Formosan Journal of Rheumatology 2008;22:30-36

Original Article

Clinical efficacy of mycophenolic acid in the treatment of lupus

nephritis
Fu-Mei Su1, Shue-Fen Luo2, Shan-Fu Yu1, Chun-Kai Chiu1, Ying-Chou Chen1, Han-Ming Lai1,
Chung-Jen Chen1, Tien-Tsai Cheng1
1
Division of Allergy, Immunology and Rheumatology, Chang Gung Memorial Hospital-Kaohsiung Medical
Center, Chang Gung University College of Medicine, Kaohsiung, Taiwan.
2
Division of Allergy, Immunology and Rheumatology, Chang Gung Memorial Hospital-Linkou Medical
Center, Chang Gung University College of Medicine, Linkou, Taiwan.

Objective: To demonstrate the efficacy and safety of mycophenolic acid (MPA) as an induction therapy
for lupus nephritis (LN) due to the availability of limited data in Taiwan.
Materials and Methods: This retrospective study included subjects who were treated with MPA for LN
at the rheumatology outpatient clinic in Chang Gung Memorial Hospital-Kaohsiung and Linkou Medical
Centers between January 2005 and July 2007. Subjects were categorized into 2 groups according to the
dose of MPA. We measured complete blood count (CBC), levels of serum creatinine (Scr), albumin,
complement (C3 and C4), anti-double-stranded DNA (anti-dsDNA) antibody titer, and daily urinary
protein at the baseline, 12 weeks, and 24 weeks after MPA therapy, and therapeutic response and adverse
effects were analyzed.
Results: A total of 37 subjects were enrolled: 26 in group I (Gr I) and 11 in group II (Gr II). At both 12
and 24 weeks, 1 subject from each group achieved a complete response (CR). One-third of the subjects
in Gr I achieved partial response (PR) at 12 weeks and 43% achieved it at 24 weeks, while 67% and 75%
of subjects in Gr II achieved CR at 12 and 24 weeks, respectively. Except for a significant improvement
in percent changes in the Scr levels in Gr II, the changes in the daily urinary protein, serum albumin,
complement, and anti-dsDNA levels of both the groups were not statistically significant but showed a
similar trend of improvement. Only one serious adverse event occurred in each group.
Conclusions: Compared to treatment with mycophenolate mofetil (MMF) at 1 g/day or MPA at 720 mg/
day, treatment with either MMF at 2 g/day or MPA at 1440 mg/day had a better therapeutic effect on LN.
In general, the regimen followed in our investigation was safe.

Key words: Mycophenolic acid, lupus nephritis

Introduction The kidney is the major organ involved in systemic

Corresponding author: Tien-Tsai Cheng, M.D.
Department of Rheumatology, Immunology and Allergy, Chang
Gung Memorial Hospital-Kaohsiung Medical Center, Chang Gung
University College of Medicine, Kaohsiung, Taiwan. 123, Ta-Pei
Road, Niao-Sung Hsiang, Kaohsiung Hsein, 833, Taiwan
TEL: +886-7-7317123 ext 8800, FAX: +886-7-7322402
E-mail: tiantsai@ms2.hinet.net
Received: March 11, 2008
Revised: June 10, 2008
Accepted: June 26, 2008
lupus erythematosus (SLE). Up to 60% of SLE patients
develop renal manifestations at some point during the
course of the disease [1]. The clinical presentation of
kidney involvement is highly variable, ranging from
mild asymptomatic proteinuria to rapidly progressive
glomerulonephritis, hematuria with red cell casts,
and/or acute renal failure [1]. The histopathological
manifestations of lupus nephritis (LN) are classified
into 6 categories that are defined by the World Health
Organization (WHO) [2]. The optimal treatment regimen

