Evaluation of the effectiveness of the belatacept (Nulojix®) Patient Alert Card in patients following renal transplantation in 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, retrospective chart review study

Study drug and medical condition

• Medicinal product name:
  NULOJIX
• Study drug International non-proprietary name (INN) or common name:
  BELATACEPT
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA28) belatacept

  belatacept
• Medical condition to be studied:
  Renal transplant

Population studied

• Short description of the study population:
  Adult renal transplant patients treated with belatacept (Nulojix®) within the previous 3 months and healthcare professionals (nephrologists and nurses) involved in prescribing, administering or managing belatacept-treated patients within the previous 6 months.
• 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 renal transplantation
• Estimated number of subjects:
  70

Study design details

• Study design:
  Non-interventional observational study comprising a patient survey, an HCP survey and a retrospective chart review evaluating awareness, understanding and implementation of key PAC messages and their association with clinical outcomes.
• Main study objective:
  The main objective of the study was to evaluate the effectiveness of the belatacept (Nulojix®) Patient Alert Card by assessing distribution, awareness, utilization, utility, knowledge, comprehension and behaviour among patients and healthcare professionals, and by evaluating the association between these measures and clinical outcomes in patients
• Setting:
  The study was conducted in France, Germany, Sweden and Austria in hospital and physician renal units. Eligible patients were adult renal transplant recipients who had received belatacept within the previous 3 months. Eligible HCPs were nephrologists and nurses involved in prescribing, administering or managing belatacept-treated patients within the previous 6 months.
• Outcomes:
  Patient survey: awareness, distribution, utilization, utility, knowledge/comprehension, behaviour and overall understanding and implementation of PAC messages. ; ; HCP survey: awareness, distribution, utilization, utility, knowledge/comprehension, behaviour and overall understanding and implementation of PAC messages. ; ; Clinical outcomes study: serious infections and infections leading to hospitalization (primary outcomes); infections leading to discontinuation, time from infection symptom onset to medical attention or treatment, and time from transplantation to biopsy-confirmed graft rejection (secondary outcomes).
• Data analysis plan:
  Descriptive analyses estimated awareness, distribution, utilization, utility, knowledge, comprehension and behaviour outcomes. Univariate and multivariable regression analyses were used to identify determinants of understanding and implementation. Associations between understanding/implementation scores and clinical outcomes were evaluated using regression methods and Kaplan–Meier analyses where appropriate.
• Summary results:
  Among patients, 27% were aware of the PAC, 94% of those aware reported receiving it and 77% had read it. Knowledge, utility and behaviour scores were higher among patients who recalled receiving the PAC. Among HCPs, 69% were aware of the PAC and 58% had accessed it. Serious infections were more frequent among patients with lower understanding and implementation scores, although the association was not statistically significant. The PAC appeared to contribute to patient-HCP communication but was not systematically incorporated into clinical care.