Open Journal of Blood Diseases, 2012, 85-89
http://dx.doi.org/10.4236/ojbd.2012.24016 Published Online December 2012 (http://www.SciRP.org/journal/ojbd)
85
Comparison of High-Dose Dexamethasone and Prednisone
for Initial Treatment of Adult Primary Immune
Thrombocytopenia
Masanao Teramura, Midori Ishiyama, Hiroshi Kazama, Kentaro Yoshinaga, Masayuki Shiseki,
Naoki Mori, Toshiko Motoji
Department of Hematology, Tokyo Women’s Medical University, Tokyo, Japan.
Email: teramura@dh.twmu.ac.jp
Received October 14th, 2012; revised November 18th, 2012; accepted November 30th, 2012
ABSTRACT
Prednisone is the most common first-line treatment for adult primary immune thrombocytopenia (ITP). However, the
best initial therapeutic approach is still a matter of debate. Prior studies have shown that high-dose dexamethasone
(HD-DXM) produces a high sustained efficacy not achieved by conventional prednisone therapy. However, the defini-
tion of response widely differs between individual reports, and this heterogeneity makes comparison of the efficacy
difficult. The aim of our study was to compare the therapeutic outcomes of a conventional dose of prednisone with
HD-DXM for adult ITP patients as initial therapy. Thirty patients treated with prednisone and 22 patients treated
HD-DXM were retrospectively analyzed. No significant differences between the HD-DXM and prednisone groups were
observed for the rates of complete response (68% vs. 70%) and response (18% vs. 17%). However, 1 year probability of
sustained response was significantly greater in the HD-DXM group than in the prednisone group (78% vs. 38%; P =
0.008). No adverse events necessitating discontinuation of treatment were observed in either group. Our retrospective
analysis showed that initial treatment with HD-DXM produced longer response duration compared to a conventional
dose of prednisone. Randomized clinical trials are warranted to establish the optimal initial steroid therapy for adult
ITP.
Keywords: Primary Immune Thrombocytopenia; High-Dose Dexamethasone; Prednisone
1. Introduction
Primary immune thrombocytopenia (ITP) previously
called idiopathic thrombocytopenic purpura is an ac-
quired immune-mediated disorder characterized by iso-
lated thrombocytopenia defined as a peripheral blood
platelet count less than 100 × 109/L, and the absence of
any obvious initiating and/or underlying cause of the
thrombocytopenia [1]. Treatment is generally given for
patients with a low platelet count (20 × 109/L or 30 ×
109/L) or clinically significant bleeding. The standard
initial treatment for adult patients with ITP is corticos-
teroids. Among corticosteroids, prednisone is widely
regarded as the standard first-line treatment. The starting
dose is usually set at 1 mg/kg per day and continued for 2
to 4 weeks. If an increase in platelet count is obtained,
the dose is gradually tapered. With this approach, an ini-
tial response rate of 50% to 60% is obtained, although
long-term remission rate after discontinuation are very
low (10% to 25%) [2-7].
A short course of high-dose dexamethasone (HD-DXM)
has been used in patients with refractory ITP, but its ef-
ficacy is controversial [8-10]. In 2003, a study on initial
treatment of ITP with HD-DXM found beneficial out-
comes. In adult patients with previously untreated ITP,
dexamethasone was given in a single 4-day course (40
mg/day, orally). The initial response rate was 85% of
patients (106 of 125 patients), and the sustained response
(a platelet count > 50,000/μL 6 months after initial treat-
ment) was 50% [11]. Subsequently, a multicenter study
reported that 89% (16 of 18) ITP patients responded to
initial HD-DXM treatment (1 to 6 courses) with 59%
achieving 2 - 31 months efficacy [12]. In another large
cohort study, 4 cycles of HD-DXM given every 14 days
for previously untreated ITP patients produced an 85.6%
(77 of 90 patients) response rate with 74% efficacy last-
ing for a median duration of 8 months [13].