30

for LN varies according to the WHO class [2]. Based
on investigations conducted at the National Institutes
of Health over the past 20 years [3,4], intravenous
cyclophosphamide (CYC) has become the standard
therapy for LN [5]. Induction therapies that combine
CYC and steroids have better renal outcomes and
achieve lower rates of recurrence than those obtained
with steroid therapy alone [6,7]. These benefits,
however, continue to be mitigated by significant drug-
related toxicity. Several immediate and long-term side
effects are noted. The immediate toxicities of pulse
CYC therapy include nausea, vomiting, hair loss,
and fatigue. The major toxicities include cytopenia,
serious infections, hemorrhagic cystitis, malignancy,
and importantly, gonadal failure (26–52%). The risk
of toxicity increases with increase in both the dose and
duration of CYC therapy [8-10].
Recently, mycophenolic acid (MPA) has emerged
as a promising alternative induction and maintenance
therapy for LN. MPA is an inhibitor of a crucial
enzyme involved in the de novo synthesis of guanosine
nucleotides [11,12]. Since lymphocytes do not possess a
salvage pathway for the synthesis of these nucleotides,
MPA selectively blocks B- and T-cell proliferation.
Evidence from early observational studies suggests that
MPA may be effective in inducing LN remission [13].
Subsequent studies have revealed similar results [14-17].
The optimal dose of MPA for LN remains uncertain
since there is no head-to-head comparison of low-dose
and high-dose MPA therapy for severe active LN.
Materials and Methods
Patients
We retrospectively reviewed charts of patients
with LN who had received MPA at the rheumatology
outpatient clinic of Chang Gung Memorial Hospital-
Kaohsiung and Linkou Medical Centers from January
2005 to July 2007. All the patients fulfilled the
revised criteria defined by the American College of
Rheumatology in 1997 [18]. The therapeutic strategy
for LN was an induction therapy of MPA. All patients
were administered MPA therapy for resistant or relapsed
LN, regardless of their previous conditions such as prior
CYC therapy, relapse after maintenance therapy with
azathioprine (AZA), intolerable side effects to CYC, or
refusal to undergo initial CYC therapy. In this hospital,
2 drugs possessing MPA activity are available. The
pharmacodynamic potency of 1 tablet of Cellcept®
(mycophenolate mofetil (MMF): 250 mg/tablet, Roche)
Su et al
is equal to that of 1 tablet of Myfortic® (MPA: 180
mg/tablet, Novartis). Hence, these tablets may be used
interchangeably in clinical settings. The dose used was
arbitrary and was selected after the consideration of body
weight of patients, heavy proteinuria, or side effects by
the clinical staff. Patients were categorized into 2 groups
according to the dose of MPA: those who received MMF
at 1 g/day or MPA at 720 mg/day were included in Gr I,
and those who received MMF at 2 g/day or MPA at 1440
mg/day were included in Gr II. The following laboratory
data were collected at the baseline and at 12 and 24
weeks after MPA therapy: complete blood count (CBC),
serum albumin, and serum creatinine (Scr) levels; daily
urinary protein and serum complement (C3 and C4)
levels; and anti-double-stranded DNA (anti-dsDNA)
antibody titer, if available.
To assess the therapeutic effects, we used the
modified criteria defined by Ellen et al in 2005 [14]. The
primary endpoint was complete response (CR) at 12 and
24 weeks. CR was defined as the return to within 10%
of normal values of Scr levels and a daily urinary protein
of less than 500 mg. A secondary endpoint was partial
response (PR) at 12 and 24 weeks. PR was defined as an
improvement of 30% in the Scr levels or daily urinary
protein compared to the corresponding baseline values.
Additional secondary endpoints included changes in the
hemoglobin level, platelet count, levels of complement
components (C3 and C4), anti-dsDNA antibody titer,
and serum albumin levels. Treatment failure was defined
as a condition requiring doses of steroids higher than
those administered for disease control or failure to
achieve CR or PR at 24 weeks. Toxic effects requiring
discontinuation of the study drug or withdrawal from
the study for any other reason were also considered as
treatment failure.
Statistical analysis
The Mann-Whitney test and Friedaman’s test were
used to compare the continuous variables between the
groups and within the groups, respectively. The chi-
square test was performed to evaluate the treatment
response. Data are expressed as the median value
(interquartile range), unless otherwise specified.
Statistical analyses were performed using the software
package SPSS 15.0 for Windows (Apache Software
Foundation). All the tests were two-tailed, and a p value
of <0.05 was considered statistically significant.
31
 MPA in lupus nephritis

