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Systematic review: outcomes and adverse events from randomised trials in Crohn's disease
BACKGROUND: The suitability of disease activity indices has been challenged, with growing interest in objective measures of inflammation. AIM: To undertake a systematic review of efficacy and safety outcomes in placebo‐controlled randomised controlled trials (RCTs) of patients with Crohn's dise...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6492112/ https://www.ncbi.nlm.nih.gov/pubmed/30828852 http://dx.doi.org/10.1111/apt.15174 |
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author | Catt, Heather Hughes, Dyfrig Kirkham, Jamie J. Bodger, Keith |
author_facet | Catt, Heather Hughes, Dyfrig Kirkham, Jamie J. Bodger, Keith |
author_sort | Catt, Heather |
collection | PubMed |
description | BACKGROUND: The suitability of disease activity indices has been challenged, with growing interest in objective measures of inflammation. AIM: To undertake a systematic review of efficacy and safety outcomes in placebo‐controlled randomised controlled trials (RCTs) of patients with Crohn's disease. METHODS: MEDLINE, EMBASE, CINAHL and Cochrane Library were searched until November 2015, for RCTs of adult Crohn's disease patients treated with medical or surgical therapies. Data on efficacy and safety outcomes, end‐point definitions, and measurement instruments were extracted and stratified by publication date (pre‐2009 and 2009 onwards). RESULTS: One hundred and eighty‐one RCTs (110 induction and 71 maintenance) were identified, including 23 850 patients. About 92.3% reported clinical efficacy endpoints. The Crohn's Disease Activity Index (CDAI) dominated, defining clinical response or remission in 63.5% of trials (35 definitions of response or remission). CDAI < 150 was the commonest endpoint, but reporting reduced between periods (46.4%‐41.1%), whilst use of CDAI100 increased (16.8%‐30.4%). Fistula studies most commonly reported fistula closure (9, 90.0%). Reporting of biomarker, endoscopy and histology endpoints increased overall (33.3%‐40.6%, 14.4%‐30.4% and 3.2%‐12.5%, respectively), but were heterogeneous and rarely reported in fistula trials. Patient‐reported outcome measures were reported in 41.4% of trials and safety endpoints in 35.4%. Many of the common adverse events relate to disease exacerbation or treatment failure. CONCLUSIONS: Trial endpoints vary across studies, over time and are distinct in fistula studies. Despite growth in reporting of objective measures of inflammation and in patient‐reported outcome measures, there is a lack of standardisation. This confirms the need for a core outcome set for comparative effectiveness research in Crohn's disease. |
format | Online Article Text |
id | pubmed-6492112 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-64921122019-05-06 Systematic review: outcomes and adverse events from randomised trials in Crohn's disease Catt, Heather Hughes, Dyfrig Kirkham, Jamie J. Bodger, Keith Aliment Pharmacol Ther Systematic Review BACKGROUND: The suitability of disease activity indices has been challenged, with growing interest in objective measures of inflammation. AIM: To undertake a systematic review of efficacy and safety outcomes in placebo‐controlled randomised controlled trials (RCTs) of patients with Crohn's disease. METHODS: MEDLINE, EMBASE, CINAHL and Cochrane Library were searched until November 2015, for RCTs of adult Crohn's disease patients treated with medical or surgical therapies. Data on efficacy and safety outcomes, end‐point definitions, and measurement instruments were extracted and stratified by publication date (pre‐2009 and 2009 onwards). RESULTS: One hundred and eighty‐one RCTs (110 induction and 71 maintenance) were identified, including 23 850 patients. About 92.3% reported clinical efficacy endpoints. The Crohn's Disease Activity Index (CDAI) dominated, defining clinical response or remission in 63.5% of trials (35 definitions of response or remission). CDAI < 150 was the commonest endpoint, but reporting reduced between periods (46.4%‐41.1%), whilst use of CDAI100 increased (16.8%‐30.4%). Fistula studies most commonly reported fistula closure (9, 90.0%). Reporting of biomarker, endoscopy and histology endpoints increased overall (33.3%‐40.6%, 14.4%‐30.4% and 3.2%‐12.5%, respectively), but were heterogeneous and rarely reported in fistula trials. Patient‐reported outcome measures were reported in 41.4% of trials and safety endpoints in 35.4%. Many of the common adverse events relate to disease exacerbation or treatment failure. CONCLUSIONS: Trial endpoints vary across studies, over time and are distinct in fistula studies. Despite growth in reporting of objective measures of inflammation and in patient‐reported outcome measures, there is a lack of standardisation. This confirms the need for a core outcome set for comparative effectiveness research in Crohn's disease. John Wiley and Sons Inc. 2019-03-03 2019-04 /pmc/articles/PMC6492112/ /pubmed/30828852 http://dx.doi.org/10.1111/apt.15174 Text en © 2019 The Authors. Alimentary Pharmacology & Therapeutics Published by John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Systematic Review Catt, Heather Hughes, Dyfrig Kirkham, Jamie J. Bodger, Keith Systematic review: outcomes and adverse events from randomised trials in Crohn's disease |
title | Systematic review: outcomes and adverse events from randomised trials in Crohn's disease |
title_full | Systematic review: outcomes and adverse events from randomised trials in Crohn's disease |
title_fullStr | Systematic review: outcomes and adverse events from randomised trials in Crohn's disease |
title_full_unstemmed | Systematic review: outcomes and adverse events from randomised trials in Crohn's disease |
title_short | Systematic review: outcomes and adverse events from randomised trials in Crohn's disease |
title_sort | systematic review: outcomes and adverse events from randomised trials in crohn's disease |
topic | Systematic Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6492112/ https://www.ncbi.nlm.nih.gov/pubmed/30828852 http://dx.doi.org/10.1111/apt.15174 |
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