Etanercept

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
Broms (Controls exposed to other treatments), 2020	population based cohort retrospective	The national prescribed drug registers. Information was also identified from the National Patient Register (Denmark), from the register for biologic treatment (Finland) and from the ARTIS and PsoReg registers (Sweden).	Medical birth registers and patient registers. The registers prospectively record information on pregnancy, delivery and the neonatal period.	No adjustment for this group of exposure.
Broms (Controls unexposed, disease free), 2020	population based cohort retrospective	The national prescribed drug registers. Information was also identified from the National Patient Register (Denmark), from the register for biologic treatment (Finland) and from the ARTIS and PsoReg registers (Sweden).	Medical birth registers and patient registers. The registers prospectively record information on pregnancy, delivery and the neonatal period.	No adjustment for this group of comparison.
Bröms (controls unexposed, disease free), 2016	population based cohort retrospective	The national registers on prescribed drugs. Anti-TNF treatment also identified from visits recorded in the patient register covering all Danish hospitals using a specific treatment code (Denmark) or from the ARTIS and PsoReg registers (Sweden).	The national medical birth registers and patient registers.	No adjustment for this control group.
Bröms (controls unexposed, sick), 2016	population based cohort retrospective	The national registers on prescribed drugs. Anti-TNF treatment also identified from visits recorded in the patient register covering all Danish hospitals using a specific treatment code (Denmark) or from the ARTIS and PsoReg registers (Sweden).	The national medical birth registers and patient registers.	Adjusted for country, chronic inflammatory diagnosis, maternal age, parity, smoking, BMI, multiple birth.
Carman (Control unexposed, disease free), 2017	retrospective cohort (claims database)	The ETN‐exposure was defined as having at least one administration or pharmacy dispensing during pregnancy. Provider‐administered drug exposures were identified using procedure codes for injections or infusions pharmacy dispensing claims.	Infant outcomes were identified using claims‐based procedure or ICD‐9 diagnosis codes for: Low Birth Weight; prematurity and malformations. Medical records of all Optum‐affiliated infants with MCM claims, and their mothers, were subsequently sought for expert adjudication of the claims.	Matched by maternal age and year of pregnancy end. No adjustment for this group of exposure.
Carman (Control unexposed, sick), 2017	retrospective cohort (claims database)	The ETN‐exposure was defined as having at least one administration or pharmacy dispensing during pregnancy. Provider‐administered drug exposures were identified using procedure codes for injections or infusions pharmacy dispensing claims.	Infant outcomes were identified using claims‐based procedure or ICD‐9 diagnosis codes for: Low Birth Weight; prematurity and malformations. Medical records of all Optum‐affiliated infants with MCM claims, and their mothers, were subsequently sought for expert adjudication of the claims.	No adjustment for this group of exposure.
Chambers, 2015	prospective cohort	Women were followed up with multiple telephone interviews and medical record review.	Women were followed up with multiple telephone interviews and medical record review. Development was evaluated with the Ages and Stages Questionnaire (ASQ)	Outcomes were compared using multivariable regression and survival methods.
De Lorenzo (Controls unexposed, disease free), 2020	retrospective cohort	Data were collected retrospectively during paediatric consultations.	Data were collected retrospectively during paediatric consultations.	None
De Lorenzo (Controls unexposed, sick), 2020	retrospective cohort	Data were collected retrospectively during paediatric consultations.	Data were collected retrospectively during paediatric consultations.	None
Drechsel, 2020	prospective cohort	Patients were asked to participate in a structured telephone interview about their pregnancies. Patients were contacted at the first notification of pregnancy.	By patient interview, data on pregnancy and outcomes were collected. Whenever complications, hospitalizations, child medical findings were reported, confirmation was obtained from the attending physicians or with the child a medical report.	None
Fu, 2019	randomized controlled trial	The patients were randomized assigned to the two arms of the study, by means of a computer-generated randomization number sequence.	All the patients were followed up during the pregnancy, and every 2 weeks, they underwent transvaginal ultrasound scans from the 4th through 12th GW to observe embryo or to diagnose miscarriage. All the babies born underwent a paediatric examination to exclude congenital malformations.	No adjustment. Randomisation.
Hoxha, 2017	prospective cohort	A form including information on biological agents exposure, the concomitant use of disease modifying antirheumatic drugs was filled out by the treating rheumatologist.	A form including information about the pregnancy and foetal outcomes was filled out by the treating rheumatologist collecting pregnancy complications, congenital malformation and vaccine adverse events. Children’s follow-up was performed through maternal reports during their outpatient follow-up.	None
Hyrich, 2006	retrospective cohort	The British Society for Rheumatology Biologics Register (BSRBR) database was searched for all reports of pregnancy. Details on exposure to disease-modifying antirheumatic drugs (DMARDs) and biologic drugs were collected using standardized forms.	The British Society for Rheumatology Biologics Register (BSRBR) database was searched for all reports of pregnancy. Details on maternal and fetal outcomes were collected using standardized forms.	None
Langen, 2014	retrospective cohort	Data were collected from review of medical records and included medication use.	Data were collected from review of medical records and included pregnancy outcomes.	None
Viktil (Controls exposed to other treatments), 2012	population based cohort propective	Prescriptions were recorded from 3 months prior to conception until labour from the Norwegian Prescription Database (NorPD).	The Medical Birth Registry of Norway (MBRN), a population based register that contains information about all births, including late abortion, from 12 weeks of gestation onwards.	None for this group of exposure. Singletons only.
Viktil (Controls unexposed, NOS), 2012	population based cohort propective	Prescriptions were recorded from 3 months prior to conception until labour from the Norwegian Prescription Database (NorPD).	The Medical Birth Registry of Norway (MBRN), a population based register that contains information about all births, including late abortion, from 12 weeks of gestation onwards.	None for this group of exposure. Singletons only.
Vinet (Unexposed controls, disease free), 2018	retrospective cohort	The MarketScan commercial database, a large prospective US database of >230 million subjects, containing drug prescription claims.	The MarketScan commercial database, a large prospective US database of >230 million subjects, containing data on hospitalizations and outpatient visits. Serious infections in the offspring was based on ≥1 hospitalization with infection within the first 12 months of life.	No matching for this group of exposure.
Vinet (Unexposed controls, sick), 2018	retrospective cohort	The MarketScan commercial database, a large prospective US database of >230 million subjects, containing drug prescription claims.	The MarketScan commercial database, a large prospective US database of >230 million subjects, containing data on hospitalizations and outpatient visits. Serious infections in the offspring was based on ≥1 hospitalization with infection within the first 12 months of life.	None
Weber-Schoendorfer, 2015	prospective cohort	Data were collected on exposure (including both prescription and over-thecounter) from structured telephone or face-to-face interviews and/or mailed questionnaires obtained from both the mother and/or her physician(s) after oral informed consent.	Data were collected on outcome from structured telephone or face-to-face interviews and/or mailed questionnaires obtained from both the mother and/or her physician(s) after oral informed consent. Blinded classification according EUROCAT.	No adjustment for this group of exposure.

master protocol