Table 1. Baseline characteristics of the study patients

Characteristics Gr I (n=26) Gr II (n=11) pb
Age (years) 34 ± 10c 32 ± 14 0.27
Number of females (%) 24 (92.3) 9 (81.8) 0.89
Scr (mg/dL), No. 1.0 (0.7~1.6), 26 1.2 (0.8~2.3), 11 0.40
Daily urinary protein (g), No. 3.5 (2.0~4.6), 22d 4.7 (4.1~6.4), 9 0.02
Albumin (g/dL), No. 2.9 (2.5~3.6), 25 2.2 (1.4~2.9), 11 0.02
C3 (mg/dL), No. 72.9 (49.8~101), 19 48.7 (39.4~77.3), 11 0.09
C4 (mg/dL), No. 7.1 (5.3~17.6), 16 9.4 (8.5~14.9), 11 0.88
dsDNA (IU/mL), No. 402 (290~824), 14 252 (178~2334), 11 1.00
Abbreviations: Scr = serum creatinine; dsDNA = anti-double-stranded DNA antibodies
a
Patients in Gr I (Group I) received MMF at 1 g/day or MPA at 720 mg/day. Patients in GR II (Group II) received MMF at 2 g/day or MPA
at 1440 mg/day.
b
Mann-Whitney test & mean ± SD
c
Median (interquartile range)
d
Number of patients analyzed; those with missing data were excluded.

Results (p=0.007) was noted in both the groups. There was no

Thirty-seven subjects were enrolled in this study: 26
subjects in Gr I and 11 subjects in Gr II. Gr I comprised
24 women and 2 men with a mean age of 34 ± 10 years,
while Gr II comprised 10 women and 1 man with a
mean age of 32 ± 14 years. The median baseline daily
urinary protein was 3.5 g/day in Gr I and 4.7 g/day in Gr
II, and the median value of serum albumin level was 2.9
g/dL in Gr I and 2.2 g/dL in Gr II. As shown in Table 1,
the baseline characteristics of the patients in the 2 groups
were similar, except with regard to daily urinary protein
and the serum albumin level.
At both 12 and 24 weeks, 1 patient each from both
groups reached CR. At 12 weeks, PR was noted in 7
patients (33%) in Gr I and in 6 patients (67%) in Gr II.
At 24 weeks, PR was observed in 9 patients (43%) in Gr
I and in 6 patients (67%) in Gr II (Table 2). At 12 and 24
weeks, there was no obvious difference in the percentage
of PR (p=0.12 and 0.21, respectively) between
the groups. A significant difference in the absolute
improvement of Scr levels at 12 (p=0.02) and 24 weeks
Table 2. Partial (PR) and complete (CR) response rate at
the 12th and 24th weeksa in Gr I). No drug-related hematologic toxic effects
Gr I No. (%) Gr II No. (%) pb
PR12 c
7/21 (33) 6/9 (67) 0.12
PR24 9/21 (43) 6/8 (75) 0.21
CR12 1 1
CR24 1 1
a
Patients in Gr I (Group I) received MMF at 1 g/day or MPA at
720 mg/day. Patients in GR II (Group II) received MMF at 2
g/day or MPA at 1440 mg/day.
b percent of patients in Gr I and 75% of patients in Gr
Chi-square test
c
Number of patients analyzed; those with missing data were
excluded.
significant difference in the percent change of daily
urinary protein (p=0.09 and 0.23 at 12 and 24 weeks,
respectively). There was a trend of improvement in the
percent change in daily urinary protein as compared to
the baseline value at each time point (Table 3). As shown
in Table 4, no significant changes but a similar trend
was observed in the Scr, daily urinary protein, serum
albumin, hemoglobin, platelet, WBC, complements C3
and C4, and anti-dsDNA levels after treatment in both
the groups.
Adverse events
One serious adverse event was noted during the
treatment period in each group. One patient from Gr
I was hospitalized due to an asthma attack, and one
patient from Gr II was hospitalized due to fever. Other
adverse events included upper respiratory tract infection
(4 patients in Gr I and 3 in Gr II), oral candidiasis (2
patients in Gr II), upper gastrointestinal (GI) discomfort
(4 patients in Gr I and 5 in Gr II), urinary tract infection
(2 patients in Gr II), arthralgia (3 patients in Gr I and 1
in Gr II), and gingivitis-related gum bleeding (1 patient
were noted in both the groups. GI disturbances and the
incidence of infections were similar in both the groups.
Discussion
In our short-term study, only 1 subject from each
group achieved a CR at 12 and 24 weeks. Forty-three
II achieved a PR at 24 weeks. There is no uniformly
accepted definition of remission. In most studies,

