Evaluation of the risks of biologic drugs exposure during pregnancy in patients with rheumatic chronic inflammatory diseases: data from the French national healthcare data system (SNDS) (BIOGRIC)

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB) Tumor necrosis factor alpha (TNF-alpha) inhibitors

  Tumor necrosis factor alpha (TNF-alpha) inhibitors
• Medical condition to be studied:
  Rheumatoid arthritis

  Psoriatic arthropathy

  Spondylitis

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  84100

Study design details

• Main study objective:
  To compare the risks of poor pregnancy outcomes in patients with RA, SpA or PsoA exposed to TNFi versus unexposed patients with RA, SpA or PsoA.
• Outcomes:
  Poor pregnancy outcome: intrauterine growth restriction, therapeutic abortion, stillbirth (death of a fetus with a gestational age ≥ 22 weeks or birth weight > 500gr), preterm delivery, perinatal mortality, maternal hospitalization due to infection, small for gestational age (birth weight < 3th percentile) or hospitalization in neonatal intensive care unit at 37 weeks. - Treatment during pregnancy: NSAID, corticoids, conventional and biologic DMARDS - All the individual items of the composite main outcome - Severe and non-severe maternal infections, severe perinatal infections of the offspring, severe infections of the offspring the first year of life, severe congenital malformations, gestational diabetes, spontaneous and elective abortions, preterm delivery.
• Data analysis plan:
  The main analysis focuses on the comparison of event risk between women exposed to TNFi and women not exposed to biologics (therefore pregnancies that are exposed to another biologic than a TNFi will be excluded from this analysis). Event rates will be compared by a logistic model. To account for the fact that exposed women are likely to be different from unexposed women, a propensity score will be constructed using both pregnancy-related variables and underlying rheumatologic disease variables.