A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data from Women with Severe Asthma Exposed to Tezepelumab (TREATY)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  TEZSPIRE 210 mg - Solution for injection
• Study drug International non-proprietary name (INN) or common name:
  TEZEPELUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (R03DX11) tezepelumab
• Medical condition to be studied:
  Asthma
• Additional medical condition(s):
  Severe Asthma

Population studied

• Short description of the study population:
  The source population comprises of women with asthma and at least one pregnancy record during the study period. Pregnancies are identified using maternal medical records related to pregnancy, including pregnancy loss, antenatal visits, deliveries and other EoP events. Inclusion and exclusion criteria will be applied to each pregnancy to create the study population consisting of pregnancies in women with severe asthma during pregnancy, from which the exposed and unexposed cohorts will be identified. ; ; Inclusion criteria: 1) start of pregnancy available as recorded or calculated based on gestational age information at pregnancy record, 2) continuous database enrollment at least 12 months prior to pregnancy, 3) severe asthma overlapping with pregnancy (based on treatment algorithm for asthma severity as specified in GINA guidelines); ; Exclusion criteria: 1) pregnancies following IVF treatment, 2) multiples, 3) foetal chromosomal abnormalities, pregnancies with exposure to other known teratogens, 4) maternal MCM diagnosed prior to current pregnancy and not in relation to previous pregnancies.
• Age groups:
  In utero

  Neonate

  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  441

Study design details

• Study design:
  The study will apply a non-interventional, longitudinal, population-based, cohort design using multiple secondary data sources. The study will describe and compare outcomes in pregnancies and offspring of women with severe asthma treated with SOC with vs without exposure to tezepelumab in pregnancy.
• Main study objective:
  To estimate the risk and relative risk of major congenital malformations in live and non-live offspring, and termination of pregnancy for foetal anomaly (TOPFA) among women with severe asthma treated with SOC with vs without exposure to tezepelumab during first trimester of pregnancy.
• Setting:
  A total of four large longitudinal patient-level data sources have been selected for this study, representing four countries: Denmark, France, Sweden, and USA.; ; The included data sources are:; ; 1. Danish National Health and Socioeconomic Registries (Denmark); 2. French National Health Data System (SNDS) (France); 3. Swedish National Health Registries (Sweden); 4. Carelon (USA)
• Comparators:
  Pregnancy and infant outcomes in pregnancies among women exposed to tezepelumab in addition to standard of care (SOC) will be compared to women exposed to SOC but unexposed to tezepelumab during pregnancy. A sensitivity analysis will compare to SOC excluding all other biologics.
• Outcomes:
  Major and minor congenital malformations, foetal death (individual and composite of miscarriage, stillbirth and ectopic pregnancy), termination of pregnancy, pre-eclampsia, emergency c-section, preterm birth, small for gestational age, low birth weight.
• Data analysis plan:
  A full description of the analytical approach will be developed and described in the SAP. Details on data derivations, category definitions, analyses, handling of missing data, and presentation of the study results will be provided in SAP. SAP will be finalised prior to the conduct of the study analyses. All study results will be presented separately for each country in the study reports, as appropriate when data become available. The final study report will include all descriptive, comparative, exploratory and sensitivity analyses as well as the meta-analysis for all the data sources.