Evaluation of the effectiveness of the abatacept (ORENCIA®) intravenous and subcutaneous formulation Patient Alert Cards in patients with rheumatoid arthritis in a sample of European Economic Area countries

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)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Healthcare professional survey, patient survey and retrospective chart review study

Study drug and medical condition

• Medicinal product name:
  ORENCIA
• Study drug International non-proprietary name (INN) or common name:
  ABATACEPT
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA24) abatacept

  abatacept
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Short description of the study population:
  Patients with rheumatoid arthritis and rheumatologists/nurses.
• 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:
  Immunocompromised
• Estimated number of subjects:
  400

Study design details

• Study design:
  Cross-sectional surveys of HCPs and patients ; A retrospective chart review
• Main study objective:
  The main objective of the study was to evaluate the effectiveness of the abatacept (ORENCIA®) IV and SC Patient Alert Cards (PACs) by: (1) assessing awareness, distribution, utilisation, utility, knowledge, comprehension and behaviour among patients and healthcare professionals (HCPs); and (2) evaluating the association between these measures in patients and the occurrence of infections leading to hospitalisation in the same patients.
• Setting:
  The study was conducted in France, Germany, Spain, Sweden and the United Kingdom. It comprised three epidemiological sub-studies: a patient cross-sectional survey, an HCP cross-sectional survey, and a retrospective chart review of patients treated with abatacept for rheumatoid arthritis. Eligible patients had received abatacept within the previous 3 months; eligible HCPs had prescribed, administered or managed abatacept-treated patients within the previous 6 months.
• Outcomes:
  Patient survey: awareness, distribution, utilisation, utility, knowledge/comprehension, behaviour/communication implementation, and overall understanding and implementation of key PAC messages.; ; HCP survey: awareness, distribution, utilisation, utility, knowledge/comprehension, behaviour/communication implementation, and overall understanding and implementation of key PAC messages.; ; Clinical outcomes study: proportion of patients with infections leading to hospitalisation (primary outcome); proportion screened for tuberculosis and viral hepatitis before abatacept initiation; time from infection symptom onset to receiving medical attention; infections leading to emergency room visits; and unplanned hospitalisations.
• Data analysis plan:
  Descriptive analyses were performed to estimate awareness, distribution, utilisation, utility, knowledge/comprehension and behaviour outcomes among patients and HCPs. Associations between baseline characteristics and understanding/implementation of key messages were evaluated using univariate and multivariable logistic regression analyses. Correlations between patient understanding/implementation scores and clinical outcomes were assessed using regression techniques and Kaplan–Meier methods for time-to-event analyses.
• Summary results:
  Among patients, 60% were aware of the PAC, 95% of those aware had received it and 84% had read it. Knowledge of infection risks was higher among patients who had received the PAC. Among HCPs, 90% were aware of the PAC and 68% had accessed it. The proportion of patients with infections leading to hospitalisation increased as understanding and implementation scores decreased, although the association was not statistically significant. Overall, the results supported the effectiveness of the abatacept PACs.