Occurrence of serious infection among patients with rheumatoid arthritis or psoriatic arthritis concurrently exposed to an immunosuppressive biologic and denosumab: US physician practice chart review study (20150207)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Occurrence of serious infection in patients concurrently exposed to denosumab treatment for osteoporosis and immunosuppressive biologic medications for treatment of rheumatoid arthritis and psoriatic arthritis.
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective chart review

Study drug and medical condition

• Medicinal product name:
  PROLIA
• Anatomical Therapeutic Chemical (ATC) code:
  (M05BX04) denosumab

  denosumab
• Medical condition to be studied:
  Rheumatoid arthritis

  Psoriatic arthropathy

Population studied

• Short description of the study population:
  Patients with Rheumatoid arthritis (RA) and Psoriatic arthropathy (PsA) who are using an immunosuppressive biologic and denosumab concurrently and are - ; • Administered at least one dose of denosumab prior to 18 March 2015 and during use of immunosuppressive biologic (date of initiating denosumab marks the index date) ; • Administered at least one dose of an immunosuppressive RA or PsA biologic agent during the pre-index period ; • Received care at one of the two participating clinics before and after denosumab initiation
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  This study will be conducted to describe the occurrence of serious infections in patients with rheumatoid arthritis or psoriatic arthritis who are concurrently treated with an immunosuppressive biologic and denosumab at two rheumatology clinics in the United States.
• Outcomes:
  The primary outcome is the occurrence of serious infection, defined as infection requiring hospitalization and/or intravenous antibiotics.
• Data analysis plan:
  Descriptive analyses include assessment of cumulative incidence/percent of patients with serious infection, number of serious infection episodes (events), and incidence rate of serious infection before and up to 12 months after treatment initiation. Infection rate will be the total number of serious infection events divided by the sum of patient-time at risk.