The results of these studies suggest that HD-DXM
treatment for adult ITP may produce better outcomes
than conventional prednisone therapy. However, the
definition of response widely differs between individual
Copyright © 2012 SciRes. OJBD
Comparison of High-Dose Dexamethasone and Prednisone for Initial Treatment of Adult
Primary Immune Thrombocytopenia
86
reports, and this heterogeneity makes comparison of the
efficacy of these two treatments difficult. To address this
issue, in 2009, an international working group proposed
standard criteria for assessing response to ITP treatments
[1]. The aim of this study is to compare the efficacy of
HD-DXM and conventional prednisone treatments using
these criteria through the retrospective analysis of ITP
patients treated at our institution.
2. Patients and Method
2.1. Patient Selection
Adult patients diagnosed with ITP and initially treated
with either a conventional dose of prednisone or HD-
DXM between 1995-2011 at our institution were retro-
spectively analyzed for this study. Diagnosis of ITP was
based on findings from complete blood cytology, and
other laboratory testing, which were used to rule out
other causes of thrombocytopenia. To confirm the diag-
nosis, bone marrow aspirate was obtained from all pa-
tients, and only those with the presence of a normal or
increased number of megakaryocytes without pathologic
alterations of erythroblasts, granulocytes or lymphocytes
were in- cluded. In addition, all patients had either a plate-
let count 20 × 109/L or clinically significant bleeding
with a platelet count 50 × 109/L.
2.2. Treatment
For the HD-DXM group, oral dexamethasone was given
as at least 1 cycle of a single daily dose of 40 mg for 4
consecutive days. A maximum of 3 cycles of HD-DEX
with a treatment interval of 14 days were given. For the
prednisone group, 1 mg/kg per day of prednisone was
given for 4 weeks, and in responders, the dose was
gradually tapered over several weeks and then stopped.
During the initial treatment, all patients did not receive
other ITP-specific concomitant treatment including Heli-
cobacter pylori eradication.
Response was evaluated according to the proposed
criteria from an international working group [1]. Com-
plete response (CR) was defined as any platelet count of
at least 100 × 109/L, and response (R) was defined as any
platelet count between 30 and 100 × 109/L and at least
doubling of the baseline count. No response (NR) was
defined as any platelet count lower than 30 × 109/L or
less than doubling of the baseline count. The definition
of response required concurrent resolution of bleeding
symptoms. Loss of CR was defined as a CR patient
whose platelet count later fell below 100 × 109/L, or ex-
perienced bleeding. Loss of R was defined as a patient
whose platelet count fell later below 30 × 109/L, or to
less than 2-fold increase of baseline platelet count or
experienced bleeding. Patients who did not respond until
4 weeks after initiation of prednisone, and those who did
not response until 2 weeks after completion of HD-DXM
were defined as non-responders.
The duration of response was measured from the time
of achievement of CR or R to time of loss of CR or R
(from R). We also measured the duration of response
from the time of achievement of CR or R to loss of R
(from CR or R). This study was approved by the ethical
committee of Tokyo Women’s Medical University.
2.3. Statistical Analysis
Prednisone and HD-DXM groups were compared with
respect to age, sex, and platelet counts before treatment,
initial response rate, and the duration of response. Fisher’s
exact test was used to compare categorical variables, and
Mann-Whitney U test or Student’s t-test was used to
compare continuous variables. The duration of response
was analyzed using the Kaplan-Meier method [14].
3. Results
3.1. Patient Characteristics
Fifty two patients diagnosed of ITP were analyzed, of
whom 30 were treated with prednisone and 22 treated
with HD-DXM. The main clinical characteristics of both
groups are listed in Table 1. There were no significant
differences between the 2 groups in terms of age, sex,
and the pretreatment white blood cell count, platelet
count, and Hemoglobin level. In the HD-DXM group, 11,
4, and 7 patients received 1, 2, or 3 treatment cycles, re-
spectively.
3.2. Treatment Response
The rates of CR, R and overall response (CR plus R) are
shown in Table 2. No significant differences between the
two treatments groups were observed with respect to the
rate of CR, R, and overall response.
3.3. Duration of Response
Loss of CR and loss of R (from R) were observed in 10
of 19 patients in the HD-DXM group with a median time
of 5.8 months (range 1 - 71 months) after response achie-
vement, and in 22 of 26 patients in the prednisone group
with a median time of 5.9 months (range 1 - 147 months).
