Risk of Significant Infection in Rheumatoid Arthritis Patients Switching Anti-Tumor Necrosis Factor-α Drugs

Objectives To describe rates of first significant infection of rheumatoid arthritis patients who switch between anti-tumor necrosis factor (aTNF) drugs. Methods Subjects with rheumatoid arthritis who received only aTNF drugs were observed in an insurance claims database from January 2001 to December...

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Veröffentlicht in:Seminars in arthritis and rheumatism 2012-10, Vol.42 (2), p.119-126
Hauptverfasser: Nguyen-Khoa, Bao-Anh, PharmD, MPH, Goehring, Earl L, Alexander, Kimberly A., PhD, Dong, Wei, PhD, Napalkov, Pavel, PhD, Jones, Judith K., MD, PhD
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container_end_page 126
container_issue 2
container_start_page 119
container_title Seminars in arthritis and rheumatism
container_volume 42
creator Nguyen-Khoa, Bao-Anh, PharmD, MPH
Goehring, Earl L
Alexander, Kimberly A., PhD
Dong, Wei, PhD
Napalkov, Pavel, PhD
Jones, Judith K., MD, PhD
description Objectives To describe rates of first significant infection of rheumatoid arthritis patients who switch between anti-tumor necrosis factor (aTNF) drugs. Methods Subjects with rheumatoid arthritis who received only aTNF drugs were observed in an insurance claims database from January 2001 to December 2007. Nonswitchers (NS) remained on one aTNF throughout the study period (date of the first aTNF claim was the index date); switchers (S) received at least one other aTNF (claim date for the 2nd agent was the index date). Significant infections included those that required intravenous antibiotics or hospitalization. Two attributable risk periods were used: (1) an infection occurring ≤90 days following a claim for an aTNF (90-day) and (2) an infection occurring after the index date (ever-treated). Follow-up was censored at the first occurrence of a significant infection event, end of eligibility, or end of study period. Data were analyzed using Cox regression. Results In 13,752 NS and 2293 S patients, time-stratified rates declined 2- to 3-fold between the first year versus ≥2 years. Risk of significant infection was not different for either attribution model [90-day hazard ratio (HR) = 0.93, 95CI: 0.74 to 1.17, P = 0.55; ever treated HR = 0.94, 95CI: 0.78 to 1.15, P = 0.57]. First and second year rates were similar. Predictors included age ≥50 years; history of significant or opportunistic infection, diabetes, respiratory disease; Charlson score ≥2; or prior hospitalizations. Conclusions The risk of a significant infection was not different between NS and S patients. Regardless of switching status, the rate of infection was greater in the first year. This study was limited by the lack of clinical data to determine the reason for switching.
doi_str_mv 10.1016/j.semarthrit.2012.04.001
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Methods Subjects with rheumatoid arthritis who received only aTNF drugs were observed in an insurance claims database from January 2001 to December 2007. Nonswitchers (NS) remained on one aTNF throughout the study period (date of the first aTNF claim was the index date); switchers (S) received at least one other aTNF (claim date for the 2nd agent was the index date). Significant infections included those that required intravenous antibiotics or hospitalization. Two attributable risk periods were used: (1) an infection occurring ≤90 days following a claim for an aTNF (90-day) and (2) an infection occurring after the index date (ever-treated). Follow-up was censored at the first occurrence of a significant infection event, end of eligibility, or end of study period. Data were analyzed using Cox regression. Results In 13,752 NS and 2293 S patients, time-stratified rates declined 2- to 3-fold between the first year versus ≥2 years. Risk of significant