Representation of older adults in randomized controlled trials on systemic treatment in plaque psoriasis: A systematic review

Schaap, M.; Winden, Marieke E.C. van; Seyger, M.M.B.; Jong, E.M.G.J. de; Lubeek, Satish F K

doi:10.1016/j.jaad.2019.07.079

Cited by 14 publications

(19 citation statements)

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“…Literature on this growing population is scarce, since older adults are often excluded from clinical trials (7,8). Furthermore, conflicting results have been reported regarding treatment safety, implicating that much is still unknown in this population (9)(10)(11).…”

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confidence: 99%

Safety Assessment of Conventional and Biological Systemic Therapy in Older Adults with Psoriasis, a Real-world Multicentre Cohort Study

et al. 2022

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Optimal selection of systemic therapy in older adults with psoriasis can be challenging, due to sparse evidence-based guidance. This multicentre retrospective study investigated the safety of systemic therapy with causality assessment in a real-world cohort of older adults (≥ 65 years) with psoriasis. Data from 6 hospitals on (severe) adverse events were collected, causality assessment performed and incidence rate ratios calculated. Potential predictors for adverse events-occurrence were studied using multivariable logistic regression analysis. In total, 117 patients with 176 treatment episodes and 390 patient-years were included, comprising 115 (65.3%) and 61 (34.7%) treatment episodes with conventional systemic therapy and biologics/apremilast, respectively. After causality assessment, 232 of 319 (72.7%) adverse events remained and were analysed further, including 12 severe adverse events. No significant differences in incidence rate ratios were found between the systemic treatment types. In regression analysis, increasing age was associated with causality assessed adverse events-occurrence (odds ratio 1.195; p=0.022). Comorbidity, polypharmacy, and treatment type were not associated with causality assessed adverse events-occurrence. In conclusion, increasing age was associated with a higher causality assessed adverse events-occurrence. Causality assessed severe adverse events were rare, reversible and/or manageable in clinical practice. In conclusion, the safety profile of systemic antipsoriatic therapy within this population is reassuring.

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confidence: 99%

Safety Assessment of Conventional and Biological Systemic Therapy in Older Adults with Psoriasis, a Real-world Multicentre Cohort Study

et al. 2022

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“…The few available studies show similar disease severity compared with younger patients, although prescribed therapies appear to differ ( 6 , 7 ). Moreover, data concerning the use of systemic treatment in geriatric psoriasis are scarce, since older adults are frequently excluded from clinical trials ( 8 , 9 ). Therefore, it is currently unclear what risks are associated with antipsoriatic treatment in this growing population and whether geriatric patients with psoriasis are treated optimally.…”

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confidence: 99%

Disease and Treatment Characteristics in Geriatric Psoriasis: A Patient Survey Comparing Age Groups

Winden¹,

Haar²,

Groenewoud³

et al. 2020

Acta Derm Venereol

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Little is known about geriatric psoriasis, although health problems and medication can complicate the management of psoriasis. To compare characteristics of patients ≥ 65 years old with those < 65 years old, a survey was sent to all members (3,310) of the Dutch Psoriasis Association. In total, 985 (29.7%) patients returned the survey, 414 (43.6%) respondents were ≥ 65 years old. Despite more comorbidities and medication use in ≥ 65 years old, no difference was seen between age groups regarding systemic antipsoriatic treatment (38.3% vs 42.3%). Side-effects were reported more frequently by patients < 65 years old. Thus, age alone should not limit psoriasis treatment, and proper attention must be paid to patient-related factors. Little is known about psoriasis in geriatric patients, whereas treating this growing population can be challenging due to comorbidities, comedication and physical impairments. To compare disease and treatment characteristics of psoriasis patients ≥ 65 years old with patients < 65 years old, a self-assessment survey was sent to all members of the Dutch Psoriasis Association (n = 3,310). In total, 985 (29.7%) patients returned the survey, 414 (43.6%) respondents were ≥ 65 years old. Patients ≥ 65 years old had experienced erythrodermic psoriasis significantly more frequently than patients < 65 years old, other disease characteristics were highly comparable. Despite a significantly higher prevalence of comorbidities and comedication use in patients ≥ 65 years old, no difference was seen between the age groups regarding systemic antipsoriatic treatment (38.3% in ≥ 65 years old vs 42.3% in < 65 years old; p = 0.219). Remarkably, treatment-related side-effects were reported more frequently by patients < 65 years old. In conclusion, age alone should not be a limiting factor in psoriasis management, and proper attention must be paid to additional patient-related factors.

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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.…”

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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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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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Representation of older adults in randomized controlled trials on systemic treatment in plaque psoriasis: A systematic review

Cited by 14 publications

References 158 publications

Safety Assessment of Conventional and Biological Systemic Therapy in Older Adults with Psoriasis, a Real-world Multicentre Cohort Study

Safety Assessment of Conventional and Biological Systemic Therapy in Older Adults with Psoriasis, a Real-world Multicentre Cohort Study

Disease and Treatment Characteristics in Geriatric Psoriasis: A Patient Survey Comparing Age Groups

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

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