Placebo Response in Phase 3 Trials of Systemic Therapies for Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-Analysis

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Placebo Response in Phase 3 Trials of Systemic Therapies for Moderate-to-Severe Plaque Psoriasis : A Systematic Review and Meta-Analysis. / Ambikaibalan, Danni; Quaade, Anna Sophie; Halling, Anne Sofie; Thyssen, Jacob P.; Egeberg, Alexander.

In: Dermatology, Vol. 237, No. 2, 2021, p. 158-165.

Research output: Contribution to journal › Review › Research › peer-review

Harvard

Ambikaibalan, D, Quaade, AS, Halling, AS, Thyssen, JP & Egeberg, A 2021, 'Placebo Response in Phase 3 Trials of Systemic Therapies for Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-Analysis', Dermatology, vol. 237, no. 2, pp. 158-165. https://doi.org/10.1159/000509295

APA

Ambikaibalan, D., Quaade, A. S., Halling, A. S., Thyssen, J. P., & Egeberg, A. (2021). Placebo Response in Phase 3 Trials of Systemic Therapies for Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-Analysis. Dermatology, 237(2), 158-165. https://doi.org/10.1159/000509295

Vancouver

Ambikaibalan D, Quaade AS, Halling AS, Thyssen JP, Egeberg A. Placebo Response in Phase 3 Trials of Systemic Therapies for Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-Analysis. Dermatology. 2021;237(2):158-165. https://doi.org/10.1159/000509295

Author

Ambikaibalan, Danni ; Quaade, Anna Sophie ; Halling, Anne Sofie ; Thyssen, Jacob P. ; Egeberg, Alexander. / Placebo Response in Phase 3 Trials of Systemic Therapies for Moderate-to-Severe Plaque Psoriasis : A Systematic Review and Meta-Analysis. In: Dermatology. 2021 ; Vol. 237, No. 2. pp. 158-165.

Bibtex

@article{f5baf182b8fd468bbddaac0a91aec977,
title = "Placebo Response in Phase 3 Trials of Systemic Therapies for Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-Analysis",
abstract = "Background: Wide fluctuations in placebo responses have been reported in phase 3 trials of systemic therapies for moderate-to-severe plaque psoriasis. Methods: In this systematic review and meta-analysis, we assessed placebo responses in phase 3 trials of systemic therapies for moderate-to-severe plaque psoriasis. The medical databases PubMed Medline, Embase, and Web of Science were searched for studies reporting on phase 3 psoriasis trials. A proportion meta-analysis determined the proportion of placebo-treated psoriasis patients obtaining a 75, 90, or 100% reduction in Psoriasis Area and Severity Index (PASI), that is, PASI75, PASI90, or PASI100, respectively, at week 12. In the assessment of PASI75 response, 44 trials with a total number of 7,972 patients were included. Conclusion: In pooled analyses, 5.2% (95% CI 4.7-5.7%) obtained PASI75, 2.1% (95% CI 1.7-2.4%) obtained PASI90, and 0.3% (95% CI 0.1-0.5%) obtained PASI100 among placebo receivers. No temporal changes were observed. The overall proportion of placebo responders in phase 3 psoriasis trials is low and does not appear to be increasing in recent years. ",
keywords = "Clinical trials, Meta-analysis, Placebo response, Psoriasis, Systematic review",
author = "Danni Ambikaibalan and Quaade, {Anna Sophie} and Halling, {Anne Sofie} and Thyssen, {Jacob P.} and Alexander Egeberg",
note = "Publisher Copyright: {\textcopyright} 2020 S. Karger AG, Basel.",
year = "2021",
doi = "10.1159/000509295",
language = "English",
volume = "237",
pages = "158--165",
journal = "Dermatology",
issn = "1018-8665",
publisher = "S Karger AG",
number = "2",

}

RIS

TY - JOUR

T1 - Placebo Response in Phase 3 Trials of Systemic Therapies for Moderate-to-Severe Plaque Psoriasis

T2 - A Systematic Review and Meta-Analysis

AU - Ambikaibalan, Danni

AU - Quaade, Anna Sophie

AU - Halling, Anne Sofie

AU - Thyssen, Jacob P.

AU - Egeberg, Alexander

N1 - Publisher Copyright: © 2020 S. Karger AG, Basel.

PY - 2021

Y1 - 2021

N2 - Background: Wide fluctuations in placebo responses have been reported in phase 3 trials of systemic therapies for moderate-to-severe plaque psoriasis. Methods: In this systematic review and meta-analysis, we assessed placebo responses in phase 3 trials of systemic therapies for moderate-to-severe plaque psoriasis. The medical databases PubMed Medline, Embase, and Web of Science were searched for studies reporting on phase 3 psoriasis trials. A proportion meta-analysis determined the proportion of placebo-treated psoriasis patients obtaining a 75, 90, or 100% reduction in Psoriasis Area and Severity Index (PASI), that is, PASI75, PASI90, or PASI100, respectively, at week 12. In the assessment of PASI75 response, 44 trials with a total number of 7,972 patients were included. Conclusion: In pooled analyses, 5.2% (95% CI 4.7-5.7%) obtained PASI75, 2.1% (95% CI 1.7-2.4%) obtained PASI90, and 0.3% (95% CI 0.1-0.5%) obtained PASI100 among placebo receivers. No temporal changes were observed. The overall proportion of placebo responders in phase 3 psoriasis trials is low and does not appear to be increasing in recent years.

AB - Background: Wide fluctuations in placebo responses have been reported in phase 3 trials of systemic therapies for moderate-to-severe plaque psoriasis. Methods: In this systematic review and meta-analysis, we assessed placebo responses in phase 3 trials of systemic therapies for moderate-to-severe plaque psoriasis. The medical databases PubMed Medline, Embase, and Web of Science were searched for studies reporting on phase 3 psoriasis trials. A proportion meta-analysis determined the proportion of placebo-treated psoriasis patients obtaining a 75, 90, or 100% reduction in Psoriasis Area and Severity Index (PASI), that is, PASI75, PASI90, or PASI100, respectively, at week 12. In the assessment of PASI75 response, 44 trials with a total number of 7,972 patients were included. Conclusion: In pooled analyses, 5.2% (95% CI 4.7-5.7%) obtained PASI75, 2.1% (95% CI 1.7-2.4%) obtained PASI90, and 0.3% (95% CI 0.1-0.5%) obtained PASI100 among placebo receivers. No temporal changes were observed. The overall proportion of placebo responders in phase 3 psoriasis trials is low and does not appear to be increasing in recent years.

KW - Clinical trials

KW - Meta-analysis

KW - Placebo response

KW - Psoriasis

KW - Systematic review

U2 - 10.1159/000509295

DO - 10.1159/000509295

M3 - Review

C2 - 32894834

AN - SCOPUS:85091279175

VL - 237

SP - 158

EP - 165

JO - Dermatology

JF - Dermatology

SN - 1018-8665

IS - 2

ER -

ID: 304364249