The State of Autoimmune Disease in America

Comprehensive Research Report: June–November 2025

15M
Americans Affected
4.6%
Population Prevalence
$100B+
Annual Healthcare Costs
63%
Female Patients

Executive Summary

Critical Findings

  • 15 million Americans (4.6%) diagnosed with at least one autoimmune disease
  • 34% have multiple autoimmune diseases
  • Annual increase of 3-12% in prevalence rates
  • FDA approved first neuroimmune modulation device for rheumatoid arthritis
  • NIH released inaugural Strategic Plan for Autoimmune Disease Research
  • Nobel Prize 2025 awarded for regulatory T-cell discoveries

Epidemiological Landscape

Top 5 Most Prevalent Autoimmune Diseases

Rheumatoid Arthritis
Highest
Psoriasis
High
Type 1 Diabetes
High
Graves' Disease
Moderate
Autoimmune Thyroiditis
Moderate
📊

Demographics

  • Female prevalence: 5.8% (2x higher than males)
  • Male prevalence: 3.5%
  • Study analyzed 10M+ patient records
  • 6 major medical systems across US
📈

Temporal Trends

  • ANA prevalence: 11% (1988) → 15.9% (2012)
  • Global incidence rising 19.1% annually
  • T1D doubled in adults over 40 years
  • Celiac disease increased 5x in 30 years

Revolutionary Treatment Breakthroughs

July 2025

SetPoint System FDA Approval

First-in-class neuroimmune modulation device for rheumatoid arthritis. 75% of patients free of biologics at 12 months. Once-daily vagus nerve stimulation activates anti-inflammatory pathways.

October 2025

Ianalumab Phase III Success

First targeted therapy for Sjögren's disease showing sustained efficacy through 52 weeks. Dual-mechanism antibody targeting B-cell depletion and BAFF receptor blockade.

September 2025

CAR-T Expansion to Autoimmune

University of Chicago launched Phase 2 trials for lupus, myositis, and systemic sclerosis. Cabaletta Bio demonstrated drug-free clinical responses without preconditioning chemotherapy.

June 2025

Zimislecel T1D Results

83% of patients (10/12) remained insulin-independent one year after stem cell-derived therapy. HbA1c <7% and >70% time-in-range achieved, demonstrating physiological islet function restoration.

Digital Health & AI Revolution

🔬

Wearable Devices

  • Predict IBD flares 7 weeks in advance
  • 95% accuracy in RA flare prediction
  • Apple Watch, Fitbit, Oura Ring validated
  • 300+ participants across 36 states
🤖

AI Diagnostics

  • 89% accuracy in autoimmune encephalitis diagnosis
  • 25-1000% more accurate disease progression prediction
  • ImmunoNet deep learning framework launched
  • Treatment recommendation personalization
📱

Telemedicine Adoption

  • 72.7% adoption rate among patients
  • 67.5% utilized video consultations
  • Overall satisfaction: 7.3/10
  • Real-time integration with wearables

Mental Health Comorbidity Crisis

Mental Health Risk Elevation

Depression & Anxiety Risk Increase 87-97%
Lifetime Mood Disorder Prevalence (vs General Pop) 29% vs 18%
Cognitive Problems (Brain Fog) 70%
Clinical Depression in MS Patients 40%

Study Highlights: University of Edinburgh (1.5M Participants)

  • Women show 32% affective disorder prevalence vs 21% in men
  • Elevated risks persist after adjusting for age, income, parental psychiatric history
  • Chronic inflammation may be causally associated with greater psychiatric risk
  • Cambridge study: >50% experience depression/anxiety, 70% report cognitive issues

Healthcare Economics & Access

Cost Category Amount Impact
Annual National Healthcare Costs $100+ Billion NIH estimate
Excess Costs Per Employee $2,200-$33,500 Annually
Employer Costs (per 1,000 employees) $580,000 5 major conditions
Medical Costs Increase Up to 6x vs general population
Prescription Costs Increase Up to 16x vs general population
Average Lost Work Days (STD) 73 days/year $27,000 economic value
Medicare Part D Out-of-Pocket Cap $2,000 Effective Jan 2025
💊

Biosimilar Expansion

  • FDA accelerated approvals Oct 2025
  • 74 FDA-approved biosimilars (April 2025)
  • $100-129B projected savings (2021-2027)
  • 1.2M patients could gain access in 2025
⚠️

Insurance Barriers

  • 3 out of 4 plans scored "C" or "F" for access
  • Covers 15.9M Americans with autoimmune
  • Minimal physician decision-making deference
  • Knowledge gaps: only 16% prescribers "very prepared"

Emerging Risk Factors

😴

Sleep Disruption Impact

  • Cutaneous lupus risk: 2.1x increase
  • Rheumatoid arthritis risk: 1.4x increase
  • Sjögren syndrome risk: 1.8x increase
  • Study: 351,366 subjects per cohort
  • One night sleep deprivation alters immune profile
🦠

Gut Microbiome Connection

  • Strongest disease association (R²=3.67%)
  • 79 bacterial genera significantly associated
  • Enterococcus, Veillonella enriched across datasets
  • Microbiota-driven antigenic mimicry disrupts tolerance
  • Consistent reduction in microbial diversity
🧬

Vitamin D Deficiency

  • Correlates with higher disease activity
  • Thymus ages more quickly without vitamin D
  • Finnish study: 5x lower T1D risk with supplementation
  • High-dose (4,000 IU/day) shows promise
  • Affects lymphocyte activation and T-helper polarization