infection was not different for either attribution model [90-day hazard ratio (HR) = 0.93, 95CI: 0.74 to 1.17, P = 0.55; ever treated HR = 0.94, 95CI: 0.78 to 1.15, P = 0.57]. First and second year rates were similar. Predictors included age ≥50 years; history of significant or opportunistic infection, diabetes, respiratory disease; Charlson score ≥2; or prior hospitalizations. Conclusions The risk of a significant infection was not different between NS and S patients. Regardless of switching status, the rate of infection was greater in the first year. This study was limited by the lack of clinical data to determine the reason for switching.</description><identifier>ISSN: 0049-0172</identifier><identifier>EISSN: 1532-866X</identifier><identifier>DOI: 10.1016/j.semarthrit.2012.04.001</identifier><identifier>PMID: 22595643</identifier><identifier>CODEN: SAHRBF</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Aged ; Anti-Bacterial Agents - therapeutic use ; Antirheumatic Agents - therapeutic use ; Arthritis, Rheumatoid - drug therapy ; Arthritis, Rheumatoid - epidemiology ; Arthritis, Rheumatoid - microbiology ; Bacterial Infections - drug therapy ; Bacterial Infections - epidemiology ; Bacterial Infections - microbiology ; Biological and medical sciences ; Bones, joints and connective tissue. Antiinflammatory agents ; Comorbidity ; Diseases of the osteoarticular system ; Drug Substitution ; drug switching ; Female ; Humans ; Immunocompromised Host ; Incidence ; Inflammatory joint diseases ; Injections, Intravenous ; Insurance Claim Review - statistics &amp; numerical data ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; rheumatoid arthritis ; Rheumatology ; Risk Factors ; significant infections ; tumor necrosis factor antagonists ; Tumor Necrosis Factor-alpha - antagonists &amp; inhibitors ; Tumor Necrosis Factor-alpha - immunology ; Young Adult</subject><ispartof>Seminars in arthritis and rheumatism, 2012-10, Vol.42 (2), p.119-126</ispartof><rights>Elsevier Inc.</rights><rights>2012 Elsevier Inc.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2012 Elsevier Inc. 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Methods Subjects with rheumatoid arthritis who received only aTNF drugs were observed in an insurance claims database from January 2001 to December 2007. Nonswitchers (NS) remained on one aTNF throughout the study period (date of the first aTNF claim was the index date); switchers (S) received at least one other aTNF (claim date for the 2nd agent was the index date). Significant infections included those that required intravenous antibiotics or hospitalization. Two attributable risk periods were used: (1) an infection occurring ≤90 days following a claim for an aTNF (90-day) and (2) an infection occurring after the index date (ever-treated). Follow-up was censored at the first occurrence of a significant infection event, end of eligibility, or end of study period. Data were analyzed using Cox regression. Results In 13,752 NS and 2293 S patients, time-stratified rates declined 2- to 3-fold between the first year versus ≥2 years. Risk of significant infection was not different for either attribution model [90-day hazard ratio (HR) = 0.93, 95CI: 0.74 to 1.17, P = 0.55; ever treated HR = 0.94, 95CI: 0.78 to 1.15, P = 0.57]. First and second year rates were similar. Predictors included age ≥50 years; history of significant or opportunistic infection, diabetes, respiratory disease; Charlson score ≥2; or prior hospitalizations. Conclusions The risk of a significant infection was not different between NS and S patients. Regardless of switching status, the rate of infection was greater in the first year. 