Evaluation of the effectiveness of additional risk minimisation measures (aRMM) materials for Xeljanz® (tofacitinib) in Europe via a survey of healthcare professionals (HCPs): A non interventional (NI) post authorisation safety study (PASS)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Multimodal survey study

Study drug and medical condition

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

Population studied

• Short description of the study population:
  The study population included healthcare professionals identified through the proprietary IQVIA OneKey database prescribed Xeljanz for the treatment of psoriatic arthritis (PsA), rheumatoid arthritis (RA), or ulcerative colitis (UC) in 8 European countries (France, Germany, the Netherlands, Poland, Romania, Spain, Sweden, and the United Kingdom).
• 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:
  300

Study design details

• Main study objective:
  the objectives of this study are to evaluate: • The aRMM program implementation ; • The HCPs’ knowledge of the key risk messages pertaining to special warnings and precautions associated with Xeljanz, as specified in the aRMM materials; and • The HCPs’ self reported adherence to the risk minimisation practices recommended in the aRMM materials.
• Outcomes:
  the number and proportion with -Awareness (Receipt) and Utilisation -Knowledge of Key Risk Messages -Adherence to the Risk Minimisation Practices Recommended in the aRMM Materials, description of: -HCP Practice Characteristics; -Attitude Towards the aRMM Materials; -Source of HCPs’ Information on the Safety of Xeljanz; -Response Rate, Cooperation Rate, Refusal Rate, and Contact Rate.
• Data analysis plan:
  The data collected from the RA/PsA survey will be analysed separately from the data collected from the UC survey. For each survey (RA/PsA and UC), all primary analyses will be conducted using the pooled data from all countries, specialties (applies to the RA/PsA survey only), and indications (applies to the RA/PsA survey only), and will be descriptive in nature; no statistical comparisons within or between countries, specialties, and/or indications will be conducted. Only submitted and completed surveys i.e., all of Questions of the survey answered (taking into account skip patterns) by HCPs eligible to participate in the survey—will be used in the analyses. Categorical variables will be presented using frequencies and proportions. Continuous variables will be presented using means, standard deviations (SDs), minimums, 25th percentiles, medians, 75th percentiles, and maximums.

Documents

Study report

A3921334_FINAL STUDY REPORT_ 08DEC2022