Observational Study of Pregnancy and Infant Outcomes Among Women Exposed to Mirikizumab During Pregnancy in US-based Administrative Claims Data (I6T-MC-B003)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  OMVOH
• Study drug International non-proprietary name (INN) or common name:
  MIRIKIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AC24) mirikizumab

  mirikizumab
• Medical condition to be studied:
  Colitis ulcerative

Population studied

• Short description of the study population:
  426 mirikizumab-treated patients and their mother-infant linked pregnancies
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  426

Study design details

• Main study objective:
  Describe the occurrence of adverse pregnancy & infant outcomes among pregnant women with ulcerative colitis who are exposed to mirikizumab & infants linked to those mothers & in women with ulcerative colitis exposed to comparator medications.
• Outcomes:
  Major congenital malformations, Spontaneous abortions, stillbirth, preterm birth, small for gestational age
• Data analysis plan:
  Dichotomous & categorical covariates will be summarized using counts with percentages, & non-missing values of continuous variables will be summarized using means with standard deviations & medians with interquartile range. Counts of outcomes will be presented, along with timing of exposure to mirikizumab or comparator group treatments. The prevalence of each outcome will be reported as count per 100 pregnancies or live births along with the 95% confidence intervals. Additionally, incidence rates will be reported for the major congenital malformation outcome. Crude and propensity score adjusted relative risks (95% CI) will be estimated by robust (modified) Poisson regression using a log link and a Poisson distribution without an offset parameter. Several sensitivity analyses will be conducted to test robustness of results to study specifications.