title: 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 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Janssen Scientific Affairs, LLC, Horsham, Pennsylvania 19044, USA. sbolge@its.jnj.com
authors.forename: Susan C
authors.initials: SC
authors.lastname: Bolge
authors.forename: Chureen T
authors.initials: CT
authors.lastname: Carter
authors.forename: Cynthia S
authors.initials: CS
authors.lastname: Mueller
authors.forename: Robert A
authors.initials: RA
authors.lastname: Bailey
authors.forename: Michael P
authors.initials: MP
authors.lastname: Ingham
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D018501:Antirheumatic Agents / Q000008:administration & dosage*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D016208:Databases, Factual; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D000069285:Infliximab