Etanercept

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
Broms (Controls exposed to other treatments)
2020 		Denmark, Finland and Sweden
2006 - 2013
population based cohort retrospective 		A population-based study based on nationwide medical birth registers, patient registers, and registers of prescribed drugs, Women who filled prescriptions for Etanercept within 90 days before their LMP until delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Women who filled prescriptions for Nonbiologic systemic treatment (mainly azathioprine, corticosteroids, sulfasalazine, anti-malarials, and methotrexate) within 90 days before their LMP until delivery. 		3 months (or more) before pregnancy or during pregnancy 510 / 9393
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).
Bröms (controls unexposed, disease free)
2016 		Denmark and Sweden
2004/6 - 2012
population based cohort retrospective 		National danish and swedish population-based health registers: the national medical birth registers, patient registers, and registers on prescribed drugs Women who had filled prescriptions for Etanercept within 90 days before and 90 days after their last menstrual period. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Women without disease or TNF treatment (ie, the general population). 		3 months or more before pregnancy or1st trimester 344 / 1250192 Primary analyse on Anti-TNF, with individual result by substance (n=2 Certolizumab). Controls: Corticosteroids (7.7%); anti-inflammatory treatments (20.8%: AZA, mercaptopurine, cyclosporine, acitretin, mycophenolate...); MTX (0.2%).
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).
Broms (Controls unexposed, disease free)
2020 		Denmark, Finland and Sweden
2006 - 2013
population based cohort retrospective 		A population-based study based on nationwide medical birth registers, patient registers, and registers of prescribed drugs, Women who filled prescriptions for Etanercept within 90 days before their LMP until delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
The general population (women without the diseases of interest and without treatment). 		3 months (or more) before pregnancy or during pregnancy 510 / 1623483
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).
Bröms (controls unexposed, sick)
2016 		Denmark and Sweden
2004/6 - 2012
population based cohort retrospective 		National danish and swedish population-based health registers: the national medical birth registers, patient registers, and registers on prescribed drugs Women who had filled prescriptions for etanercept within 90 days before and 90 days after their last menstrual period. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Women with chronic inflammatory disease but no anti-TNF treatment. 		3 months or more before pregnancy or1st trimester 344 / 21549 Primary analyse on Anti-TNF, with individual result by substance (n=344 ETN). Controls: Corticosteroids (7.7%); anti-inflammatory treatments (20.8%: AZA, mercaptopurine, cyclosporine, acitretin, mycophenolate...); MTX (0.2%).
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).
Carman (Control unexposed, disease free)
2017 		USA
1995 - 2012
retrospective cohort (claims database) 		Claims‐based data from a large US health plan research database affiliated with Optum (ORD) Pregnant women diagnosed with chronic inflammatory arthritis (cIA) or Psoriasis (PsO) treated with etanercept during pregnancy. unexposed, disease free
General population comparator group without chronic inflammatory arthritis (cIA) or Psoriasis (PsO) or TNFi treatment (ETN, adalimumab, certolizumab, golimumab, or infliximab). 		during pregnancy (anytime or not specified) 337 / 1685 Addition of Chronic Inflammatory Arthritis (n=256) and Psoriasis (n=81) patients and their respective control group (n=1280 and 405).
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.
Carman (Control unexposed, sick)
2017 		USA
1995 - 2012
retrospective cohort (claims database) 		Claims‐based data from a large US health plan research database affiliated with Optum (ORD) Pregnant women diagnosed with chronic inflammatory arthritis (cIA) or Psoriasis (PsO) treated with etanercept during pregnancy. unexposed, sick
Pregnant women diagnosed with chronic inflammatory arthritis (cIA) or Psoriasis (PsO) not treated with any TNFi (ETN, adalimumab, certolizumab, golimumab, or infliximab). 		during pregnancy (anytime or not specified) 337 / 2861 Addition of Chronic Inflammatory Arthritis (n=256) and Psoriasis (n=81) patients and their respective control group (n=1512 and 1349).
