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Journal of the American Academy of Dermatology
Sous presse. Epreuves corrigées par l'auteur. Disponible en ligne depuis le mardi 4 février 2020
Doi : 10.1016/j.jaad.2019.07.079
accepted : 19 July 2019
Representation of older adults in randomized controlled trials on systemic treatment in plaque psoriasis: A systematic review
 

Mirjam J. Schaap, MD , Marieke E.C. van Winden, MD, Marieke M.B. Seyger, MD PhD, Elke M.G.J. de Jong, MD, PhD, Satish F.K. Lubeek, MD, PhD
 Department of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands 

Correspondence to: Mirjam J. Schaap, MD, Afdeling Dermatologie (Route 370), René Descartesdreef 1, Postbus 9101, 6500 HB Nijmegen, The Netherlands.Afdeling Dermatologie (Route 370)René Descartesdreef 1, Postbus 9101Nijmegen6500 HBThe Netherlands
Abstract
Background

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.

Objective

To determine the representation of older adults (≥65 years) in RCTs studying systemic treatment in plaque psoriasis.

Methods

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.

Results

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.

Limitations

Only published RCTs were included.

Conclusion

Older adults might be poorly represented in RCTs studying systemic treatment in plaque psoriasis because of a high rate of direct and indirect exclusion.

The full text of this article is available in PDF format.

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.
 Reprints not available from the authors.



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