Adalimumab


Study Exclusion reasons Rmk Reference
Kanis, 2018 inadequate or absent control group EXCLUDED: all pregnant women exposed to adalimumab or infliximab, two anti-TNF, with limited data on pregnancy. No adequate control group.

Kanis J Crohns Colitis 2018; 12:939-947 10.1093/ecco-jcc/jjy058
Julsgaard, 2016 inadequate or absent control group EXCLUDED: all pregnant women exposed to adalimumab or infliximab, two anti-TNF, with limited data on pregnancy. No adequate control group.

Julsgaard M Gastroenterology 2016;151:110-9 10.1053/j.gastro.2016.04.002
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. No separate analysis of adalimumab and infliximab.

Julsgaard Inflamm. Bowel Dis. 2020; 26:93-102 10.1093/ibd/izz110
Alijotas-Reig, 2019 inadequate or absent control group EXCLUDED: all pregnancies exposed to anti-TNF (adalimumab or certolizumab). No adequate control group.

Alijotas-Reig Semin. Arthritis Rheum. 2019; 49:314-318 10.1016/j.semarthrit.2019.02.006
Seow, 2017 inadequate or absent control group EXCLUDED: pregnancies exposed to infliximab or adalimumab. No adequate control group.

Seow Aliment. Pharmacol. Ther. 2017; 45:1329-1338 10.1111/apt.14040
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
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. No analysis according treatment.

Kammerlander Inflamm. Bowel Dis. 2017; 23:1011-1018 10.1097/MIB.0000000000001102
Odorici, 2019 case report or case series EXCLUDED: case-series (all patients treated with secukinumab, infliximab, etanercept or adalimumab).

Odorici J Eur Acad Dermatol Venereol 2019; 33:e374-e377 10.1111/jdv.15671
Snarski, 2015 case report or case series EXCLUDED: no control group and no analysis according to treatments.

Snarski Bone Marrow Transplant. 2015; 50:216-20 10.1038/bmt.2014.248
Kawai, 2019 case report or case series EXCLUDED: all pregnant women exposed to adalimumab. No control group.

Kawai Dig Dis 2019; 37:123-130 10.1159/000493462
Esteve-Solé, 2017 other reason 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 other reason 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
Burmester (Unexposed control, disease free) (RA only), 2017 repeat population groups, duplicate reports (most recent study included) EXCLUDED: data updated by Chambers 2019 a whole publication on a longer period study (2004-2016) and with more outcomes studied.

Burmester GR Ann Rheum Dis 2017;76:414-417 10.1136/annrheumdis-2016-209322

Chambers CD Gastroenterology; 2015;148(S1):405.

Chambers (Controls, sick) (RA only), 2015 repeat population groups, duplicate reports (most recent study included) EXCLUDED: data included in the last Short Communication published (Chambers 2017). Updates of these data regularly published (Burmester, 2017; Chambers 2015; Chambers 2007; Johnson 2009; Johnson 2011).

Chambers CD Gastroenterology; 2015;148(S1):405.

Burmester (Controls, sick) (RA only), 2017 repeat population groups, duplicate reports (most recent study included) EXCLUDED: data updated by Chambers 2019 a whole publication on a longer period study (2004-2016) and with more outcomes studied.

Burmester GR Ann Rheum Dis 2017;76:414-417 10.1136/annrheumdis-2016-209322

Chambers CD Gastroenterology; 2015;148(S1):405.

Chambers (Controls, sick), 2017 repeat population groups, duplicate reports (most recent study included) EXCLUDED: data updated by Chambers 2019 a whole publication on a longer period study (2004-2016) and with more outcomes studied.

Chambers CD Pharmacoepidemiology and Drug Safety 2017;26:218–219

Chambers (Control unexposed, disease free), 2017 repeat population groups, duplicate reports (most recent study included) EXCLUDED: data updated by Chambers 2019 a whole publication on a longer period study (2004-2016) and with more outcomes studied.

