Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

XELJANZ

Medical condition to be studied

Psoriatic arthropathy
Rheumatoid arthritis
Colitis ulcerative
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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

Safety comparison between tofacitinib and TNF inhibitors/ vedolizumab among RA and UC patients.

Outcomes

Incidence of malignancies, excluding non-melanoma skin cancer and acute cardiovascular events with tofacitinib vs TNFi or vedolizumab (VDZ), separately for UC, RA, and PsA patients. Co-primary endpoint according to age (below and above 65yo) Incidence of serious infections and thromboembolic events with tofacitinib vs TNFi or VDZ, according to age. Treatment duration and persistence of tofacitinib, TNFi or VDZ. Effectiveness of tofacitinib vs TNFi or VDZ.

Data analysis plan

Analyses will be performed separately per type of IMID (RA, PsA, UC). For both primary and secondary safety objectives, a Cox model will be used. In case of sufficient power, a marginal structural Cox proportional hazard regression models (MSM) will also be implemented. Descriptive statistics will be used to describe demographic characteristics of patients treated with tofa, TNFi and vedolizumab. Competing Risk Model – Fine & Gray will be used to compare the effectiveness of tofacitinib vs TNFi.