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Impact of Etanercept Therapy on Disease Activity and Health-Related Quality of Life in Moderate Rheumatoid Arthritis Patients Population from a National British Observational Cohort
Abstract Objectives To describe a population with moderate rheumatoid arthritis (RA) before biologic initiation and assess change in disease status, health-related quality of life (HRQOL), and adverse events in etanercept (ETN)-treated patients. Methods Data on adult patients with moderate RA (3.2 &...
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Published in: | Value in health 2015-09, Vol.18 (6), p.817-823 |
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creator | Kotak, Sameer, MS, MBA Mardekian, Jack, PhD Horowicz-Mehler, Nathalie, MS, MPh Shah, Ankit, MS Burgess, Andrew, BS Kim, Joseph, PhD Gemmen, Eric, MA Boyd, Helen, BSc Koenig, Andrew, D.O., F.A.C.R |
description | Abstract Objectives To describe a population with moderate rheumatoid arthritis (RA) before biologic initiation and assess change in disease status, health-related quality of life (HRQOL), and adverse events in etanercept (ETN)-treated patients. Methods Data on adult patients with moderate RA (3.2 < Disease Activity Score in 28 Joints [DAS28] ≤ 5.1) were retrospectively analyzed from the British Society for Rheumatology Biologics Register comparing a nonbiologic-treated group (nBG) using at least one traditional disease-modifying antirheumatic drug to a biologic group (BG) treated with ETN. The HRQOL was assessed by using the Health Assessment Questionnaire disability index score. To mitigate confounding, we controlled for drivers of progression. Appropriate univariate, multivariate, and regression analyses were used. Results A total of 1754 patients with RA were assessed (211 BG and 1543 nBG). Compared with the nBG, the BG tended toward higher disease activity, such as significantly higher tender joints and DAS28. The BG compared with the nBG had 1) a greater reduction in DAS28 and Health Assessment Questionnaire scores; 2) disease remission occurring more often (odds ratio = 2.7; P = 0.006); and 3) progression occurring in fewer patients (odds ratio = 0.3; P = 0.002). BG patients had a higher incidence of “other serious infection” and “other central nervous system–related events,” with no significant differences in associated hospitalization rates or deaths. Conclusions Among patients with moderate RA from a clinical practice registry, ETN-treated patients had significantly higher disease activity at the time of biologic initiation but significantly reduced disease activity and better HRQOL after 6 months compared with nBG patients, although the possibility of unmeasured confounding remains. The ETN group reported significantly higher incidences of “other serious infections” and “other central nervous system–related events” without higher hospitalization rates. |
doi_str_mv | 10.1016/j.jval.2015.05.005 |
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Methods Data on adult patients with moderate RA (3.2 < Disease Activity Score in 28 Joints [DAS28] ≤ 5.1) were retrospectively analyzed from the British Society for Rheumatology Biologics Register comparing a nonbiologic-treated group (nBG) using at least one traditional disease-modifying antirheumatic drug to a biologic group (BG) treated with ETN. The HRQOL was assessed by using the Health Assessment Questionnaire disability index score. To mitigate confounding, we controlled for drivers of progression. Appropriate univariate, multivariate, and regression analyses were used. Results A total of 1754 patients with RA were assessed (211 BG and 1543 nBG). Compared with the nBG, the BG tended toward higher disease activity, such as significantly higher tender joints and DAS28. The BG compared with the nBG had 1) a greater reduction in DAS28 and Health Assessment Questionnaire scores; 2) disease remission occurring more often (odds ratio = 2.7; P = 0.006); and 3) progression occurring in fewer patients (odds ratio = 0.3; P = 0.002). BG patients had a higher incidence of “other serious infection” and “other central nervous system–related events,” with no significant differences in associated hospitalization rates or deaths. Conclusions Among patients with moderate RA from a clinical practice registry, ETN-treated patients had significantly higher disease activity at the time of biologic initiation but significantly reduced disease activity and better HRQOL after 6 months compared with nBG patients, although the possibility of unmeasured confounding remains. The ETN group reported significantly higher incidences of “other serious infections” and “other central nervous system–related events” without higher hospitalization rates.