National Institute of Arthritis and Musculoskeletal and Skin Diseases Congressional Justification FY 2023

Director’s Overview

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The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is the primary Federal agency supporting biomedical research on diseases of the bones, joints, muscles, and skin. The NIAMS mission is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases.

NIAMS is committed to fostering a rich research environment that encourages investigators at all levels to take advantage of scientific opportunities and contribute to the emergence of new areas with the potential to advance our understanding of diseases in the NIAMS mission. To that end, NIAMS supports new investigators, researchers from underrepresented groups, and both early-stage and mid-career scientists through several targeted programs and funding opportunities. For example, NIAMS hosts a forum for mentored clinician scientist awardees to discuss issues they may face when transitioning to independence, and address challenges at their current career stage. Additionally, NIAMS has launched the Diversity Supplement Scholars program and also provides supplemental funding to early-career National Institutes of Health (NIH) investigators through the Supplements to Advance Research (STAR) program, both of which are discussed in more detail in subsequent sections.

Diseases covered by the NIAMS mission are tremendously burdensome in terms of pain and suffering, health care costs, and lost productivity. Though these conditions affect individuals of all ages and racial and ethnic backgrounds, many affect women and underserved populations disproportionately, both in terms of the number of individuals affected and increased disease severity. In 2017, there were approximately 1.3 billion prevalent cases of musculoskeletal disorders.[1] Overall, musculoskeletal diseases affect more than one out of two adults in the United States, and nearly three out of four individuals age 65 years and over.[2] Further, disability-adjusted life year rates for skin and subcutaneous diseases increased in the United States from 1990-2017.[3] Most diseases within the NIAMS mission are chronic and can cause lifelong pain, disability, or disfigurement and many, such as osteoarthritis – the most common form of arthritis that already affects over 32.5 million Americans[4] – will become more burdensome as the population ages.

Team Science, Partnerships, and Collaborations

Research on molecular mechanisms of disease has shown that seemingly disparate diseases may have important molecular similarities with implications for diagnosis and therapeutic development. To learn more about potential shared and disease-specific mechanisms among autoimmune and other diseases involving the immune system, NIAMS is participating with the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Dental and Craniofacial Research (NIDCR), and the NIH Office of Research on Women’s Health (ORWH) in the Accelerating Medicines Partnership® Autoimmune and Immune-mediated Diseases (AMP ® AIM) program. AMP AIM expands on earlier work that focused exclusively on rheumatoid arthritis and lupus to include psoriasis, psoriatic arthritis, and Sjögren’s syndrome. More broadly, the NIH is interested in whether data from the AMP projects can be integrated to better understand the role systemic inflammation plays across different diseases, including rheumatoid arthritis, lupus, Parkinson’ disease, common metabolic diseases, and Alzheimer’s disease. The AMP programs in these areas have produced large datasets that suggest activation of inflammatory pathways as a contributor to pathology. NIH is currently considering how this wealth of data could be used to generate large-scale computational models to form a Systems Biology of Inflammation program leading to identification of shared pathways of inflammation and enabling better treatments for diseases where inflammation plays a role.

The Institute works closely with the NIAMS Coalition, a group of more than 90 professional and voluntary organizations interested in arthritis and musculoskeletal and skin diseases. Recent activities include a webinar on Reaching Research Goals During the COVID-19 Pandemic and the biennial Coalition Outreach and Education Day --held virtually in FY 2022 --which focused on NIH efforts to promote diversity and inclusion in clinical studies, COVID-19 research, and combating opioid addiction.

Diversity, Disparities, Equity, and Inclusion

NIAMS was proud to be recognized by the NIH Office of Equity, Diversity, and Inclusion in 2021 for its efforts related to diversity and inclusion, and the Institute continues to look for new ways to spur progress in these areas. In FY 2021, NIAMS launched the Diversity Supplement Scholars program to enhance support for recipients of NIAMS-funded Research Supplements to Promote Diversity in Health-Related Research. The program seeks to increase the Institute’s engagement with the scholars, provide resources to address their career development needs, and encourage collaboration and networking among these investigators. Activities thus far have included a presentation to the scholars by a professor who described his path from a diversity supplement recipient to independently-funded scientist. The program advances NIAMS goals of recruiting and retaining a diverse workforce in its mission areas and enhancing support for early-stage investigators.

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Responding to COVID

As the global SARS-CoV-2 pandemic emerged, NIAMS intramural researchers quickly pivoted their research efforts and leveraged their expertise to address the public health threat. One focus of those efforts involved nanobodies, which are smaller versions of the antibodies humans naturally produce in response to most infections that naturally occur in camelid animals, such as llamas, alpacas, and camels. Importantly, these nanobodies have the potential to recognize parts of pathogens conventional antibodies would miss. NIAMS intramural researchers and collaborators isolated nanobodies against SARS-CoV-2 from llamas and mice engineered to generate camelid nanobodies. Testing showed that these nanobodies bound very strongly to the “spike” of the coronavirus and recognized regions of the spike protein human antibodies could not. The researchers believe these nanobodies are a promising treatment against COVID-19 with the potential to prevent mortality even as new coronavirus variants emerge.

Around the world, investigators are leveraging NIH-supported research and infrastructure to test therapies for COVID-19 infection. For example, the drug tofacitinib, developed under a Cooperative Research and Development Agreement between NIAMS and Pfizer, has recently been shown to benefit patients hospitalized with COVID-19 pneumonia. NIAMS intramural investigators continue to help inform the design and testing of therapies to intervene against complications such as the cytokine storm seen in severe cases of COVID-19.