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.
Chambers
2015 		USA and Canada
2005 - 2012
prospective cohort 		OTIS (Organization of Teratology Information Specialists) Pregnancy outcomes in women treated with Etanercept. A total of 344 women received ETA in the first trimester; and 51% used ETA in the third trimester. unexposed, sick
Pregnancy outcomes in disease-matched (DM) women. 		at least 1st trimester 370 / 164 There were no significant differences between groups in prenatal or postnatal growth, rates of serious or opportunistic infections, or developmental concerns on the ASQ. No malignancies were reported.
Women were followed up with multiple telephone interviews and medical record review.
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 Etanercept 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 6 / 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 Etanercept 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 6 / 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.
Drechsel
2020 		Not specified
2007 - 2018
prospective cohort 		The Juvenile idiopathic arthritis (JIA) registry Biologics in Paediatric Rheumatology (BiKeR) and its follow-up registry, Juvenile arthritis Methotrexate/Biologics long-term Observation (JuMBO). Pregnancies with maternal etanercept only exposure. unexposed, sick
Pregnancies unexposed to disease modifying antirheumatic drug (DMARD). 		1st trimester 13 / 85 Major congenital anomalies were classified according to the guidelines of the European Surveillance of Congenital Anomalies.
Patients were asked to participate in a structured telephone interview about their pregnancies. Patients were contacted at the first notification of pregnancy.
Fu
2019 		China
2014 - 2017
randomized controlled trial 		The Weifang people's hospital. Women administered basic treatment (heparin, aspirin, prednisone, cyclosporine) and etanercept (daily s.c. administration at a dosage of 25 mg from the end of menstruation until the occurrence of menstruation or to the end of the 10th week of gestation). unexposed, sick
Women administered basic treatment (heparin, aspirin, prednisone, cyclosporine) and placebo (daily with s.c. saline solution at the same dosage and same time). 		1st trimester 95 / 93
The patients were randomized assigned to the two arms of the study, by means of a computer-generated randomization number sequence.
Hoxha
2017 		Italia
2008 - 2015
prospective cohort 		Four Rheumatology Units (Belluno, Padua, Trento and Udine) Pregnancies in patients which were treated with Etanercept at conception/ 1st trimester [anti-TNFa therapy was discontinued between 7th-11th weeks of gestations (WG)]. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Pregnancies in women withdrawn anti-TNFa prior to conception [anti-TNFa therapy was discontinued between one to six months prior to conception, following the leaflet recommendations]. 		1st trimester 17 / 11 Primary analyse concerned AntiTNFa group, which was further categorized into those exposed to ETN (n=17), ADA (n=5) or CZP (n=2) at conception; and 3 paternal exposures (ETN). Raw individual data provided for each substance and used for the meta-analysis.
A form including information on biological agents exposure, the concomitant use of disease modifying antirheumatic drugs was filled out by the treating rheumatologist.
Hyrich
2006 		United Kingdom
Until 2005
retrospective cohort 		The British Society for Rheumatology Biologics Register (BSRBR) Patients who were directly exposed to etanercept at the time of conception. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Patients who electively discontinued their anti-TNFa therapy prior to conceiving (range 1–10 months before conception). 		1st trimester 17 / 9 All but 2 etanercept patients discontinued their during the first trimester of pregnancy.
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.
Langen
2014 		USA
2001 - 2009
retrospective cohort 		Perinatal database of a tertiary care referral hospital. Women with etanercept near the time of conception. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Women with prednisone only near the time of conception. (This is a subgroup of exposure among the whole exposed group considered in the study). 		at least 1st trimester 1 / 15 Co-exposure Prednisolone, plaquenil and etanercept (discontinuation of Plaquenil and etanercept).
Data were collected from review of medical records and included medication use.
