Lupus & antiphospholipid syndrome
A retrospective analysis of the safety of tacrolimus use and its optimal cut-off concentration during pregnancy in women with systemic lupus erythematosus: study from two Japanese tertiary referral centers
Authors' conclusion
Tacrolimus use during pregnancy with SLE and lupus nephritis showed no significant influence on APO, blood pressure, or renal function; therefore tacrolimus may be suitable for controlling lupus activity during pregnancy.
Study context
- Population
- Pregnant patients with systemic lupus erythematosus (SLE) followed up at two Japanese tertiary referral centres
- Participants
- 124 pregnancies
- Exposure
- Tacrolimus exposure vs no tacrolimus during pregnancy in SLE
- Tacrolimusn = 29
- Outcome
- Adverse pregnancy outcomes (APO): overall, maternal, neonatal and PROMISSE APO
Methodological detailstwo Japanese tertiary referral centres, multivariate logistic regression
- Two Japanese tertiary referral centres
- Multivariate logistic regression
Main finding
As reported in the abstract
Overall adverse pregnancy outcome (APO), aOR
0.69; 95% CI, 0.23-2.03
p = 0.50
Maternal APO, aOR
1.17; 95% CI, 0.36-3.83
p = 0.80
Neonatal APO, aOR
1.10; 95% CI, 0.38-3.21
p = 0.86
PROMISSE APO, aOR
0.50; 95% CI, 0.14-1.74
p = 0.27
Observational data: associations, not effects.
Further findings
Blood pressure and estimated glomerular filtration rate (eGFR) during pregnancy and after delivery
- Did not differ between the two groups
Tacrolimus concentration > 2.6 ng/ml and reduced preterm birth rate (ROC)
- AUC
- 0.85, 95% CI: 0.61-1.00
- Sensitivity
- 93%
- Specificity
- 75%
APO in LN (subgroup), tacrolimus vs no tacrolimus
- Overall APO, OR
- 1.00; 95% CI, 0.25-4.08; p = 0.98
- Maternal APO, OR
- 1.60, 95% CI, 0.39-6.64; p = 0.51
- Neonatal APO, OR
- 0.71; 95% CI, 0.17-3.03; p = 0.65
- PROMISSE APO, OR
- 0.50; 95% CI, 0.08-3.22; p = 0.47
- No increased risk of APO, blood pressure or eGFR during pregnancy and after delivery
Tacrolimus-aspirin combination vs tacrolimus alone
- Protective tendency against hypertensive disorders during pregnancy, preeclampsia and low birth weight
Original publication
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