NIAMS also has a keen interest in supporting extramural research addressing SARS-CoV-2 and COVID-19. In FY 2021, NIAMS notified the community of an opportunity to apply for grants exploring basic, translational, pre-clinical, and clinical research questions related to whether people with underlying rheumatic, skin, or musculoskeletal diseases or conditions are affected differently by COVID-19 vaccines and treatments as compared to those without such conditions. Research awarded under this Notice of Special Interest (NOSI) will continue to be supported in FY 2023, pending receipt of meritorious applications and the availability of funds.

Activities Enabled by FY 2015-2021 Funding Increases

In FY 2015, NIAMS launched the STAR awards program to provide additional support for new NIH investigators. Supplemental funding provided by the STAR awards allowed investigators who renewed their first NIAMS-funded R01 grant to pursue innovative, high-risk research within the broader scope of their NIAMS-funded, peer-reviewed research projects. The awards helped investigators expand their single, structured research projects into broader multi-faceted research programs. The program was modified in FY 2019 to limit eligibility to investigators who received their first R01 award as early-stage investigators as defined by the NIH.

NIAMS has taken an active role in research efforts to better understand pain, which is a debilitating component of many diseases and conditions within the NIAMS mission. In FY 2021, NIAMS funded a new Center to explore the mechanisms underlying pain associated with musculoskeletal and rheumatic diseases, with the ultimate goal of pain management and prevention. Through the NIH Helping to End Addiction Long-term® (HEAL®) Initiative, NIAMS is leading the Back Pain Consortium (BACPAC). BACPAC is a translational, patient-centric research effort to develop effective, personalized treatments for chronic low back pain. BACPAC is focused on addressing whether treating pain and mood together can improve outcomes for people with chronic low back pain, characterizing patients to better understand the mechanisms underlying this complex condition, and identifying pathways and targets for new drugs to reduce pain and improve function without the risk of addiction associated with opioids. The Institute plans for increases provided for the HEAL Initiative in the FY 2023 President’s Budget include partnering with other Institutes and Centers on a funding opportunity announcement to encourage the development of imaging and other biomarkers of myofascial tissues to facilitate pain management. NIAMS also plans on leading a multi-Institute and Center effort to support three-dimensional, global mapping of the sensory nerve endings in the different tissues of the joint, which is expected to reveal pain treatment strategies. The FY 2023 President’s Budget also proposes an increase directly to NIAMS for pain research. NIAMS intends to invest this addition to advance the understanding of mechanisms of pain in adults and children in disease areas within the NIAMS mission. Researchers would be encouraged to conduct basic, clinical, and translational projects that integrate precision medicine approaches to address significant challenges in prevention, treatment, and health equity in chronic pain. These may require a highly collaborative research infrastructure with the participation, interaction, and coordination of activities carried out across multiple research laboratories and disciplines.

In addition to HEAL, NIAMS has been able to leverage other NIH-wide programs. One such example is the NIH Common Fund-supported Molecular Transducers of Physical Activity Consortium (MoTrPAC). Funded in FY 2017, MoTrPAC arose from a roundtable hosted by NIAMS and attended by investigators from around the United States as well as program staff from the two Institutes that would become partners in the MoTrPAC endeavor -- the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute on Aging (NIA). The program aims to uncover, at the molecular level, how exercise improves and preserves the health of the body’s tissues and organs, and enable clinicians to make more specific recommendations when prescribing exercise to their patients.

NIAMS also participates in the FY 2018 INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project. Research interests include examining arthritic and other rheumatic, musculoskeletal, and skin anomalies and disorders in Down syndrome and causes, treatment, and prevention of these conditions. Additionally, because many chemical threat agents affect the skin, NIAMS is able to leverage opportunities available through the NIH Countermeasures Against Chemical Threats (CounterACT) program. These include the Research Centers of Excellence program, exploratory and developmental projects, efforts to optimize small molecules or biologic compounds that are strong candidates for therapeutic development, and a funding opportunity announcement to encourage early-stage investigators to pursue research in this area.

IC Fact Sheet

Major Changes in the Budget Request

Major changes by budget mechanism and/or budget activity detail are briefly described below. Note that there may be overlap between budget mechanism and activity detail, and these highlights will not sum to the total change for the FY 2023 President’s Budget request for NIAMS, which is $676.3 million, an increase of $42.0 million from the FY 2022 Continuing Resolution (CR) level. $24 million of the proposed budget increase for NIAMS is intended to enhance the Institute’s research efforts to understand the underlying mechanisms of pain, which may lead to the development of safer, non-addictive interventions for pain, and thereby reduce the need for opioids. NIAMS continues to place a priority on support to early-stage investigators. Within this funding level, NIAMS will pursue its highest research priorities through strategic investments and careful stewardship of appropriated funds.

Research Project Grants (RPGs) (+$26.9 million; total $445.6 million):
NIAMS will support a total of 1,049 Research Project Grant (RPG) awards in FY 2023. Noncompeting awards will decrease by $16.9 million. Competing RPGs will increase by 87 awards and $34.8 million.

Other Research (+$1.2 million; total $28.7 million):
NIAMS will support a total of 187 Other Research awards in FY 2023. Research Careers will increase by 8 awards and $1.2 million from the FY 2022 CR level.

