Tacrolimus (all routes)

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
Al-Otaibi
2019
Kuwait
2004 - 2017
retrospective cohort
The Hamed Alessa Organ Transplant Center of Kuwait Pregnant women maintained on tacrolimus-based regimen (all patients also maintained on steroids plus azathioprine). exposed to other treatment, sick
Pregnant women maintained on cyclosporin-based regimen (all patients also maintained on steroids plus azathioprine).
throughout pregnancy 33 / 49
All pregnancy data were collected from medical records maintained by the institution.
Alvaro
2013
Spain
1986 - 2011
retrospective cohort
Hospital Universitario 12 de Octubre Surgery. Pregnant women with orthotopic liver transplantation using tacrolimus during pregnancy. exposed to other treatment, sick
Pregnant women with orthotopic liver transplantation using cyclosporine during pregnancy.
throughout pregnancy 15 / 5 No mention of mycophenomate mofetil.
Examination of the records of all women recipients of reproductive age who underwent transplantation from 1986 to 2011.
Ichinose
2018
Japan
2008 - 2016
retrospective cohort
Nagasaki University Hospital, National Hospital Organization (NHO) Nagasaki Medical Center, and Japan Community Healthcare Organization (JCHO) Isahaya General Hospital. Mothers with systemic lupus erythematosus treated with tacrolimus during the pregnancy. unexposed, sick
Mothers with systemic lupus erythematosus never treated with tacrolimus during pregnancy.
during pregnancy (anytime or not specified) 15 / 39 The patients for whom tacrolimus treatment was terminated during a pregnancy were excluded.
Patients’ medical records were reviewed retrospectively including clinical and laboratory information.
Kim
2015
Seoul, Korea
1991 - 2012
prospective cohort
Asan Medical Center and Seoul National University Hospital Deliveries given tacrolimus-based immunosuppressants mostly combined with azathioprine and/or steroids (prednisolone or methylprednisolone). exposed to other treatment, sick
Deliveries given cyclosporine-based immunosuppressants mostly combined with azathioprine and/or steroids (prednisolone or methylprednisolone).
throughout pregnancy 28 / 60 None of the pregnancies were exposed to mycophenolic acid.
Medical records. Whole blood trough drug concentrations of CNI were examined at eight consecutive time points: from 12 months before delivery to 12 months after.
Perales-Puchalt
2012
Valencia, Spain
1995 - 2009
retrospective cohort
Hospital Universitario La Fe Immunosuppressive drugs used was Tacrolimus. All patients used Prednisone as a co-adjuvant therapy. The treatment protocol of the patients remained unchanged during the study period. exposed to other treatment, sick
Immunosuppressive drugs used were Cyclosporine-A and four had a combination with Azathioprine. All patients used Prednisone as a co-adjuvant therapy. The treatment protocol of the patients remained unchanged during the study period.
throughout pregnancy 9 / 11 Cyclosporine-A (CsA) and Azathioprine (AZA) groups could not be add because four pregnancies had a combination of CsA and AZA. Combinations are detailed and no mycophenolate mofetil involved.
Patient information was gathered for clinical records, used to obtain the information for the study in a retrospective manner. The treatment protocol of the patients remained unchanged during the study period.
Thompson
2003
England
1976 - 2001
retrospective cohort
Centre for Nephrology and Department of Obstetrics and Gynaecology, Royal Free and University College School of Medicine, London. Pregnant transplanted patients under tacrolimus, prednisolone and azathioprine. exposed to other treatment, sick
Pregnant transplanted patients under prednisolone, azathioprine -based regimens, with or without cyclosporine.
throughout pregnancy 4 / 23 No mycophenolate mofetil.
Review of the case notes detailed doses of immunosuppression and dose changes made during pregnancy, and other medications.
Wielgos
2012
Poland
2005 - 2010
retrospective cohort
A retrospective, single-center study conducted in the Department of Obstetrics and Gynecology, Medical University of Warsaw. Pregnant women who underwent renal or liver transplantation treated with tacrolimus-based regimen (alone or with prednisolone and/or azathioprine). exposed to other treatment, sick
Pregnant women who underwent renal or liver transplantation treated with cyclosporine-based regimen (alone or with prednisolone and/or azathioprine)..
throughout pregnancy 21 / 9 Data of patients treated with tacrolimus who underwent both renal and liver transplantation were added. None of women were treated with mycophenolate mofetil nor sirolimus during the time of pregnancy.
Complete data was obtained for doses and regimens of immunosuppressive medication and maternal/fetal outcomes (Not otherwise specified).

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
Sugawara
2019
Japan
2007 - 2016
nested case control
Hokkaido University Hospital in Hokkaido, Japan Pregnant women with any maternal and/or fetal complications. Pregnant women without any maternal and/or fetal complications. Clinical characteristics including history of rheumatic diseases treatment were recorded from medical records. during pregnancy (anytime or not specified) 34 / 23 Maternal adverse events: 34 cases and 23 controls. Fetal adverse events: 27 cases and 30 controls. Authors made some comparison with general obstetric population in Japan (GOP), but there is no distinction between treatments (results not reported here).
Data on pregnancy outcomes and maternal complications were collected (Not other specified).

Risk of bias: : NA;   : low;   : moderate;   : serious;   : critical;   : unclear;  

master protocol