title: Prescribing Patterns of Intravenous Golimumab for Rheumatoid Arthritis.
abstract: OBJECTIVE
  The use of intravenous golimumab (GLM-IV), in combination with methotrexate, was approved by the US Food and Drug Administration in July 2013 for the treatment of moderate to severe, active rheumatoid arthritis (RA). GLM-IV is available in 50-mg vials, and the prescribing information specifies a dosing regimen of 2 mg/kg at 0 and 4 weeks and then every 8 weeks thereafter. The purpose of this study was to examine the patterns of prescribing and administration of GLM-IV, including the demographic, clinical, and utilization characteristics of patients with RA newly treated with GLM-IV.
  
  
  METHODS
  Rheumatology practices across the continental United States were solicited for a chart-review study. Inclusion criteria were: (1) diagnosis of RA; (2) current treatment with GLM-IV; (3) age ≥18 years; and (4) lack of pregnancy (in female patients). Physicians were offered a monetary incentive for each eligible chart provided. An electronic case-report form was developed to aid in the chart data extraction and included fields for demographic characteristics, available comorbid diagnoses, prior RA treatments, and doses and dates of GLM-IV administration.
  
  
  RESULTS
  A total of 117 eligible patient charts from 15 rheumatologist practices were reviewed. The patient sample was predominantly female (81.2%), with a mean (SD) age of 55.4 (14.5) years. A total of 55.6% of patients had evidence of biologic treatment before receiving GLM-IV, and 53% had at least 1 comorbid condition. In total, 300 individual GLM-IV infusions from this sample were reviewed. Due to the relatively recent approval of GLM-IV use by the US Food and Drug Administration, the majority of patients in this sample (69.2%) had received only between 2 and 4 infusions at the time of the review. For infusion records with valid dose data, the mean number of administered vials was 3.6 (0.8) (total dose, 180 mg); the majority of patients received a dose consistent with the prescribed dose of 2 mg/kg. Combination therapy with methotrexate was observed in the charts of a minority of patients (27.4%). The mean interval between induction and the first follow-up infusion was 32.9 (11.4) days, with a mean maintenance interval of 56.5 (13.3) days.
  
  
  CONCLUSIONS
  This analysis provides an early glimpse of the patterns of prescribing GLM-IV. Overall, patients appeared to have been receiving GLM-IV in accordance with Food and Drug Administration labeling; although the rate of prescribing methotrexate was low, dosages and administration intervals were within the expected ranges.
authors.affiliation: Health Analytics, Columbia, Maryland. Electronic address: bbrady@healthanalytic.com.
authors.forename: Brenna L
authors.initials: BL
authors.lastname: Brady
authors.affiliation: Health Analytics, Columbia, Maryland.
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Tkacz
authors.affiliation: Janssen Scientific Affairs, Horsham, Pennsylvania.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Lofland
authors.affiliation: Janssen Scientific Affairs, Horsham, Pennsylvania.
authors.forename: Roxanne
authors.initials: R
authors.lastname: Meyer
authors.affiliation: Janssen Scientific Affairs, Horsham, Pennsylvania.
authors.forename: Susan C
authors.initials: SC
authors.lastname: Bolge
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004334:Drug Administration Schedule; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D014481:United States
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab; D008727:Methotrexate
keywords: anti-TNF; biologic; chart review; intravenous golimumab; rheumatoid arthritis