The underrepresentation of older adults in clinical trials of Janus kinase inhibitors in the treatment of atopic dermatitis

Sreekantaswamy, Shreya; Tully, Janell; Edelman, Linda S.; Supiano, Mark A.; Butler, David F.

doi:10.1016/j.jaad.2022.02.051

Cited by 7 publications

(2 citation statements)

References 4 publications

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“…Available data for the treatment of AD with baricitinib are largely derived from clinical trials. This may lead to potential biases related to the inclusion and exclusion criteria of these trials and the risk of under-representation of at-risk patients or those with comorbidities; significant differences may also be seen between efficacy in clinical trials vs daily practice ( 20 , 21 ). In baricitinib phase III studies, more patients achieved an EASI75 score in the baricitinib 4 mg and 2 mg arms compared with placebo.…”

Section: Discussionmentioning

confidence: 99%

Impact of Baricitinib on Patients’ Quality of Life after One Year of Treatment for Atopic Dermatitis in Real-World Practice: Results of the Observatory of Chronic Inflammatory Skin Diseases Registry

Reguiai,

Becherel,

Perrot

et al. 2023

Acta Derm Venereol

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The efficacy and safety of baricitinib for treatment of atopic dermatitis have been demonstrated in clinical trials; however, very few real-life studies have been published to date. The Observatory of Chronic Inflammatory Skin Diseases (OMCCI) registry was initiated to prospectively determine the long-term impairment caused by chronic inflammatory dermatoses on patients’ lives. The study included 88 patients starting baricitinib for treatment of atopic dermatitis. Clinical evaluation and patient-reported outcomes were recorded at baseline and after 6 and 12 months. After 6 months and 1 year of follow-up, 65 and 47 patients, respectively, were still being treated with baricitinib. Treatment failure was the main reason for discontinuation. Only 1 patient stopped baricitinib because of a side-effect. After 1 year of follow-up, the mean Eczema Area and Severity Index score decreased significantly from 20.7 to 6.4; the percentage of patients with severe atopic dermatitis decreased from 42.9% to 6.5% and a significant improvement in most patient-reported outcomes was noted. There was no difference in terms of efficacy whether or not patients were previously treated with dupilumab. The results remained stable after 6 and 12 months of treatment, which suggests a sustained efficacy of the treatment in patients who initially responded well.

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Section: Discussionmentioning

confidence: 99%

Impact of Baricitinib on Patients’ Quality of Life after One Year of Treatment for Atopic Dermatitis in Real-World Practice: Results of the Observatory of Chronic Inflammatory Skin Diseases Registry

Reguiai,

Becherel,

Perrot

et al. 2023

Acta Derm Venereol

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“…It also has the potential to restore the skin barrier function by increasing the production of proteins involved in terminal differentiation, like filaggrin. 84 Daniel et al 85 analyzed 32 Phase II and phase III clinical trials involving five JAK inhibitors (abrocitinib, baricitinib, upadacitinib, ruxolitinib, and delgocitinib) in adult patients. 83 , 84 , 86 , 87 Among these trials, the proportion of participants aged over 65 years ranged from 2.1%–8.0%.…”

Section: Jak Inhibitorsmentioning

confidence: 99%

Current and Emerging Therapies for Atopic Dermatitis in the Elderly

Teng,

Zhong,

Yang

et al. 2023

CIA

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Atopic dermatitis (AD) in the elderly has recently emerged as a distinct subgroup of AD, garnering widespread concern due to its increasing global incidence rate. Epidermal barrier dysfunction, inflammatory response, and chronic pruritus interact with each other, contributing to the pathogenesis and pathophysiology of AD in the elderly. Although fundamental medications are essential for managing AD in the elderly, older adults often struggle with regular usage of moisturizing emollients, topical medications, and avoidance of environmental triggers, leading to recurrent or even exacerbated disease progression. Therefore, a systematic medication approach is necessary to control pruritus and skin lesions. Traditional systemic treatments may not adequately meet the treatment needs of moderate and severe AD in the elderly and may even pose certain safety risks. Biologics and Janus kinase (JAK) inhibitors, exhibiting excellent clinical efficacy, have made significant breakthroughs in AD treatment. Existing evidence suggests that dupilumab, a human monoclonal IgG4 antibody, has been confirmed as an effective and safe first-line systematic treatment for moderate to severe AD in the elderly, with no notable differences between adults and the elderly. However, the limited inclusion of elderly patients in related clinical studies hinders the generalizability of these findings. As older patients face a higher risk of adverse events with JAK inhibitors, JAK inhibitors are recommended when no other suitable treatment options are available. Obtaining population-specific data is crucial for making evidence-based treatment choices when managing AD in older adults with JAK inhibitors.

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