Intramural Research (+$6.1 million; total $76.0 million):
NIAMS will increase funding for intramural research by 8.7 percent. These increases are distributed across all programmatic areas and basic, translational or clinical research.

Mechanism		FY2021 Final		FY2022 CR		FY2023 President's Budget		FY2023 +/- FY2022
		Number	Amount	Number	Amount	Number	Amount	Number	Amount
Research Projects
Noncompeting		715	$283,154	714	$310,306	716	$293,413	2	-$16,893
Administrative Supplements		(66)	$5,387	(70)	$6,100	(70)	$6,100	(0)	$0
Competing:
Renewal		38	$21,102	27	$15,111	40	$22,882	13	$7,771
New		234	$94,546	168	$67,704	255	$102,523	87	$34,819
Supplements		0	$0	0	$0	0	$0	0	$0
Subtotal, Competing		272	$115,648	195	$82,815	295	$125,405	100	$42,590
Subtotal, RPGs		987	$404,189	909	$399,220	1,011	$424,918	102	$25,697
SBIR/STTR		35	$19,031	36	$19,496	38	$20,675	2	$1,179
Research Project Grants		1,022	$423,221	945	$418,716	1,049	$445,593	104	$26,876
Research Centers
Specialized/Comprehensive		43	$44,734	37	$41,411	40	$44,722	3	$3,311
Clinical Research		0	$0	0	$0	0	$0	0	$0
Biotechnology		0	$0	0	$0	0	$0	0	$0
Comparative Medicine		0	$50	0	$50	0	$50	0	$0
Research Centers in Minority Institutions		0	$0	0	$0	0	$0	0	$0
Research Centers		43	$44,784	37	$41,461	40	$44,772	3	$3,311
Other Research:
Research Careers		141	$21,255	157	$24,108	165	$25,313	8	$1,205
Cancer Education		0	$0	0	$0	0	$0	0	$0
Cooperative Clinical Research		0	$0	0	$0	0	$0	0	$0
Biomedical Research Support		0	$0	0	$0	0	$0	0	$0
Minority Biomedical Research Support		0	$250	0	$250	0	$250	0	$0
Other		11	$2,371	22	$3,108	22	$3,108	0	$0
Other Research		152	$23,875	179	$27,466	187	$28,671	8	$1,205
Total Research Grants		1,217	$491,880	1,161	$487,644	1,276	$519,036	115	$31,392
Ruth L Kirschstein Training Awards:		FTTPs		FTTPs		FTTPs		FTTPs
Individual Awards		77	$3,458	81	$3,766	83	$3,954	2	$188
Institutional Awards		218	$13,904	228	$14,993	235	$15,743	7	$750
Total Research Training		295	$17,361	309	$18,759	318	$19,697	9	$938
Research & Develop. Contracts		31	$20,361	31	$21,630	32	$24,130	1	$2,500
SBIR/STTR (non-add)		(0)	($200)	(0)	($202)	(0)	($0)	(0)	-($202)
Intramural Research		118	$67,353	123	$69,909	125	$76,001	2	$6,092
Res. Management & Support		111	$35,427	115	$36,350	117	$37,390	2	$1,040
SBIR/Admin. (non-add)		(0)	($0)	(0)	($0)	(0)	($0)	(0)	($0)
Construction			$0		$0		$0		$0
Buildings and Facilities			$0		$0		$0		$0
Total, NIAMS		229	$632,382	238	$634,292	242	$676,254	4	$41,962

* All items in italics and brackets are non-add entries.

FY 2022 CR	$634,292
FY 2023 President's Budget	$676,254
Net change	$41,962

CHANGES				FY 2022 CR		FY 2023 President's Budget		Built-In Change from FY 2022 CR
				FTEs	Budget Authority	FTEs	Budget Authority	FTEs	Budget Authority
A. Built-in:
1. Intramural Research:
a. Annualization of January 2022 pay increase & benefits					$24,047		$25,344		$159
b. January FY 2023 pay increase & benefits					$24,047		$25,344		$814
c. Paid days adjustment					$24,047		$25,344		-$91
d. Differences attributable to change in FTE					$24,047		$25,344		$391
e. Payment for centrally furnished services					$12,128		$12,370		$243
f. Cost of laboratory supplies, materials, other expenses, and non-recurring costs					$33,735		$38,286		$723
Subtotal									$2,239
2. Research Management and Support:
a. Annualization of January 2022 pay increase & benefits					$20,152		$21,233		$133
b. January FY 2023 pay increase & benefits					$20,152		$21,233		$681
c. Paid days adjustment					$20,152		$21,233		-$77
d. Differences attributable to change in FTE					$20,152		$21,233		$350
e. Payment for centrally furnished services					$3,699		$3,773		$74
f. Cost of laboratory supplies, materials, other expenses, and non-recurring costs					$12,499		$12,384		$262
Subtotal									$1,425
Subtotal, Built-in									$3,664
CHANGES				FY 2022 CR		FY 2023 President's Budget		Program Change from FY 2022 CR
				No.	Amount	No.	Amount	No.	Amount
B. Program:
1. Research Project Grants:
a. Noncompeting				714	$316,406	716	$299,513	2	-$16,893
b. Competing				195	$82,815	295	$125,405	100	$42,590
c. SBIR/STTR				36	$19,496	38	$20,675	2	$1,179
Subtotal, RPGs				945	$418,716	1,049	$445,593	104	$26,876
2. Research Centers				37	$41,461	40	$44,772	3	$3,311
3. Other Research				179	$27,466	187	$28,671	8	$1,205
4. Research Training				309	$18,759	318	$19,697	9	$938
5. Research and development contracts				31	$21,630	32	$24,130	1	$2,500
Subtotal, Extramural					$528,033		$562,863		$34,830
6. Intramural Research				123	$69,909	125	$76,001	2	$3,853
7. Research Management and Support				115	$36,350	117	$37,390	2	-$385
8. Construction					$0		$0		$0
9. Buildings and Facilities					$0		$0		$0
Subtotal, Program				238	$634,292	242	$676,254	4	$38,298
Total built-in and program changes									$41,962

