A Post-Authorisation Safety Study of the Utilisation and Prescribing Patterns of Xeljanz® (tofacitinib) in the European Union Using Secondary Data Sources

Study type

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

  Drug utilisation

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA29) tofacitinib

  tofacitinib

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  1200

Study design details

• Main study objective:
  To determine whether there evidence that prescribers in the European Union (EU) are compliant with the recommendations and limitations for use described in the tofacitinib additional risk minimisation measures (aRMM) materials?
• Outcomes:
  1. Describe the characteristics of patients treated with tofacitinib, stratified by study country and indication, in terms of demographics and comorbidities and prior and current medication use. 2. Evaluate prescribers’ adherence to the tofacitinib aRMMs. 1. Describe prescribing patterns over time. 2. Describe changes in the utilisation of tofacitinib following the updated recommendations and limitations for use implemented after the 2019 Article 20 referral and the 2021 signal evaluation procedure.
• Data analysis plan:
  The primary analyses will be conducted per approved indication per country, unless otherwise specified. Data will not be pooled across countries due to heterogeneity in: how the data are recorded in each database, local data protection laws, and prescribing and coding practices. Results will be provided as descriptive statistics, no comparative statistical analyses will be conducted. Categorical variables will be reported using frequency distributions. Ordinal variables will be reported using frequency distributions, means, standard deviations (SD), minimums, 25th percentiles, medians, 75th percentiles, and maximums, unless otherwise specified. Continuous variables will be reported using means, SDs, minimums, 25th percentiles, medians, 75th percentiles, and maximums, unless otherwise specified. Missing values will be reported as missing and no imputation will be undertaken. Results will be summarized in tables and figures in Microsoft® Excel and/or Word format.