Real-world comparative effectiveness of tofacitinib, tumour necrosis factor inhibitors, and interleukin 17 inhibitors among patients with axial spondylarthritis and psoriatic arthritis

Study type

• Study topic:
  Disease /health condition

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

  Effectiveness study (incl. comparative)

  Healthcare resource utilisation
• Data collection methods:
  Secondary use of data

Study drug and medical condition

• Medicinal product name:
  XELJANZ
• Study drug International non-proprietary name (INN) or common name:
  TOFACITINIB
• Medical condition to be studied:
  Axial spondyloarthritis
• Additional medical condition(s):
  Psoriatic Arthritis

Population studied

• Short description of the study population:
  Adults (ages ≥18 years of age) with AxSpA or PsA

Study design details

• Study design:
  This non-interventional study is a population-based retrospective cohort study.
• Main study objective:
  Primary objectives:; 1. To compare the proportion of AxSpA patients fulfilling effectiveness criteria within 6 months after initiating treatment with tofacitinib vs TNFi vs IL-17i among patients with at least 6 months of continuous enrollment after index date.; 2. To compare the proportion of b/tsDMARD-naïve PsA patients fulfilling effectiveness criteria within 6 months after initiating treatment with tofacitinib vs TNFi vs IL-17i among patients with at least 6 months of continuous enrollment after index date.; ; Secondary objectives:; 1. To compare the proportion of AxSpA patients fulfilling effectiveness criteria within 12 months after initiating treatment with tofacitinib vs TNFi vs IL-17i among patients with at least 12 months of continuous enrollment after index date.; 2. To compare the proportion of b/tsDMARD-naïve PsA patients fulfilling effectiveness criteria within 12 months after initiating treatment with tofacitinib vs TNFi vs IL-17i among patients with at least 12 months of continuous enrollment after index date. ; 3. Evaluate drug persistence (median time to therapy discontinuation) among AxSpA patients within 12 months of treatment with tofacitinib vs TNFi vs IL-17i among patients with at least 12 months of continuous enrollment after index date.; 4. Evaluate drug persistence (median time to therapy discontinuation) among b/tsDMARD-naive PsA patients within 12 months of treatment with tofacitinib vs TNFi vs IL-17i among the sample of patients with at least 12 months of continuous enrollment after index date.; 5. Evaluate health care resource utilization and cost data for AxSpA patients within 6 and 12 months of treatment with tofacitinib vs TNFi vs IL-17i among patients with at least 6 or 12 months of continuous enrollment after index date, respectively.
• Setting:
  Komodo Healthcare Map database (Komodo)
• Outcomes:
  The number and proportion of patients that satisfy the effectiveness criteria. ; Primary Outcome: ;  Patients that satisfy all the 8 effectiveness criteria; Secondary Outcome:;  Patients that satisfy each of the effectiveness criterion– pending feasibility ; Additional secondary outcomes of this study are persistence, HCRU, and costs. These will be assessed during the follow-up period