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Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis
BACKGROUND: To evaluate the impact of tanezumab on health status, non-work activities, and work productivity in a pooled analysis of two large phase 3 osteoarthritis (OA) studies. METHODS: Subcutaneous tanezumab (2.5 mg and 5 mg) was tested in double-blind, placebo-controlled, 16-week (NCT02697773)...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8809015/ https://www.ncbi.nlm.nih.gov/pubmed/35105318 http://dx.doi.org/10.1186/s12891-022-05029-x |
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author | Conaghan, Philip G. Abraham, Lucy Viktrup, Lars Cislo, Paul |
author_facet | Conaghan, Philip G. Abraham, Lucy Viktrup, Lars Cislo, Paul |
author_sort | Conaghan, Philip G. |
collection | PubMed |
description | BACKGROUND: To evaluate the impact of tanezumab on health status, non-work activities, and work productivity in a pooled analysis of two large phase 3 osteoarthritis (OA) studies. METHODS: Subcutaneous tanezumab (2.5 mg and 5 mg) was tested in double-blind, placebo-controlled, 16-week (NCT02697773) and 24-week (NCT02709486) clinical trials in patients with moderate-to-severe OA of the hip or knee. At baseline and week 16, all patients completed EQ-5D-5L and the Work Productivity and Activity Impairment-OA (WPAI-OA) activity impairment item. Those currently employed also completed WPAI-OA work time missed, impairment while working, and overall work impairment items. Between-group differences in least squares (LS) mean changes from baseline at week 16 were tested using analysis of covariance. RESULTS: Of 1545 pooled patients, 576 were employed at baseline. Improvements in EQ-5D-5L index value at week 16 were significantly greater for the tanezumab 2.5-mg group (difference in LS means [95% confidence interval (CI), 0.03 [0.01, 0.05]; p = 0.0083) versus placebo. Percent improvements (95% CI) in activity impairment (− 5.92 [− 8.87, − 2.98]; p < 0.0001), impairment while working (− 7.34 [− 13.01, − 1.68]; p = 0.0112), and overall work impairment (− 7.44 [− 13.22, − 1.67]; p = 0.0116) at week 16 were significantly greater for the tanezumab 2.5-mg group versus placebo. Results for the tanezumab 5-mg group were generally comparable to the tanezumab 2.5-mg group, although, compared with placebo, percent improvement (95% CI) in work time missed was significantly greater for the tanezumab 5-mg group (− 3.40 [− 6.47, − 0.34]; p = 0.0294), but not the tanezumab 2.5-mg group (− 0.66 [− 3.63, 2.32]; p = 0.6637). CONCLUSIONS: These pooled analyses showed that health status, non-work activities, and work productivity were significantly improved following tanezumab administration, compared with placebo. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02697773, NCT02709486. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12891-022-05029-x. |
format | Online Article Text |
id | pubmed-8809015 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-88090152022-02-03 Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis Conaghan, Philip G. Abraham, Lucy Viktrup, Lars Cislo, Paul BMC Musculoskelet Disord Research BACKGROUND: To evaluate the impact of tanezumab on health status, non-work activities, and work productivity in a pooled analysis of two large phase 3 osteoarthritis (OA) studies. METHODS: Subcutaneous tanezumab (2.5 mg and 5 mg) was tested in double-blind, placebo-controlled, 16-week (NCT02697773) and 24-week (NCT02709486) clinical trials in patients with moderate-to-severe OA of the hip or knee. At baseline and week 16, all patients completed EQ-5D-5L and the Work Productivity and Activity Impairment-OA (WPAI-OA) activity impairment item. Those currently employed also completed WPAI-OA work time missed, impairment while working, and overall work impairment items. Between-group differences in least squares (LS) mean changes from baseline at week 16 were tested using analysis of covariance. RESULTS: Of 1545 pooled patients, 576 were employed at baseline. Improvements in EQ-5D-5L index value at week 16 were significantly greater for the tanezumab 2.5-mg group (difference in LS means [95% confidence interval (CI), 0.03 [0.01, 0.05]; p = 0.0083) versus placebo. Percent improvements (95% CI) in activity impairment (− 5.92 [− 8.87, − 2.98]; p < 0.0001), impairment while working (− 7.34 [− 13.01, − 1.68]; p = 0.0112), and overall work impairment (− 7.44 [− 13.22, − 1.67]; p = 0.0116) at week 16 were significantly greater for the tanezumab 2.5-mg group versus placebo. Results for the tanezumab 5-mg group were generally comparable to the tanezumab 2.5-mg group, although, compared with placebo, percent improvement (95% CI) in work time missed was significantly greater for the tanezumab 5-mg group (− 3.40 [− 6.47, − 0.34]; p = 0.0294), but not the tanezumab 2.5-mg group (− 0.66 [− 3.63, 2.32]; p = 0.6637). CONCLUSIONS: These pooled analyses showed that health status, non-work activities, and work productivity were significantly improved following tanezumab administration, compared with placebo. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02697773, NCT02709486. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12891-022-05029-x. BioMed Central 2022-02-01 /pmc/articles/PMC8809015/ /pubmed/35105318 http://dx.doi.org/10.1186/s12891-022-05029-x Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Conaghan, Philip G. Abraham, Lucy Viktrup, Lars Cislo, Paul Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis |
title | Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis |
title_full | Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis |
title_fullStr | Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis |
title_full_unstemmed | Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis |
title_short | Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis |
title_sort | impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8809015/ https://www.ncbi.nlm.nih.gov/pubmed/35105318 http://dx.doi.org/10.1186/s12891-022-05029-x |
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