title: Drug usage analysis and health care resources consumption in naïve patients with rheumatoid arthritis.
abstract: OBJECTIVE
  The use of biologic agents has revolutionized the management of rheumatoid arthritis (RA) in the past 2 decades. These biologic agents directly target molecules and cells involved in the pathogenesis of RA. The purpose of this study was to assess the usage of biologic agents in terms of persistence to treatment, dose escalation, and consumption of health care resources (hospitalizations, drugs, and outpatients service) in the real clinical practice in naïve patients with RA.
  
  
  METHODS
  We conducted a real-world, retrospective, observational cohort study based on data obtained from administrative databases of three Local Health Units in Italy. The population included adults diagnosed with RA who had at least one prescription between January 1, 2009 and December 31, 2011, for a biologic that was approved for treatment of RA. The patients were followed for 12 months after enrollment. The clinical characteristics of the patients enrolled in this study were also investigated in the 1-year period before the index date. The main and secondary endpoints were evaluated only in biologic-naïve patients without switches. The overall health care costs for patients were evaluated.
  
  
  RESULTS
  A total of 594 patients met the study criteria (mean age 53.5±13.5, female:male ratio =3:1). Thirty-nine percent received etanercept, 25% adalimumab, 14% infliximab, 10% abatacept, 9% tocilizumab, and 3% golimumab. After 1 year of observation, patients showed similar use of other RA-related medication. For the naïve patients without switches, the persistence levels were: 78% for etanercept, 72% for tocilizumab, 71% for adalimumab, 69% for infliximab, and 64% for abatacept. For all agents, dose escalation was 21.4% for infliximab, 11.5% for adalimumab, 5.6% for abatacept, 4% for tocilizumab, and 3.8% for etanercept. The annual costs per treated patients were €12,803 for adalimumab, €11,924 for etanercept, €11,830 for tocilizumab, €11,201 for infliximab, and €10,943 for abatacept.
  
  
  CONCLUSIONS
  The role of biologic therapies in the treatment of RA continues to evolve; our study reflects real-world drug utilization data in adult patients with RA. These observations could be used by decision makers to support formulary decisions, although further research is needed using a larger sample to validate these results.
authors.affiliation: CliCon S.r.l., Health, Economics and Outcomes Research, Ravenna, Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Sangiorgi
authors.affiliation: Unit of Rheumatology, S. Giovanni di Dio Hospital, Florence, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Benucci
authors.affiliation: Bristol Myers Squibb S.r.l., Rome, Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Nappi
authors.affiliation: CliCon S.r.l., Health, Economics and Outcomes Research, Ravenna, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Perrone
authors.affiliation: CliCon S.r.l., Health, Economics and Outcomes Research, Ravenna, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Buda
authors.affiliation: CliCon S.r.l., Health, Economics and Outcomes Research, Ravenna, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Degli Esposti
keywords: biologic agents; real-world data; rheumatoid arthritis