Thiopurines (Azathioprine, Mercaptopurin)


Study Exclusion reasons Rmk Reference
Aggarwal, 2011 inadequate or absent control group EXCLUDED : Absent control group.

Aggarwal 2011; 284:281-5 10.1007/s00404-010-1618-7
Martinez-Rueda, 1996 inadequate or absent control group EXCLUDED: Controls may have been exposed to other treatments, such as chloroquine or cyclophosphamide, which may not be safe. => No adequate control group.

Martinez-Rueda 1996; 5:113-9 10.1177/096120339600500205
Fischer-Betz, 2013 inadequate or absent control group EXCLUDED : inadequate control group. The study compares outcome in pregnancies in a group of women taking AZA versus a group of women switching from MMF to AZA.

Fischer-Betz Rheumatology (Oxford) 2013; 52:1070-6 10.1093/rheumatology/kes425
Kociszewska-Najman, 2016 inadequate or absent control group EXCLUDED : Table 2 shows types of Infection in the newborns associated with the scheme of immunosuppression administered to pregnant women but if a women took more than one immunosuppressive drug she's counted in both groups, thus we can't compare groups.

Kociszewska-Najman Transplant Proc 2016; 48:1556-60 10.1016/j.transproceed.2016.01.088
Ong, 2021 inadequate or absent control group EXCLUDED : Absent group control.

Ong Med J Malaysia 2021; 76:466-473

Ntali, 2022 inadequate or absent control group EXCLUDED : Absent group control.

Ntali Clin Exp Rheumatol 2022; :

Thai, 2020 inadequate or absent control group EXCLUDED: comparison of Azathioprine versus mychophenolate (a well known teratogenic drug). => No adequate control group.

Thai Pharmacoepidemiol Drug Saf 2020; 29:716-724 10.1002/pds.5017

Thai, T.N. Pharmacoepidemiol. Drug Saf. 2019; 28:30-. 10.1002/pds.4864
Wang, 2019 inadequate or absent control group EXCLUDED: Comparison of women exposed to biologics (monotherapy or in combination with immunomodulator) compared to immunomodulator (IM) alone (azathioprine or 6-mercatopurine). => AZA in both group => No adequate control group.

Wang, S. Gastroenterology 2019; 156:S-406-. 10.1016/S0016-5085(19)37866-7
Coscia, 2014 inadequate or absent control group EXCLUDED: data provided for 'Azathioprine and/or Prednisone', without analysis for each treatment; and potential control groups may include azathioprine or mycophenolic acid products and/or prednisone => no adequate control group.

Coscia Best Pract Res Clin Obstet Gynaecol 2014; 28:1174-87 10.1016/j.bpobgyn.2014.07.020
Prentice, 2024 inadequate or absent control group EXCLUDED: Analysis of obstetric, hematological and biochemical outcomes in thiopurine versus biologic–exposed pregnancies, whose safety is unknown => no adequate control group.

Prentice Inflamm Bowel Dis 2024; 30:2323-2334 10.1093/ibd/izae008
Azzam, 2025 other reason EXCLUDED: One result provided for Anti-TNF agents and Azathioprine but OR and 95%CI are not consistent (14.6 (0.06-1.437)).

Azzam, N. J. Crohn's Colitis 2025; 19:i1042-. 10.1093/ecco-jcc/jjae190.0678
De Lima-Karagiannis, 2016 not relevant exposure EXCLUDED : Not relevant exposure. It studies effect of the activity of the disease on fetal outcome. No analysis about the impact of the treatment.

de Lima-Karagiannis Am J Gastroenterol 2016; 111:1305-12 10.1038/ajg.2016.254
Skorpen, 2018 not relevant exposure EXCLUDED: Analysis of the impact of illness and prednisolone but not hydroxychloroquine ('there were no significant differences in the use of hydroxychloroquine or azathioprine between the groups in any of the trimesters').

Skorpen 2018; 77:264-269 10.1136/annrheumdis-2017-211641
Al-Otaibi, 2019 not relevant exposure EXCLUDED : study aim to compare tacrolmus to cyclosporine, some women took azathioprine but there is no specific analysis.

Al-Otaibi 2019; 17:99-104 10.6002/ect.MESOT2018.O42
Malgarinos, 2007 not relevant exposure EXCLUDED : not relevant exposure. This study was not designed to evaluated the impact of AZA on birth outcomes. We chose not to built exposed/control groups within the IBD group, based on informations given in the publication.

Malgarinos Rev Med Chir Soc Med Nat Iasi ; 111:613-9

Cortes-Hernandez, 2002 not relevant exposure EXCLUDED: analysis of predictors of flare during pregnancy. Analysis of prednisone treatment impact on maternal or fetal outcomes but no analysis for azathioprine treatment.

