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:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  Incidence rates of select safety outcomes
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  XELJANZ
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AF01) tofacitinib

  tofacitinib
• Medical condition to be studied:
  Colitis ulcerative

  Psoriatic arthropathy

Population studied

• Short description of the study population:
  Inclusion criteria for the study were as follows: aged ≥18 years, diagnosed with UC or PsA, at least 365 days of continuous enrollment in database prior to index date, and initiated at least 1 approved advanced treatment. Exclusion criteria were as follows: tofacitinib users with prescriptions of other approved JAK inhibitors, other advanced treatment users with history of any JAK inhibitor, and (for PsA only), evidence of rheumatoid arthritis.
• 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

• Study design:
  This was a population-based retrospective cohort study of adults with UC and PsA identified through Komodo’s Healthcare Map, an administrative claims data source based in the US.;
• 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.
• Setting:
  Identification of disease populations, safety outcomes of interest, and drugs prescribed were implemented using ICD-10 codes, CPT procedure codes, and prescribing data (e.g., NDC) in the patients’ records.;
• 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.
• Summary results:
  The mean age at index was 43.1 for the UC cohort and 48.9 for the PsA cohort; mean duration of follow-up was approximately one year in both studies. In the overall, adjusted UC analyses, tofacitinib was associated with lower rates of serious infection and VTE, but higher rate of malignancy, compared to TNFi; no significant differences were observed for any of the safety events between tofacitinib and vedolizumab. In the overall,; adjusted PsA analyses, tofacitinib was associated with higher rates of VTE, DVT, and PE compared to TNFi and adalimumab; no significant differences were observed for any of the safety events between ustekinumab or risankizumab versus tofacitinib.;