Etanercept - Medication and Pregnancy KB

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

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

21 studies, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.

master protocol