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Antiinflammatory agents</subject><subject>Comorbidity</subject><subject>Diseases of the osteoarticular system</subject><subject>Drug Substitution</subject><subject>drug switching</subject><subject>Female</subject><subject>Humans</subject><subject>Immunocompromised Host</subject><subject>Incidence</subject><subject>Inflammatory joint diseases</subject><subject>Injections, Intravenous</subject><subject>Insurance Claim Review - statistics &amp; numerical data</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>rheumatoid arthritis</subject><subject>Rheumatology</subject><subject>Risk Factors</subject><subject>significant infections</subject><subject>tumor necrosis factor antagonists</subject><subject>Tumor Necrosis Factor-alpha - antagonists &amp; inhibitors</subject><subject>Tumor Necrosis Factor-alpha - immunology</subject><subject>Young Adult</subject><issn>0049-0172</issn><issn>1532-866X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNksFu1DAQhi0EotuFV0C-IHFJsB3HTi5IS6FQqQLULRI3y3Hs3dlmnWI7VH0sXoRnwtEuVOLEaS7fPzP6ZhDClJSUUPF6V0a71yFtA6SSEcpKwktC6CO0oHXFikaIb4_RghDeFoRKdoJOY9xlgAoin6ITxuq2FrxaoOEK4g0eHV7DxoMDo33CF95Zk2D0GDy-2tppr9MIPV4dJkLEX3QC61PE6ztIZgt-g1c-QXE97ceAP1kTxpixc23SGIpfP_G7MG3iM_TE6SHa58e6RF_P31-ffSwuP3-4OFtdFobXbSraqquZpX1HKOG1ka6TjWTSEMlF1eieOddoyQ1tOkGJZjXTpHaCm67vBGmbaoleHfrehvH7ZGNSe4jGDoP2dpyiormTlLTNrpaoOaDzxjFYp24DZLX3GVKza7VTD67V7FoRrrLKHH1xnDJ1e9v_Df6Rm4GXR0BHowcXtDcQHzhRtU1DeebeHjibnfwAG1Q02a6xPYR8B9WP8D_bvPmniRnA53sON_bext04BZ-dK6pizqj1_Bvza1BGCGlZVf0GfI-4YQ</recordid><startdate>20121001</startdate><enddate>20121001</enddate><creator>Nguyen-Khoa, Bao-Anh, PharmD, MPH</creator><creator>Goehring, Earl L</creator><creator>Alexander, Kimberly A., PhD</creator><creator>Dong, Wei, PhD</creator><creator>Napalkov, Pavel, PhD</creator><creator>Jones, Judith K., MD, PhD</creator><general>Elsevier Inc</general><general>Elsevier</general><scope>IQODW</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>20121001</creationdate><title>Risk of Significant Infection in Rheumatoid Arthritis Patients Switching Anti-Tumor Necrosis Factor-α Drugs</title><author>Nguyen-Khoa, Bao-Anh, PharmD, MPH ; Goehring, Earl L ; Alexander, Kimberly A., PhD ; Dong, Wei, PhD ; Napalkov, Pavel, PhD ; Jones, Judith K., MD, PhD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c459t-93b52e1db01045c7fb78727c074638ad2ff8a74c18b610a252a05f64cbdb60983</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Anti-Bacterial Agents - therapeutic use</topic><topic>Antirheumatic Agents - therapeutic use</topic><topic>Arthritis, Rheumatoid - drug therapy</topic><topic>Arthritis, Rheumatoid - epidemiology</topic><topic>Arthritis, Rheumatoid - microbiology</topic><topic>Bacterial Infections - drug therapy</topic><topic>Bacterial Infections - epidemiology</topic><topic>Bacterial Infections - microbiology</topic><topic>Biological and medical sciences</topic><topic>Bones, joints and connective tissue. Antiinflammatory agents</topic><topic>Comorbidity</topic><topic>Diseases of the osteoarticular system</topic><topic>Drug Substitution</topic><topic>drug switching</topic><topic>Female</topic><topic>Humans</topic><topic>Immunocompromised Host</topic><topic>Incidence</topic><topic>Inflammatory joint diseases</topic><topic>Injections, Intravenous</topic><topic>Insurance Claim Review - statistics &amp; numerical data</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>rheumatoid arthritis</topic><topic>Rheumatology</topic><topic>Risk Factors</topic><topic>significant infections</topic><topic>tumor necrosis factor antagonists</topic><topic>Tumor Necrosis Factor-alpha - antagonists &amp; inhibitors</topic><topic>Tumor Necrosis Factor-alpha - immunology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nguyen-Khoa, Bao-Anh, PharmD, MPH</creatorcontrib><creatorcontrib>Goehring, Earl L</creatorcontrib><creatorcontrib>Alexander, Kimberly A., PhD</creatorcontrib><creatorcontrib>Dong, Wei, PhD</creatorcontrib><creatorcontrib>Napalkov, Pavel, PhD</creatorcontrib><creatorcontrib>Jones, Judith