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Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA
BACKGROUND AND AIMS: Randomised trials have described the benefits of adalimumab [ADA] for ulcerative colitis [UC]; however, few data are available on health-related quality of life [HRQL] and health care costs in clinical practice. METHODS: InspirADA, a multicentre, prospective study, evaluated the...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5881702/ https://www.ncbi.nlm.nih.gov/pubmed/28981846 http://dx.doi.org/10.1093/ecco-jcc/jjx093 |
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author | Travis, Simon Feagan, Brian G Peyrin-Biroulet, Laurent Panaccione, Remo Danese, Silvio Lazar, Andreas Robinson, Anne M Petersson, Joel Pappalardo, Brandee L Bereswill, Mareike Chen, Naijun Wang, Song Skup, Martha Thakkar, Roopal B Chao, Jingdong |
author_facet | Travis, Simon Feagan, Brian G Peyrin-Biroulet, Laurent Panaccione, Remo Danese, Silvio Lazar, Andreas Robinson, Anne M Petersson, Joel Pappalardo, Brandee L Bereswill, Mareike Chen, Naijun Wang, Song Skup, Martha Thakkar, Roopal B Chao, Jingdong |
author_sort | Travis, Simon |
collection | PubMed |
description | BACKGROUND AND AIMS: Randomised trials have described the benefits of adalimumab [ADA] for ulcerative colitis [UC]; however, few data are available on health-related quality of life [HRQL] and health care costs in clinical practice. METHODS: InspirADA, a multicentre, prospective study, evaluated the effect of ADA in patients with moderate to severe UC treated according to usual clinical practice. Outcomes assessed were: Simple Clinical Colitis Activity Index [SCCAI] response/remission rates; changes in HRQL; all-cause direct costs; and UC-related direct and indirect costs from baseline to Week 26. RESULTS: Data from 463 patients were analysed. At Week 26, 67% (95% confidence interval [CI]: 62%, 71%) of patients achieved response; 48% [95% CI: 44%, 53%] were in remission. For the overall population, significant [all p < 0.001] improvements from baseline to Week 26 were observed for the Short Inflammatory Bowel Disease Questionnaire [SIBDQ] (mean change ± standard deviation [SD]: 17.4 ± 14.5) and the European Quality of Life—5 Dimensions—5 Level [EQ-5D-5L] (index: 0.1 ± 0.2; visual analogue scale [VAS]: 19.5 ± 25.8). Parallel improvements were seen in work productivity [11% absolute decrease in absenteeism; 25% absolute decrease in impairment while working; and 27% absolute decrease in impairment of ability to perform daily activities, all p < 0.001]. Among study completers, cumulative all-cause medical costs and UC-related medical costs were significantly [both p < 0.001] reduced by 59% and 77%, respectively, 6 months after initiation of therapy compared with the preceding 6 months. The safety profile of ADA was consistent with that observed in previous clinical trials. CONCLUSIONS: ADA therapy in usual clinical practice is effective at improving and maintaining symptomatic control, improving HRQL, and decreasing costs of medical care among patients with UC. |
format | Online Article Text |
id | pubmed-5881702 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-58817022018-04-05 Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA Travis, Simon Feagan, Brian G Peyrin-Biroulet, Laurent Panaccione, Remo Danese, Silvio Lazar, Andreas Robinson, Anne M Petersson, Joel Pappalardo, Brandee L Bereswill, Mareike Chen, Naijun Wang, Song Skup, Martha Thakkar, Roopal B Chao, Jingdong J Crohns Colitis Original Articles BACKGROUND AND AIMS: Randomised trials have described the benefits of adalimumab [ADA] for ulcerative colitis [UC]; however, few data are available on health-related quality of life [HRQL] and health care costs in clinical practice. METHODS: InspirADA, a multicentre, prospective study, evaluated the effect of ADA in patients with moderate to severe UC treated according to usual clinical practice. Outcomes assessed were: Simple Clinical Colitis Activity Index [SCCAI] response/remission rates; changes in HRQL; all-cause direct costs; and UC-related direct and indirect costs from baseline to Week 26. RESULTS: Data from 463 patients were analysed. At Week 26, 67% (95% confidence interval [CI]: 62%, 71%) of patients achieved response; 48% [95% CI: 44%, 53%] were in remission. For the overall population, significant [all p < 0.001] improvements from baseline to Week 26 were observed for the Short Inflammatory Bowel Disease Questionnaire [SIBDQ] (mean change ± standard deviation [SD]: 17.4 ± 14.5) and the European Quality of Life—5 Dimensions—5 Level [EQ-5D-5L] (index: 0.1 ± 0.2; visual analogue scale [VAS]: 19.5 ± 25.8). Parallel improvements were seen in work productivity [11% absolute decrease in absenteeism; 25% absolute decrease in impairment while working; and 27% absolute decrease in impairment of ability to perform daily activities, all p < 0.001]. Among study completers, cumulative all-cause medical costs and UC-related medical costs were significantly [both p < 0.001] reduced by 59% and 77%, respectively, 6 months after initiation of therapy compared with the preceding 6 months. The safety profile of ADA was consistent with that observed in previous clinical trials. CONCLUSIONS: ADA therapy in usual clinical practice is effective at improving and maintaining symptomatic control, improving HRQL, and decreasing costs of medical care among patients with UC. Oxford University Press 2017-10 2017-07-17 /pmc/articles/PMC5881702/ /pubmed/28981846 http://dx.doi.org/10.1093/ecco-jcc/jjx093 Text en © European Crohn’s and Colitis Organisation (ECCO) 2017. http://creativecommons.org/licenses/by-nc/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Original Articles Travis, Simon Feagan, Brian G Peyrin-Biroulet, Laurent Panaccione, Remo Danese, Silvio Lazar, Andreas Robinson, Anne M Petersson, Joel Pappalardo, Brandee L Bereswill, Mareike Chen, Naijun Wang, Song Skup, Martha Thakkar, Roopal B Chao, Jingdong Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA |
title | Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA |
title_full | Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA |
title_fullStr | Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA |
title_full_unstemmed | Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA |
title_short | Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA |
title_sort | effect of adalimumab on clinical outcomes and health-related quality of life among patients with ulcerative colitis in a clinical practice setting: results from inspirada |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5881702/ https://www.ncbi.nlm.nih.gov/pubmed/28981846 http://dx.doi.org/10.1093/ecco-jcc/jjx093 |
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