Chambers CD Pharmacoepidemiology and Drug Safety 2017;26:218–219

Johnson, 2009 repeat population groups, duplicate reports (most recent study included) EXCLUDED: data included in the last Abstract published (Chambers, 2017). Updates of these data regularly published (Burmester, 2017; Chambers 2015; Chambers 2007; Johnson 2009; Johnson 2011).

Johnson DL Gastroenterology 2009;136(5):A-27.

Chambers, 2007 repeat population groups, duplicate reports (most recent study included) EXCLUDED: data included in the last Abstract published (Chambers, 2017). Updates of these data regularly published (Burmester, 2017; Chambers 2015; Chambers 2007; Johnson 2009; Johnson 2011).

Chambers CD Journal of the American Academy of Dermatology 2007;56(2), Supplement 2, Page AB10

Johnson, 2011 repeat population groups, duplicate reports (most recent study included) EXCLUDED: data included in the last Abstract published (Chambers, 2017). Updates of these data regularly published (Burmester, 2017; Chambers 2015; Chambers 2007; Johnson 2009; Johnson 2011).

Johnson DL 2011;1874. Available on: https://acr.confex.com/acr/2011/webprogram/Paper19261.html

Chambers (Unexposed controls, disease free) (RA only), 2015 repeat population groups, duplicate reports (most recent study included) EXCLUDED: data included in the last Abstract published (Chambers, 2017). Updates of these data regularly published (Burmester, 2017; Chambers 2015; Chambers 2007; Johnson 2009; Johnson 2011).

Chambers CD Gastroenterology; 2015;148(S1):405.

De Lima, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Analyses were performed for the group of TNF-α inhibitors (ADA and IFX), without individual analysis by substance and provided raw data did not allow to calculate the birth defects. Exposure: IFX (n=8); ADA (n=7)

de Lima A J Crohns Colitis 2018;12:948-953 10.1093/ecco-jcc/jjy053
Sheibani, 2016 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: The aims were to assess birth outcomes and infants’ health outcomes at 1 year for IFX and ADA separately. Outcome data provided for IFX and ADA as a whole, without distinction between substance.

Sheibani S Dig Dis Sci 2016;61:1622-7 10.1007/s10620-015-3992-2
Beaulieu, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Analyses performed for the group of pregnancies exposed to biologic exposed patients, without analysis for each substance : 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
Bortlik, 2013 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: no distinction in outcomes after ADA or IFX exposure.

Bortlik Scand. J. Gastroenterol. 2013; 48:951-8 10.3109/00365521.2013.812141
Tsao, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: biologic treatments (Infliximab, Etanercept, Adalimumab,abatacept, alefacept, certolizumab pegol,golimumab, rituximab, tocilizumab and ustekinumab) studied as a whole, without distinction between treatments.

Tsao BMJ Open 2019; 9:e023714 10.1136/bmjopen-2018-023714
Cooper, 2014 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of Tumor necrosis factor inhibitors (included etanercept, infliximab, adalimumab) as a whole, without distinction between treatment.

Cooper 2014; 66:444-50 10.1002/art.38262
Chaparro, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of Anti-TNF as a whole, without distinction between treatments.

Chaparro Am. J. Gastroenterol. 2018; 113:396-403 10.1038/ajg.2017.501
Broms, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis performed according illness status without distinction between treatments.

Broms Acta Derm. Venereol. 2018; 98:728-734 10.2340/00015555-2923
Drechsel, 2020 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis according to DMARD as a whole, with specific data only for TNF and Etanercept but not for other treatments.

Drechsel Rheumatology (Oxford) 2020; 59:603-612 10.1093/rheumatology/kez309
Duricova, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of children exposed to anti-TNF, without distinction between infliximab or adalimumab exposure.

Duricova Inflamm. Bowel Dis. 2019; 25:789-796 10.1093/ibd/izy294
Diav-Citrin (Control exposed to other treatments), 2014 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Analyses were performed for the group of 3 TNF-α inhibitors (ADA, ETA, and IFX), without individual analysis by substance and provided raw data did not allow to calculate the birth defects (ex: denominator not available for malformation rates).

