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EQ-5D-3L full health state discriminates between drug and placebo in clinical trials of systemic lupus erythematosus
OBJECTIVES: The objectives of this study were to investigate the discriminative ability of EQ-5D-3L full health state (FHS) in clinical trials of SLE, and to identify factors associated with FHS after treatment. METHODS: Data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials of belim...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8487305/ https://www.ncbi.nlm.nih.gov/pubmed/33502473 http://dx.doi.org/10.1093/rheumatology/keab080 |
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author | Lindblom, Julius Gomez, Alvaro Borg, Alexander Emamikia, Sharzad Ladakis, Dimitris Matilla, Joaquin Pehr, Martin Cobar, Flordelyn Enman, Yvonne Heintz, Emelie Regardt, Malin Parodis, Ioannis |
author_facet | Lindblom, Julius Gomez, Alvaro Borg, Alexander Emamikia, Sharzad Ladakis, Dimitris Matilla, Joaquin Pehr, Martin Cobar, Flordelyn Enman, Yvonne Heintz, Emelie Regardt, Malin Parodis, Ioannis |
author_sort | Lindblom, Julius |
collection | PubMed |
description | OBJECTIVES: The objectives of this study were to investigate the discriminative ability of EQ-5D-3L full health state (FHS) in clinical trials of SLE, and to identify factors associated with FHS after treatment. METHODS: Data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials of belimumab (N = 1684) were utilized. FHS was defined as a response of no problems in all five EQ-5D-3L dimensions, yielding an index score of 1. The Pearson’s χ(2) or Fisher’s exact test was employed for comparisons, and logistic regression for adjustments and assessment of independence. RESULTS: We demonstrated higher EQ-5D-3L FHS frequencies among patients given standard therapy (ST) plus the licensed belimumab dose vs ST alone (26.1% vs 19.4%; P = 0.001; week 52), and within SRI-4 responders vs non-responders (27.0% vs 19.8%; P < 0.001; week 52) from weeks 36 to 52. In multivariable regression analysis, SLEDAI-2K (OR: 0.90; 95% CI: 0.87, 0.94; P < 0.001) and SLICC/ACR Damage Index (OR: 0.79; 95% CI: 0.69, 0.91; P = 0.001) scores were independently associated with lower FHS frequencies at week 52, while adding monthly infusions of belimumab 10 mg/kg to ST favoured FHS perception (OR: 1.60; 95% CI: 1.15, 2.24; P = 0.006). Add-on belimumab 10 mg/kg yielded higher FHS frequencies in antimalarial users vs non-users (29.9% vs 20.1%; P = 0.011), and in anti-dsDNA- and anti-Sm- positive vs negative patients (31.4% vs 13.4%; P < 0.001 and 33.0% vs 22.6%; P = 0.010, respectively), whereas no significant differences were observed in patients given ST alone. CONCLUSION: EQ-5D-3L FHS distinguished belimumab from placebo and responders from non-responders, and exhibited known-group validity in subgroup analysis. FHS may prove a useful patient-reported outcome in SLE studies. |
format | Online Article Text |
id | pubmed-8487305 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-84873052021-10-04 EQ-5D-3L full health state discriminates between drug and placebo in clinical trials of systemic lupus erythematosus Lindblom, Julius Gomez, Alvaro Borg, Alexander Emamikia, Sharzad Ladakis, Dimitris Matilla, Joaquin Pehr, Martin Cobar, Flordelyn Enman, Yvonne Heintz, Emelie Regardt, Malin Parodis, Ioannis Rheumatology (Oxford) Clinical Science OBJECTIVES: The objectives of this study were to investigate the discriminative ability of EQ-5D-3L full health state (FHS) in clinical trials of SLE, and to identify factors associated with FHS after treatment. METHODS: Data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials of belimumab (N = 1684) were utilized. FHS was defined as a response of no problems in all five EQ-5D-3L dimensions, yielding an index score of 1. The Pearson’s χ(2) or Fisher’s exact test was employed for comparisons, and logistic regression for adjustments and assessment of independence. RESULTS: We demonstrated higher EQ-5D-3L FHS frequencies among patients given standard therapy (ST) plus the licensed belimumab dose vs ST alone (26.1% vs 19.4%; P = 0.001; week 52), and within SRI-4 responders vs non-responders (27.0% vs 19.8%; P < 0.001; week 52) from weeks 36 to 52. In multivariable regression analysis, SLEDAI-2K (OR: 0.90; 95% CI: 0.87, 0.94; P < 0.001) and SLICC/ACR Damage Index (OR: 0.79; 95% CI: 0.69, 0.91; P = 0.001) scores were independently associated with lower FHS frequencies at week 52, while adding monthly infusions of belimumab 10 mg/kg to ST favoured FHS perception (OR: 1.60; 95% CI: 1.15, 2.24; P = 0.006). Add-on belimumab 10 mg/kg yielded higher FHS frequencies in antimalarial users vs non-users (29.9% vs 20.1%; P = 0.011), and in anti-dsDNA- and anti-Sm- positive vs negative patients (31.4% vs 13.4%; P < 0.001 and 33.0% vs 22.6%; P = 0.010, respectively), whereas no significant differences were observed in patients given ST alone. CONCLUSION: EQ-5D-3L FHS distinguished belimumab from placebo and responders from non-responders, and exhibited known-group validity in subgroup analysis. FHS may prove a useful patient-reported outcome in SLE studies. Oxford University Press 2021-01-27 /pmc/articles/PMC8487305/ /pubmed/33502473 http://dx.doi.org/10.1093/rheumatology/keab080 Text en © The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. https://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 (https://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 | Clinical Science Lindblom, Julius Gomez, Alvaro Borg, Alexander Emamikia, Sharzad Ladakis, Dimitris Matilla, Joaquin Pehr, Martin Cobar, Flordelyn Enman, Yvonne Heintz, Emelie Regardt, Malin Parodis, Ioannis EQ-5D-3L full health state discriminates between drug and placebo in clinical trials of systemic lupus erythematosus |
title | EQ-5D-3L full health state discriminates between drug and placebo in clinical trials of systemic lupus erythematosus |
title_full | EQ-5D-3L full health state discriminates between drug and placebo in clinical trials of systemic lupus erythematosus |
title_fullStr | EQ-5D-3L full health state discriminates between drug and placebo in clinical trials of systemic lupus erythematosus |
title_full_unstemmed | EQ-5D-3L full health state discriminates between drug and placebo in clinical trials of systemic lupus erythematosus |
title_short | EQ-5D-3L full health state discriminates between drug and placebo in clinical trials of systemic lupus erythematosus |
title_sort | eq-5d-3l full health state discriminates between drug and placebo in clinical trials of systemic lupus erythematosus |
topic | Clinical Science |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8487305/ https://www.ncbi.nlm.nih.gov/pubmed/33502473 http://dx.doi.org/10.1093/rheumatology/keab080 |
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