Federal Policy Landmark: NIH Strategic Plan

First-Ever NIH-Wide Strategic Plan (FY 2026-2030)

  • Released July 21, 2025 after extensive stakeholder engagement
  • Office of Autoimmune Disease Research established within NIH
  • 83 responses to Request for Information from scientists, clinicians, advocates, patients
  • Portfolio analysis of 140+ autoimmune and related diseases
  • Built on 2022 National Academies of Sciences recommendations

Five Strategic Priorities

Accelerate Discovery
Diagnosis, Treatment, Prevention, Cure
Promote Health Research
For Those Living With & At Risk
Understand Complexity
Disease Mechanisms & Interactions
Build Capacity
Research Infrastructure & Workforce
Strengthen Partnerships
Interdisciplinary Collaboration

Long COVID & Autoimmunity Intersection

🦠

Epidemiological Links

  • May unmask, trigger, or worsen autoimmune conditions
  • Overall prevalence: 2.4‰ in 192,651-patient study
  • 3-10x higher with multiple infections
  • Post-pandemic thrombotic events doubled (>60 age group)
  • Affects both vaccinated and unvaccinated
⚕️

Autoimmune-Like Mechanisms

  • Presence of autoantibodies detected
  • Prolonged immune activation observed
  • May trigger disease in susceptible individuals
  • Guillain-Barré syndrome cases reported
  • Antiphospholipid syndrome documented

Health Disparities & Equity Challenges

ACR Convergence 2025 Findings

  • Persistent racial/ethnic disparities in kidney transplant outcomes for lupus patients
  • Disparities in DMARD receipt for late-onset RA in Medicare beneficiaries
  • Women with autoimmune disease face higher cardiovascular death rates than men
  • Women 2x more likely to die of irregular heart rhythm or cardiac arrest
  • Racial minorities visit doctors less frequently and have higher uninsured rates
  • 56% of physicians are white; Hispanic and Black physicians combine for ~11%

Sex-Based Differences

Overall Prevalence Ratio (Female:Male) 1.9:1
Affective Disorder Prevalence: Women 32%
Affective Disorder Prevalence: Men 21%

Research Funding Landscape (Summer 2025)

🎓

Yale's Colton Center

  • 9 proposals selected for funding
  • Nearly $1M total support
  • Novel diagnostics, therapeutics, vaccines
  • Announced August 2025
💡

Eshelman Innovation

  • Therapeutics Accelerator launched
  • Single-cell & spatial transcriptomics
  • AI and machine learning approaches
  • Awards announced Sept 15, 2025
🔬

Multiple Foundations

  • Arthritis National Research Foundation: $50K-$250K
  • Myositis Association: $107.5K over 18-24 months
  • Focus on early-career investigators
  • Applications opened November 2025

Vaccine Safety Evidence

Landmark Danish Study (July 2025)

  • Analyzed data from 1+ million children born 1997-2018
  • No association between aluminum-containing vaccines and 50 health conditions
  • No link to autism, asthma, or autoimmune diseases found
  • "Absolutely no indication that very small aluminum amounts increase risk"
  • WHO GACVS reviewed all vaccine safety data worldwide (1999-2019)
  • Conclusion: "Vaccines do not increase the risk of autoimmune diseases"

COVID-19 Vaccine Safety (IDSA 2025 Guidelines)

Finding Evidence Level Details
Serious Adverse Events Low certainty Little or no serious adverse events reported
Thrombotic Events Moderate certainty Less frequent in vaccinated populations
Myocarditis Low certainty Lower risk in vaccinated vs unvaccinated
Disease Exacerbations Moderate certainty Do not increase due to vaccination
MS Lesions on Imaging Low certainty Reported in one study, clinical implications uncertain

Conclusion & Future Outlook

Key Takeaways

  • June-November 2025 marks inflection point with revolutionary cellular therapies advancing
  • CAR-T, neuroimmune modulation, and targeted biologics showing unprecedented efficacy
  • Digital health innovations enable disease flare prediction weeks in advance
  • AI achieving clinical-grade performance in diagnosis and progression prediction
  • Mental health comorbidity demands integration into standard care paradigms
  • Persistent racial, ethnic, and sex-based disparities require targeted interventions
  • NIH Strategic Plan provides coordinated framework for FY2026-2030
  • Biosimilar expansion promises improved access and affordability
  • Sleep disruption, gut microbiome, and vitamin D emerge as modifiable risk factors
  • Sustained federal funding and policy support essential for translating breakthroughs

Critical Needs for Next 5 Years

Sustained NIH Funding
Critical Priority
Insurance Coverage Reform
Critical Priority
Mental Health Integration
High Priority
Disparity Reduction Programs
High Priority
Digital Health Infrastructure
High Priority
Diverse Trial Participation
Moderate-High Priority

About the Author

👤

Toni Bailey

Toni Bailey is a leading patient advocate and research specialist in autoimmune and rare diseases.As co-founder of Oregon Coast AI, Toni has the capabilities to research emerging trends in diagnostics, treatment, and patient-reported outcomes, helping to close the gap between clinical research and real-world patient needs. With a background that bridges personal patient experience with deep expertise in medical data analysis, Toni is dedicated to translating complex scientific breakthroughs into accessible, empowering insights for patients and caregivers.