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A multi-item Physician Global Assessment scale to assess psoriasis disease severity: validation based on four phase III tofacitinib studies
BACKGROUND: Several different Physician Global Assessment (PGA) versions have been used in clinical studies as a co-primary end point to evaluate psoriasis severity. Tofacitinib is an oral Janus kinase inhibitor. We performed an analysis of the PGA using data from studies of tofacitinib in moderate...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6555979/ https://www.ncbi.nlm.nih.gov/pubmed/31174539 http://dx.doi.org/10.1186/s12895-019-0088-2 |
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author | Callis Duffin, Kristina Bushmakin, Andrew G. Cappelleri, Joseph C. Mallbris, Lotus Mamolo, Carla |
author_facet | Callis Duffin, Kristina Bushmakin, Andrew G. Cappelleri, Joseph C. Mallbris, Lotus Mamolo, Carla |
author_sort | Callis Duffin, Kristina |
collection | PubMed |
description | BACKGROUND: Several different Physician Global Assessment (PGA) versions have been used in clinical studies as a co-primary end point to evaluate psoriasis severity. Tofacitinib is an oral Janus kinase inhibitor. We performed an analysis of the PGA using data from studies of tofacitinib in moderate to severe chronic plaque psoriasis. METHODS: Data from 3641 patients with moderate to severe chronic plaque psoriasis, enrolled in one of four phase III tofacitinib studies (OPT Pivotal 1 and 2, OPT Compare and OPT Retreatment), were used to evaluate a three-item PGA scale. RESULTS: Confirmatory Factor Analyses showed that equal weighting of the three items (erythema, induration and scaling) was appropriate. The PGA demonstrated acceptable test–retest reliability (Intraclass Correlation Coefficient, 0.7) and internal consistency (Cronbach’s Coefficient Alpha ≥ 0.9 at primary time points). The Clinically Important Difference was estimated as 0.55 (95% confidence interval: 0.546–0.563). Known-group validity was shown by demonstrating that PGA scores could discriminate between different degrees of disease severity. The PGA was significantly correlated with other clinical end points in the studies (Psoriasis Area and Severity Index, r = 0.75–0.79; Dermatology Life Quality Index, r = 0.44–0.57; Patient Global Assessment, r = 0.66–0.72). CONCLUSIONS: Consistent with previous findings from a phase II study, these results indicate that this PGA is a valid, reliable instrument for evaluating disease severity in clinical studies of psoriasis. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12895-019-0088-2) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6555979 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-65559792019-06-10 A multi-item Physician Global Assessment scale to assess psoriasis disease severity: validation based on four phase III tofacitinib studies Callis Duffin, Kristina Bushmakin, Andrew G. Cappelleri, Joseph C. Mallbris, Lotus Mamolo, Carla BMC Dermatol Research Article BACKGROUND: Several different Physician Global Assessment (PGA) versions have been used in clinical studies as a co-primary end point to evaluate psoriasis severity. Tofacitinib is an oral Janus kinase inhibitor. We performed an analysis of the PGA using data from studies of tofacitinib in moderate to severe chronic plaque psoriasis. METHODS: Data from 3641 patients with moderate to severe chronic plaque psoriasis, enrolled in one of four phase III tofacitinib studies (OPT Pivotal 1 and 2, OPT Compare and OPT Retreatment), were used to evaluate a three-item PGA scale. RESULTS: Confirmatory Factor Analyses showed that equal weighting of the three items (erythema, induration and scaling) was appropriate. The PGA demonstrated acceptable test–retest reliability (Intraclass Correlation Coefficient, 0.7) and internal consistency (Cronbach’s Coefficient Alpha ≥ 0.9 at primary time points). The Clinically Important Difference was estimated as 0.55 (95% confidence interval: 0.546–0.563). Known-group validity was shown by demonstrating that PGA scores could discriminate between different degrees of disease severity. The PGA was significantly correlated with other clinical end points in the studies (Psoriasis Area and Severity Index, r = 0.75–0.79; Dermatology Life Quality Index, r = 0.44–0.57; Patient Global Assessment, r = 0.66–0.72). CONCLUSIONS: Consistent with previous findings from a phase II study, these results indicate that this PGA is a valid, reliable instrument for evaluating disease severity in clinical studies of psoriasis. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12895-019-0088-2) contains supplementary material, which is available to authorized users. BioMed Central 2019-06-07 /pmc/articles/PMC6555979/ /pubmed/31174539 http://dx.doi.org/10.1186/s12895-019-0088-2 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Callis Duffin, Kristina Bushmakin, Andrew G. Cappelleri, Joseph C. Mallbris, Lotus Mamolo, Carla A multi-item Physician Global Assessment scale to assess psoriasis disease severity: validation based on four phase III tofacitinib studies |
title | A multi-item Physician Global Assessment scale to assess psoriasis disease severity: validation based on four phase III tofacitinib studies |
title_full | A multi-item Physician Global Assessment scale to assess psoriasis disease severity: validation based on four phase III tofacitinib studies |
title_fullStr | A multi-item Physician Global Assessment scale to assess psoriasis disease severity: validation based on four phase III tofacitinib studies |
title_full_unstemmed | A multi-item Physician Global Assessment scale to assess psoriasis disease severity: validation based on four phase III tofacitinib studies |
title_short | A multi-item Physician Global Assessment scale to assess psoriasis disease severity: validation based on four phase III tofacitinib studies |
title_sort | multi-item physician global assessment scale to assess psoriasis disease severity: validation based on four phase iii tofacitinib studies |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6555979/ https://www.ncbi.nlm.nih.gov/pubmed/31174539 http://dx.doi.org/10.1186/s12895-019-0088-2 |
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