Suspected Damage to Fetus From Biologic Agents Clinical Trial
Official title:
Study on the Safety for the Newborn of the Use of Biologics During Pregnancy
The goal of the study is to evaluate the effects on the offspring and therefore the safety of using biologic agents during pregnancy and their eventual consequences on children. The effects considered are divided into peri-partum and more long-term effects. Demonstration of safety in children born from mothers who received biologics during pregnancy will pave the way of their use in other women affected by autoimmune diseases unresponsive to standard treatment.
Biologic agents are a group of genetically engineered drugs that target the immune system and
have gained a lot of popularity in recent years. They act by interfering with cytokine
function or production, inhibiting the "second signal" required for T-cell activation or by
depleting B-cells. They are used for the treatment of a wide variety of diseases including
Rheumatoid Arthritis, Psoriatic Arthritis, Systemic Lupus Erythematosus (SLE), some types of
vasculitis and many more. Many of these pathologies occur in young women during child-bearing
years and so it is important for these drugs to not only be safe to use for the patient but
also during pregnancy for fetus and child. Many studies are conducted on their safety for the
patients but few studies are present on the safety of use during pregnancy. There are even
fewer studies that follow up for long term effects on the children outside of the perinatal
period.
The goal of the study is to evaluate the effects on the offspring and therefore the safety of
using biologic agents during pregnancy and their eventual consequences on children. The
effects considered are divided into peri-partum and more long-term effects. Demonstration of
safety in children born from mothers who received biologics during pregnancy will pave the
way of their use in other women affected by autoimmune diseases unresponsive to standard
treatment.
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