Dr Drucker on the Need for Older Adults in Atopic Dermatitis Clinical Trials

The upcoming issue of JAMA Dermatology features several articles on the lack of evidence for treating older patients with common skin diseases, such as psoriasis and atopic dermatitis (AD). One of the systematic reviews assessed the inclusion of older patients in clinical trials that had examined the safety and efficacy of AD therapies.¹ In this review, Lam et al found several trials either included an age limit or had exclusion criteria that would disproportionately exclude older adults. Read our full coverage of the study.

In an interview with The Dermatologist, corresponding author Aaron Drucker, MD, ScM, discussed the implications of these findings further, as well as steps needed to address the gaps in evidence-based medicine for older adults. Dr Drucker is an assistant professor of dermatology in the Department of Medicine at the University of Toronto, a scientist at Women’s College Research Institute, and a dermatologist at Women’s College Hospital in Toronto, Canada.

The Dermatologist: Why did you and your team decide to conduct a study to assess the inclusion of older adults in clinical trials?

Dr Drucker: Evidence suggests AD is fairly common among older adults, and I care for a number of such patients in my practice. We know from other areas of medicine that older patients are often excluded from clinical trials, so we wanted to see if that same problem existed in AD trials.

The Dermatologist: Could you briefly outline some of the findings that really stuck out to you? Were there any that surprised you?

Dr Drucker: The findings were not surprising! But, it is still striking how often older adults are explicitly excluded from trials, and even when there are not explicit age-based exclusion criteria, they are not well represented.

The Dermatologist: The upper age limits for some of the studies ranged from age 42 to 70 years, which included middle-aged adults with AD. Did you expect to see exclusions of adults younger than 60 from trials?

Dr Drucker: We did not expect this.

The Dermatologist: Your study showed that safety and efficacy data are not stratified by age. How does this impact interpretation of these results when using a therapy on an older patient?

Dr Drucker: Ideally, we would know how effective and safe a therapy is for specific populations, such as men vs women or different age groups. This is particularly true for older adults, who are more vulnerable to potential adverse events. Without stratified analyses, we do not know if their risk is or is not higher than a younger patient.

Also, we do not have adequate evidence to make informed decisions specific to older adults. Clinicians and older patients are left to make shared treatment decisions using assumptions from other populations.

The Dermatologist: What areas of future research are needed to improve evidence-based treatment approaches for older patients with atopic dermatitis?

Dr Drucker: A few approaches that could improve this are:

• Eliminate explicit upper age limits from clinical trials
• Encourage enrollment of older adults in clinical trials and conduct stratified analyses by age in clinical trials
• Conduct observational studies to assess efficacy and, perhaps more importantly, safety, of systemic therapies in older adults

Reference

1. Lam M, Zhu JW, Maqbool T, et al. Inclusion of older adults in randomized clinical trials for systemic medications for atopic dermatitis: a systematic review. JAMA Dermatol. Published online August 19, 2020. doi:10.1001/jamadermatol.2020.2940