epstein-Barr virus |
| ELISA | enzyme-linked immunoassay |
| EmA | immunoflourescent anti-edmysium |
| EPA | Environmental Protection Agency |
| ERA | Electronic Research Administration |
| ESRD | end-stage renal disease |
| FDA | Food and Drug Administration |
| FGF | fibroblast growth factor |
| FIC | Fogarty International Center |
| FOA | funding opportunity announcement |
| FXR | Farnesoid X Receptor |
| FY | fiscal year |
| GGT | gamma-glutamyl transferase |
| HHS | Department of Health and Human Services |
| HIV | human immunodeficiency virus |
| HLA | human leukocyte antigen |
| HRSA | Health Resources and Services Administration |
| HSS | Hospital of Special Surgery |
| IBD | inflammatory bowel disease |
| IC | NIH Institute or Center |
| ICD | International Classification of Diseases |
| iEdison | Interagency Edison Database |
| IFNs | interferons |
| Ig | immunoglobulin |
| IHS | Indian Health Services |
| IL | interleukin |
| IMSGC | International Multiple Sclerosis Genetics Consortium |
| IOM | Institute of Medicine |
| IRP | National Institutes of Health Intramural Research Program |
| ISN | International Society of Nephrology |
| ITN | Immune Tolerance Network |
| JAK | Janus kinase inhibitor |
| JIA | juvenile idiopathic arthritis |
| JIF | journal impact factor |
| LDA | latent dirichlet allocation |
| LFA | Lupus Foundation for America |
| LFT | liver function tests |
| LHHS | Labor, Health, and Human Services |
| LFWG | Lupus Federal Working Group |
| MG | myasthenia gravis |
| MGNet | Myasthenia Gravis Rare Disease Network |
| MOG-Antibody | myelin oligodendrocyte glycoprotein |
| MRI | magnetic resonance imaging |
| mRNA | messenger ribonucleic acid |
| MS | multiple sclerosis |
| NAM | National Academies of Medicine |
| NASEM | National Academies of Sciences, Engineering, and Medicine |
| NCAPG | National Coalition of Autoimmune Patient Groups |
| NCATS | National Center for Advancing Translational Sciences |
| NCCIH | National Center for Complementary and Integrative Health |
| NCI | National Cancer Institute |
| NEI | National Eye Institute |
| NHANES | National Health and Nutrition Examination Survey |
| NHGRI | National Human Genome Research Institute |
| NHLBI | National Heart, Lung, and Blood Institute |
| NIA | National Institute on Aging |
| NIAID | National Institute of Allergy and Infectious Diseases |
| NIAAA | National Institute on Alcohol Abuse and Alcoholism |
| NIADAR | National Institute of Autoimmune Disease and Autoimmunity Research |
| NIAMS | National Institute of Allergy and Infectious Diseases |
| NIBIB | National Institute of Biomedical Imaging and Bioengineering |
| NICHD | Eunice Kennedy Shriver National Institute of Child Health and Human Development |
| NIDA | National Institute on Drug Abuse |
| NIDCD | National Institute on Deafness and Other Communications Disorders |
| NIDCR | National Institute of Dental and Craniofacial Research |
| NIDDK | National Institute of Diabetes and Digestive and Kidney Diseases |
| NIEHS | National Institute of Environmental Health Sciences |
| NIGMS | National Institute of General Medical Sciences |
| NIH | National Institutes of Health |
| NIMH | National Institute of Mental Health |
| NIMHD | National Institute on Minority Health and Health Disparities |
| NINDS | National Institute of Neurological Disorders and Stroke |
| NINR | National Institute of Nursing Research |
| NLM | National Library of Medicine |
| NLP | natural language processing |
| NMSS | National Multiple Sclerosis Society |
| NOD | non-obese diabetic |
| NORD | National Organization of Rare Diseases |
| norUDCA | norursodeoxycholic acid |
| NOSI | notice of special interest |
| NPP | National Priorities Partnership |
| NPSLE | neuropsychiatric systemic lupus erythematosus |
| NQF | National Quality Forum |
| NSAIDs | nonsteroidal anti-inflammatory drugs |
| OAD/AR | Office of Autoimmune Disease/Autoimmunity Research |
| OAR | Office of AIDS Research |
| OBSSR | Office of Behavioral and Social Sciences Research |
| OCA | obeticholic acid |
| OD | Office of the Director |
| OPA | Office of Portfolio Analysis |
| OS | Office of the Secretary |
| ORWH | Office of Research on Women’s Health |
| PA | program announcement |
| pANCA | perinuclear anti-neutrophil cytoplasmic antibody |
| PBC | primary biliary cholangitis (historically: primary biliary cirrhosis) |
| PPAR | peroxisome proliferated activated receptor |
| PROMIS® | Patient-Reported Outcomes Measurement Information System |
| PROTECT | Study Predicting Response to Standardized Pediatric Colitis Therapy |
| PSC | primary sclerosing cholangitis |
| RA | rheumatoid arthritis |
| RCDC | NIH Research, Condition, and Disease Categorization |
| RCR | relative citation ratio |
| RCT | randomized controlled trial |
| RePORT | Research Portfolio Online Reporting Tools |
| RePORTER | NIH Research Portfolio Expenditures and Results system |
| RF | rheumatoid factor |
| RFA | request for applications |
| RFI | request for information |
| RFP | request for proposals |
| RHYTHM | Rheumatoid Arthritis Study of the Myocardium |
| RNA | ribonucleic acid |
| RPS | Renal Pathology Society |
| SAMHSA | Substance Abuse and Mental Health Services Administration |
| SARS-COV-2 | severe acute respiratory syndrome Coronavirus 2 |
| SEER | Surveillance, Epidemiology, and End Results |
| SGMRO | Sexual and Gender Minority Research Office |
| sJIA | systemic juvenile idiopathic arthritis |
| SLE | systemic lupus erythematosus |
| SpA | spondyloarthropathy |
| SPIRES | Scientific Publication Information Retrieval and Evaluation System |
| SRG | Scientific Review Group |
| SRO | Scientific Review Officer |
| SSc | systemic sclerosis |
| ST | suppression of tumorigenicity |
| STTR | small business technology transfer |
| T1D | type 1 diabetes |
| TEDDY | The Environmental Determinants of Diabetes in the Young |
| Th | t helper |
| TLR | toll-like receptor |
| TNF | tumor necrosis factor |
| TPN | total parenteral nutrition |
| TRAPS | tumor necrosis factor receptor-associated periodic syndrome |
| tTG | tissue transglutaminase |
| tTGA | tissue transglutaminase autoantibodies |
| UC | ulcerative colitis |
| UDCA | ursodeoxycholic acid |
| USPTO | U.S. Patent and Trade Office |
| VA | Department of Veterans Affairs |
| VEXAS | vacuoles, E1 enzyme, X-linked, autoinflammatory and somatic syndrome |
| WHO | World Health Organization |