K., MD, PhD</creatorcontrib><collection>Pascal-Francis</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>Seminars in arthritis and rheumatism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nguyen-Khoa, Bao-Anh, PharmD, MPH</au><au>Goehring, Earl L</au><au>Alexander, Kimberly A., PhD</au><au>Dong, Wei, PhD</au><au>Napalkov, Pavel, PhD</au><au>Jones, Judith K., MD, PhD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Risk of Significant Infection in Rheumatoid Arthritis Patients Switching Anti-Tumor Necrosis Factor-α Drugs</atitle><jtitle>Seminars in arthritis and rheumatism</jtitle><addtitle>Semin Arthritis Rheum</addtitle><date>2012-10-01</date><risdate>2012</risdate><volume>42</volume><issue>2</issue><spage>119</spage><epage>126</epage><pages>119-126</pages><issn>0049-0172</issn><eissn>1532-866X</eissn><coden>SAHRBF</coden><abstract>Objectives To describe rates of first significant infection of rheumatoid arthritis patients who switch between anti-tumor necrosis factor (aTNF) drugs. Methods Subjects with rheumatoid arthritis who received only aTNF drugs were observed in an insurance claims database from January 2001 to December 2007. Nonswitchers (NS) remained on one aTNF throughout the study period (date of the first aTNF claim was the index date); switchers (S) received at least one other aTNF (claim date for the 2nd agent was the index date). Significant infections included those that required intravenous antibiotics or hospitalization. Two attributable risk periods were used: (1) an infection occurring ≤90 days following a claim for an aTNF (90-day) and (2) an infection occurring after the index date (ever-treated). Follow-up was censored at the first occurrence of a significant infection event, end of eligibility, or end of study period. Data were analyzed using Cox regression. Results In 13,752 NS and 2293 S patients, time-stratified rates declined 2- to 3-fold between the first year versus ≥2 years. Risk of significant infection was not different for either attribution model [90-day hazard ratio (HR) = 0.93, 95CI: 0.74 to 1.17, P = 0.55; ever treated HR = 0.94, 95CI: 0.78 to 1.15, P = 0.57]. First and second year rates were similar. Predictors included age ≥50 years; history of significant or opportunistic infection, diabetes, respiratory disease; Charlson score ≥2; or prior hospitalizations. Conclusions The risk of a significant infection was not different between NS and S patients. Regardless of switching status, the rate of infection was greater in the first year. This study was limited by the lack of clinical data to determine the reason for switching.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>22595643</pmid><doi>10.1016/j.semarthrit.2012.04.001</doi><tpages>8</tpages></addata></record>
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subjects Adolescent
Adult
Aged
Anti-Bacterial Agents - therapeutic use
Antirheumatic Agents - therapeutic use
Arthritis, Rheumatoid - drug therapy
Arthritis, Rheumatoid - epidemiology
Arthritis, Rheumatoid - microbiology
Bacterial Infections - drug therapy
Bacterial Infections - epidemiology
Bacterial Infections - microbiology
Biological and medical sciences
Bones, joints and connective tissue. Antiinflammatory agents
Comorbidity
Diseases of the osteoarticular system
Drug Substitution
drug switching
Female
Humans
Immunocompromised Host
Incidence
Inflammatory joint diseases
Injections, Intravenous
Insurance Claim Review - statistics & numerical data
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
rheumatoid arthritis
Rheumatology
Risk Factors
significant infections
tumor necrosis factor antagonists
Tumor Necrosis Factor-alpha - antagonists & inhibitors
Tumor Necrosis Factor-alpha - immunology
Young Adult
title Risk of Significant Infection in Rheumatoid Arthritis Patients Switching Anti-Tumor Necrosis Factor-α Drugs
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