Prevalence of immunology testing in patients treated with alglucosidase alfa with significant hypersensitivity/anaphylactic reactions (ALGMYC07390)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  MYOZYME
• Study drug International non-proprietary name (INN) or common name:
  ALGLUCOSIDASE ALFA
• Anatomical Therapeutic Chemical (ATC) code:
  (A16AB07) alglucosidase alfa

  alglucosidase alfa
• Medical condition to be studied:
  Glycogen storage disease type II

Population studied

• Short description of the study population:
  The population included all patients treated with alglucosidase alfa with a spontaneously reported significant hypersensitivity/anaphylactic reaction to the Sanofi Genzyme Pharmacovigilance adverse event database during the study period within European countries in which the revised SIP had been distributed by March 31, 2016.
• Age groups:
  Infants and toddlers (28 days – 23 months)

  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:
  1

Study design details

• Main study objective:
  This study aims to determine the prevalence of patients treated with alglucosidase alfa with significant hypersensitivity/anaphylactic reactions who undergo immunology testing. The difference in prevalence of testing between the two periods of 3 years before and after the implementation of the revised SIP (version 8.2) will be assessed as a measure of effectiveness of risk minimization measures.
• Data analysis plan:
  The primary analysis population will be patients from Europe.The analyses will be descriptive and will be made on all patients available in the databases at time of each analysis. The prevalence of testing will be provided for each period (3-year period before and 3-year period after implementation of the revised SIP). The results will be displayed by 3-year period before and after the implementation of revised SIP and by country in Europe when appropriate.

Documents

Study results

rdct-alglucosidase-alfa-PASS-immunology-testing_finalreport_abstract_FINAL 08 June 2020-PDFA