Infliximab - Medication and Pregnancy KB

Infliximab

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 Infliximab 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.	208 / 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 Infliximab 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).	208 / 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 Infliximab 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).	156 / 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 Infliximab 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.	156 / 21549	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%).
Casanova, 2013	Spain Not specified	All women who had become pregnant after the diagnosis of Crohn’s disease (CD) or ulcerative colitis (UC) followed in the IBD Units from 24 Spanish hospitals.	Pregnancies in IBD patients on Infliximab during pregnancy or during the 3 months before conception. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Pregnancies in IBD patients which did not receive these drugs either during pregnancy or the 3 months before conception.	20 / 318	Primary aim: evaluate the safety of thiopurines and anti-TNF-α during conception and pregnancy in IBD patients. Exposed population divided in 2 groups: A) thiopurines alone; B) anti-TNF-α drugs (IFX, ADA, and CZB) with or without concomitant thiopurines.
De Lorenzo (Controls unexposed, disease free), 2020	Italy 2009 - 2017	Mothers who attended the Clinic.	Children born to mothers with autoimmune diseases on Infliximab 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.	3 / 36
De Lorenzo (Controls unexposed, sick), 2020	Italy 2009 - 2017	Mothers who attended the Clinic.	Children born to mothers with autoimmune diseases on Infliximab 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).	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.
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 infliximab 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).	3 / 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 infliximab 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 and infliximab (discontinuation of infliximab).
Lichtenstein, 2018	North America 1999 - 2012	Crohn’s disease (CD) patients.	Pregnancy in CD patients treated with infliximab (at least one infliximab infusion), ≤ 365 days before the pregnancy outcome date.	exposed to other treatment, sick Pregnancy in CD patients treated with non-biologic CD treatments only (such as azathioprine, methotrexate, 6-mercaptopurine, prednisone, and antibiotics or narcotic analgesics).	106 / 106	2 analyses: IFX gestational exposure (≤365 days before the pregnancy outcome date) and IFX pre-gestational exposure (>365 days before the pregnancy outcome date => NOT REPORTED here).
Schnitzler (Unexposed control, disease free), 2011	Belgium 1994 - 2007	Pregnant women who delivered at the University Hospital in Leuven.	Pregnant IBD patients treated with IFX within 3 months prior to conception and/or during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Matched pregnancies of healthy women out of the Flemish population who delivered at the University Hospital in Leuven.	35 / 56	Main analysis: pregnancies with IFX (n=35) or ADA (n =7), but for malformations, raw data provided for each substance and used for this meta-analysis.
Schnitzler (Unexposed control, sick), 2011	Belgium 1994 - 2007	Pregnant women who delivered at the University Hospital in Leuven	Pregnant IBD patients treated with IFX within 3 months prior to conception and/or during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Pregnancies after diagnosis of IBD but prior to IFX treatment.	35 / 78	Main analysis: pregnancies with IFX (n=35) or ADA (n =7), but for malformations, raw data provided for each substance and used for this meta-analysis.
Seirafi, 2014	France and Belgium 2009 - 2010	Pregnant IBD patients.	Pregnant IBD patients under Infliximab within 3 months prior to conception and/or during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Pregnant IBD patients not treated with anti-TNF therapy.	86 / 99	Design seems to be a retrospective cohort rather than a case–control study as mentioned by authors. Exposures: IFX (n=86), ADA (n=42) or CTZ (n=5). Anti-TNFs were preventively discontinued before GW 30 in 73% of patients having completed their pregnancy.
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 Infliximab 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).	37 / 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 Infliximab 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).	37 / 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 IFX 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.	168 / 1532	Analyses were performed for the group of 5 TNF-α inhibitors (172 ADA, 7 CZP, 140 ETA, 3 GOL and 168 IFX). 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.

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

master protocol