Viktil (Controls exposed to other treatments)
2012 		Norway
2004 - 2007
population based cohort propective 		Two nationwide health registers, the Norwegian Prescription Database (NorPD) and the Medical Birth Registry of Norway (MBRN) Women with dispensation of Etanercept from 3 months prior to pregnancy to delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Women with dispensation of other anti-rheumatic drugs (Prednisolone, NSAIDs, Sulfasalazine, Hydroxychloroquine, Etanercept, Adalimumab, Methotrexate, Leflunomid, or Anakinra) from 3 months prior to pregnancy to delivery. 		3 months or more before pregnancy or1st trimester 37 / 1424 Analysis performed on anti-rheumatic drugs as a whole, no individual analyse for each substance. Raw data (number of exposed pregnancies and malformations) were available in the text and were used for this meta-analysis.
Prescriptions were recorded from 3 months prior to conception until labour from the Norwegian Prescription Database (NorPD).
Viktil (Controls unexposed, NOS)
2012 		Norway
2004 - 2007
population based cohort propective 		Two nationwide health registers, the Norwegian Prescription Database (NorPD) and the Medical Birth Registry of Norway (MBRN) Women with dispensation of Etanercept from 3 months prior to pregnancy to delivery. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Singleton pregnancies whose mothers did not received an anti-rheumatic drugs in the period 3 months prior to conception until labour. 		3 months or more before pregnancy or1st trimester 37 / 154976 Analysis performed on anti-rheumatic drugs as a whole, no individual analyse for each substance. Raw data (number of exposed pregnancies and malformations) were available in the text and were used for this meta-analysis.
Prescriptions were recorded from 3 months prior to conception until labour from the Norwegian Prescription Database (NorPD).
Vinet (Unexposed controls, disease free)
2018 		USA
2011 - 2015
retrospective cohort 		The RA Mothers and Outcomes in Offspring in the United States (PAROUS) cohort and the MarketScan commercial databases. Children born of rheumatoid arthritis (RA) women with ≥1 filled prescription of Etanercept during the preconception and/or gestational periods. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Children born to non-RA mothers without TNFi exposure (i.e., no prescription filled or infusion procedure claim within the preconception and gestational periods). 		during pregnancy (anytime or not specified) 195 / 14596 Primary analysis performed on the group of TNFi, but raw data related to serious infections provided by type of TNFi and used in this meta-analysis.
The MarketScan commercial database, a large prospective US database of >230 million subjects, containing drug prescription claims.
Vinet (Unexposed controls, sick)
2018 		USA
2011 - 2015
retrospective cohort 		The RA Mothers and Outcomes in Offspring in the United States (PAROUS) cohort and the MarketScan commercial databases. Children born of rheumatoid arthritis (RA) women with ≥1 filled prescription of Etanercept during the preconception and/or gestational periods. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Children born of rheumatoid arthritis (RA) women without TNFi exposure (i.e., no prescription filled or infusion procedure claim within the gestational period and the 12 weeks preceding it). 		during pregnancy (anytime or not specified) 195 / 2476 Primary analysis performed on the group of TNFi, but raw data related to serious infections provided by type of TNFi and used in this meta-analysis.
The MarketScan commercial database, a large prospective US database of >230 million subjects, containing drug prescription claims.
Weber-Schoendorfer
2015 		Australia, Finland, France, Italy, The Netherlands, Turkey, Switzerland and the United Kingdom
1998 - 2013
prospective cohort 		European Network of Teratology information services (TIS) Pregnant women who had been exposed to more than one dose of ETA at any time during the first 12 weeks after the last menstrual period (LMP). (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, disease free
Pregnant women identified through spontaneous TIS consultations for other conditions or exposures such as hairdyeing, urinary tract infection, asthma or depression. 		1st trimester 140 / 1532 Analyses were performed for the group of 5 TNF-α inhibitors (172 ADA, 7 CZP, 140 ETA, 3 GOL and 168 IFX). Indications: IBD (48,1%) et RA (26,9%). Raw data were provided for major malformations and used for the meta-analysis.
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.

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.

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