Etanercept

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Broms (Controls exposed to other treatments), 2020 Denmark, Finland and Sweden
2006 - 2013
All women who gave birth to a singleton infant during the study period. 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.
510 / 9393
Broms (Controls unexposed, disease free), 2020 Denmark, Finland and Sweden
2006 - 2013
All women who gave birth to a singleton infant during the study period. 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).
510 / 1623483
Bröms (controls unexposed, disease free), 2016 Denmark and Sweden
2004/6 - 2012
Women and their infants up to 1 year of age (among all 15 million residents of Denmark and Sweden). 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).
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%).
Bröms (controls unexposed, sick), 2016 Denmark and Sweden
2004/6 - 2012
Women and their infants up to 1 year of age (among all 15 million residents of Denmark and Sweden). 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.
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%).
Carman (Control unexposed, disease free), 2017 USA
1995 - 2012
All women with diagnosis or procedure codes suggestive of pregnancy and all mother‐infant pairs enrolled during the study period. 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).
337 / 1685 Addition of Chronic Inflammatory Arthritis (n=256) and Psoriasis (n=81) patients and their respective control group (n=1280 and 405).
Carman (Control unexposed, sick), 2017 USA
1995 - 2012
All women with diagnosis or procedure codes suggestive of pregnancy and all mother‐infant pairs enrolled during the study period. 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).
337 / 2861 Addition of Chronic Inflammatory Arthritis (n=256) and Psoriasis (n=81) patients and their respective control group (n=1512 and 1349).
Chambers, 2015 USA and Canada
2005 - 2012
Women enrolled in the OTIS Autoimmune Diseases in Pregnancy Project. 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.
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.
De Lorenzo (Controls unexposed, disease free), 2020 Italy
2009 - 2017
Mothers who attended the Clinic. 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.
6 / 36
De Lorenzo (Controls unexposed, sick), 2020 Italy
2009 - 2017
Mothers who attended the Clinic. 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).
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.
Drechsel, 2020 Not specified
2007 - 2018
Patients with Juvenile idiopathic arthritis (JIA) who were enrolled in BiKeR during childhood and were subsequently transferred to JuMBO, and reported at least one pregnancy in JuMBO. Pregnancies with maternal etanercept only exposure. unexposed, sick
Pregnancies unexposed to disease modifying antirheumatic drug (DMARD).
13 / 85 Major congenital anomalies were classified according to the guidelines of the European Surveillance of Congenital Anomalies.
Fu, 2019 China
2014 - 2017
Refractory recurrent spontaneous abortion patients with innate immune disorders and failure of conventional treatment for RSA (heparin, aspirin, prednisone, cyclosporine A). 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).
95 / 93
Hoxha, 2017 Italia
2008 - 2015
Patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis attending four Rheumatology Units. 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].
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.
Hyrich, 2006 United Kingdom
Until 2005
Patients with rheumatic diseases directly exposed to anti-TNFa therapies during or immediately prior to pregnancy. 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).
17 / 9 All but 2 etanercept patients discontinued their during the first trimester of pregnancy.
Langen, 2014 USA
2001 - 2009
All pregnancies complicated by Rheumatoid arthritis (RA) delivered at the institution. 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).
1 / 15 Co-exposure Prednisolone, plaquenil and etanercept (discontinuation of Plaquenil and etanercept).
Viktil (Controls exposed to other treatments), 2012 Norway
2004 - 2007
Singleton pregnancies in women receiving at least 1 prescription during the study period. 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.
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.
Viktil (Controls unexposed, NOS), 2012 Norway
2004 - 2007
Singleton pregnancies in women receiving at least 1 prescription during the study period. 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.
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.
Vinet (Unexposed controls, disease free), 2018 USA
2011 - 2015
The Pregnancies in RA Mothers and matched control group of children born to unaffected mothers. 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).
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.
Vinet (Unexposed controls, sick), 2018 USA
2011 - 2015
The Pregnancies in RA Mothers and matched control group of children born to unaffected mothers. 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).
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.
Weber-Schoendorfer, 2015 Australia, Finland, France, Italy, The Netherlands, Turkey, Switzerland and the United Kingdom
1998 - 2013
Pregnant women who contact a Teratology information services (TIS), directly or via her health care professional. 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.
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.

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk

master protocol