32
 Su et al

Table 3. Parameters at each time pointa

Timing Weekb Gr I (n=26) Gr II (n=11) pc
DPL reduction %, No. 12 11 (–31~42)d (17)e 42 (–12~88) (9) 0.09
24 31 (–9~47) (14) 60 (0.3~80) (5) 0.23
Scr reduction %, No. 12 5 (–16~17) (26) 20 (0~56) (11) 0.02
24 0 (–6~15) (26) 26 (0~100) (11) 0.01
Albumin (g/dL), No. 12 3.3 (2.6~3.6) (23) 2.4 (1.9~3.2) (10) 0.06
24 3.4 (2.9~3.8) (24) 3.2 (1.9~3.7) (6) 0.47
C3 (mg/dL), No. 12 76.4 (68.5~93.8) (13) 63.1 (43.1~67.1) (7) 0.09
24 83.3 (68.9~93.2) (17) 77.7 (53~127.5) (5) 0.94
C4 (mg/dL), No. 12 9.2 (7.3~19.6) (13) 24.2 (15.0~27.4) (7) 0.14
24 13.5 (8.9~18.3) (17) 24.9 (12.6~29.0) (5) 0.17
dsDNA (IU/mL), No. 12 210 (66~304) (12) 370 (41~1222) (6) 0.85
24 124 (52~304) (14) 63 (29~699) (5) 0.52
Abbreviations: DPL = daily urinary protein; Scr = serum creatinine; dsDNA = anti-double-stranded DNA antibodies
a
Patients in Gr I (Group I) received MMF at 1 g/day or MPA at 720 mg/day. Patients in GR II (Group II) received MMF at 2 g/day or MPA
at 1440 mg/day.
b
Time: at the 12th and 24th weeks
c
Mann-Whitney test
d
Median (interquartile range)
e
Number of patients analyzed; those with missing data were excluded

remission is defined as a composite of improvement in
proteinuria and renal function and reduction in urinary
sediments. The definition of proteinuria varies widely
in the literature. By considering a 50% reduction in
proteinuria as PR and proteinuria of less than 500 mg/
day as CR, Appel et al. achieved a PR rate of 29.6% with
MMF (2 g) and a CR rate of 19.7% over 24 weeks [19].
Ong et al achieved a complete remission rate of 26%
with MMF (2 g) treatment for 6 months. The proteinuria
of patients with CR reduced to less than 0.3 g/day [15].
An earlier randomized controlled study by Chan et al.
reported that treatment with MMF (2 g) for 6 months,
followed by maintenance therapy with MMF (1 g),
achieved a 1-year CR rate of 81% and a PR rate of 14%.
Patients with proteinuria of less than 0.3 g/day were
considered to show CR, while patients with PR excreted
0.3-3 g of urinary protein per day [13]. It is suggested
that severe LN follows a different course in different
ethnic groups; therefore, the results related to LN cannot
be generalized across countries [15]. In the study of
Ong, the patient population was heterogeneous, and
half of the participants were of non-Chinese origin [15].

