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Real-World Postmarketing Study of the Impact of Adalimumab Treatment on Work Productivity and Activity Impairment in Patients with Psoriatic Arthritis
INTRODUCTION: This study investigated the effectiveness of adalimumab treatment in improving Work Productivity and Activity Impairment (WPAI) in patients with psoriatic arthritis (PsA) in real-world settings in Japan. METHODS: This 24-week, single-arm, postmarketing surveillance study (2014–2017), c...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6824343/ https://www.ncbi.nlm.nih.gov/pubmed/30661197 http://dx.doi.org/10.1007/s12325-018-0866-y |
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author | Nakagawa, Hidemi Tanaka, Yoshiya Sano, Shigetoshi Kameda, Hideto Taniguchi, Atsuo Kashiwagi, Tomoko Kawaberi, Takeshi Kimura, Junko Morita, Akimichi |
author_facet | Nakagawa, Hidemi Tanaka, Yoshiya Sano, Shigetoshi Kameda, Hideto Taniguchi, Atsuo Kashiwagi, Tomoko Kawaberi, Takeshi Kimura, Junko Morita, Akimichi |
author_sort | Nakagawa, Hidemi |
collection | PubMed |
description | INTRODUCTION: This study investigated the effectiveness of adalimumab treatment in improving Work Productivity and Activity Impairment (WPAI) in patients with psoriatic arthritis (PsA) in real-world settings in Japan. METHODS: This 24-week, single-arm, postmarketing surveillance study (2014–2017), conducted at 75 centers in Japan, enrolled adalimumab-naïve patients (paid workers, including part-time) meeting ClASsification criteria for Psoriatic ARthritis (CASPAR). The primary endpoint was improvement in overall work impairment (OWI) scores from baseline to week 24. Secondary endpoints included changes in WPAI-PsA (OWI, absenteeism, presenteeism, and activity impairment), Psoriasis Area and Severity Index (PASI), psoriatic arthritis screening and evaluation (PASE) scores, Disease Activity Scores in 28 joints using C-reactive protein (DAS28[CRP]), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores, Health Assessment Questionnaire-Disability Index (HAQ-DI) scores, and PASI75/90 and American College of Rheumatology (ACR) 20/50/70 rates. RESULTS: In the effectiveness population (n = 106; 72.6% men; mean ± standard deviation [SD] age, 49.3 ± 10.7 years), OWI scores significantly improved (mean ± SD change, − 25.2 ± 35.3; p < 0.0001) from baseline to week 24. Other WPAI domain scores also improved significantly. Changes in OWI were significantly correlated (p < 0.0001) with PASE (r = 0.6284), DAS28(CRP) (r = 0.6059), BASDAI (r = 0.7281), and HAQ-DI (r = 0.6161) scores and were significantly influenced by previous nonsteroidal anti-inflammatory drug use (p = 0.0142), and baseline PASE (p = 0.0098), DAS28(CRP) (p = 0.0026), HAQ-DI (p = 0.0004), and BASDAI (p < 0.0001) scores. At the last evaluation, rate (95% confidence interval) of PASI 75 and 90 (n = 100) was 58.0% (47.7–67.8) and 39.0% (29.4–49.3), respectively, and that of ACR 20, 50, and 70 (n = 58) was 86.2% (74.6–93.9), 70.7% (57.3–81.9), and 53.4% (39.9–66.7), respectively. No new safety signals were observed in the safety population (n = 148). CONCLUSION: Adalimumab treatment improved WPAI in patients with PsA. Improvements in OWI and joint symptoms were significantly associated. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT02414633. FUNDING: AbbVie GK and Eisai Co., Ltd. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s12325-018-0866-y) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6824343 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-68243432019-11-06 Real-World Postmarketing Study of the Impact of Adalimumab Treatment on Work Productivity and Activity Impairment in Patients with Psoriatic Arthritis Nakagawa, Hidemi Tanaka, Yoshiya Sano, Shigetoshi Kameda, Hideto Taniguchi, Atsuo Kashiwagi, Tomoko Kawaberi, Takeshi Kimura, Junko Morita, Akimichi Adv Ther Original Research INTRODUCTION: This study investigated the effectiveness of adalimumab treatment in improving Work Productivity