Global Recruiting Patterns and Placebo Response Rates in Clinical Trials of Psoriatic Arthritis and Plaque Psoriasis.
Objective: Placebo effects are a significant challenge in the conduct of clinical trials. We explored how global recruitment patterns influence the extent of placebo responses in randomized controlled trials of psoriatic arthritis and plaque psoriasis. Methods: We conducted an analysis of 51 trials...
| Publicado en: | Arthritis & Rheumatology Vol. 78; no. 1; pp. 141 - 152 |
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| Autores principales: | , , , , , , , , |
| Formato: | pictorial research tables/charts Journal Article |
| Publicado: |
Wiley-Blackwell
Jan2026
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=191211786&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 191211786 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 23265191 H06R jtl: Arthritis & Rheumatology issn: 23265191 maglogo: N pubinfo: dt: Jan2026 vid: 78 iid: 1 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 191211786 188145594 191211786 191211786 10.1002/art.43302 191211786 ppf: 141 ppct: 11 formats: tig: atl: Global Recruiting Patterns and Placebo Response Rates in Clinical Trials of Psoriatic Arthritis and Plaque Psoriasis. aug: au: Kerschbaumer, Andreas Steiner, Marlene Khalili, Suzanne Shehab, Azad Jordanov, Alexander Wildner, Brigitte Maad, Magdalena Smolen, Josef S. Aletaha, Daniel affil: Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria sug: subj: Research Subject Recruitment Randomized Controlled Trials Arthritis, Psoriatic Psoriasis Socioeconomic Factors Placebos Human Female Male Biological Products Therapeutic Use Therapeutics Confidence Intervals Descriptive Statistics Antirheumatic Agents Therapeutic Use Adult Middle Age Disease Duration Adult: 19-44 years Middle Aged: 45-64 years Female Male ab: Objective: Placebo effects are a significant challenge in the conduct of clinical trials. We explored how global recruitment patterns influence the extent of placebo responses in randomized controlled trials of psoriatic arthritis and plaque psoriasis. Methods: We conducted an analysis of 51 trials (6,843 patients; 52% ± 5.7% female) in psoriatic arthritis and 43 trials (5,671 patients; 32% ± 7.1% female) in plaque psoriasis investigating biologic and targeted synthetic therapeutics. We investigated to what extent global recruitment patterns are related to the extent of response rates in the placebo arms of these clinical trials by investigating underlying socioeconomic factors using the average per capita gross national income (GNI; weighted for recruiting study centers per country) as proxy of these patterns in linear mixed models. Results: We identified a negative association of GNI and placebo response rates on the primary endpoints across psoriatic arthritis trials (American College of Rheumatology 20%: β = ‐5.7% per 10,000 international dollars; 95% confidence interval [CI] −7.8% to −3.5%; P < 0.001) and plaque psoriasis trials (Psoriasis Area and Severity Index 75%: β = ‐1.1%; 95% CI −2.0 to −0.3; P = 0.011). Sensitivity analyses using other outcome measures and alternative economic metrics, such as the United Nations Human Development Index and World Health Organization out‐of‐pocket health expenditures, were confirmatory. Conclusion: The global expansion of trial recruitment to less affluent countries may increase placebo rates in studies of psoriatic arthritis and plaque psoriasis. These higher placebo rates may reflect the higher perceived benefit in these countries, leading to regression to the mean after patients have been successfully enrolled. pubtype: Academic Journal doctype: pictorial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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