Comparative Multidatabase Analysis of Dosing Patterns and Infusion Intervals for the First 12 Infliximab Infusions in Patients With Rheumatoid Arthritis

Abstract Background According to prescribing information for rheumatoid arthritis (RA) treatments in the United States, infliximab should be administered at weeks 1, 2, 6, and then every 8 weeks starting at a 3-mg/kg dose, with flexible dosing up to 10 mg/kg and/or every 4 weeks based on clinical re...

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Veröffentlicht in:Clinical therapeutics 2012-12, Vol.34 (12), p.2286-2292
Hauptverfasser: Bolge, Susan C., PhD, Carter, Chureen T., PharmD, MS, Mueller, Cynthia S., PhD, Bailey, Robert A., MD, FASN, Ingham, Michael P., MSc
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container_end_page 2292
container_issue 12
container_start_page 2286
container_title Clinical therapeutics
container_volume 34
creator Bolge, Susan C., PhD
Carter, Chureen T., PharmD, MS
Mueller, Cynthia S., PhD
Bailey, Robert A., MD, FASN
Ingham, Michael P., MSc
description Abstract Background According to prescribing information for rheumatoid arthritis (RA) treatments in the United States, infliximab should be administered at weeks 1, 2, 6, and then every 8 weeks starting at a 3-mg/kg dose, with flexible dosing up to 10 mg/kg and/or every 4 weeks based on clinical response. Objective This study evaluated dosing and intervals of the first 12 infliximab infusions in patients with RA across multiple large administrative databases. Methods Data were obtained from 4 databases: HealthCore Integrated Research Database (HIRD), IMS LifeLink Health Plan Claims Database (IMS Lifelink), Premier Perspective Database (PPD), and Wolters Kluwer Pharma Solutions (WKPS). Patients were aged ≥18 years, diagnosed with RA, and naive to biologic therapy. Patients with other select inflammatory conditions were excluded. The induction period included infusions 1 through 3; the maintenance period included infusions 4 through 12. Results Observed dosing patterns from the HIRD, IMS LifeLink, PPD, and WKPS databases demonstrated minimal dose increases from the first infusion (93.5, 103.3, 58.8, and 73.2 mg, respectively) and from the first maintenance infusion (69.1, 64.3, 45.7, and 45.7 mg, respectively) to the highest dose during the first 12 infusions. The mean number of days between infusions in the maintenance period ranged from 53.3 to 63.5 in HIRD, 53.7 to 60.3 in IMS LifeLink, 53.4 to 59.4 in PPD, and 52.3 to 55.0 in the WKPS database. Conclusion Data from multiple databases of patients with RA suggest that, in clinical practice, infliximab dosing and intervals are consistent with FDA prescribing information and remain relatively stable during the first 12 infusions.