Table 4. Response kinetics: Laboratory values at the baseline, 12 weeks, and 24 weeksa
Baseline 12th week 24th week pb
Gr I Scr 1.0 (0.7–1.6) (26)c 0.9 (0.8–1.3) (26) 1.0 (0.7–1.4) (26) 0.99
DPL 3.5 (2.0–4.6) (22) 3.4 (2.0–4.9) (18) 2.8 (0.9–4.3) (14) 0.17
Albumin 2.9 (2.5–3.6) (25) 3.3 (2.6–3.6) (23) 3.4 (2.9–3.8) (24) 0.14
C3 72.9 (49.8–101) (19) 76.4 (68.5–93.8) (13) 83.3 (68.9–93.2) (17) 0.31
C4 7.1 (5.3–17.6) (16) 9.2 (7.3–19.6) (13) 13.5 (8.9–18.3) (17) 0.07
dsDNA 402 (290–824) (14) 210 (66–304) (12) 14 (9–18) (17) 0.02
Gr II Scr 1.2 (0.8–2.3) (11) 0.8 (0.7–1.0) (11) 0.9 (0.8–1.1) (8) 0.02
DPL 4.7 (4.1–6.4) (9) 2.3 (1.4–4.6) (9) 2.9 (1.7–5.4) (6) 0.07
Albumin 2.2 (1.4–2.9) (11) 2.4 (1.9–3.2) (10) 3.2 (1.9–3.7) (6) 0.10
C3 48.7 (39.4–77.3) (11) 63.1 (43.1–67.1) (7) 77.7 (53–127.5) (5) 0.09
C4 9.4 (8.5–14.9) (11) 24.2 (15.0–27.4) (7) 24.9 (12.6–29.0) (5) 0.09
dsDNA 252 (178–2334) (11) 370 (41–1222) (6) 63 (29–699) (5) 0.14
Abbreviations: Scr = serum creatinine; DPL = daily urinary protein; dsDNA = anti-double-stranded DNA antibodies
a
Patients in Gr I (Group I) received MMF at 1 g/day or MPA at 720 mg/day. Patients in GR II (Group II) received MMF at 2 g/day or MPA
at 1440 mg/day.
b
Friedaman’s test
c
Number of patients analyzed; those with missing data were excluded

33
 MPA in lupus nephritis
Chan et al reported excellent results for a trial involving
Chinese patients [13]. In their report, all the patients with
PR had nephrotic-range proteinuria at the baseline. In
the present study, all the patients were Chinese, and most
of them had nephrotic-range proteinuria at the baseline
level; this may explain the relatively higher PR rate
(43% in Gr I and 75% in Gr II) at 24 weeks. In contrast
to the results obtained in previous studies, our low CR
rate with MMF in both the groups may be related to the
inherent limitations of our retrospective study. Daily
urinary protein was not assessed at the baseline in 6 of
37 subjects; further, it was not assessed in 10 patients at
12 weeks and in 17 patients at 24 weeks.
The improvement in daily urinary protein was
reflected by an upward trend in the serum albumin
level over 24 weeks in both the groups; this finding is
comparable to the results of Chan et al.; however, there
was no statistically significant difference between the
daily urinary protein values of both the groups.
The median Scr concentration was slightly lower
than the baseline value after 12 weeks of therapy in
both the groups. Further, it remained stable over the
next 12 weeks in each group, although there were no
significant differences between the Scr concentrations
in the 2 groups. Nonetheless, the percent changes of Scr
levels showed a statistical significance with the regimen
of MMF 2 g/day or MPA 1440 mg/day as compared
to the regimen of MMF 1 g/day or MPA 720 mg/day
(p=0.02 and p=0.01 at 12 and 24 weeks, respectively).
In the study by Chan et al. [13], the dose of MMF was
empirically reduced from 1 g twice daily to 500 mg
twice daily after 6 months. Three of the 20 patients (15%)
showed relapse of LN within 3 months after reduction in
the MMF dose [13]. Based on our findings, MMF at 2
g/day or MPA at 1440 mg/day showed better therapeutic
effects for LN than MMF at 1 g/day or MPA at 720 mg/
day. We have provided additional evidence that MMF
at 2 g/day is an effective regimen for treating LN in
Chinese patients.
The median serum C3 and C4 concentrations
were higher than the baseline values at 12 weeks
and remained higher at 24 weeks in both the groups.
Further, the median anti-dsDNA antibody titer was
lower than the baseline value at 12 weeks and remained
lower at 24 weeks in both the groups. MMF was
effective with respect to the other secondary endpoints
mentioned in previous studies [15,17,19], including
renal function, C3 and C4 levels, anti-dsDNA antibody
titer, and hematological parameters. Our data suggest
that a significant proportion of patients with LN
in both groups demonstrated a clinical response to
34
MMF therapy administered for 24 weeks. Our results
suggest that MMF has potential value as a therapy for
SLE. As reported by Sibilia [20], MMF is effective in
patients with other patterns of severe refractory SLE
characterized by hematological, cutaneous, pulmonary,
or neurological manifestations.
The profile of short-term adverse events with MMF
therapy was similar in both the groups. Most events
were mild, and only 2 patients were hospitalized due
to severe adverse events. In our study, there was a low
incidence of mild self-limiting GI symptoms in both the
groups; however, in the study by Ginzler et al., upper
GI symptoms such as nausea, vomiting, and diarrhea
occurred frequently following MMF therapy [14]. The
frequent GI symptoms may be related to the high target
dose of 3 g/day MMF. We also observed that MMF
exerted a leukocyte-sparing effect; only 1 Gr II patient
developed mild leucopenia. Our results suggest that MPA
at a dose of 2 g/day is tolerated well by Chinese patients
with LN, and the results of our study are comparable to
those of Chan et al. [13].
Our study had a few limitations: small sample size,
non-homogeneous groups, absence of pathological
reports for some subjects, and insufficient duration of
follow-up. However, to the best of our knowledge, this
investigation is the first report of MPA as an induction
therapy for LN in Taiwan.
In summary, in our cohort, the 2-g/day regimen of
MMF (or equivalent) seems more effective than the 1-g/
day regimen of MMF as an induction therapy for LN. In
general, the regimen followed in our investigation was
safe.
Acknowledgments
We are grateful to Dr. Guo-tai Xu for contributing to
patient recruitment and to Ms. Zhi-Yun Lin for assistance
in statistical analysis.
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R, Teo SM, et al. Randomized controlled trial of pulse
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35
 MPA in lupus nephritis

