TNF-alpha inhibitors

Study	Exclusion reasons	Rmk	Reference
Kammerlander, 2017	inadequate or absent control group	EXCLUDED: Women were exposed to anti–TNF-a therapy during the third trimester VERSUS women stopped the anti–TNF-a therapy before the third trimester. All pregnancies exposed. No adequate control group.	Kammerlander H Inflamm Bowel Dis 2017;23:1916-1923 10.1097/MIB.0000000000001234
Mahadevan, 2014	inadequate or absent control group	EXCLUDED: analyses performed on the timing of biologic exposure (not between exposed versus unexposed). 422 exposed to a biologic in T3 (214 IFX, 117 ADA, 89 CZP, 9 NAT); 597 unexposed in T3 of whom 70 had T1, T2 exposure but stopped prior to T3.	Mahadevan U Gastroenterology 2014;146:170-170
Julsgaard, 2016	inadequate or absent control group	EXCLUDED: all pregnant women were exposed (IFX or ADA). No adequate control group.	Julsgaard M Gastroenterology 2016;151:110-9 10.1053/j.gastro.2016.04.002
Kanis, 2018	inadequate or absent control group	EXCLUDED: all pregnant women were exposed (IFX or ADA).	Kanis J Crohns Colitis 2018; 12:939-947 10.1093/ecco-jcc/jjy058
Chakravarty, 2003	inadequate or absent control group	EXCLUDED: All pregnancies were exposed to disease modifying antirheumatic drugs (DMARD) methotrexate (MTX), leflunomide (LF), etanercept (ET), and infliximab (IN). No adequate control group.	Chakravarty J. Rheumatol. 2003; 30:241-6
Genest, 2018	inadequate or absent control group	EXCLUDED: All pregnant women exposed to TNF at least a part of pregnancy ("women who continued their TNFi throughout pregnancy compared to women who interrupted TNFi during pregnancy").	Genest J. Rheumatol. 2018; 45:1109-1115 10.3899/jrheum.171152
Julsgaard, 2020	inadequate or absent control group	EXCLUDED: Comparison of pregnancies who stopped Anti-TNF before 30 GW and those who continued after GW30. All pregnant women exposed to TNFi.	Julsgaard Inflamm. Bowel Dis. 2020; 26:93-102 10.1093/ibd/izz110
Larsen, 2016	not relevant exposure	EXCLUDED: paternal exposure.	Larsen MD Am J Gastroenterol 2016;111:1608-1613 10.1038/ajg.2016.405
Micu, 2019	not relevant exposure	EXCLUDED: exposure of male partner to TNF (no maternal exposure).	Micu J. Rheumatol. 2019; 46:1084-1088 10.3899/jrheum.180588
Uyaroglu, 2020	not relevant exposure	EXCLUDED: exposure of male partner to TNF (no maternal exposure).	Uyaroglu Rheumatol. Int. 2020; : 10.1007/s00296-020-04518-3
Shimada, 2019	not in pregnancy	EXCLUDED: no exposure during pregnancy: bDMARDs were discontinued at the time of conception.	Shimada Clin. Rheumatol. 2019; 38:1453-1458 10.1007/s10067-019-04450-3
De Lima-Karagiannis, 2016	not relevant outcome	EXCLUDED: study on the impact of pregnancy on the disease relapse (antiTNFalpha only one of the characteristic of illness patients).	de Lima-Karagiannis A Am J Gastroenterol 2016;111:1305-12 10.1038/ajg.2016.254
Esteve-Solé, 2017	not relevant outcome	EXCLUDED: only continuous variables studied (related to the human immune system development (such as cytokine excretion, blood counts, maturation of lymphocytes...). Exposure: ADA (n=5) or IFX (n=2).	Esteve-Solé A Front Immunol 2017;8:1123 10.3389/fimmu.2017.01123
Kattah, 2018	not relevant outcome	EXCLUDED: only continuous variables studied (immunophenotype of B-cell and T-cell subsets). Exposure: ADA or IFX monotherapy (n=11); CZP monotherapy (n=4); IFX/ADA and thiopurine (n=4); CZP and thiopurine (n=2).	Kattah MG Clin Transl Gastroenterol 2018;9:143 10.1038/s41424-018-0018-3
Mahadevan, 2014	not relevant outcome	EXCLUDED: only continuous variables. Infants in Group A, B and AB had equivalent or better achievement of milestones compared to unexposed.	Mahadevan Gastroenterology 2014;146:1-1
Kelly, 2014	repeat population groups, duplicate reports (most recent study included)	EXCLUDED: data certainly included in the data published by Chaparro 2018 (also a large European cohort, with Doherty as a co-author in the 2 publications)	Kelly J Crohn’s Colitis 2014; 8:S204–S05.
