A Retrospective Database Study to Evaluate Rates of Influenza and Related Diagnoses between Patients Treated with Tofacitinib and Other Systemic Therapies within Cohorts of RA, PsA, and UC Patients: A Post-Authorization Safety Study of Tofacitinib

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective record-based study

Study drug and medical condition

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

  Psoriatic arthropathy

  Colitis ulcerative

Population studied

• Short description of the study population:
  Patients aged 18 years or older diagnosed with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ulcerative colitis (UC) received treatment with tofacitinib and other systemic therapies identified from the Optum database for the study period of 1 June 2014 through 31 May 2019.; Inclusion criteria:; 1. Age ≥18 years at index date.; 2. Evidence of at least 1 inpatient diagnosis code or 2 outpatient diagnosis codes 7-365 days apart for RA, PsA, or UC.; 3. Evidence of initiation for at least 1 approved systemic treatment (tofacitinib, JAKi, TNFi, non-TNFi, csDMARD) for the corresponding identified indication.; 4. At least 180 days of continuous enrollment in prior to index date.; ; Exclusion criteria:; 1. Evidence of >1 indications of interest during the whole study period.
• 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:
  Other
• Special population of interest, other:
  Patients with rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis
• Estimated number of subjects:
  199697

Study design details

• Main study objective:
  To describe the rates of influenza and influenza like illness, including associated morbidity and mortality, among persons prescribed Xeljanz or other systemic therapies among cohorts of patients with RA, PsA and UC
• Outcomes:
  To describe demographics, comorbidities and clinical characteristics of RA, PsA, and UC patient. To describe the frequency, incidence rates and clinical outcomes of influenza infections and influenza like illness and their complications.
• Data analysis plan:
  Baseline demographics, comorbidities and clinical characteristics will be analyzed using baseline data for RA, PsA and UC patients, then stratified by index treatment and age. The frequency and incidence rates for influenza and influenza like illness among patients treated for RA, PsA, and UC in subsets of patients defined by different index treatments will be provided, the frequency of influenza complications, drug use around influenza diagnosis, influenza-related hospitalization and mortality among these patients will also be provided. By influenza season analysis will be performed when applicable.

Documents

Study results

A3921383 Non Interventional Study Report Abstract 10 February 2023_Redacted

Study report

A3921383 Non Interventional Study Report 10 February 2023_Redacted