Research Article

Real-World Experience of Safety of Mycophenolate Mofetil in 119 Japanese Patients with Systemic Lupus Erythematosus: A Retrospective Single-Center Study

Table 1

Characteristics of patients in the AE and no-AE groups.

OverallNo-AE groupAE group value

Age at start of MMF therapy, median (IQR)38 (31–46)39 (31–46)33 (29–45)0.20
Female sex, (%)101 (85)74 (82)27 (93)0.23
Body weight (kg), median (IQR)55 (48–63)57 (48–64)54 (46–62)0.23
Duration of SLE, months, median (IQR)138 (39–242)133 (40–227)160 (23–262)0.68
MMF started as induction therapy, (%)96 (81)72 (81)24 (83)1.00
Malar rash, (%)62 (52)51 (57)11 (38)0.09
Discoid rash, (%)23 (20)16 (18)7 (24)0.59
Photosensitivity, (%)31 (26)21 (24)10 (35)0.15
Oral ulcers, (%)31 (27)20 (23)11 (38)0.33
Arthritis, (%)75 (64)54 (61)21 (72)0.28
Serositis, (%)28 (24)23 (26)5 (17)0.45
Renal disorder, (%)81 (68)62 (69)19 (66)0.82
Neurologic disorder, (%)9 (8)6 (7)3 (10)0.69
Hematologic disorder, (%)89 (75)68 (76)21 (72)0.8
Immunologic disorder, (%)118 (99)89 (99)29 (100)1.00
Antinuclear antibody, (%)119 (100)90 (100)29 (100)N/A
SLEDAI at start of MMF therapy, median (IQR)6 (4–10)6 (4–10)8 (4–13)0.14
Number of SLE flare-ups, median (IQR)1 (1–3)2 (1–2)1 (0–3)0.30
WBC count (/μL), median (IQR)6,600 (4,500–7,900)6,100 (4,400–7,600)7,000 (5,800–9,500)0.07
Lymphocytes (/μL), median (IQR)1,001 (598–1,335)925 (544–1,326)1,039 (619–1,404)0.41
Hemoglobin (g/dL), median (IQR)11.8 (10.6–13.1)12.1 (11.1–13.2)11.2 (10–12.3)0.014
Platelets (104/μL), median (IQR)23.3 (18.6–28.8)23.6 (19.3–28)22.4 (17.8–30.7)0.91
AST (U/L), median (IQR)19 (15–24)18 (15–24)19 (15–25)0.67
ALT (U/L), median (IQR)18 (12–28)16 (11–25)25 (15–34)0.011
Albumin (g/dL), median (IQR)3.5 (3–3.9)3.6 (3.1–3.9)3.2 (2.6–3.8)0.06
BUN (mg/dL), median (IQR)15 (11–20)14 (10–19)18 (14–27)0.006
Creatinine (mg/dL), median (IQR)0.62 (0.49–0.83)0.62 (0.49–0.78)0.57 (0.48–0.99)0.48
eGFR (mL/min/1.73 m2), median (IQR)91 (67–115)92 (70–115)89 (46–124)0.63
CH50 (U/mL), median (IQR)28 (20–38)29 (21–39)25 (16–37)0.33
C3 (mg/dL), median (IQR)66 (48–84)69 (52–85)61 (44–83)0.38
C4 (mg/dL), median (IQR)11 (7–18)12 (7–19)10 (5–17)0.31
IgG (mg/dL), median (IQR)1,220 (914–1,455)1,243 (943–1,431)1,151 (597–1,718)0.59
Anti-DNA antibody (RIA) (IU/mL), median (IQR)11 (0–62)7 (0–50)30 (5–188)0.053
Anti-U1-RNP antibody, positivity, (%)43 (36)34 (38)9 (31)0.52
Anti-Sm antibody, positivity, (%)16 (14)14 (16)2 (7)0.35
Anti-CL antibody, positivity, (%)26 (22)22 (25)4 (14)0.30
Anti-CLβ2GP1 antibody, positivity, (%)13 (11)9 (10)4 (14)1.00
Lupus anticoagulant, median (IQR)0.9 (0.9–1)1 (0.9–1)0.9 (0.8–1)0.51
Proteinuria (g/day), median (IQR)0.6 (0–2.3)0.5 (0–2.1)0.7 (0–2.5)0.46
Hematuria, positivity, (%)38 (33)28 (33)10 (35)1.00
GC dose at start of MMF therapy (mg/day), median (IQR)20 (10–40)19 (10–36)28 (12–55)0.07
Overall maximum GC dose (mg/day), median (IQR)50 (40–60)50 (40–60)50 (40–60)0.93
LLDAS at last observation, (%)67 (57)57 (64)10 (35)0.009

AE: adverse event; MMF: mycophenolate mofetil; IQR: interquartile range; SLE: systemic lupus erythematosus; SLEDAI: SLE disease activity index; WBC: white blood cell; AST: aspartate aminotransferase; ALT: alanine aminotransferase; BUN: blood urea nitrogen; eGFR: estimated glomerular filtration rate; IgG: immunoglobulin G; DNA: deoxyribonucleic acid; RIA: radioimmunoassay; U1RNP: U1-ribonucleoprotein; Sm: Smith; CL: cardiolipin; CLβ 2GP1: cardiolipin β2-glycoprotein I; GC: glucocorticoid; LLDAS: lupus low disease activity state. . .