Anakinra

Exposed non-exposed, cohort studies

Study Country
Study period
Study design
Data source Exposure definition Non-exposure definition Exposition period Sample size
(exposed/unexposed) Or (case / control)
Remarks Risk of bias
De Lorenzo (Controls unexposed, disease free)
2020
Italy
2009 - 2017
retrospective cohort
The Clinic for Pregnancy and Autoimmunity at the San Raffaele University Hospital, Milan, Italy. Children born to mothers with autoimmune diseases on Anakinra therapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Children born to healthy mothers.
at least 1st trimester 3 / 36
Data were collected retrospectively during paediatric consultations.
De Lorenzo (Controls unexposed, sick)
2020
Italy
2009 - 2017
retrospective cohort
The Clinic for Pregnancy and Autoimmunity at the San Raffaele University Hospital, Milan, Italy. Children born to mothers with autoimmune diseases on Anakinra therapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Children born to mothers with autoimmune diseases not treated with Biologic disease-modifying anti-rheumatic drugs (bDMARDs).
at least 1st trimester 3 / 32 Unexposed: 13 of 32 neonates were born to mothers under no immunosuppressive, 15 to HCQ, 1 to AZA and 3 to both AZA and HCQ.
Data were collected retrospectively during paediatric consultations.

Case-control studies

Study Country
Study period
Study design
Data source Case Control Exposition Exposition period Sample size
(exposed/unexposed) Or (case / control)
Remarks Risk of bias

Risk of bias: : NA;   : low;   : moderate;   : serious;   : critical;   : unclear;  

Empty. There are no case-control studies available for this drug.

master protocol