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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.Le texte complet de cet article est disponible en PDF.
Key words : aged, exclusion, older adults, plaque psoriasis, randomized controlled trial, representation, systematic review, systemic therapy, upper age limit
Abbreviation used : RCT
| Disclosure: Dr Schaap has carried out clinical trials for Celgene, Janssen, and Lilly. Dr van Winden has carried out investigator-initiated research partially funded by Almirall. Dr Seyger received grants from/was involved in clinical trials with AbbVie, Almirall, Janssen, Leo Pharma, Lilly, and Pfizer and served as a consultant for AbbVie, Almirall, Boehringer Ingelheim, Janssen, Leo Pharma, Lilly, and Pfizer; fees were paid directly to the institution. Prof Dr de Jong has received research grants for the independent research fund of the Department of Dermatology of the Radboud University Medical Center, Nijmegen, The Netherlands from AbbVie, Pfizer, and Janssen and has acted as consultant and/or paid speaker for and/or participated in research sponsored by companies that manufacture drugs used for the treatment of psoriasis including AbbVie, Almirall, Janssen, MSD, Pfizer, Novartis, Lilly, and Celgene; all funding is not personal but goes to the independent research fund of the Department of Dermatology of Radboud University Medical Center, Nijmegen, The Netherlands. Dr Lubeek has received research grants for investigator-initiated research by Almirall.
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