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Table 1 Inclusion characteristics (of the 26 systemic lupus erythematosus patients) and their ability to predict clinical outcome (univariate analysis)

From: Steady-state mycophenolate mofetil pharmacokinetic parameters enable prediction of systemic lupus erythematosus clinical flares: an observational cohort study

Inclusion characteristic

Total

n= 26

Successes

n= 17

Failures

n= 8

Pvaluea

Demographic

    

   Females/Males, number

16/10

12/5

4/4

0.28b

   Age, years

46 (35-61)a

46.5 (35-61)

46 (38-61)

0.9

   Body weight, kg

60 (56-75)

60 (56-75)

62 (58-82.5)

0.62

Disease

    

   Duration before entry, months

11 (7-14)

11 (7-12)

10 (6-13)

0.30

   SLEDAI score

0 (0-2)

0 (0-2)

0 (0-2)

0.20

   C3, g/L

1 (0.6-1.1)

1 (0.9-1.1)

0.8 (0.56-0.96)

0.21

   C4, g/L

0.2 (0.1-0.2)

0.2 (0.1-0.2)

0.2 (0.16-0.24)

0.78

   Anti-double-stranded DNA, IU/mL

24 (6-51)

8 (1 -32)

38 (9 -55)

0.19

Biological

    

   GFR, mL/minute

95 (67-125)

95 (67-125)

93.5 (76-109)

0.64

   Albumin, g/L

40 (39.8-43.8)

40 (37.9-43.8)

42.8 (40-46.9)

0.33

   Aspartate aminotransferase, IU/L

23 (19-26)

23 (17.5-24.5)

28 (20-33)

0.26

   Alanine aminotransferase, IU/L

22 (15-29)

19 (13-24.5)

25 (19-37)

0.21

   γ-Glutamyltransferase, IU/L

24 (17-63)

23 (17-21)

42 (17-61)

0.92

Treatment

    

   MMF, g/day

2 (2-2)

2 (2-2)

2 (2-2)

0.9

   Corticosteroids, mg/day

11 (7-35)

10 (5-20)

15 (7-45)

0.37

   Months of MMF therapy

2 (1-3)

2 (1-3)

2 (1-3)

0.56

   Months of corticosteroids

10 (6-13)

10 (5-15)

9 (5-14)

0.12

MPA pharmacokinetic parameters

    

   AUC0-12 h, mg/hour per L

64.7 (38.2-82)

73.1 (61.8-95)

37.7 (32-43.7)

0.003

   Cmax, mg/L

16.1 (9.5-18.5)

16.3 (9.7-17.4)

13.3 (7-22.5)

0.69

   Tmax, hours

1 (1-2)

1 (1-2)

1.1 (1-2)

0.82

   C12 h, mg/L

2.4 (1.5-4.1)

3.7 (2.3-4.9)

1.5 (0.6-2.1)

0.008

MPAG pharmacokinetic parameters

    

   AUC0-12 h, mg/hour per L

775.3 (475-1,026)

791 (635-1,166)

678.8 (426-840.6)

0.22

   Tmax, hours

2 (2-3)

2.3 (2-3)

1.3 (1-2)

0.01

   C12 h, mg/L

32.1 (24.3-41.9)

34.7 (26.4-49.2)

29.8 (15.5-40)

0.26

MPAG/MPA AUC0-12 h ratio

11.5 (8.3-20.7)

10.9 (6.2-14.8)

18.7 (14.1-22.7)

0.07

MPAG/MPA C12 h ratio

11.5 (6.8-17.3)

10.2 (6.3-15)

18.7 (11.5-47.2)

0.02

  1. Values are expressed as median (interquartile range) unless stated otherwise. aMann-Whitney U test; bFisher exact test. AUC0-12 h, area under the plasma concentration-versus-time curves for hours 0 to 12; C12 h, 12-hour trough concentration; Cmax, maximal concentration; GFR, glomerular filtration rate (estimated with the Cockcroft-Gault formula); MMF, mycophenolate mofetil; MPA, mycophenolic acid; MPAG, mycophenolic acid glucuronide; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index; Tmax, time to maximal concentration.