Lebrikizumab Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS) MotherToBaby Pregnancy Registry (J2T-MC-B005)

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  EBGLYSS
• Study drug International non-proprietary name (INN) or common name:
  LEBRIKIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (D11AH10) lebrikizumab

  lebrikizumab

Population studied

• Short description of the study population:
  The study population includes pregnant women who reside in the US or Canada.; The 3 groups of women enrolled and followed for pregnancy and infant outcomes ; include:; (1) Pregnant women with AD and who have received at least 1 dose of lebrikizumab; anytime during pregnancy or within 5 half-lives (123 days) prior to the estimated ; DOC.; (2) Pregnant women with AD exposed to phototherapy or systemic therapy, other than; IL-13–targeting biologics, during pregnancy or within 5 half-lives prior to the ; estimated DOC (primary comparator).; (3) Pregnant women with AD who may or may not have received treatment for AD but ; who have not been exposed to any dose of lebrikizumab, phototherapy, or systemic ; therapy within 5 half-lives prior to the estimated DOC (secondary comparator).; Pregnant women exposed to lebrikizumab who do not meet the eligibility criteria (see ; eligibility criteria) of this study may be followed separately as part of an exposure series.
• Special population of interest:
  Pregnant women

Study design details

• Study design:
  prospective, observational cohort study of pregnancy and infant outcomes among pregnant women exposed to any dose of lebrikizumab within 5 half-lives prior to the estimated DOC or anytime during pregnancy, enrolled into the OTIS Lebrikizumab Pregnancy Registry
• Main study objective:
  The objective of this study is to assess pregnancy and infant outcomes among women who become pregnant while exposed to lebrikizumab relative to the outcomes in 2 matched comparator populations.
• Setting:
  The registry cohort study will be conducted by the OTIS, which is a network of university- and health department–based telephone information centers serving pregnant women and HCPs throughout North America (Leen-Mitchell et al. 2000).
• Outcomes:
  The outcomes are major structural defects identified in children up to 1 year of age, as well as rate of spontaneous ; abortion, elective termination/abortion, stillbirth, preterm delivery, a pattern of minor structural birth defects, small for gestational age at birth, small for age for postnatal growth at 1 year of age, serious infections up to 1 year of age, developmental milestones, and neonatal death.