</description><identifier>ISSN: 1098-3015</identifier><identifier>EISSN: 1524-4733</identifier><identifier>DOI: 10.1016/j.jval.2015.05.005</identifier><identifier>PMID: 26409609</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Antirheumatic Agents - adverse effects ; Antirheumatic Agents - therapeutic use ; Arthritis, Rheumatoid - diagnosis ; Arthritis, Rheumatoid - drug therapy ; Arthritis, Rheumatoid - physiopathology ; Arthritis, Rheumatoid - psychology ; Chi-Square Distribution ; Comparative Effectiveness Research ; Disability Evaluation ; etanercept ; Etanercept - adverse effects ; Etanercept - therapeutic use ; Female ; Health Status ; health-related quality of life ; Humans ; Internal Medicine ; Male ; Middle Aged ; Multivariate Analysis ; Odds Ratio ; Predictive Value of Tests ; Quality of Life ; Quality-Adjusted Life Years ; Registries ; Remission Induction ; Retrospective Studies ; rheumatoid arthritis ; Risk Factors ; Severity of Illness Index ; Surveys and Questionnaires ; Time Factors ; treatment comparison ; Treatment Outcome ; United Kingdom</subject><ispartof>Value in health, 2015-09, Vol.18 (6), p.817-823</ispartof><rights>International Society for Pharmacoeconomics and Outcomes Research (ISPOR)</rights><rights>2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR)</rights><rights>Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c455t-5606f729bb5cf3f258e344878a93f9da8436b6d1eea32497837274296a24bb2a3</citedby><cites>FETCH-LOGICAL-c455t-5606f729bb5cf3f258e344878a93f9da8436b6d1eea32497837274296a24bb2a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26409609$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kotak, Sameer, MS, MBA</creatorcontrib><creatorcontrib>Mardekian, Jack, PhD</creatorcontrib><creatorcontrib>Horowicz-Mehler, Nathalie, MS, MPh</creatorcontrib><creatorcontrib>Shah, Ankit, MS</creatorcontrib><creatorcontrib>Burgess, Andrew, BS</creatorcontrib><creatorcontrib>Kim, Joseph, PhD</creatorcontrib><creatorcontrib>Gemmen, Eric, MA</creatorcontrib><creatorcontrib>Boyd, Helen, BSc</creatorcontrib><creatorcontrib>Koenig, Andrew, D.O., F.A.C.R</creatorcontrib><title>Impact of Etanercept Therapy on Disease Activity and Health-Related Quality of Life in Moderate Rheumatoid Arthritis Patients Population from a National British Observational Cohort</title><title>Value in health</title><addtitle>Value Health</addtitle><description>Abstract Objectives To describe a population with moderate rheumatoid arthritis (RA) before biologic initiation and assess change in disease status, health-related quality of life (HRQOL), and adverse events in etanercept (ETN)-treated patients. Methods Data on adult patients with moderate RA (3.2 < Disease Activity Score in 28 Joints [DAS28] ≤ 5.1) were retrospectively analyzed from the British Society for Rheumatology Biologics Register comparing a nonbiologic-treated group (nBG) using at least one traditional disease-modifying antirheumatic drug to a biologic group (BG) treated with ETN. The HRQOL was assessed by using the Health Assessment Questionnaire disability index score. To mitigate confounding, we controlled for drivers of progression. Appropriate univariate, multivariate, and regression analyses were used. Results A total of 1754 patients with RA were assessed (211 BG and 1543 nBG). Compared with the nBG, the BG tended toward higher disease activity, such as significantly higher tender joints and DAS28. The BG compared with the nBG had 1) a greater reduction in DAS28 and Health Assessment Questionnaire scores; 2) disease remission occurring more often (odds ratio = 2.7; P = 0.006); and 3) progression occurring in fewer patients (odds ratio = 0.3; P = 0.002). BG patients had a higher incidence of “other serious infection” and “other central nervous system–related events,” with no significant differences in associated hospitalization rates or deaths. Conclusions Among patients with moderate RA from a clinical practice registry, ETN-treated patients had significantly higher disease activity at the time of biologic initiation but significantly reduced disease activity and better HRQOL after 6 months compared with nBG patients, although the possibility of unmeasured confounding remains. The ETN group reported significantly higher incidences of “other serious infections” and “other central nervous system–related events” without higher hospitalization rates.