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Subcutaneous Biological Treatments for Moderate to Severe Psoriasis: Interpreting Safety Data by Network Meta-Analysis

BACKGROUND: When multiple treatments are available, network meta-analysis can synthesize evidence and rank their relative profile in terms of effectiveness and/or safety. We applied this approach to the safety of subcutaneous biologicals used in the treatment of moderate to severe psoriasis. METHODS...

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Autores principales: Messori, Andrea, Trippoli, Sabrina, Fadda, Valeria, Maratea, Dario, Marinai, Claudio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4883196/
https://www.ncbi.nlm.nih.gov/pubmed/27747609
http://dx.doi.org/10.1007/s40801-014-0006-1
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author Messori, Andrea
Trippoli, Sabrina
Fadda, Valeria
Maratea, Dario
Marinai, Claudio
author_facet Messori, Andrea
Trippoli, Sabrina
Fadda, Valeria
Maratea, Dario
Marinai, Claudio
author_sort Messori, Andrea
collection PubMed
description BACKGROUND: When multiple treatments are available, network meta-analysis can synthesize evidence and rank their relative profile in terms of effectiveness and/or safety. We applied this approach to the safety of subcutaneous biologicals used in the treatment of moderate to severe psoriasis. METHODS: Our literature search covered the articles published from January 2000 to September 2014 and was restricted to randomized controlled trials. The agents eligible for our analysis were subcutaneous biological drugs used in patients with moderate to severe psoriasis. A network meta-analysis was conducted using the Bayesian model. The analysis was aimed to compare the safety of these treatments based on 95 % credible intervals and to consequently generate a ranking in safety across the treatments. Two safety end-points were considered: any serious adverse events (AE) and any infectious AE. Risk difference was the outcome measure. The analysis estimated 95 % credible intervals for all direct and indirect comparisons as well as the ranking histogram across the treatments which was determined according to model-based probabilistic analysis. RESULTS: Our literature search selected a total of 13 randomized controlled trials of which three evaluated adalimumab, five ustekinumab (45 and 90 mg), four etanercept (both high-dose and low-dose) and one high-dose etanercept and ustekinumab (45 and 90 mg). For both end-points of any serious AE and any infectious AE, the Bayesian analysis showed no significant difference in all indirect head-to-head comparisons between active agents. For the end-point of any serious AE, the ranking was ustekinumab 45 mg and ustekinumab 90 mg (at the same rank), followed by placebo and by adalimumab and high-dose etanercept (at the same rank). For any infectious AE, the ranking was: low-dose etanercept, placebo, ustekinumab 45 mg and ustekinumab 90 mg, adalimumab and high-dose etanercept. CONCLUSION: Our analysis synthesized the current evidence on the safety of subcutaneous biological treatments for patients with moderate to severe psoriasis and was successful in defining their respective rankings. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40801-014-0006-1) contains supplementary material, which is available to authorized users.
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spelling pubmed-48831962016-08-19 Subcutaneous Biological Treatments for Moderate to Severe Psoriasis: Interpreting Safety Data by Network Meta-Analysis Messori, Andrea Trippoli, Sabrina Fadda, Valeria Maratea, Dario Marinai, Claudio Drugs Real World Outcomes Original Research Article BACKGROUND: When multiple treatments are available, network meta-analysis can synthesize evidence and rank their relative profile in terms of effectiveness and/or safety. We applied this approach to the safety of subcutaneous biologicals used in the treatment of moderate to severe psoriasis. METHODS: Our literature search covered the articles published from January 2000 to September 2014 and was restricted to randomized controlled trials. The agents eligible for our analysis were subcutaneous biological drugs used in patients with moderate to severe psoriasis. A network meta-analysis was conducted using the Bayesian model. The analysis was aimed to compare the safety of these treatments based on 95 % credible intervals and to consequently generate a ranking in safety across the treatments. Two safety end-points were considered: any serious adverse events (AE) and any infectious AE. Risk difference was the outcome measure. The analysis estimated 95 % credible intervals for all direct and indirect comparisons as well as the ranking histogram across the treatments which was determined according to model-based probabilistic analysis. RESULTS: Our literature search selected a total of 13 randomized controlled trials of which three evaluated adalimumab, five ustekinumab (45 and 90 mg), four etanercept (both high-dose and low-dose) and one high-dose etanercept and ustekinumab (45 and 90 mg). For both end-points of any serious AE and any infectious AE, the Bayesian analysis showed no significant difference in all indirect head-to-head comparisons between active agents. For the end-point of any serious AE, the ranking was ustekinumab 45 mg and ustekinumab 90 mg (at the same rank), followed by placebo and by adalimumab and high-dose etanercept (at the same rank). For any infectious AE, the ranking was: low-dose etanercept, placebo, ustekinumab 45 mg and ustekinumab 90 mg, adalimumab and high-dose etanercept. CONCLUSION: Our analysis synthesized the current evidence on the safety of subcutaneous biological treatments for patients with moderate to severe psoriasis and was successful in defining their respective rankings. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40801-014-0006-1) contains supplementary material, which is available to authorized users. Springer International Publishing 2015-01-08 /pmc/articles/PMC4883196/ /pubmed/27747609 http://dx.doi.org/10.1007/s40801-014-0006-1 Text en © The Author(s) 2015 https://creativecommons.org/licenses/by-nc/4.0/ Open AccessThis article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Research Article
Messori, Andrea
Trippoli, Sabrina
Fadda, Valeria
Maratea, Dario
Marinai, Claudio
Subcutaneous Biological Treatments for Moderate to Severe Psoriasis: Interpreting Safety Data by Network Meta-Analysis
title Subcutaneous Biological Treatments for Moderate to Severe Psoriasis: Interpreting Safety Data by Network Meta-Analysis
title_full Subcutaneous Biological Treatments for Moderate to Severe Psoriasis: Interpreting Safety Data by Network Meta-Analysis
title_fullStr Subcutaneous Biological Treatments for Moderate to Severe Psoriasis: Interpreting Safety Data by Network Meta-Analysis
title_full_unstemmed Subcutaneous Biological Treatments for Moderate to Severe Psoriasis: Interpreting Safety Data by Network Meta-Analysis
title_short Subcutaneous Biological Treatments for Moderate to Severe Psoriasis: Interpreting Safety Data by Network Meta-Analysis
title_sort subcutaneous biological treatments for moderate to severe psoriasis: interpreting safety data by network meta-analysis
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4883196/
https://www.ncbi.nlm.nih.gov/pubmed/27747609
http://dx.doi.org/10.1007/s40801-014-0006-1
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