Satralizumab Single-Arm Pregnancy Safety Study: A Global, Observational, Single-Arm, 10-Year Study of Pregnancy and Infant Outcomes in Satralizumab-Exposed Women With Neuromyelitis Optica Spectrum Disorder

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Single-arm, Non-interventional pregnancy safety study

Study drug and medical condition

• Name of medicine:
  ENSPRYNG
• Medical condition to be studied:
  Neuromyelitis optica spectrum disorder

Population studied

• 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:
  60

Study design details

• Main study objective:
  The main objective of the study is to collect and describe maternal, fetal, and infant adverse outcomes among women with neuromyelitis optica spectrum disorder (NMOSD) exposed to satralizumab during the 6 months prior to the last menstrual period (LMP) or at any time during pregnancy.
• Outcomes:
  To observe and report selected adverse pregnancy and birth outcomes and pregnancy complications in women with NMOSD exposed to satralizumab during a defined exposure window, and to observe and report selected adverse fetal/neonatal/infant outcomes at birth and through the first year of life of infants from pregnancies in women with NMOSD exposed to satralizumab during the defined exposure window.
• Data analysis plan:
  Descriptive analyses will be performed to gain an understanding of the qualitative and quantitative nature of the data collected and the characteristics of the study sample. If there are sufficient numbers of subjects enrolled in the pregnancy safety study, descriptive statistics will be reported using summary tables and figures (where appropriate). Continuous variables will be summarized using mean, standard deviation, range (min-max), median and interquartile range. Categorical variables will be summarized using counts and proportions (%). The number of subjects with non-missing data will be presented.