Cortés-Hernández 2002; 41:643-50 10.1093/rheumatology/41.6.643
Lichtenstein, 2025 not relevant exposure EXCLUDED: Pregnancy outcomes only provided for certolizumab (investigation of association between lymphoma and the use of azathioprin not after pregnancy).

Lichtenstein, G.R. Crohn's Colitis 360 2025; 7:S19-. 10.1093/crocol/otae083
Azevedo, 1998 not in pregnancy EXCLUDED : Not in pregnancy. This study compares renal transplant in an SLE group and a non-SLE group. Pregnancy rates is one of the outcomes studied, but no details are given.

Azevedo 1998; 13:2894-8 10.1093/ndt/13.11.2894
Deepak, 2014 not relevant study design EXCLUDED :Data based on individual safety reports of adverse events from the Food and Drug Administration Adverse Event Reporting System. To many biais in this type of data sources.

Deepak 2014; 40:1035-43 10.1111/apt.12936
Magee, 2000 not relevant outcome EXCLUDED : Not relevant outcome. This study aim to examine erythropoiesis in renal transplant pregnancies.

Magee 2000; 14:127-35 10.1034/j.1399-0012.2000.140205.x
Fischer, 2005 not relevant outcome EXCLUDED : Not relevant outcome. This study show the effect of pregnancy on renal graft survival.

Fischer 2005; 5:2732-9 10.1111/j.1600-6143.2005.01091.x
Mountifield, 2010 not relevant outcome EXCLUDED : Not relevant outcome. Composite outcome "Major adverse event" = fetal malformations, low birth weight, preterm labour or any permanent defect or problem requiring ongoing management.

Mountifield 2010; 4:176-82 10.1016/j.crohns.2009.10.001
Andrade, 2008 not relevant outcome EXCLUDED: analysis of treatments used before the pregnancy without information during the pregnancy (“these patients were not followed during their pregnancies. Thus we are unable to determine … continuity of treatment during pregnancy”).

Andrade ; 26:268-74

Yun, 2019 not relevant outcome EXCLUDED : not relevant outcome. The study aimed to compare success of clinical pregnancy in a group of women taking AZA versus a group of women taking deflazacort (glucorticoïdes).

Yun 2019; 20:161 10.1186/s12882-019-1346-6
Reddy, 2008 not relevant outcome EXCLUDED : Not relevant outcome. In this case control study authors evaluated the risk of relapse of IBD during pregnancy.

Reddy 2008; 103:1203-9 10.1111/j.1572-0241.2007.01756.x
De Meije, 2013 not relevant outcome EXCLUDED : The scale used for the outocmes in this study is not validated.

de Meij 2013; 38:38-43 10.1111/apt.12334
Tafreshian, 2025 not relevant outcome EXCLUDED: Adverse fetal outcomes included miscarriages, low birth weight, preterm labor, and fetal heart block => not a group of outcomes considered in metaPreg.

Tafreshian, S. J. Obstet. Gynecol. India 2025; 75:287-. 10.1007/s13224-024-01974-w
Al Arfaj, 2010 data not abstractable EXCLUDED : Data from table 5 are not abstractable.

Al Arfaj 2010; 19:1665-73 10.1177/0961203310378669
Tandon, 2020 data not abstractable EXCLUDED: data not extractable: OR not provided by authors, nor the number of patients in the exposed and unexposed groups, nor the number of cases in each group (only % in each group).

Tandon, P. J. Can. Ass. Gastroenterol. 2020; 3:320-. 10.1093/jcag/gwz047.243
Mainbourg, 2023 data not abstractable EXCLUDED: Data not extractable ('In utero exposure to AZA was not associated with combined or specific neurodevelopmental disorders' => no quantitative results).

Mainbourg, S. Birth Defects Res. 2023; 115:855-. 10.1002/bdr2.2181
Norgard, 2007 repeat population groups, duplicate reports (most recent study included) EXCLUDED: For all outcomes, overlapping between Langagergaard 2007 and Norgard 2007. Data of Langagergaard 2007 were reported because it included more exposures (65 versus 20) and used a more relevant period of exposure for malformations (T1).

Nørgård Am J Gastroenterol 2007; 102:1406-13 10.1111/j.1572-0241.2007.01216.x
Mahadevan, 2012 repeat population groups, duplicate reports (most recent study included) EXCLUDED : Most recent study included, Mahadevan 2021.

2012; 8:1-24

Motta, 2007 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : Study without separate analysis of the considered drug from other drugs (exposed=glucocorticoïdes /- immunosuppressant like azathioprine; controls=low dose aspirin).

Motta 2007; 24:441-7 10.1055/s-2007-986679
Candido, 2016 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : Study without separate analysis of the considered drug from other drugs.

