Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Postauthorisation Safety Study (PASS)

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000094389

  Iron, parenteral preparations
• Medical condition to be studied:
  Anaphylactic reaction

Population studied

• Short description of the study population:
  The study cohort comprised all adults from the source population who had a firstrecorded dispensing/administration of IV iron during the study period, were continuously enrolled or registered in the data source for at least 12 months before the first recorded iron treatment and were at least 18 years of age on the date of the first dispensing/administration of IV iron. Second or subsequent dispensing/administration of the same type of IV iron meeting the inclusion criteria were also considered for the corresponding analyses. For the KfH QiN dialysis registry in Germany, the eligibility requirement for a minimum continuous enrolment of 12 months before the first IV iron administration was not applied because medical information is captured only from the date patients’ initiate dialysis. The same selection criteria were applied to the IV penicillins cohort in the data sources where IV penicillins use was captured (i.e., Danish national and regional linked registries and databases, PHARMO-NL, SNDS in France, and GePaRD in Germany).
• 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:
  Renal impaired
• Estimated number of subjects:
  250000

Study design details

• Main study objective:
  To assess the risk of anaphylactic or severe immediate hypersensitivity reactions on the day of or the day after the first intravenous iron use among patients with various indications for intravenous iron, overall and by groups and types, and to compare the risk between intravenous iron groups (i.e.
• Outcomes:
  Anaphylactic reactions or severe immediate hypersensitivity reactions.
• Data analysis plan:
  Descriptive statistics will be calculated to summarise baseline characteristics at cohort entry by groups and specific intravenous iron types and for the cohorts of intravenous penicillin. Propensity scores will be estimated by using multivariable logistic regression, with the dependent variable 1 for the primary intravenous iron group (or type) of interest or 0 for the comparator intravenous iron group (or type) and all of the prespecified covariates included as independent variables. If numbers are adequate, incidence proportions and risk ratios will be estimated individually in each data source by intravenous iron group and for each intravenous iron type, using iron sucrose as the common comparator group. Analyses will be conducted in each data source separately, and pooled estimates will be calculated if deemed appropriate.

Documents

Results tables

IV Iron PASS_Abstract_results_Redacted

IV Iron PASS_Final Report_Revised V1.3_20Nov2020_Redacted

Study, other information

Annex5_DoIForm_EUPASnumber__Update11Feb2020

Annex5_DOI_SAB_ABircher

IV Iron_DoIForms_2_2

IV Iron_DoIForms_2_2_update_5Feb2019

IV Iron_DoIForms_3_3

IV-IRON_DOI CDP-20190207

NewDoI_updated_5Feb2019

Study publications

Fortuny J, von Gersdorff G, Lassalle R, Linder M, Overbeek J, Reinold J, Toft G…

de Sordi D, Kappen S, Otto‐Sobotka F, Kulschewski A, Weyland A, Gutierrez L, Fo…

Gutierrez L, Bezemer ID, Dress J, Ehrenstein V, Forstner M, Franzoni C, Lassall…

Gutierrez L, Blin P, Dress J, Droz-Perroteau C, Ehrenstein V, Franzoni C, Kollh…