Rheumatology’s Blind Spot: The Persistent Exclusion of Older Adults Save

As the population ages globally, rheumatologists are caring for an increasingly older patient population more than ever before. In rheumatoid arthritis alone, nearly 40 percent of patients are now aged 65 years or older. Yet the evidence guiding our treatment decisions continues to come from studies that rarely include them, giving rise to a fundamental question: do we really know how best to treat older adults with rheumatic diseases?

At the 2025 ACR Convergence in Chicago, Abstract #1072, titled “Inclusion of Older Adults in Pharmacologic Randomized Controlled Clinical Trials of Autoimmune Rheumatic Diseases: A Systematic Review,” painted a sobering picture of the age gap that persists across the field.

This systematic review, led by Drs. Manuel Carpio Tumba, Sebastian Sattui, and colleagues, represents the largest and most comprehensive assessment to date of how older adults are represented in rheumatology drug trials. The team analyzed 514 randomized controlled trials involving more than 150,000 participants, published between 2010 and 2023, across seven autoimmune rheumatic diseases: rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), spondyloarthritis (SpA), systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), giant cell arteritis and polymyalgia rheumatica (GCA/PMR), and idiopathic inflammatory myopathies (IIM).

The review builds on an earlier analysis of RA trials conducted from 2016 to 2017 by Palmowski et al. but expands both the timeframe and the scope. For RA, the new review began in 2017 to avoid overlap, offering a clear view of whether inclusion practices have evolved. The answer, unfortunately, is no—older adults remain persistently underrepresented.

Over half of RCTs (56 percent) imposed an upper age limit, most often excluding adults older than 70 years. Only one-third (33 percent) of studies explicitly reported data on older adults. The result is a persistent “representation gap” between who we study and who we treat. The gap was widest in RA, SLE, SpA, and SSc—the very conditions most commonly seen in practice—while trials in AAV, GCA/PMR, and IIM were somewhat more age-aligned. When compared with observational cohort data, mean participant ages in nearly every disease were younger than those of real-world patients.

This matters because clinical practice guidelines, the backbone of evidence-based medicine, are largely built on these same RCTs. When older adults are excluded, the guidance that follows risks being incomplete or misleading for the population most affected. Older adults often have multimorbidity, altered drug metabolism, and polypharmacy that can change both risk and response. The impact of biologics or targeted synthetic DMARDs may differ substantially when used alongside common comorbidities like chronic kidney disease, heart failure, or diabetes. Yet dosing, monitoring, and safety recommendations are still based on trial populations that rarely reflect these complexities. As a result, clinicians are left navigating uncharted territory and forced to extrapolate efficacy and safety data to an age group that was systematically left out of the evidence base.

The authors emphasize that addressing these gaps will require intentional design rather than passive inclusion. Efforts such as the NIH Inclusion Across the Lifespan Policy have laid the groundwork, but meaningful change demands practical strategies that make participation feasible for older adults. One emerging approach is the 5Ts Framework for Research Inclusion, which provides a roadmap for embedding age inclusivity into study design. It calls for creating target populations that reflect real-world demographics, assembling multidisciplinary teams that include geriatric and aging-science expertise, using appropriate tools such as functional and patient-reported outcome measures that balance data needs with participant burden, allowing additional time for study visits and follow-up when comorbidities make participation slower or more complex, and adopting practical accommodations such as transportation support, large-print materials, or caregiver involvement to help older adults take part.

This systematic review underscores a persistent disconnect between the populations we study and the patients we serve. As the field continues to innovate in therapeutics, it must also evolve in inclusion. Our patients are aging. Representation in research isn’t optional—it’s essential for relevance and for truly reflecting the patients filling our waiting rooms, those managing arthritis alongside aging.