Candido 2016; 38:421-426 10.5935/0101-2800.20160067
Lima, 1995 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : Not relevant exposure. It studied effect of lupus flares during pregnancy on fetal outcomes. There is no separate analysis of different drugs taken by the women during pregnancy.

Lima 1995; 25:184-92 10.1016/s0049-0172(95)80030-1
Many, 1992 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : Study without separate analysis of the considered drug from other drugs.

Many ; 28:216-8 10.1111/j.1600-0897.1992.tb00795.x
Palmsten, 2012 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of Disease-Modifying Antirheumatic Drug (DMARD) as a whole, without distinction between treatments.

Palmsten Arthritis Care Res (Hoboken) 2012; 64:1730-8 10.1002/acr.21807
Cararach, 1993 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : Study without separate analysis of the considered drug from other drugs.

Cararach 1993; 100:122-5 10.1111/j.1471-0528.1993.tb15205.x
Cooper, 2014 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : Study without separate analysis of AZA from other immunosuppressive.

Cooper 2014; 66:444-50 10.1002/art.38262
Lichtenstein, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : "non biologic treatment" as a whole, no separate analysis.

Lichtenstein 2018; 113:1678-1688 10.1038/s41395-018-0202-9
Buchanan, 1992 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : The study doesn't evaluate the impact of treatment but of the disease on pregnancy outcomes.

Buchanan American journal of reproductive immunology; 28:192-4 10.1111/j.1600-0897.1992.tb00789.x
Schreiber-Zamora, 2014 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis performed on illness status, without distinction between treatments.

Schreiber-Zamora 2014; 46:2798-801 10.1016/j.transproceed.2014.09.061
Mohamed-Ahmed, 2014 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis performed on illness status, without distinction between treatments (most women took more than one immunoppressant drug).

Mohamed-Ahmed 2014; 9:e89151 10.1371/journal.pone.0089151
Pakhathirathien, 2021 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : Table 3 shows pregnancy outcomes depending on treatment and activity of the disease but it's not possible to constitute a control group with corticosteroids as some women in corticosteroid group may also took azathioprine.

Pakhathirathien J Trop Pediatr 2021; 67: 10.1093/tropej/fmab058
Abisror, 2020 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : study without separate analysis for the considered drug from other drugs.

Abisror 2020; 39:2707-2713 10.1007/s10067-020-05024-4
Bortoli, 2011 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of immunomodulator therapy (azathioprine, cyclosporine, corticosteroids, infliximab) as a whole, without distinction between treatments.

Bortoli 2011; 34:724-34 10.1111/j.1365-2036.2011.04794.x
Gohr, 2022 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of maternal and foetal/neonatal adverse pregnancy outcomes according to illness, without distinction between treatments.

Gohr Lupus 2022; 31:1202-1210 10.1177/09612033221107538
Plauborg, 2016 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: AZA and corticosteroid exposures analysed as a whole (no separate analyse).

Plauborg Birth Defects Res. Part A Clin. Mol. Teratol. 2016; 106:494-9 10.1002/bdra.23509
Lever, 2022 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis performed on illness status, without distinction between treatments

Lever J Clin Med 2022; 11: 10.3390/jcm11102919
Chen, 2021 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: immunosuppressant (cyclosporin or azathioprine) studied as a whole without distinction between cyclosporin and azathioprine.

Chen Lupus 2021; 30:393-402 10.1177/0961203320980531
Bar-Gil, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: conventional therapy (5-aminosalicylic acid agents and thiopurines) studied as a whole without distinction between treatments.

Bar-Gil Shitrit Am J Gastroenterol 2019; 114:1172-1175 10.14309/ajg.0000000000000186
Friedman, 2020 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of children born of women with illness versus women without illness, without distinction between treatments (included as cofounding factors).

Friedman J Crohns Colitis 2020; 14:1709-1716 10.1093/ecco-jcc/jjaa106
Venne, 2021 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Azathioprine, cyclosporine and sulfasalazine studied as a whole, without distinction between treatments.

Venne Lupus 2021; 30:484-488 10.1177/0961203320979741
Hammami, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: for long-term outcomes: no distinction between treatments (other congenital anomalies reported in more details in Mahadevan 2021).

Hammami, M.B. Gastroenterology 2019; 156:S-18-. 10.1016/S0016-5085(19)36817-9
Ollech, 2021 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of maternal and fetal outcomes according to study medications as a whole, without distinction.

Ollech Clin Gastroenterol Hepatol 2021; 19:2444-2446.e2 10.1016/j.cgh.2020.10.035
Julkunen, 1994 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : Study without separate analysis of the considered drug.