and Activity Impairment (WPAI) in patients with psoriatic arthritis (PsA) in real-world settings in Japan. METHODS: This 24-week, single-arm, postmarketing surveillance study (2014–2017), conducted at 75 centers in Japan, enrolled adalimumab-naïve patients (paid workers, including part-time) meeting ClASsification criteria for Psoriatic ARthritis (CASPAR). The primary endpoint was improvement in overall work impairment (OWI) scores from baseline to week 24. Secondary endpoints included changes in WPAI-PsA (OWI, absenteeism, presenteeism, and activity impairment), Psoriasis Area and Severity Index (PASI), psoriatic arthritis screening and evaluation (PASE) scores, Disease Activity Scores in 28 joints using C-reactive protein (DAS28[CRP]), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores, Health Assessment Questionnaire-Disability Index (HAQ-DI) scores, and PASI75/90 and American College of Rheumatology (ACR) 20/50/70 rates. RESULTS: In the effectiveness population (n = 106; 72.6% men; mean ± standard deviation [SD] age, 49.3 ± 10.7 years), OWI scores significantly improved (mean ± SD change, − 25.2 ± 35.3; p < 0.0001) from baseline to week 24. Other WPAI domain scores also improved significantly. Changes in OWI were significantly correlated (p < 0.0001) with PASE (r = 0.6284), DAS28(CRP) (r = 0.6059), BASDAI (r = 0.7281), and HAQ-DI (r = 0.6161) scores and were significantly influenced by previous nonsteroidal anti-inflammatory drug use (p = 0.0142), and baseline PASE (p = 0.0098), DAS28(CRP) (p = 0.0026), HAQ-DI (p = 0.0004), and BASDAI (p < 0.0001) scores. At the last evaluation, rate (95% confidence interval) of PASI 75 and 90 (n = 100) was 58.0% (47.7–67.8) and 39.0% (29.4–49.3), respectively, and that of ACR 20, 50, and 70 (n = 58) was 86.2% (74.6–93.9), 70.7% (57.3–81.9), and 53.4% (39.9–66.7), respectively. No new safety signals were observed in the safety population (n = 148). CONCLUSION: Adalimumab treatment improved WPAI in patients with PsA. Improvements in OWI and joint symptoms were significantly associated. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT02414633. FUNDING: AbbVie GK and Eisai Co., Ltd. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s12325-018-0866-y) contains supplementary material, which is available to authorized users. Springer Healthcare 2019-01-19 2019 /pmc/articles/PMC6824343/ /pubmed/30661197 http://dx.doi.org/10.1007/s12325-018-0866-y Text en © The Author(s) 2019 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Nakagawa, Hidemi Tanaka, Yoshiya Sano, Shigetoshi Kameda, Hideto Taniguchi, Atsuo Kashiwagi, Tomoko Kawaberi, Takeshi Kimura, Junko Morita, Akimichi Real-World Postmarketing Study of the Impact of Adalimumab Treatment on Work Productivity and Activity Impairment in Patients with Psoriatic Arthritis |
title | Real-World Postmarketing Study of the Impact of Adalimumab Treatment on Work Productivity and Activity Impairment in Patients with Psoriatic Arthritis |
title_full | Real-World Postmarketing Study of the Impact of Adalimumab Treatment on Work Productivity and Activity Impairment in Patients with Psoriatic Arthritis |
title_fullStr | Real-World Postmarketing Study of the Impact of Adalimumab Treatment on Work Productivity and Activity Impairment in Patients with Psoriatic Arthritis |
title_full_unstemmed | Real-World Postmarketing Study of the Impact of Adalimumab Treatment on Work Productivity and Activity Impairment in Patients with Psoriatic Arthritis |
title_short | Real-World Postmarketing Study of the Impact of Adalimumab Treatment on Work Productivity and Activity Impairment in Patients with Psoriatic Arthritis |
title_sort | real-world postmarketing study of the impact of adalimumab treatment on work productivity and activity impairment in patients with psoriatic arthritis |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6824343/ https://www.ncbi.nlm.nih.gov/pubmed/30661197 http://dx.doi.org/10.1007/s12325-018-0866-y |
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