Risk of Safety Events Among Patients with UC and PsA Treated with Tofacitinib and Other Advanced Treatments in the United States

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Other
• If ‘other’, further details on the scope of the study:
  Incidence rates of select safety outcomes

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  XELJANZ
• Medical condition to be studied:
  Colitis ulcerative

  Psoriatic arthropathy

Population studied

• 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)
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  This non-interventional study aims to provide additional insights into incidence rates of select safety outcomes in ulcerative colitis and Psoriatic arthritis populations using active comparator groups in routine clinical practice in the United States.
• Outcomes:
  Primary outcomes in this study include incidence rates in patients on tofacitinib and other forms of advanced treatment of the following safety events: major adverse cardiovascular events, venous thromboembolic disease (defined as deep vein thrombosis and pulmonary embolism), malignancy (excluding non-melanoma skin cancer) and serious infections. ; Estimates of safety events will be stratified by the following factors: ; 1. Age: younger than 50 years or at least 50 years and older ; 2. Age: younger than 65 years or at least 65 years and older ; 3. Systemic glucocorticoid use at baseline ; 4. Previous biologic or other advanced treatment used prior to baseline ; 5. History of major adverse cardiovascular events or venous thromboembolic diseases
• Data analysis plan:
  This is a descriptive analyses. ; Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a statistical analysis plan. ; Baseline demographic and clinical characteristics will be tabulated among the two cohorts of patients (ulcerative colitis and Psoriatic arthritis), and each exposure category within the disease cohorts. Incidence rates for select safety events will be calculated with person-time at risk starting on the index date and ending on the date of a censoring event. ; Statistical methods for propensity score matching will be detailed in the statistical analysis plan. ; Hazard rates will be estimated using an inverse probability weighted Cox proportional hazards model with time since treatment start as timescale.

Documents

Study, other information

A3921431 Non Interventional PASS ABSTRACT 22Feb2023_Redacted

A3921431 Non-Interventional Study Protocol V3.0 18Nov2024.pdf