Diav-Citrin O Reprod Toxicol 2014;43:78-84 10.1016/j.reprotox.2013.11.004
Koslowsky, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: no distinction between treatments.

Koslowsky Inflamm. Bowel Dis. 2018; 24:1826-1832 10.1093/ibd/izy081
Mills, 2020 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: developmental milestone outcomes analysis before or after maternal AIRD diagnosis. No detailed analysis according to the medications.

Mills J. Rheumatol. 2020; 47:149-154 10.3899/jrheum.181067
Diav-Citrin (Unexposed control), 2014 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Analyses were performed for the group of 3 TNF-α inhibitors (ADA, ETA, and IFX), without individual analysis by substance and provided raw data did not allow to calculate the birth defects (ex: denominator not available for malformation rates).

Diav-Citrin O Reprod Toxicol 2014;43:78-84 10.1016/j.reprotox.2013.11.004
Moens, 2020 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of anti-TNF as a whole without distinction between treatments.

Moens Aliment. Pharmacol. Ther. 2020; 51:129-138 10.1111/apt.15539
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 immunosuppressants (adalimumab, etanercept, infliximab, certolizumab, golimumab, abatacept, anakinra, rituximab and tocilizumab), without analysis for each substance.

Bérard A Ann Rheum Dis 2018;77:500-509 10.1136/annrheumdis-2017-212078
Eudy, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: analysis of pregnancy outcomes in women with RA versus healthy controls, without distinction between treatments.

Eudy Clin. Rheumatol. 2018; 37:789-794 10.1007/s10067-017-3939-4
Verstappen, 2011 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: no specific analysis for substance. 4 groups according to anti-TNF exposure: (1) anti-TNF and MTX and/or LEF at conception (n=21); (2) anti-TNF at conception (n=50); (3) anti-TNF prior to conception (n=59); (4) no exposure to anti-TNF (n=10).

Verstappen SM Ann Rheum Dis 2011;70:823-6 10.1136/ard.2010.140822
Luu, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Analyses were performed for the group of TNF-α inhibitors (mainly ADA and IFX), without individual analysis by substance and provided raw data did not allow to calculate the birth defects.

Luu Aliment. Pharmacol. Ther. 2019; 50:1181-1188 10.1111/apt.15504
De Lima, 2016 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Analyses were performed for the group of TNF-α inhibitors (ADA and IFX), without individual analysis by substance and provided raw data did not allow to calculate the birth defects.

de Lima A Gut 2016;65:1261-8 10.1136/gutjnl-2015-309321
Broms, 2016 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Analyses performed for the group of pregnancies exposed to antiTNFa, without analysis for each substance: ETN (338), ADA (77), IFX (28), GOL (4) (data obtained through personal communication with authors by Mirdamadi et al., 2018).

Broms G Scand J Gastroenterol 2016;51:1462-1469 10.1080/00365521.2016.1208269
Luu, 2018 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: Analyses were performed for the group of TNF-α inhibitors (mainly ADA and IFX), without individual analysis by substance and provided raw data did not allow to calculate the birth defects.

Luu M Am J Gastroenterol 2018;113:1669-1677 10.1038/s41395-018-0176-7
Sugawara, 2019 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: outcomes of the pregnancies exposed to Adalimumab were not reported separately.

Sugawara Lupus 2019; 28:1407-1416 10.1177/0961203319877258
Gaujoux-Viala, 2009 Studies without separate analysis of the considered drug/class from other drugs/class EXCLUDED: outcomes of pregnancies exposed to TNFi reported as a whole without distinction between treatments.

Gaujoux-Viala Clinical and Experimental Rheumatology 2009; 27:1059-.

Viktil, 2009 pattern of exposure EXCLUDED: Pattern of exposure without data on fetal/maternal/neonatal safety outcomes.

Viktil KK Pharmacoepidemiol Drug Saf 2009;18:737-42 10.1002/pds.1775
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

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