Infliximab

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 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. 		3 months (or more) before pregnancy or during pregnancy 208 / 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 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). 		3 months or more before pregnancy or1st trimester 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%).
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 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). 		3 months (or more) before pregnancy or during pregnancy 208 / 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 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. 		3 months or more before pregnancy or1st trimester 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%).
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).
Casanova
2013 		Spain
Not specified
retrospective cohort 		Inflammatory bowel disease (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. 		3 months (or more) before pregnancy or during pregnancy 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.
Data were obtained from the review of medical records and an interview with the patient when additional information was necessary was conducted. Collected data including data on drugs received during 3 months before conception and during pregnancy.
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 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. 		at least 1st trimester 3 / 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 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). 		at least 1st trimester 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.
Data were collected retrospectively during paediatric consultations.
Hyrich
2006 		United Kingdom
Until 2005
retrospective cohort 		The British Society for Rheumatology Biologics Register (BSRBR) 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). 		1st trimester 3 / 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 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). 		at least 1st trimester 1 / 15 Co-exposure Prednisolone and infliximab (discontinuation of infliximab).
Data were collected from review of medical records and included medication use.
Lichtenstein
2018 		North America
1999 - 2012
prospective cohort 		TREAT Registry (The Crohn’s Therapy, Resource, Evaluation, and Assessment Tool) 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). 		3 months (or more) before pregnancy or during pregnancy, 3 months or more before pregnancy or1st trimester 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).
Patient data were collected at registry enrollment by gastroenterologists and then semi-annually (January, July), including medication use, concomitant CD medication use; and the number of infliximab infusions before, during, and after pregnancy.
Schnitzler (Unexposed control, disease free)
2011 		Belgium
1994 - 2007
prospective cohort 		Cohort 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. 		3 months (or more) before pregnancy or during pregnancy 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.
Patients were treated with IFX or with ADA in our IBD unit at the University Hospital in Leuven and were prospectively followed.
Schnitzler (Unexposed control, sick)
2011 		Belgium
1994 - 2007
prospective cohort 		Cohort 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. 		3 months (or more) before pregnancy or during pregnancy 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.
Patients were treated with IFX or with ADA in our IBD unit at the University Hospital in Leuven and were prospectively followed.
Seirafi
2014 		France and Belgium
2009 - 2010
retrospective cohort 		GETAID (Groupe d’Etude Thérapeutique des Affections du Tube Digestif) centres and CESAME registry 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. 		3 months (or more) before pregnancy or during pregnancy 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.
Inclusion: patient records from hospital IBD units and patients were contacted by phone when data were missing. During pregnancy, information collected included dose and duration of anti-TNFs and concomitant treatments.
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 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). 		during pregnancy (anytime or not specified) 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.
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 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). 		during pregnancy (anytime or not specified) 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.
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 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. 		1st trimester 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.
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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