Cargando…
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...
Autores principales: | , , , , , , |
---|---|
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 |
_version_ | 1783690526068834304 |
---|---|
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. |
format | Online Article Text |
id | pubmed-8111554 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT macalusofabiosalvatore headtoheadcomparisonofbiologicaldrugsforinflammatoryboweldiseasefromrandomizedcontrolledtrialstorealworldexperience AT maidamarcello headtoheadcomparisonofbiologicaldrugsforinflammatoryboweldiseasefromrandomizedcontrolledtrialstorealworldexperience AT grovamauro headtoheadcomparisonofbiologicaldrugsforinflammatoryboweldiseasefromrandomizedcontrolledtrialstorealworldexperience AT crispinofederica headtoheadcomparisonofbiologicaldrugsforinflammatoryboweldiseasefromrandomizedcontrolledtrialstorealworldexperience AT teresigiulia headtoheadcomparisonofbiologicaldrugsforinflammatoryboweldiseasefromrandomizedcontrolledtrialstorealworldexperience AT orlandoadele headtoheadcomparisonofbiologicaldrugsforinflammatoryboweldiseasefromrandomizedcontrolledtrialstorealworldexperience AT orlandoambrogio headtoheadcomparisonofbiologicaldrugsforinflammatoryboweldiseasefromrandomizedcontrolledtrialstorealworldexperience |