History of Budget Authority and FTEs:

Distribution by Mechanism:

Change by Selected Mechanisms:

	FY 2021 Final	FY 2022 CR	FY 2023 President's Budget	FY 2023 +/- FY 2022 CR
Extramural Research	FTE Amount	FTE Amount	FTE Amount	FTE Amount
Detail
Systemic Rheumatic and Autoimmune Diseases	$99,882	$99,586	$106,155	$6,569
Skin Biology and Diseases	$107,761	$107,442	$114,529	$7,087
Muscle Biology and Diseases	$82,750	$82,505	$87,947	$5,442
Joint Biology and Diseases and Orthopaedics	$162,181	$161,700	$172,366	$10,666
Bone Biology and Diseases	$77,028	$76,799	$81,865	$5,066
Subtotal, Extramural	$529,602	$528,033	$562,863	$34,830
Intramural Research	118 $67,353	123 $69,909	125 $76,001	2 $6,092
Research Management & Support	111 $35,427	115 $36,350	117 $37,390	2 $1,040
TOTAL	229 $632,382	238 $634,292	242 $676,254	4 $41,962

* Includes FTEs whose payroll obligations are supported by the NIH Common Fund.

Justification of Budget Request

	FY 2021 Final	FY 2022 Continuing Resolution	FY 2023 President's Budget	FY 2023+/- FY 2022
BA FTE	$632,382,000 229	$634,292,000 238	$676,254,000 242	+$41,962,000 +4

Program funds are allocated as follows: Competitive Grants/Cooperative Agreements; Contracts; Direct Federal/Intramural and Other.

Overall Budget Policy:
The FY 2023 President’s Budget request for NIAMS is $676.3 million, an increase of $42.0 million or 6.6 percent compared to the FY 2022 CR level. This increase includes $24.0 million targeted to enhance pain research across the NIAMS portfolio, as part of an NIH-wide initiative to increase research into opioids and pain management.

Program Descriptions

Systemic Rheumatic and Autoimmune Diseases
This program supports research to understand the causes of rheumatic and autoimmune diseases and to develop new knowledge that will improve treatment and enable disease prevention. Within this program, research on lupus and rheumatoid arthritis includes studies to understand periodic episodes of worsening disease symptoms, known as flares. For example, a study by NIAMS-funded researchers suggests that urinary tract infections and other common bacterial infections, previously believed to be harmless, may trigger lupus flares in some individuals. Compared to patients in remission, blood samples from lupus patients experiencing a flare had significantly higher levels of antibodies against a bacterial product that correlated with persistent but asymptomatic E. coli-triggered urinary tract infections. Subsequent studies with larger numbers of lupus patients may support a change in clinical approach, such as the treatment of subclinical infections. Investigators studying rheumatoid arthritis (RA) provided new evidence that impaired drainage of lymph, a fluid that contains white blood cells, from the joints may contribute to RA flares. In a small NIAMS-sponsored study, scientists developed a new imaging technique and used it to compare lymph node responses in the upper extremities of healthy individuals and in RA patients experiencing a flare in the hand or wrist. They found that lymphatic drainage in the hands of RA patients with active disease was reduced compared to healthy controls. Further studies are needed to explore the potential use of drugs that increase lymphatic drainage to treat RA flares.

The program also supports studies of systemic sclerosis (SSc), which have led to translational and clinical research advances. One study focused on fibrosis, a process that leads to excessive scarring in the skin and damage to lungs and other organs of individuals with SSc. The investigators showed that a protein called CD38 is substantially elevated in the skin of patients with SSc. CD38 levels were associated with clinical disease severity and an increase in the cell signaling activity known to spur fibrosis. Deleting the CD38 gene in mice or using a drug to inhibit CD38 activity in mouse fibroblasts cells or SSc skin biopsies reduced fibrosis. Based on these results, dampening CD38 activity might provide a new therapeutic strategy for diminishing multiple organ fibrosis in SSc. Another study supported by NIAMS showed that adding a baseline high-resolution computed tomography (HRCT) scan as a screening tool in addition to pulmonary function testing improves diagnosis of interstitial lung disease (ILD), a potentially life-threatening SSc comorbidity, among patients with diffuse cutaneous systemic sclerosis. The findings provide important information for health care providers to facilitate early detection and treatment of SSc-ILD, both of which have been shown to improve disease outcomes.

Budget Policy:
The FY 2023 President’s Budget request for this program is $106.2 million, an increase of $6.6 million or 6.6 percent compared to the FY 2022 CR level. In FY 2023, NIAMS will continue participation in the Accelerating Medicines Partnership® Autoimmune and Immune-mediated Diseases (AMP® AIM) program. AMP AIM builds on the success of the earlier AMP in rheumatoid arthritis and lupus (AMP RA/SLE) program and extends this effort to include dermatological diseases (see the Skin Biology and Diseases program description for more information). AMP AIM is exploring the relationships and interactions between the previously identified cells and pathways to improve understanding of how these interactions may drive inflammation and tissue damage in RA and lupus. This focus on the molecular causes of disease is expected to accelerate the discovery and prioritization of new targets for drug development.

