Leflunomide

Study	Exclusion reasons	Rmk	Reference
Cassina, 2012	inadequate or absent control group	EXCLUDED: Control could still have been exposed to some level of leflunomide during pregnancy. 2 OTIS articles NOT the same data. Cassina 2012 included women which did not meet the strict criteria of Chambers 2010.	Cassina M Arthritis Rheum 2012;64:2085-94 10.1002/art.34419
Chen, 2015	not relevant exposure	EXCLUDED: no exposure to leflunomide during pregnancy ("Methotrexate, mycophenolate mofetil and leflunomide were discontinued").	Chen Int J Environ Res Public Health 2015; 12:9876-88 10.3390/ijerph120809876
Verstappen, 2011	Studies without separate analysis of the considered drug/class from other drugs/class	EXCLUDED: no analysis for leflunomide (n=3). 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
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
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
Abdulrahman, 2020	Studies without separate analysis of the considered drug/class from other drugs/class	EXCLUDED: analysis according to illness and to some treatments (MET, NSAIDS,...) but not leflunomide.	Abdulrahman, M.A. Egyptian Rheumatologist 2020; 42:83-. 10.1016/j.ejr.2019.11.001
Cooper, 2014	Studies without separate analysis of the considered drug/class from other drugs/class	EXCLUDED: Leflunomide analyzed with other immunosuppressive medications (gold, sulfasalazine, leflunomide, azathioprine, and minocycline (no methotrexate, TNF-I, or hydroxychloroquine).	Cooper 2014; 66:444-50 10.1002/art.38262
Hyrich, 2006	Studies without separate analysis of the considered drug/class from other drugs/class	EXCLUDED: pregnancy outcomes of the 2 pregnant women exposed to LEF not reported.	Hyrich Arthritis Rheum. 2006; 54:2701-2 10.1002/art.22028
Drechsel, 2020	Studies without separate analysis of the considered drug/class from other drugs/class	EXCLUDED: analysis according to LEF and MTX as a whole (without specific data for Leflunomide).	Drechsel Rheumatology (Oxford) 2020; 59:603-612 10.1093/rheumatology/kez309
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
Wagner, 2006	pattern of exposure	EXCLUDED: pattern of exposure, without data on safety fetal/neonate/maternal outcomes.	Wagner Pharmacoepidemiol Drug Saf 2006; 15:369-86 10.1002/pds.1193
Zusman, 2019	pattern of exposure	EXCLUDED: analysis of treatment patterns of exposure, without safety data on fetal/neonatal/maternal outcomes.	Zusman Lupus 2019; 28:1205-1213 10.1177/0961203319863111