A non-interventional, post-authorization safety study (PASS) to evaluate long-term safety of anakinra (Kineret®) in patients with systemic juvenile idiopathic arthritis

Study type

• Study topic:
  Human medicinal product

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

  Other
• If ‘other’, further details on the scope of the study:
  Pharmacovigilance
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Single-armed, pharmacovigilance registry study

Study drug and medical condition

• Name of medicine:
  KINERET
• Medical condition to be studied:
  Juvenile idiopathic arthritis

Population studied

• Short description of the study population:
  Male and female patients with a diagnosis of systemic juvenile idiopathic arthritis (SJIA) as per the International League of Associations for Rheumatology (ILAR) classification criteria included in the Pharmachild JIA registry study and who were ever treated with Kineret subsequently to SJIA diagnosis were included in the study.
• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  306

Study design details

• Main study objective:
  The endpoints are:• The occurrence of non-serious AEs of at least moderate severity andserious AEs (SAEs), including MAS as an ESI.• The duration of Kineret treatment in a real-world setting.• The reasons for Kineret treatment discontinuation.
• Data analysis plan:
  Patient characteristics at baseline will be summarized and presented.The analysis will include calculation of unique incidence rates (with 95% CI)and incidence proportions of each reported term of non-serious AE (moderateand severe) and SAE. A patient may contribute with multiple events of thesame AE term. AE specific incidence rates and proportions will be presentedoverall for the whole study period and also by time windows defined withreference to the first dose of Kineret following a SJIA diagnosis. Analyses ofsub-populations with long-term Kineret treatment will enable descriptivecomparisons of incidence early in the treatment cycle and incidence resultingfrom long-term treatment.This study will pay a special interest to the incidence of MAS. Summary statistics for the duration of Kineret treatment will be presentedoverall and by time window.The reasons for Kineret treatment discontinuation will be summarized withnumber and percentage.