In FY 2023, NIAMS also will continue to follow up on findings of an FY 2022 roundtable on the role of inflammation resolution within the NIAMS portfolio. The roundtable meeting is expected to spur additional interest and ideas for new research on inflammation resolution in NIAMS mission areas. By disseminating information from the meeting, NIAMS also hopes to increase the participation of NIAMS investigators in the Notice of Special Interest (NOSI) on Promoting Fundamental and Applied Research in Inflammation Resolution, which was released in FY 2020 by the National Institute of Environmental Health Science (NIEHS) with participation by the NIAMS and the National Heart, Lung, and Blood Institute (NHLBI).

Skin Biology and Diseases
This program funds research to understand the properties and functions of healthy skin, the causes of skin disease, and new approaches for skin disease prevention and treatment. Researchers supported by this program are exploring wound healing in the skin. A NIAMS-supported research group discovered that a drug called imiquimod, currently used to treat precancerous lesions, can help mouse ear wounds heal without scarring. The research team found that imiquimod acts on a protein called TRPA1, which was previously identified as a pain sensor in cells within the nervous system. The findings were surprising because TRPA1, which previously was known only to function in pain sensing, appeared to have a new and unanticipated role in activating immune cells to promote wound healing.

Another emerging area of research focuses on how the microbes that live in our bodies and on our skin contribute to health and disease, and whether such microbes could potentially be harnessed for new therapies. A small clinical study by NIAMS-funded researchers evaluated the safety and mechanisms of action of Staphylococcus hominis A9 (ShA9), a bacterium isolated from healthy human skin, as a topical therapy for people with atopic dermatitis (AD). Results indicated that ShA9 cleared some strains of Staphylococcus aureus, a skin pathogen that promotes skin inflammation, in patients with AD. While the researchers found that ShA9 treatment is safe, it did not significantly decrease AD severity in this study. Additional clinical studies that augment the duration of treatment and optimize the clinical design are needed to better assess the therapeutic potential of ShA9. Another study funded in part by NIAMS showed that drugs called caspase inhibitors could clear methicillin-resistant Staphylococcus aureus (MRSA) bacterial infections in mice. MRSA is particularly dangerous and difficult to treat because it is resistant to many antibiotics. Although additional research is needed, results suggest that caspase inhibitors could be a potential new method to treat infections caused by some antibiotic resistant bacteria.

Budget Policy:
The FY 2023 President’s Budget request for this program is $114.5 million, an increase of $7.1 million or 6.6 percent compared to the FY 2022 CR level. In FY 2023, NIAMS will continue to support the Accelerating Medicines Partnership® (AMP) Autoimmune and Immune-mediated Diseases (AMP® AIM) program. The AMP AIM program will apply methods previously used in the AMP RA/SLE to additional diseases including psoriasis and psoriatic arthritis. The inclusion of psoriatic spectrum diseases in AMP AIM is expected not only to improve treatments for these diseases, but also to determine the commonalities and differences among autoimmune and immune-mediated conditions. Inclusion of psoriasis also is expected to enhance the participation of dermatology and skin biology researchers in the AMP program.

Bone Biology and Diseases
This program supports projects ranging from fundamental research into the genetic and cellular mechanisms involved in the build-up and breakdown of bone to epidemiologic studies of lifestyle factors that can preserve bone health. It encompasses common diseases such as osteoporosis, which affects millions of Americans, as well as rare conditions that occur in only a few individuals worldwide. Researchers supported by the program have leveraged large datasets for their osteoporosis and bone health studies. For example, investigators found that after 5 years of treatment with an oral osteoporosis drug from a class of medications called bisphosphonates, continuing treatment for an additional 5 years does not further decrease hip fracture risk. Another group of researchers looked at nearly 60 genetic markers of bone mineral density (BMD), a measurement used to diagnose bone health and osteoporosis, from a large group of Europeans, and identified only three of the markers in groups of people with African ancestry. They also identified novel BMD-associated genetic markers in the African ancestry populations. Studies such as this highlight genetic differences that may impact targeted disease therapies and risk prediction, not only in osteoporosis, but all diseases.

Muscle Biology and Diseases
This program’s overarching objective is to explain the muscle’s role in health and, ultimately, to treat or prevent skeletal muscle diseases and disorders such as the muscular dystrophies, muscle ion channel diseases, inflammatory myopathies, disuse atrophy, skeletal muscle injury, and loss of muscle mass and strength associated with aging and diseases. For example, one group of investigators demonstrated that muscle wasting in a mouse model of ovarian cancer is driven not by protein degradation, but by a decrease in protein production. A second group identified a protein that is critical for muscle mass gains, a finding that may have applications for people who are unable to exercise due to injury or illness.

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Muscular dystrophies are an area of emphasis within the NIAMS muscle research portfolio. Muscle biopsy is an integral part of most clinical studies on Duchenne muscular dystrophy and all dystrophies. However, the patient population is particularly vulnerable to the injury caused by the biopsy, and repeated open muscle biopsies of the same muscle are not recommended. With NIAMS support, investigators examined nearly 500 needle biopsies from Duchenne muscular dystrophy patients and determined that high quality tissue was retrieved with minimal complications via this technique. In addition, repeated measure of the same limb was possible 6 months later, which is not recommended with open biopsy. This study has the potential to change clinical trials in a way that would reduce burden on the participants. Duchenne muscular dystrophy patients also have an increased risk of low bone mineral density and can get mineral deposits in soft tissues such as muscles (a condition called ectopic calcification). Researchers are using a mouse model to elucidate the mechanism by which ectopic calcification is occurring and their results, if confirmed in human patients, could provide an avenue to restore calcium balance between calcified muscle and weakened bone.