Loss of R (from CR or R) was observed in 5 of 19 pa-
tients in the HD-DXM group with a median time of 13.6
months (range 1 - 75 months) after response achievement,
and in 20 of 26 patients in the prednisone group with a
median duration of 8.4 months (range 1 - 147 months).
Kaplan-Meier response duration curves for 2 groups
were shown in Figure 1. Response duration calculated
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Comparison of High-Dose Dexamethasone and Prednisone for Initial Treatment of Adult
Primary Immune Thrombocytopenia
87
Table 1. Clinical characteristics of patients treated with
high-dose dexamethasone and prednisone .
HD-DXM Prednisone P value
No. of patients 22 30
Age (year) 66 (23 - 84)* 56 (20 - 73)* 0.06
Sex (male/female) 6/16 10/20 0.76
WBC (×109/L) 5.3 5.4 0.29
(2.6 - 8.7)* (3.7 - 9.3)*
Hb (g/dL) 13.0 13.3 0.39
(7.2 - 16.1)* (10.2 - 15.7)*
Platelet (×109/L) 12 13 0.27
(2 - 32)* (2 - 50)*
*Median (range); HD-DXM: high-dose dexamethasone; WBC: white blood
cell count; Hb: Hemoglobin.
Table 2. Patient outcomes.
HD-DXM Prednisone
No. (%) No. (%)
P value
Complete response (CR) 15 (68) 21 (70) 0.562
Response (R) 4 (18) 5 (17) 0.585
Overall response (CR + R) 19 (86) 26 (87) 0.641
No response (NR) 3 (14) 4 (13) 0.641
HD-DXM: high-dose dexamethasone; Complete response (CR) was defined
as any platelet count of at least 100 × 109/L; and response (R) was defined
as any platelet count between 30 and 100 × 109/L and at least doubling of
the baseline count; No response (NR) was defined as any platelet count
lower than 30 × 109/L or less than doubling of the baseline count.
from the time of CR or R until loss of CR or R (from R)
was not statistically different between 2 groups (1 year
probability of response duration: HD-DXM group; 56%,
prednisone group; 23%, P = 0.09) (Figure 1(a)). Re-
sponse duration calculated from the time of CR or R until
loss of R was statistically different between 2 groups (1
year probability of response duration: HD-DXM group;
78%, prednisone group; 38%, P = 0.008) (Fi gure 1(b) ).
3.4. Adverse Events
No adverse events necessitating the discontinuation of
treatment were observed in either group. Steroid induced
hyperglycemia was observed in 2 patients in the HD-
DXM group and in 3 patients in the prednisone group. In
the prednisone group, 1 patient experience vertebral bone
compression fracture, and a transient increase in pancre-
atic enzyme was observed in 1 patient in each group.
(B)
Cumulative pr obability
res p ons e d uration time (months)
0.00
0.20
0.40
0.60
0.80
1.00
020406080100 120 140
0.00
0.20
0.40
0.60
0.80
1.00
020406080100120 140
HD-DEX
HD-DEX
Prednis one
Prednis one
res p onse duration tim e (m onth s)
Cum ulat ive prob abi lit y
P=0.09
P=0.008
(a)
(b)
Figure 1. Kaplan-Meier response duration curves. (a) Re-
sponse duration from the time of CR or R until loss of CR
or R (from R); (b) Response duration from the time of CR
or R until loss of R. HD-DXM group versus prednisone
group: (a) P = 0.09; (b) P = 0.008. Solid line: HD-DXM,
Broken line: Prednisone.
4. Discussion
We found HD-DXM and prednisone to have nearly iden-
tical initial response rates for the treatment of ITP (CR:
68% vs. 70%, and R: 18% vs. 17%). However, 1 year
probability of response duration calculated from the time
of CR or R until loss of R was significantly greater in the
HD-DXM group than in the prednisone group (78% vs.
38%). Our results therefore support the previous studies
that found HD-DXM to produce long-term responses in
previously untreated ITP patients [11-13]. In a study by
Cheng et al., a single course of HD-DXM for adult ITP
produced a 50% sustained response of platelet count
50,000/μL at 6 months after the initial treatment [11]. A
multicenter study by Borst et al. found that 59% of pre-
viously untreated adult ITP patients obtained a sustained
response 2 - 31 months after 1 - 6 cycles of HD-DXM
therapy [12]. A large cohort study by Mazzucconi et al.
found that 4 cycles of HD-DXM given every 14 days in
previously untreated adult ITP patients achieved a re-
lapse-free response rate of 60% at 15 months [13].
