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

• Published in: Journal of the American Academy of Dermatology Vol. 83; no. 2; pp. 412 - 424
• Main Authors: Schaap, Mirjam J., van Winden, Marieke E.C., Seyger, Marieke M.B., de Jong, Elke M.G.J., Lubeek, Satish F.K.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2020
• Subjects: Age Factors; Aged; Aged, 80 and over; Biological Products - therapeutic use; Comorbidity; Dermatologic Agents - therapeutic use; exclusion; Humans; Neoplasms - epidemiology; older adults; Patient Selection; plaque psoriasis; Psoriasis - drug therapy; Psoriasis - epidemiology; Psoriasis - immunology; randomized controlled trial; Randomized Controlled Trials as Topic - standards; Randomized Controlled Trials as Topic - statistics & numerical data; representation; Research Design - standards; systematic review; systemic therapy; upper age limit; RCT; upper age limit; aged; older adults; plaque psoriasis; exclusion; systematic review; systemic therapy; representation; randomized controlled trial
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2019.07.079

Psoriasis is frequently seen in older patients, and systemic treatment is often indicated. Randomized controlled trials (RCTs) generally maintain strict inclusion and exclusion criteria, which might lead to a disproportionally high exclusion rate of older adults. To determine the representation of older adults (≥65 years) in RCTs studying systemic treatment in plaque psoriasis. A systematic literature search was performed in PubMed/MEDLINE, Embase, and CENTRAL, including RCTs concerning systemic treatments in plaque psoriasis in the past 15 years. Direct exclusion (based on age limits) and indirect exclusion (other exclusion criteria) were assessed. Study selection and data extraction were performed by 2 independent reviewers. Of 162 trials reviewed in full, 54 (33.3%) maintained an upper age limit (55-85 years). Of the remaining 108 trials, 106 reported exclusion criteria and did not use an upper age limit. However, 96 (90.6%) of these trials used exclusion criteria that might unequally affect older adults. The exclusion criteria serious concurrent infection (n = 104, 66.7%) and malignancy (n = 100, 64.1%) were most commonly mentioned in the included RCTs. Only published RCTs were included. Older adults might be poorly represented in RCTs studying systemic treatment in plaque psoriasis because of a high rate of direct and indirect exclusion.