Budget Policy:
The FY 2023 President’s Budget request for this program is $87.9 million, an increase of $5.4 million or 6.6 percent compared to the FY 2022 CR level. Program plans for FY 2023 include support for two Senator Paul D. Wellstone Muscular Dystrophy Research Centers that promote collaborative basic, translational, and clinical research and provide important resources that can be used by muscular dystrophy researchers nationwide. One is organized around the central theme of preserving skeletal muscle and cardiac muscle function in the muscular dystrophies by delineating disease-modifying targets and developing therapeutic strategies. The other is developing reagents, measurements, and clinical trial methods and infrastructures to speed the development of therapies for Duchenne muscular dystrophy and facioscapulohumeral muscular dystrophy.

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Joint Biology and Diseases and Orthopaedics
This program funds a broad spectrum of basic, translational, and clinical research centered on the interplay among the body’s muscles, bones, and connective tissues. It includes research on the biology, structure, and function of joints and surrounding tissues, and the application of this knowledge to a variety of diseases and conditions. One example is a study demonstrating that fat tissue contributes to the progression of osteoarthritis in mice. The program also funds research on molecular biology to understand the mechanisms of joint tissue formation and defects thereof; imaging to improve diagnosis and treatment of bone and joint disorders; and tissue engineering and regenerative medicine to facilitate repair of damage caused by trauma to otherwise healthy tissue. For example, researchers recently improved upon the architecture of a 3D-printed scaffold by optimizing scaffold pore size and geometry to facilitate bone regeneration and vascular infiltration in a rat model of spinal fusion. Importantly, this approach did not require the use of the growth factors that have been associated with clinical complications. Other investigators are studying ways to repair damaged cartilage by guiding stem cells to form mature cartilage using both chemical and cellular approaches.

At the clinical end of the research continuum, the program focuses on treatment and prevention of bone and joint injuries, orthopaedic conditions, and osteoarthritis. One group of researchers combined their knowledge of human cell behavior following acute joint injury and the molecular mechanisms of the antidepressant paroxetine to show that administering the drug to injured mice can facilitate tissue repair. It also can protect cultured human cells from damaging agents, which offers an avenue for investigating potential uses of paroxetine to mitigate acute cartilage injury and preserve or restore joint function. Another recent finding, which made use of data from the longstanding Osteoarthritis Initiative (see Fact Sheet earlier in this chapter), demonstrated that a class of pain medications called nonsteroidal anti-inflammatory drugs (NSAIDs) may accelerate rather than halt the progression of knee osteoarthritis.

Budget Policy:
The FY 2023 President’s Budget request for this program is $172.4 million, an increase of $10.7 million or 6.6 percent compared to the FY 2022 CR level. This program is responsible for organizing an FY 2022 workshop on heath disparities in osteoarthritis, and its plans for FY 2023 include exploring ways to follow up on recommendations from the workshop. Topics are expected to include social determinants of health and personal and interpersonal influences on care.

 

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NIAMS intramural researchers also work to improve treatment of rheumatologic diseases in both children and adults. For example, juvenile dermatomyositis (JDM) is a chronic autoimmune inflammatory disease that begins in childhood. Children develop progressive muscle weakness (myositis) and skin rashes, and other organs may be involved. While some patients respond to standard anti-inflammatory therapies including corticosteroids, two-thirds do not, and novel interventions are needed for these individuals. Based on foundational studies to understand how the immune system overreacts in this disease, NIAMS clinicians planned a compassionate use clinical study to see if the Janus Kinase (JAK) inhibitor, baricitinib, could help children with chronic, treatment-resistant JDM. All participants in the study responded to the treatment and showed improvement in skin rash and/or muscle strength and inflammation. Their response has been sustained for over a year while other immunosuppressive medications they were taking were tapered or discontinued. In other work, NIAMS investigators sought to determine if a different JAK inhibitor, tofacitinib, could help people with lupus. Lupus patients are at increased risk of developing premature cardiovascular disease (CVD), and prior research conducted at NIAMS demonstrated that tofacitinib improves clinical features of CVD in a mouse model. The Phase Ib/IIa randomized, double-blind, placebo-controlled clinical trial indicated that the treatment was safe, and showed promising secondary outcomes in improving cardiometabolic and immunological indicators associated with atherosclerosis.[5] Interestingly, lupus patients who carry a genetic risk factor, called the STAT4 risk allele, have more severe lupus disease and are at significantly increased risk for CVD. While examining data from the trial, researchers found that individuals in the study who had the STAT4 risk allele had a more robust response to tofacitinib. Both studies will need further research to confirm the findings, but the work strongly suggests that the use of JAK inhibitors for these diseases when other treatments fail holds promise.

