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Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

During past years, the increasing knowledge of molecular mechanisms of inflammatory bowel disease (IBD) have led to the development of several targeted biological therapies. This great expansion of available medical options has prompted the need for comparative data between drugs. For years, given t...

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Autores principales: Macaluso, Fabio Salvatore, Maida, Marcello, Grova, Mauro, Crispino, Federica, Teresi, Giulia, Orlando, Adele, Orlando, Ambrogio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8111554/
https://www.ncbi.nlm.nih.gov/pubmed/33995582
http://dx.doi.org/10.1177/17562848211010668
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author Macaluso, Fabio Salvatore
Maida, Marcello
Grova, Mauro
Crispino, Federica
Teresi, Giulia
Orlando, Adele
Orlando, Ambrogio
author_facet Macaluso, Fabio Salvatore
Maida, Marcello
Grova, Mauro
Crispino, Federica
Teresi, Giulia
Orlando, Adele
Orlando, Ambrogio
author_sort Macaluso, Fabio Salvatore
collection PubMed
description During past years, the increasing knowledge of molecular mechanisms of inflammatory bowel disease (IBD) have led to the development of several targeted biological therapies. This great expansion of available medical options has prompted the need for comparative data between drugs. For years, given that most randomized controlled trials (RCTs) were performed only versus placebo, this demand has clashed with the absence of head-to-head trials comparing two or more treatments. The quality of evidence coming from real-world experience was low overall, so it was extremely difficult to clarify the correct positioning of the biologicals inside the therapeutic algorithms for IBD. Fortunately, times are changing: head-to-head comparative RCTs have been conducted or are ongoing, and the methodological quality of real-world studies is gradually increasing, mainly thanks to a higher rate of application of statistical methods capable of reducing the selection bias, such as the propensity score. In this evolving scenario, the increasing number of comparative RCTs is providing high-quality data for a correct drug positioning in IBD. In parallel, real-world observational studies are supporting the data coming from RCTs, and covering those comparisons not performed in the RCT setting. We believe that there is moderate evidence already available to support clinicians in the correct choice between different biologicals, and data will certainly be more robust in the near future.
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spelling pubmed-81115542021-05-13 Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience Macaluso, Fabio Salvatore Maida, Marcello Grova, Mauro Crispino, Federica Teresi, Giulia Orlando, Adele Orlando, Ambrogio Therap Adv Gastroenterol Review During past years, the increasing knowledge of molecular mechanisms of inflammatory bowel disease (IBD) have led to the development of several targeted biological therapies. This great expansion of available medical options has prompted the need for comparative data between drugs. For years, given that most randomized controlled trials (RCTs) were performed only versus placebo, this demand has clashed with the absence of head-to-head trials comparing two or more treatments. The quality of evidence coming from real-world experience was low overall, so it was extremely difficult to clarify the correct positioning of the biologicals inside the therapeutic algorithms for IBD. Fortunately, times are changing: head-to-head comparative RCTs have been conducted or are ongoing, and the methodological quality of real-world studies is gradually increasing, mainly thanks to a higher rate of application of statistical methods capable of reducing the selection bias, such as the propensity score. In this evolving scenario, the increasing number of comparative RCTs is providing high-quality data for a correct drug positioning in IBD. In parallel, real-world observational studies are supporting the data coming from RCTs, and covering those comparisons not performed in the RCT setting. We believe that there is moderate evidence already available to support clinicians in the correct choice between different biologicals, and data will certainly be more robust in the near future. SAGE Publications 2021-05-03 /pmc/articles/PMC8111554/ /pubmed/33995582 http://dx.doi.org/10.1177/17562848211010668 Text en © The Author(s), 2021 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Review
Macaluso, Fabio Salvatore
Maida, Marcello
Grova, Mauro
Crispino, Federica
Teresi, Giulia
Orlando, Adele
Orlando, Ambrogio
Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience
title Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience
title_full Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience
title_fullStr Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience
title_full_unstemmed Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience
title_short Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience
title_sort head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8111554/
https://www.ncbi.nlm.nih.gov/pubmed/33995582
http://dx.doi.org/10.1177/17562848211010668
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