Pregnancy and Infant Outcomes in Patients Exposed to Nemolizumab During Pregnancy: A Retrospective Observational Study Based on Healthcare Databases (RD.06.SPR.207424)

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:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  NEMLUVIO
• Study drug International non-proprietary name (INN) or common name:
  NEMOLIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (D11AH12) nemolizumab

  nemolizumab
• Additional medical condition(s):
  Atopic Dermatitis, Prurigo Nodularis

Population studied

• Short description of the study population:
  • In utero; • Preterm newborn infants (0 – 27 days); • Term newborn infants (0 – 27 days); • Infants and toddlers (28 days – 23 months); • Adults (18 to < 65 years);
• 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 < 65 years)

    • Adults (18 to < 46 years)
    • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women

Study design details

• Study design:
  This will be an observational cohort study that will use multiple existing databases to assess pregnancy and infant outcomes among patients with moderate to severe AD or PN.
• Main study objective:
  A) To estimate the frequency of select adverse pregnancy and birth outcomes (i.e., ectopic pregnancy, elective termination, live birth, preterm birth, spontaneous abortion, and foetal death/stillbirth) among pregnant patients with moderate to severe AD or PN who are (1) exposed to nemolizumab, (2) exposed to other treatments for moderate to severe AD or PN, and (3) unexposed.; B) To estimate the frequency of select adverse foetal, neonatal, and infant outcomes (i.e., major congenital malformations [MCMs] and small for gestational age [SGA] birth) among infants from pregnancies in patients with moderate to severe AD or PN who are (1) exposed to nemolizumab, (2) exposed to other treatments for moderate to severe AD or PN, and (3) unexposed.; C) To estimate the adjusted relative risks (RRs) and hazard ratios (HRs) for the study outcomes in pregnant patients in the nemolizumab cohort versus the 2 comparator cohorts.;
• Setting:
  The source population for this study will include pregnancies that begin (based on ECD) between 12 August 2024 and 31 March 2032 (or most recent data available at the time of the last data extract).
• Outcomes:
  During eligible follow-up, occurrence of pregnancy and infant outcomes will be identified through the presence of corresponding codes in the database. Published, validated algorithms will be used when available. The pregnancy outcomes will include ectopic pregnancy, elective termination, live birth, preterm birth, spontaneous abortion, and stillbirth, while infant outcomes are MCMs (primary outcome) and SGA birth. Code lists for all outcomes can be found in Appendix E.