</description><subject>Antirheumatic Agents - adverse effects</subject><subject>Antirheumatic Agents - therapeutic use</subject><subject>Arthritis, Rheumatoid - diagnosis</subject><subject>Arthritis, Rheumatoid - drug therapy</subject><subject>Arthritis, Rheumatoid - physiopathology</subject><subject>Arthritis, Rheumatoid - psychology</subject><subject>Chi-Square Distribution</subject><subject>Comparative Effectiveness Research</subject><subject>Disability Evaluation</subject><subject>etanercept</subject><subject>Etanercept - adverse effects</subject><subject>Etanercept - therapeutic use</subject><subject>Female</subject><subject>Health Status</subject><subject>health-related quality of life</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multivariate Analysis</subject><subject>Odds Ratio</subject><subject>Predictive Value of Tests</subject><subject>Quality of Life</subject><subject>Quality-Adjusted Life Years</subject><subject>Registries</subject><subject>Remission Induction</subject><subject>Retrospective Studies</subject><subject>rheumatoid arthritis</subject><subject>Risk Factors</subject><subject>Severity of Illness Index</subject><subject>Surveys and Questionnaires</subject><subject>Time Factors</subject><subject>treatment comparison</subject><subject>Treatment Outcome</subject><subject>United Kingdom</subject><issn>1098-3015</issn><issn>1524-4733</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><recordid>eNp9Uk1v1DAQjRCIlsIf4IB85JLFn3EiIaRlaWmlhUIpZ8txJoqXJA62s9L-sP4_nG7LgQPSSB573nvWzJsse03wimBSvNutdnvdrygmYoVTYPEkOyWC8pxLxp6mHFdlzlL5JHsRwg5jXDAqnmcntOC4KnB1mt1dDZM2EbkWnUc9gjcwRXTbgdfTAbkRfbIBdAC0NtHubTwgPTboEnQfu_wGeh2hQd9n3S-lJLK1LSA7oi-uSRIR0E0H86Cjsw1a-9h5G21A33S0MMaUuGlOGjZ91Ho3II2-3t90jz7eQzt0XQfw-8fXjeucjy-zZ63uA7x6OM-ynxfnt5vLfHv9-Wqz3uaGCxFzUeCilbSqa2Fa1lJRAuO8lKWuWFs1uuSsqIuGAGhGeSVLJqnktCo05XVNNTvL3h51J-9-zxCiGmww0PdpUm4OikgiueREygSlR6jxLgQPrZq8HbQ_KILVYpfaqcUutdilcAosEunNg_5cD9D8pTz6kwDvjwBIXe4teBVMmpyBxnowUTXO_l__wz9009vRGt3_ggOEnZt9GmrqQwWqsPqxLMyyL0RgUhUlY38AmAy97g</recordid><startdate>20150901</startdate><enddate>20150901</enddate><creator>Kotak, Sameer, MS, MBA</creator><creator>Mardekian, Jack, PhD</creator><creator>Horowicz-Mehler, Nathalie, MS, MPh</creator><creator>Shah, Ankit, MS</creator><creator>Burgess, Andrew, BS</creator><creator>Kim, Joseph, PhD</creator><creator>Gemmen, Eric, MA</creator><creator>Boyd, Helen, BSc</creator><creator>Koenig, Andrew, D.O., F.A.C.R</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20150901</creationdate><title>Impact of Etanercept Therapy on Disease Activity and Health-Related Quality of Life in Moderate Rheumatoid Arthritis Patients Population from a National British Observational Cohort</title><author>Kotak, Sameer, MS, MBA ; Mardekian, Jack, PhD ; Horowicz-Mehler, Nathalie, MS, MPh ; Shah, Ankit, MS ; Burgess, Andrew, BS ; Kim, Joseph, PhD ; Gemmen, Eric, MA ; Boyd, Helen, BSc ; Koenig, Andrew, D.O., F.A.C.R</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c455t-5606f729bb5cf3f258e344878a93f9da8436b6d1eea32497837274296a24bb2a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Antirheumatic Agents - adverse effects</topic><topic>Antirheumatic Agents - therapeutic use</topic><topic>Arthritis, Rheumatoid - diagnosis</topic><topic>Arthritis, Rheumatoid - drug therapy</topic><topic>Arthritis, Rheumatoid - physiopathology</topic><topic>Arthritis, Rheumatoid - psychology</topic><topic>Chi-Square Distribution</topic><topic>Comparative Effectiveness Research</topic><topic>Disability Evaluation</topic><topic>etanercept</topic><topic>Etanercept - adverse effects</topic><topic>Etanercept - therapeutic use</topic><topic>Female</topic><topic>Health Status</topic><topic>health-related quality of life</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multivariate Analysis</topic><topic>Odds Ratio</topic><topic>Predictive Value of Tests</topic><topic>Quality of Life</topic><topic>Quality-Adjusted Life Years</topic><topic>Registries</topic><topic>Remission Induction</topic><topic>Retrospective Studies</topic><topic>rheumatoid arthritis</topic><topic>Risk Factors</topic><topic>Severity of Illness Index</topic><topic>Surveys and Questionnaires</topic><topic>Time Factors</topic><topic>treatment comparison</topic><topic>Treatment Outcome</topic><topic>United