doi_str_mv 10.1016/j.clinthera.2012.10.010
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Objective This study evaluated dosing and intervals of the first 12 infliximab infusions in patients with RA across multiple large administrative databases. Methods Data were obtained from 4 databases: HealthCore Integrated Research Database (HIRD), IMS LifeLink Health Plan Claims Database (IMS Lifelink), Premier Perspective Database (PPD), and Wolters Kluwer Pharma Solutions (WKPS). Patients were aged ≥18 years, diagnosed with RA, and naive to biologic therapy. Patients with other select inflammatory conditions were excluded. The induction period included infusions 1 through 3; the maintenance period included infusions 4 through 12. Results Observed dosing patterns from the HIRD, IMS LifeLink, PPD, and WKPS databases demonstrated minimal dose increases from the first infusion (93.5, 103.3, 58.8, and 73.2 mg, respectively) and from the first maintenance infusion (69.1, 64.3, 45.7, and 45.7 mg, respectively) to the highest dose during the first 12 infusions. The mean number of days between infusions in the maintenance period ranged from 53.3 to 63.5 in HIRD, 53.7 to 60.3 in IMS LifeLink, 53.4 to 59.4 in PPD, and 52.3 to 55.0 in the WKPS database. Conclusion Data from multiple databases of patients with RA suggest that, in clinical practice, infliximab dosing and intervals are consistent with FDA prescribing information and remain relatively stable during the first 12 infusions.</description><identifier>ISSN: 0149-2918</identifier><identifier>EISSN: 1879-114X</identifier><identifier>DOI: 10.1016/j.clinthera.2012.10.010</identifier><identifier>PMID: 23153660</identifier><language>eng</language><publisher>Bridgewater, NJ: Elsevier Inc</publisher><subject>Antibodies, Monoclonal - administration &amp; dosage ; Antirheumatic Agents - administration &amp; dosage ; Arthritis, Rheumatoid - drug therapy ; Biological and medical sciences ; Clinical medicine ; Databases, Factual ; Disease ; Diseases of the osteoarticular system ; Dose-Response Relationship, Drug ; dosing ; Drug Administration Schedule ; Drug therapy ; Female ; Humans ; Inflammatory joint diseases ; Infliximab ; infusion intervals ; Internal Medicine ; Male ; Medical Education ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Practice Guidelines as Topic ; rheumatoid arthritis ; Rheumatology ; Teaching hospitals ; United States ; United States Food and Drug Administration</subject><ispartof>Clinical therapeutics, 2012-12, Vol.34 (12), p.2286-2292</ispartof><rights>Elsevier HS Journals, Inc.</rights><rights>2012 Elsevier HS Journals, Inc.</rights><rights>2014 INIST-CNRS</rights><rights>Copyright © 2012 Elsevier HS Journals, Inc. 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Objective This study evaluated dosing and intervals of the first 12 infliximab infusions in patients with RA across multiple large administrative databases. Methods Data were obtained from 4 databases: HealthCore Integrated Research Database (HIRD), IMS LifeLink Health Plan Claims Database (IMS Lifelink), Premier Perspective Database (PPD), and Wolters Kluwer Pharma Solutions (WKPS). Patients were aged ≥18 years, diagnosed with RA, and naive to biologic therapy. Patients with other select inflammatory conditions were excluded. The induction period included infusions 1 through 3; the maintenance period included infusions 4 through 12. Results Observed dosing patterns from the HIRD, IMS LifeLink, PPD, and WKPS databases demonstrated minimal dose increases from the first infusion (93.5, 103.3, 58.8, and 73.2 mg, respectively) and from the first maintenance infusion (69.1, 64.3, 45.7, and 45.7 mg, respectively) to the highest dose during the first 12 infusions. The mean number of days between infusions in the maintenance period ranged from 53.3 to 63.5 in HIRD, 53.7 to 60.3 in IMS LifeLink, 53.4 to 59.4 in PPD, and 52.3 to 55.0 in the WKPS database. Conclusion Data from multiple databases of patients with RA suggest that, in clinical practice, infliximab dosing and intervals are consistent with FDA prescribing information and remain relatively stable during the first 12 infusions.</description><subject>Antibodies, Monoclonal - administration &amp; dosage</subject><subject>Antirheumatic Agents - administration &amp; dosage</subject><subject>Arthritis, Rheumatoid - drug therapy</subject><subject>Biological and medical sciences</subject><subject>Clinical medicine</subject><subject>Databases, Factual</subject><subject>Disease</subject><subject>Diseases of the osteoarticular system</subject><subject>Dose-Response Relationship, Drug</subject><subject>dosing</subject><subject>Drug Administration Schedule</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Humans</subject><subject>Inflammatory joint diseases</subject><subject>Infliximab</subject><subject>infusion intervals</subject><subject>Internal Medicine</subject><subject>Male</subject><subject>Medical Education</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. 