Julkunen 1994; 21:970-1

Abdwani, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: women with SLE analyzed as a whole, without distinction between treatments (Hydroxychloroquine, azathioprine or prednisolone).

Abdwani 2018; 33:15-21 10.5001/omj.2018.04
Bar, 2003 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis performed on illness status, without distinction between treatments

Bar Am. J. Med. Genet. A 2003; 116A:31-6 10.1002/ajmg.a.10817
Rajaei, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : Study without separate analysis of the considered drug from other drugs.

Rajaei 2019; 38:3211-3215 10.1007/s10067-019-04682-3
Ammouri, 2024 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Pregnancy outcomes provided for pregnancies whatever treatment.

Ammouri, W. Ann. Rheum. Dis. 2024; 83:1902-. 10.1136/annrheumdis-2024-eular.6019
Bedin, 2022 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Pregnancy outcomes provided for pregnancies whatever treatment.

Bedin, A. J. Clin. Med. 2022; 11:599-. 10.3390/jcm11164792
Barros, 2022 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Pregnancy outcomes provided for pregnancies whatever treatment.

Barros, T. Reumatologia 2022; 60:311-. 10.5114/reum.2022.120754
Avni Biron, 2023 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Pregnancies outcomes provided according to illness, whatever treatment.

Avni Biron J Clin Med 2023; 12: 10.3390/jcm12124120
Coscia, 2025 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Pregnancies outcomes provided whatever treatment.

Coscia, L.A. J. Heart Lung Transplant. 2025; 44:S19-. 10.1016/j.healun.2025.02.044
Jakobsen, 2024 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Pregnancies outcomes provided whatever treatment.

Jakobsen, B. Ann. Rheum. Dis. 2024; 83:383-. 10.1136/annrheumdis-2024-eular.1205
Yeo, 2025 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Pregnancies outcomes provided whatever treatment.

Yeo, J.H. J. Crohn's Colitis 2025; 19:i699-. 10.1093/ecco-jcc/jjae190.0439
Da Costa, 2024 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Pregnancies outcomes provided whatever treatment.

Da Costa, J.O. Nephrol. Dial. Transplant. 2024; 39:i2089-. 10.1093/ndt/gfae069.1293
Avni-Biron, 2022 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: non-anti-TNF agents studied as a whole, without distinction between treatments.

Avni-Biron Aliment Pharmacol Ther 2022; 56:1361-1369 10.1111/apt.17224
Lopes, 2023 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Pregnancies outcomes provided whatever treatment.

Lopes, A.R. Ann. Rheum. Dis. 2023; 82:647-. 10.1136/annrheumdis-2023-eular.1772
Ozturk, 2025 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Pregnancies outcomes provided whatever treatment.

Ozturk, O. J. Crohn's Colitis 2025; 19:i1154-. 10.1093/ecco-jcc/jjae190.0751
Huong, 2001 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : Study without separate analysis of the considered drug from other drugs. In this study only one woman was treated with AZA and there is no separate analysis from other women.

Huong 2001; 60:599-604 10.1136/ard.60.6.599
Elahi, 2024 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Analysis of pregnancy outcomes according to illness, without distinction between treatments.

Elahi Lupus 2024; 33:728-736 10.1177/09612033241246642
Driouch, 2023 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Analysis of pregnancy outcomes according to illness, without distinction between treatments.

Driouch Nephrol Ther 2023; 19:109-120 10.1684/ndt.2023.2
Czeizel, 2004 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : No separated analysis for the considered drug.

Czeizel Lupus 2004; 13:740-5 10.1191/0961203303lu1095oa
Budtarad, 2025 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Analysis of pregnancy outcomes according to illness, without distinction between treatments.

Budtarad Sci Rep 2025; 15:4011 10.1038/s41598-025-88624-x
Gaughan, 1996 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : Study without separate analysis of the considered drug from other drugs.

Gaughan 1996; 28:266-9 10.1016/s0272-6386(96)90311-x
El Houssni, 2016 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED : Study without separate analysis of the considered drug from other drugs.

El Houssni 2016; 27:227-32 10.4103/1319-2442.178204
Lopes, 2024 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Pregnancies outcomes provided whatever treatment.

Lopes, A.R. Ann. Rheum. Dis. 2024; 83:2134-. 10.1136/annrheumdis-2024-eular.3296
Norgard, 2011 Review articles, letter to editor, editorial, comments EXCLUDED : This article is a thesis which regroups 8 studies. This studies are either inrelevant (not relevant exposure) or already included in another study.

Nørgård Dan Med Bull 2011; 58:B4360

Friedman, 2007 Review articles, letter to editor, editorial, comments EXCLUDED : Review article.

Friedman 2007; 102:1414-6 10.1111/j.1572-0241.2007.01214.x

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