Inclusion of Older Adults in Randomized Clinical Trials for Systemic Medications for Atopic Dermatitis

Lam, Megan; Zhu, Jie; Maqbool, Talha; Adam, Gaelen P; Tadrous, Mina; Rochon, Paula A.; Drucker, Aaron M.

doi:10.1001/jamadermatol.2020.2940

Cited by 28 publications

(42 citation statements)

References 41 publications

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“…The lack of data in older adults is in part, due to the common exclusion (either explicitly or indirectly because of factors such as comorbidities and polypharmacy) of older adults from atopic dermatitis and psoriasis RCTs. 8,9 Future RCTs should eliminate explicit upper age limits and minimize exclusion criteria that preferentially exclude older adults. In the absence of new RCT data, observational studies using routinely collected data (so-called “real-world” data) can add to our knowledge on the safety of systemic medications for atopic dermatitis and psoriasis.…”

Section: Discussionmentioning

confidence: 99%

“…6,7 While randomized controlled trials are an important source of safety data, systematic reviews have found that older adults are often excluded from studies of treatments for psoriasis and atopic dermatitis. 8,9 Additionally, randomized clinical trials often have too few participants followed over too short a duration to detect rare adverse events and adverse events with long latency periods, making observational studies an important source of safety data for inflammatory skin disease. 10 We performed a systematic review of observational studies to better understand the safety of systemic therapies in older adults treated for psoriasis and atopic dermatitis.…”

Section: Introductionmentioning

confidence: 99%

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Safety of Systemic Medications Among Older Adults With Psoriasis and Atopic Dermatitis: A Systematic Review of Observational Studies

et al. 2021

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Background Psoriasis and atopic dermatitis are common among older adults (≥65 years old), but clinical trials often exclude that population. Objective To synthesize evidence from observational studies on the safety of systemic therapies (conventional or biologic) for psoriasis and atopic dermatitis among older adults in a systematic review. Methods We searched MEDLINE and EMBASE (inception to October 31, 2019) and included observational studies reporting adverse events among older people treated with systemic therapy for psoriasis or atopic dermatitis. Outcomes were death, hospitalization, emergency department visits, infections, major cardiovascular events, renal toxicity, hepatotoxicity, and cytopenias. We assessed study quality using the Newcastle-Ottawa Scale. Results We included 22 studies on treatment for psoriasis and 2 for atopic dermatitis. Most studies were small and non-comparative and 20 of 24 were low quality. Studies comparing safety between medications or medication classes or between older and younger adults did not show apparent differences but had wide confidence intervals around relative effect estimates. Heterogeneity of study design and reporting precluded quantitative synthesis. Conclusions There is scant evidence on the safety of conventional systemic and biologic medications for older adults with psoriasis or atopic dermatitis; older adults and their clinicians should be aware of this evidence gap.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Safety of Systemic Medications Among Older Adults With Psoriasis and Atopic Dermatitis: A Systematic Review of Observational Studies

et al. 2021

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“…There is a relative lack of data on systemic therapy for AD in older patients. Despite an estimated 7% prevalence of AD in patients > 65 years, a recent systematic review showed relatively lower representation of older patients in randomized controlled trials for AD, at 4% [ 70 ]. In addition, none reported outcomes explicitly for older patients.…”

Section: Methodsmentioning

confidence: 99%

Practical Management of Patients with Atopic Dermatitis on Dupilumab

Papp

Hong

Lansang

et al. 2021

Dermatol Ther (Heidelb)

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Introduction Dupilumab is approved to treat moderate-to-severe atopic dermatitis (AD) in several countries in patients as young as 6 years of age. Since its approval, practical issues related to the use of dupilumab for AD have arisen, with particular interest in transitioning from current therapies and managing medication overlap, considerations for special populations of patients with AD, and management of potential adverse events. Methods This article aims to review the literature addressing several practical management issues related to dupilumab use for AD and to provide a framework for clinical decision-making in these circumstances and sub-populations. Each statement was reviewed, revised and voted on by authors to provide their level of agreement and degree of uncertainty for each statement. Results An agreement level > 80% was achieved for all of the statements. Conclusion The expert panel provides statements considering the practical management of patients with AD taking dupilumab to inform clinical decision-making in specific but frequently encountered clinical situations. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-021-00586-w.

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“…Lan et al recently highlighted the under‐representation of older adults in clinical trials of systemic therapies for atopic dermatitis (AD) 1 . Late‐onset AD is increasingly recognized in older adults 2 .…”

Section: Age Gender Past Medical History Treatment Duration Previous mentioning

confidence: 99%

“…atopic dermatitis, eczema, inflammatory disorders, pharmacology, quality of life, therapy-systemic Lan et al recently highlighted the under-representation of older adults in clinical trials of systemic therapies for atopic dermatitis (AD). 1 Lateonset AD is increasingly recognized in older adults. 2 Spontaneous remission is uncommon with this phenotype.…”

Section: Introductionmentioning

confidence: 99%

Novel agents for atopic dermatitis in patients over 50 years of age: A case series

Kiely

Bowe

O’Connor

et al. 2021

Dermatologic Therapy

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Lan et al recently highlighted the under-representation of older adults in clinical trials of systemic therapies for atopic dermatitis (AD). Late-onset AD is increasingly recognized in older adults. Spontaneous remission is uncommon with this phenotype. Existing drug treatments such as corticosteroids, methotrexate, ciclosporin, and azathioprine are complicated by adverse effects including increased malignancy risk, immunosuppression in the context of immunosenescence, and drug interactions in the setting of polypharmacy. A case series is presented of seven patients over 50 years of age with AD who were prescribed dupilumab or tofacitinib or upadacitinib for at least 6 months. All patients were clear or almost clear (investigator global assessment score 0/1) after 1 month of therapy. No significant adverse events were seen. This case series provides preliminary evidence about the safety and efficacy of these novel drugs for AD in older adults. Further studies with higher numbers of participants are needed to obtain realworld evidence for these drugs in older adults, given the limited data in clinical trials.

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Inclusion of Older Adults in Randomized Clinical Trials for Systemic Medications for Atopic Dermatitis

Cited by 28 publications

References 41 publications

Safety of Systemic Medications Among Older Adults With Psoriasis and Atopic Dermatitis: A Systematic Review of Observational Studies

Safety of Systemic Medications Among Older Adults With Psoriasis and Atopic Dermatitis: A Systematic Review of Observational Studies

Practical Management of Patients with Atopic Dermatitis on Dupilumab

Novel agents for atopic dermatitis in patients over 50 years of age: A case series

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