 

Budget Policy:
The FY 2023 President’s Budget request for this program is $76.0 million, an increase of $6.1 million or 8.7 percent compared to the FY 2022 CR level. Program plans for FY 2023 include continued support for basic and clinical investigations into the causes and treatment of rheumatic, skin, muscular, and inflammatory diseases. In particular, the IRP plans to capitalize on recent expansions in high-performance computing capabilities by incorporating new technologies to drive scientific discovery. The program will build on enhanced genomic sequencing capabilities and genetic counseling services to identify the genetic causes of childhood lupus. Additionally, the program will employ high-dimensional flow cytometry to study the immunological response of individuals with underlying autoimmunity to SARS-CoV-2 infection or vaccination.

Research Management and Support (RMS)
The RMS budget supports the scientific, administrative management, and information technology activities associated with NIAMS’ day-to-day operations. In FY 2021, NIAMS managed 1,217 research grants and centers, as well as 31 research and development contracts and 295 individual and institutional full-time research training positions. NIAMS supported 569 clinical research studies, including 97 clinical trials. NIAMS continues to focus on reducing its information technology (IT) risk and improving its IT security posture by assessing and refining methodologies, approaches, and resources to protect the NIAMS IT assets, systems, and applications in compliance with HHS, NIH, and NIAMS standards, policies, and guidelines. As noted above, the Institute works closely with the NIAMS Coalition to host webinars and the biennial Coalition Outreach and Education Day (held virtually in FY 2022). Additionally, NIAMS is reviewing the Institute’s approach to data science and examining how to best leverage large datasets and new tools for data storage and analysis, an effort that will be important for large research programs like AMP.

Budget Policy:
The FY 2023 President’s Budget request for this program is $37.4 million, an increase of $1.0 million or 2.9 percent compared to the FY 2022 CR level. Program plans include continued support for meetings to facilitate the Institute’s scientific planning processes. Examples include an FY 2022 roundtable on the role of inflammation resolution in diseases within the NIAMS mission and a workshop on health disparities in osteoarthritis that is currently being developed. Findings from these meetings will help to inform current and future NIAMS activities.

Fiscal Year	Budget Estimate to Congress	House Allowance	Senate Allowance	Appropriation
2014 Rescission	$540,993,000		$537,398,000	$520,053,000 $0
2015 Rescission	$520,189,000			$521,665,000 $0
2016 Rescission	$533,232,000	$528,137,000	$544,274,000	$542,141,000 $0
20171 Rescission	$541,662,000	$555,181,000	$564,131,000	$557,851,000 $0
2018 Rescission	$417,898,000	$566,515,000	$576,178,000	$586,661,000 $0
2019 Rescission	$545,494,000	$593,663,000	$605,383,000	$605,065,000 $0
2020 Rescission	$520,829,000	$634,637,000	$637,097,000	$624,889,000 $0
2021 Rescission	$568,480,000	$635,263,000	$645,237,000	$634,292,000 $0
2022 Rescission	$680,186,000	$679,410,000	$675,106,000	$634,292,000 $0
2023	$676,254,000

¹ Budget Estimate to Congress includes mandatory financing.

Source of Funding	FY 2021 Final	FY 2022 CR	FY 2023 President's Budget
Appropriation	$634,292	$634,292	$676,254
Secretary's Transfer	-1,904	0	0
OAR HIV/AIDS Transfers	-6	0	0
Subtotal, adjusted budget authority	$632,382	$634,292	$676,254
Unobligated balance, start of year	0	0	0
Unobligated balance, end of year (carryover)	0	0	0
Subtotal, adjusted budget authority	$632,382	$634,292	$676,254
Unobligated balance lapsing	-29	0	0
Total obligations<	$632,353	$634,292	$676,254

¹ Excludes the following amounts (in thousands) for reimbursable activities carried out by this account:

• FY 2021 - $7,421
• FY 2022 - $7,557
• FY 2023 - $7,699

	FY 2022 CR	FY 2023 President's Budget	FY 2023 +/- FY 2022
Total compensable work years:
Full-time equivalent	238	242	4
Full-time equivalent of overtime and holiday hours	0	0	0
Average ES salary	$204	$213	$9
Average GM/GS grade	12.8	12.8	0.0
Average GM/GS salary	$127	$134	$7
Average salary, Commissioned Corps (42 U.S.C. 207)	$97	$102	$4
Average salary of ungraded positions	$161	$168	$7
OBJECT CLASSES	FY 2022 CR	FY 2023 President's Budget	FY 2023 +/- FY2022
Personnel Compensation
11.1 Full-Time Permanent	$18,712	$19,821	$1,109
11.3 Other Than Full-Time Permanent	$9,284	$9,806	$522
11.5 Other Personnel Compensation	$1,170	$1,214	$44
11.7 Military Personnel	$282	$292	$11
11.8 Special Personnel Services Payments	$3,670	$3,807	$137
11.9 Subtotal Personnel Compensation	$33,117	$34,940	$1,823
12.1 Civilian Personnel Benefits	$10,846	$11,393	$546
12.2 Military Personnel Benefits	$235	$244	$9
13.0 Benefits to Former Personnel	$0	$0	$0
Subtotal Pay Costs	$44,199	$46,577	$2,378
21.0 Travel & Transportation of Persons	$87	$329	$242
22.0 Transportation of Things	$93	$100	$6
23.1 Rental Payments to GSA	$0	$0	$0
23.2 Rental Payments to Others	$0	$0	$0
23.3 Communications, Utilities & Misc. Charges	$160	$181	$22
24.0 Printing & Reproduction	$0	$0	$0
25.1 Consulting Services	$20,068	$20,822	$754
25.2 Other Services	$9,754	$11,089	$1,335
25.3 Purchase of Goods and Services from Government Accounts	$43,389	$47,467	$4,077
25.4 Operation & Maintenance of Facilities	$492	$535	$44
25.5 R&D Contracts	$6,292	$7,411	$1,119
25.6 Medical Care	$278	$332	$54
25.7 Operation & Maintenance of Equipment	$5,431	$6,218	$788
25.8 Subsistence & Support of Persons	$0	$0	$0
25.0 Subtotal Other Contractual Services	$85,704	$93,874	$8,170
26.0 Supplies & Materials	$3,867	$4,501	$634
31.0 Equipment	$2,123	$2,320	$197
32.0 Land and Structures	$0	$0	$0
33.0 Investments and Loans	$0	$0	$0
41.0 Grants, Subsidies & Contributions	$498,056	$528,369	$30,313
42.0 Insurance Claims & Indemnities	$0	$0	$0
43.0 Interest & Dividends	$0	$0	$0
44.0 Refunds	$0	$0	$0
Subtotal Non-Pay Costs	$590,093	$629,677	$39,584
Total Budget Authority by Object Class	$634,292	$676,254	$41,962

