An Observational Study of Xeljanz® (tofacitinib citrate) and Biologic Rheumatoid Arthritis Treatments to Characterize their General Treatment Patterns, Effectiveness and Safety in a Real-World Taiwanese Population

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, observational, multicenter, comparative effectiveness study

Study drug and medical condition

• Name of medicine:
  ENBREL

  HUMIRA

  SIMPONI

  XELJANZ
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Short description of the study population:
  The study involved participants aged 20 years or older who were newly prescribed tofacitinib or a tumor necrosis factor inhibitors (TNFi) for the treatment of rheumatoid arthritis (RA) in Taiwan.; Inclusion criteria: ; • Adults over 20 years of age; • The patient had a clinical diagnosis of RA.; • The patient is newly prescribed tofacitinib or a TNFi (ie, Enbrel®, Humira® or Simponi®) for RA at the time of enrollment. Patients switching from one TNFi to another or from one TNFi to tofacitinib will be included as long as they are incident users of a given TNFi or of tofacitinib. ; • The patient must have evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.; • The patient is able to read, write and reply the study questionnaires.; ; Exclusion criteria: ; • The patient is enrolled in any other clinical trial of an investigational product.
• 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
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The main objective of this multicenter, prospective, observational comparative effectiveness study in Taiwan is to understand general treatment patterns, effectiveness, and safety of tofacitinib compared to TNFi in a non-restricted population of RA patients in the real-world setting.
• Outcomes:
  Describe the baseline characteristics of RA patients prescribed tofacitinib or TNFi Enbrel® (etanercept), Humira® (adalimumab), or Simponi® (golimumab) and evaluate whether baseline characteristics of patients treated with tofacitinib are comparable to patients prescribed TNFi within line of therapy. Describe measures of short-term and long-term effectiveness for tofacitinib and TNFi Describe safety outcomes in patients receiving tofacitinib and TNFi. The safety outcomes of interest Targeted Adverse Events (TAE) include cardiovascular events, hepatitis B and C reactivation, tuberculosis (TB), serious infections, herpes zoster, malignancy, and liver enzyme abnormalities.
• Data analysis plan:
  Categorical variables will be summarized as proportions with 95% confidence intervals. P-values will be used to compare baseline characteristics of tofacitinib with TNFi. The effectiveness of tofacitinib will be descriptively compared to TNFi by using mixed logistic regression models with dichotomous outcome variables for HAQ-DI, CDAI and DAS-ESR. Propensity scores (PS) may be used to adjust for confounding by indication. The mean and standard deviation of WPAI-RA scores will be summarized at a given time point for each patient.

Documents

Study results

A3921275 Non Interventional Study Report Abstract 25 March 2022

Study report

A3921275 Non Interventional Study Report 25 March 2022_Redacted

A3921275 Non Interventional Study Report Summary of Changes 19Jul2022

Study, other information

A3921275 Non Interventional Study Protocol Abstract 16 March 2022

A3921275 Non Interventional Study Report Summary of Changes 19Jul2022.pdf