Burden of serious infection in patients with rheumatoid arthritis treated with Prolia ovserved in a clinical setting (20140127)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Descriptive Study
• 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

• Name of medicine:
  PROLIA
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Short description of the study population:
  The study population will be derived from a source population of adult patients with rheumatoid arthritis and osteoporosis who were receiving medical care at the Hamilton Rheumatology medical practice in Ontario, Canada, between 01 July 2010 and 31 July 2014. Inclusion criteria: Men and women ≥ 18 years old with a diagnosis of rheumatoid arthritis registered in the Hamilton Rheumatology medical practice at least 3 months before and 3 months after index date who had received at least one injection, infusion or filled a prescription for an immunosuppressive biologic therapy for RA during the study period with Pharmaca Health.
• 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:
  1200

Study design details

• Main study objective:
  Estimate frequency of serious infections among patients on immunosuppressive biolologic RA treatment and Prolia.
• Outcomes:
  serious infections, opportunistic infections
• Data analysis plan:
  Descriptive statistics will be used to describe patient characteristics in the biologics and Prolia-exposed and Prolia-unexposed patients. Mean and standard deviation, median and range will be reported for continuous variables, and frequency distributions will be reported for categorical variables. Cumulative incidence of infection (incidence proportion) in RA patients treated concomitantly with an immunosuppressive biologic and Prolia will be assessed separately over a 6 and 12-month follow up period. The incidence rate is calculated as the total number of patients with an infection divided by the summation of patient-days of applicable time at risk from all patients, where the time at risk is censored at the first occurrence of the event for patients experiencing an infection. To provide context to the findings, we will also describe the infection experience in RA patients treated with an immunosuppressive biologic agent (Prolia unexposed).

Documents

Study results

01.09.01 Clinical Study Report Abstract 2016-09-01 20140127 Final report