Kingdom</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kotak, Sameer, MS, MBA</creatorcontrib><creatorcontrib>Mardekian, Jack, PhD</creatorcontrib><creatorcontrib>Horowicz-Mehler, Nathalie, MS, MPh</creatorcontrib><creatorcontrib>Shah, Ankit, MS</creatorcontrib><creatorcontrib>Burgess, Andrew, BS</creatorcontrib><creatorcontrib>Kim, Joseph, PhD</creatorcontrib><creatorcontrib>Gemmen, Eric, MA</creatorcontrib><creatorcontrib>Boyd, Helen, BSc</creatorcontrib><creatorcontrib>Koenig, Andrew, D.O., F.A.C.R</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Value in health</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kotak, Sameer, MS, MBA</au><au>Mardekian, Jack, PhD</au><au>Horowicz-Mehler, Nathalie, MS, MPh</au><au>Shah, Ankit, MS</au><au>Burgess, Andrew, BS</au><au>Kim, Joseph, PhD</au><au>Gemmen, Eric, MA</au><au>Boyd, Helen, BSc</au><au>Koenig, Andrew, D.O., F.A.C.R</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Impact of Etanercept Therapy on Disease Activity and Health-Related Quality of Life in Moderate Rheumatoid Arthritis Patients Population from a National British Observational Cohort</atitle><jtitle>Value in health</jtitle><addtitle>Value Health</addtitle><date>2015-09-01</date><risdate>2015</risdate><volume>18</volume><issue>6</issue><spage>817</spage><epage>823</epage><pages>817-823</pages><issn>1098-3015</issn><eissn>1524-4733</eissn><abstract>Abstract Objectives To describe a population with moderate rheumatoid arthritis (RA) before biologic initiation and assess change in disease status, health-related quality of life (HRQOL), and adverse events in etanercept (ETN)-treated patients. Methods Data on adult patients with moderate RA (3.2 < Disease Activity Score in 28 Joints [DAS28] ≤ 5.1) were retrospectively analyzed from the British Society for Rheumatology Biologics Register comparing a nonbiologic-treated group (nBG) using at least one traditional disease-modifying antirheumatic drug to a biologic group (BG) treated with ETN. The HRQOL was assessed by using the Health Assessment Questionnaire disability index score. To mitigate confounding, we controlled for drivers of progression. Appropriate univariate, multivariate, and regression analyses were used. Results A total of 1754 patients with RA were assessed (211 BG and 1543 nBG). Compared with the nBG, the BG tended toward higher disease activity, such as significantly higher tender joints and DAS28. The BG compared with the nBG had 1) a greater reduction in DAS28 and Health Assessment Questionnaire scores; 2) disease remission occurring more often (odds ratio = 2.7; P = 0.006); and 3) progression occurring in fewer patients (odds ratio = 0.3; P = 0.002). BG patients had a higher incidence of “other serious infection” and “other central nervous system–related events,” with no significant differences in associated hospitalization rates or deaths. Conclusions Among patients with moderate RA from a clinical practice registry, ETN-treated patients had significantly higher disease activity at the time of biologic initiation but significantly reduced disease activity and better HRQOL after 6 months compared with nBG patients, although the possibility of unmeasured confounding remains. The ETN group reported significantly higher incidences of “other serious infections” and “other central nervous system–related events” without higher hospitalization rates.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26409609</pmid><doi>10.1016/j.jval.2015.05.005</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Antirheumatic Agents - adverse effects Antirheumatic Agents - therapeutic use Arthritis, Rheumatoid - diagnosis Arthritis, Rheumatoid - drug therapy Arthritis, Rheumatoid - physiopathology Arthritis, Rheumatoid - psychology Chi-Square Distribution Comparative Effectiveness Research Disability Evaluation etanercept Etanercept - adverse effects Etanercept - therapeutic use Female Health Status health-related quality of life Humans Internal Medicine Male Middle Aged Multivariate Analysis Odds Ratio Predictive Value of Tests Quality of Life Quality-Adjusted Life Years Registries Remission Induction Retrospective Studies rheumatoid arthritis Risk Factors Severity of Illness Index Surveys and Questionnaires Time Factors treatment comparison Treatment Outcome United Kingdom |
title | Impact of Etanercept Therapy on Disease Activity and Health-Related Quality of Life in Moderate Rheumatoid Arthritis Patients Population from a National British Observational Cohort |
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