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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.