¹ Includes FTEs whose payroll obligations are supported by the NIH Common Fund.

Object Classes	FY 2022 CR	FY 2023 President's Budget	FY 2023 +/- FY 2022
Personnel Compensation
Full-Time Permanent (11.1)	$18,712	$19,821	$1,109
Other Than Full-Time Permanent (11.3)	$9,284	$9,806	$522
Other Personnel Compensation (11.5)	$1,170	$1,214	$44
Military Personnel (11.7)	$282	$292	$11
Special Personnel Services Payments (11.8)	$3,670	$3,807	$137
Subtotal, Personnel Compensation (11.9)	$33,117	$34,940	$1,823
Civilian Personnel Benefits (12.1)	$10,846	$11,393	$546
Military Personnel Benefits (12.2)	$235	$244	$9
Benefits to Former Personnel (13.0)	$0	$0	$0
Subtotal Pay Costs	$44,199	$46,577	$2,378
Travel & Transportation of Persons (21.0)	$87	$329	$242
Transportation of Things (22.0)	$93	$100	$6
Rental Payments to Others (23.2)	$0	$0	$0
Communications, Utilities & Misc. Charges (23.3)	$160	$181	$22
Printing & Reproduction (24.0)	$0	$0	$0
Other Contractual Services
Consultant Services (25.1)	$19,888	$20,610	$722
Other Services (25.2)	$9,754	$11,089	$1,335
Purchase of Goods and Services from Government Accounts (25.3)	$27,060	$29,918	$2,858
Operation & Maintenance of Facilities (25.4)	$492	$535	$44
Operation & Maintenance of Equipment (25.7)	$5,431	$6,218	$788
Subsistence & Support of Persons (25.8)	$0	$0	$0
Subtotal Other Contractual Services	$62,625	$68,371	$5,746
Supplies & Materials (26.0)	$3,870	$4,504	$634
Subtotal Non-Pay Costs	$66,835	$73,485	$6,650
Total Administrative Costs	$111,034	$120,062	$9,029

Office						FY 2021 Final			FY 2022 CR			FY 2023 President's Budget
						Civilian	Military	Total	Civilian	Military	Total	Civilian	Military	Total
Office of the Director
Direct						57	-	57	59	-	59	60	-	60
Total:						57	-	57	59	-	59	60	-	60
Division of Extramural Research
Direct						54	-	54	56	-	56	57	-	57
Total:						54	-	54	56	-	56	57	-	57
Intramural Research Program
Direct						114	3	117	120	3	123	122	3	125
Reimbursable:						1	-	1	-	-	-	-	-	-
Total:						115	3	118	120	3	123	122	3	125
Total:						226	3	229	235	3	238	239	3	242
Includes FTEs whose payroll obligations are supported by the NIH Common Fund.
FTEs supported by funds from Cooperative Research and Development Agreements.						0	0	0	0	0	0	0	0	0
FISCAL YEAR						Average GS Grade
2019						12.6
2020						12.7
2021						12.9
2022						12.8
2023						12.8

Grade	FY 2021 Final	FY 2022 CR	FY 2023 President's Budget
Total, ES Positions	0	1	1
Total, ES Salary	$0	$203,700	$213,070
General Schedule
GM/GS-15	25	25	25
GM/GS-14	33	34	35
GM/GS-13	59	61	63
GS-12	24	26	26
GS-11	13	14	14
GS-10	0	0	0
GS-9	3	3	3
GS-8	1	1	1
GS-7	4	4	4
GS-6	1	1	1
GS-5	0	0	0
GS-4	0	0	0
GS-3	1	1	1
GS-2	0	0	0
GS-1	0	0	0
Subtotal	164	170	173
Commissioned Corps (42 U.S.C. 207)
Assistant Surgeon General	0	0	0
Director Grade	0	0	0
Senior Grade	2	2	2
Full Grade	0	0	0
Senior Assistant Grade	1	1	1
Assistant Grade	0	0	0
Subtotal	3	3	3
Ungraded	78	80	81
Total permanent positions	166	173	176
Total positions, end of year	245	254	258
Total full-time equivalent (FTE) employment, end of year	229	238	242
Average ES salary	$0	$203,700	$213,070
Average GM/GS grade	12.9	12.8	12.8
Average GM/GS salary	$124,541	$127,236	$133,788

¹ Includes FTEs whose payroll obligations are supported by the NIH Common Fund.