Accortt, 2015	repeat population groups, duplicate reports (most recent study included)	EXCLUDED: the data included in this abstract of congress has been published more recently and extensively by Carman 2017.	Accortt N Annals of the rheumatic diseases 2015;74(2): 788.3-789
Hyrich (ETN only), 2006	repeat population groups, duplicate reports (most recent study included)	EXCLUDED: these data were updated by Verstappen 2011.	Hyrich Arthritis Rheum. 2006; 54:2701-2 10.1002/art.22028
Luu, 2019	same data already obtained by other studies	EXCLUDED: data included in the larger study published by Luu et al. 2018 (study period 2011-2015).	Luu Aliment. Pharmacol. Ther. 2019; 50:1181-1188 10.1111/apt.15504
Mahadevan, 2012	no specific data	EXCLUDED: no details of results (The use of thiopurines and anti-TNF agents were not associated with an increase in “any complication”, SAB, CA, preterm birth, intrauterine growth retardation, caesarean section, or NICU stays even).	Mahadevan U Gastroenterology 2012;142:S149.
Kristjansdottir, 2019	no specific data	EXCLUDED: "Analysis of the impact of treatment with TNFi on pregnancy is not yet possible due to limited data."	Kristjansdottir Laeknabladid 2019; 105:267-275 10.17992/lbl.2019.06.235
Bérard, 2018	Studies without separate analysis of the considered drug/class from other drugs/class	EXCLUDED: Analyses performed for the group of pregnancies exposed antiTNFa and other biological immunosuppressants (adalimumab, etanercept, infliximab, certolizumab, golimumab, abatacept, anakinra, rituximab and tocilizumab).	Bérard A Ann Rheum Dis 2018;77:500-509 10.1136/annrheumdis-2017-212078
Giacuzzo, 2014	Studies without separate analysis of the considered drug/class from other drugs/class	EXCLUDED: less than 90% of AntiTNFa (85%). Exposures: 13 ETN, 6 ADA, 3 IFX, 4 RTX. All patients a-TNF treated withdrew therapy in early pregnancy (≤10 GW).	Giacuzzo S Ann Rheum Dis 2014;73(Suppl 2):414.
Beaulieu, 2018	Studies without separate analysis of the considered drug/class from other drugs/class	EXCLUDED: less than 90% of AntiTNFa (88%). Among the 42 biologic exposed patients, 27 were on infliximab, 7 on adalimumab, 3 on certolizumab, 2 each on natalizumab and ustekinumab, and 1 on vedolizumab.	Beaulieu DB Clin Gastroenterol Hepatol 2018;16:99-105 10.1016/j.cgh.2017.08.041
Strangfeld, 2015	Studies without separate analysis of the considered drug/class from other drugs/class	EXCLUDED: less than 90% of AntiTNFa (80%). 57 pregnancies were exposed to bDMARDs (29x etanercept, 11x adalimumab, 4x certolizumab pegol, 1x infliximab, 1x golimumab, 5x tocilizumab, 3x rituximab and 3x abatacept).	Strangfeld Arthritis Rheumatol. 2015; 67 (suppl 10).
Eworuke, 2019	pattern of exposure	EXCLUDED: Trends of TNFi use over the study period. No safety data on fetal/neonatal/maternal outcomes.	Eworuke Pharmacoepidemiol Drug Saf 2019; 28:296-304 10.1002/pds.4695