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Table 2 Prevalence of adverse pregnancy outcome according to tacrolimus exposure

From: 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

 

Tacrolimus exposure

Logistic regression (univariate)

Logistic regression (multivariate)

Factor

(-)

( +)

p value

OR

95% CI

P value

aOR

95% CI

P value

n

95

29

       

Overall APO (%)

46 (48.4)

16 (55.2)

0.67

1.31

0.57–3.02

0.525

0.69

0.23–2.03

0.50

Maternal APO (%)

23 (24.2)

13 (44.8)

0.056

2.54

1.07–6.07

0.035

1.17

0.36–3.83

0.80

Neonatal APO (%)

42 (44.2)

15 (51.7)

0.62

1.35

0.59–3.11

0.48

1.10

0.38–3.21

0.86

PROMISSE APO (%)

24 (25.3)

5 (17.2)

0.52

0.62

0.21–1.79

0.38

0.50

0.14–1.74

0.27

Flare during pregnancy (%)

8 (8.4)

8 (27.6)

0.017

4.14

1.39–12.3

0.010

   

Flare after delivery (%)

3 (3.4)

2 (8.7)

0.27

2.73

0.43–17.4

0.29

   

Hypertensive disorder during pregnancy (%)

13 (13.7)

7 (24.1)

0.29

2.01

0.72–5.64

0.19

   

Preeclampsia (%)

5 (5.3)

3 (10.3)

0.39

2.08

0.47–9.27

0.34

   

HELLP syndrome (%)

2 (2.1)

0 (0.0)

1.00

NA

NA

NA

   

Gestational DM (%)

8 (8.4)

6 (20.7)

0.14

2.84

0.90–9.0

0.076

   

Oligohydramnios (%)

8 (8.4)

1 (3.4)

0.68

0.38

0.05–3.21

0.38

   

Maternal death (%)

0 (0.0)

0 (0.0)

NA

NA

NA

NA

   

Total duration of gestation (days)

267.0 [257.5, 275.0]

266.0 [213.0, 273.0]

0.17

NA

NA

NA

   

Live birth (%)

88 (92.6)

23 (79.3)

0.088

0.31

0.09–0.10

0.049

   

Preterm birth (%)

16 (17.8)

5 (20.0)

1.00

1.16

0.38–3.54

0.80

   

Spontaneous abortion (%)

1 (1.1)

2 (7.4)

0.12

7.52

0.66–86.3

0.11

   

Missed abortion (%)

3 (3.2)

1 (3.7)

1.00

1.18

0.12–11.8

0.89

   

Iatrogenic abortion (%)

4 (4.2)

3 (10.3)

0.35

2.63

0.55–12.5

0.22

   

Still birth (%)

0 (0.0)

0 (0.0)

NA

NA

NA

NA

   

Planned C section (%)

14 (15.7)

3 (13.0)

1.00

0.80

0.21–3.07

0.75

   

Emergency C section (%)

28 (31.5)

13 (56.5)

0.048

2.83

1.11–7.24

0.030

   

Weight at birth (g)

2709 [2411, 3016]

2812 [2165, 2943]

1.00

NA

NA

NA

   

Low birth weight (%)

31 (35.2)

8 (34.8)

1.0

0.91

0.37–2.57

0.97

0.67

0.19–2.33

0.53

SGA (%)

15 (17.0)

4 (17.4)

0.37

1.02

0.31–3.45

NA

   

Apgar score 1 m

8.0 [8.0, 8.0]

8.00 [8.0, 8.0]

0.29

NA

NA

NA

   

Apgar score 5 m

9.0 [9.0, 9.0]

9.00 [9.0, 9.0]

0.92

NA

NA

NA

   

Major malformation (%)

1 (1.1)

1 (4.3)

0.37

3.95

0.24–65.8

0.34

   

Death of neonate (%)

0 (0.0)

1 (4.3)

0.21

NA

NA

NA

   
  1. aOR adjusted odds ratio, APO adverse pregnancy outcome, DM diabetes mellitus, HELLP hemolysis, elevated liver enzymes and low platelets, NA not available, OR odds ratio, PROMISSE Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus, SGA small for gestational age
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Arthritis Research & Therapy

ISSN: 1478-6362

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