黴菌酚酸(mycophenolic acid)治療狼瘡性腎炎的臨床經驗
1 2 1 1 1 1 1 1
蘇富美 羅淑芬 尤珊富 邱俊凱 陳英州 賴漢明 陳忠仁 鄭添財
1
長庚醫學大學 長庚紀念醫院 高雄醫學中心 過敏免疫風濕科
2
長庚醫學大學 長庚紀念醫院 林口醫學中心 過敏免疫風濕科

目的：近期的研究已證實在狼瘡性腎炎急性誘導期使用口服黴菌酚酸(MMF或MPA)，其效果和環
磷醯胺(CYC)脈衝療法類似或更好但副作用顯著減少。在台灣，探討狼瘡性腎炎病患的療效及安全
治療劑量之相關研究很少。方法：收集門診37位狼瘡腎炎患者，依據其服用黴菌酚酸劑量分成兩組
並收集實驗室檢查報告，包括全血細胞計數、血清肌酸酐、白蛋白、補體、抗雙鏈去氧核糖核酸抗
體，及二十四小時尿蛋白。回溯性分析這二組病患使用MMF/MPA類藥物後之治療反應及副作用。
結果：每日口服MMF 1克或MPA 720毫克這一組有26人，另一組每日口服MMF 2 克或MPA 1440 毫
克有11人。在這兩組中，第12和24週各有1人達到完全緩解(CR)。第一組在第12週達到部分緩解
(PR)有33%，第24週有43%。第二組在第12週達到部分緩解(PR)有67%，第24週有75%。這兩組的
血清肌酸酐下降百分比在第12週為5%和20% (p=0.02)，第24週為0%和26% (p=0.007)。除了血清肌
酸酐下降百分比之外，這兩組數據在二十四小時尿蛋白、血清白蛋白、補體、和抗雙鏈去氧核糖核
酸抗體都未達到統計學上的意義，但卻有明顯改善的趨勢，而且都沒有嚴重的副作用。結論：我們
的研究發現使用MMF 2g/day或MPA 1440mg/day治療的這一組病人，有較好的療效。

關鍵詞：黴菌酚酸(mycophenolic acid, MPA) 、狼瘡性腎炎

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