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Drug treatments</topic><topic>Practice Guidelines as Topic</topic><topic>rheumatoid arthritis</topic><topic>Rheumatology</topic><topic>Teaching hospitals</topic><topic>United States</topic><topic>United States Food and Drug Administration</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bolge, Susan C., PhD</creatorcontrib><creatorcontrib>Carter, Chureen T., PharmD, MS</creatorcontrib><creatorcontrib>Mueller, Cynthia S., PhD</creatorcontrib><creatorcontrib>Bailey, Robert A., MD, FASN</creatorcontrib><creatorcontrib>Ingham, Michael P., MSc</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><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>ProQuest Central (Corporate)</collection><collection>Nursing &amp; Allied Health Database</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Research Library (Corporate)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bolge, Susan C., PhD</au><au>Carter, Chureen T., PharmD, MS</au><au>Mueller, Cynthia S., PhD</au><au>Bailey, Robert A., MD, FASN</au><au>Ingham, Michael P., MSc</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparative Multidatabase Analysis of Dosing Patterns and Infusion Intervals for the First 12 Infliximab Infusions in Patients With Rheumatoid Arthritis</atitle><jtitle>Clinical therapeutics</jtitle><addtitle>Clin Ther</addtitle><date>2012-12-01</date><risdate>2012</risdate><volume>34</volume><issue>12</issue><spage>2286</spage><epage>2292</epage><pages>2286-2292</pages><issn>0149-2918</issn><eissn>1879-114X</eissn><abstract>Abstract Background According to prescribing information for rheumatoid arthritis (RA) treatments in the United States, infliximab should be administered at weeks 1, 2, 6, and then every 8 weeks starting at a 3-mg/kg dose, with flexible dosing up to 10 mg/kg and/or every 4 weeks based on clinical response. Objective This study evaluated dosing and intervals of the first 12 infliximab infusions in patients with RA across multiple large administrative databases. Methods Data were obtained from 4 databases: HealthCore Integrated Research Database (HIRD), IMS LifeLink Health Plan Claims Database (IMS Lifelink), Premier Perspective Database (PPD), and Wolters Kluwer Pharma Solutions (WKPS). Patients were aged ≥18 years, diagnosed with RA, and naive to biologic therapy. Patients with other select inflammatory conditions were excluded. The induction period included infusions 1 through 3; the maintenance period included infusions 4 through 12. Results Observed dosing patterns from the HIRD, IMS LifeLink, PPD, and WKPS databases demonstrated minimal dose increases from the first infusion (93.5, 103.3, 58.8, and 73.2 mg, respectively) and from the first maintenance infusion (69.1, 64.3, 45.7, and 45.7 mg, respectively) to the highest dose during the first 12 infusions. The mean number of days between infusions in the maintenance period ranged from 53.3 to 63.5 in HIRD, 53.7 to 60.3 in IMS LifeLink, 53.4 to 59.4 in PPD, and 52.3 to 55.0 in the WKPS database. Conclusion Data from multiple databases of patients with RA suggest that, in clinical practice, infliximab dosing and intervals are consistent with FDA prescribing information and remain relatively stable during the first 12 infusions.</abstract><cop>Bridgewater, NJ</cop><pub>Elsevier Inc</pub><pmid>23153660</pmid><doi>10.1016/j.clinthera.2012.10.010</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record>
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subjects Antibodies, Monoclonal - administration & dosage
Antirheumatic Agents - administration & dosage
Arthritis, Rheumatoid - drug therapy
Biological and medical sciences
Clinical medicine
Databases, Factual
Disease
Diseases of the osteoarticular system
Dose-Response Relationship, Drug
dosing
Drug Administration Schedule
Drug therapy
Female
Humans
Inflammatory joint diseases
Infliximab
infusion intervals
Internal Medicine
Male
Medical Education
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Practice Guidelines as Topic
rheumatoid arthritis
Rheumatology
Teaching hospitals
United States
United States Food and Drug Administration
title Comparative Multidatabase Analysis of Dosing Patterns and Infusion Intervals for the First 12 Infliximab Infusions in Patients With Rheumatoid Arthritis
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