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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

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@article{e276e8ab7dd047f4af1702c292202465,
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.",
author = "Danni Ambikaibalan and Quaade, {Anna Sophie} and Anne-Sofie Halling and Thyssen, {Jacob P} and Alexander Egeberg",
note = "{\textcopyright} 2020 S. Karger AG, Basel.",
year = "2021",
month = mar,
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 - © 2020 S. Karger AG, Basel.

PY - 2021/3

Y1 - 2021/3

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.

UR - http://www.scopus.com/inward/record.url?scp=85091279175&partnerID=8YFLogxK

U2 - 10.1159/000509295

DO - 10.1159/000509295

M3 - Review

C2 - 32894834

VL - 237

SP - 158

EP - 165

JO - Dermatology

JF - Dermatology

SN - 1018-8665

IS - 2

ER -

ID: 67626121