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Comparison of High-Dose Dexamethasone and Prednisone for Initial Treatment of Adult
Primary Immune Thrombocytopenia
88
The optimal number of cycles of HD-DXM for initial
ITP treatment warrants further investigation. Cheng et al.
[11] used a single course of HD-DXM, while Borst et al.
[12], Mazzucconi et al. [13], and we used between 1 - 6
courses. In the study from Mazzucconi et al., response
rate was significantly improved between the second and
third cycles (75.8% vs. 89%, P = 0.018) but not between
the third and fourth [13]. This suggests that 3 cycles of
HD-DXM may be appropriate.
The mechanism of action of HD-DXM in the treat-
ment of ITP is not entirely clear; however, several
mechanisms have been postulated. ITP is an autoimmune
disease characterized by T helper 1 (Th1) polarization.
Guo et al. reported that correction of Th1 polarization
was achieved and maintained after HD-DXM therapy in
patients who experienced a sustainable response but not
maintained in those who relapsed [15]. A subsequent
study from the same group showed that HD-DXM re-
duced plasma levels of interleukin-18 (IL-18) while in-
creasing levels of its endogenous antagonist, IL-18 bind-
ing protein (IL-18BP), yielding a reduction of IL-18/IL-
18BP ratio [16]. From these findings, it is suggested that
correction of Th1 polarization by HD-DXM is mediated
by a decrease in IL-18/IL-18BP ratio, and this could be a
potential mechanism of the long-term recovery from ITP.
Disruptions in the balance of Fcγ receptors (FcγRs), in-
cluding FcγRI, FcγRIIa, FcγRIII, and FcγRIIb have been
implicated in the pathogenesis of many autoimmune dis-
eases. In ITP, decreased expression of inhibitory FcγRIIb
and elevated expression of activating FcγRs (FcγRIIa and
FcγRIII) have been observed on monocytes, and HD-
DXM therapy for ITP could shift monocyte FcγR balance
toward the inhibitory FcγR IIb, resulting in the decrease
of monocyte phagocytic capacity [17]. This suggests that
FcγR system is possibly involved in the efficacy of
HD-DXM for ITP. Other reports have suggested that
HD-DXM may achieve its therapeutic effect by inhibit-
ing immune responses through the suppression of den-
dritic cell functions [18], reducing B-cell activating fac-
tor production [19], and increasing production of the
regulatory T-cells [20].
Recently, a prospective randomized study involving
previously untreated adult ITP comparing the efficacy of
a single course of HD-DEX to that of HD-DEX com-
bined with rituximab was conducted [21]. The rate of
sustained response (platelet count > 50 × 109/L at 6
months after treatment) was significantly higher in pa-
tients treated with HD-DEX plus rituximab than in those
treated with HD-DXM alone (63% vs. 36%). Further-
more, the HD-DXM plus rituximab regimen was effect-
tive as salvage therapy in the subgroup of patients who
were refractory to initial HD-DXM therapy, achieving a
sustained response rate of 56%. This suggests that com-
bining HD-DEX with rituximab may be a promising
second-line therapy in patients not responding to initial
HD-DEX treatment.
There are several limitations to our study. First, be-
cause our study is retrospective in nature, some bias may
have been present. The dates of treatment tended to be
different between HD-DEX and prednisone groups; all
HD-DEX patients were treated after 2003, whereas most
prednisone patients were treated before 2003. In addition,
in Japan, Helicobacter pylori eradication was adopted as
initial therapy for ITP patients during 2000s [22]. There-
fore, another limitation is that the extent of H. pylori in-
fection in the 2 groups was likely different, and the pos-
sibility that this etiological difference affected our find-
ings cannot be ruled out.
In conclusion, treatment involving steroid therapy for
ITP is used to obtain not only a high initial response rate
but also a sustainable response that avoids the need for
any further treatment. Based on our findings, HD-DXM
could be used as a first-line treatment for adult patients
with ITP because it accomplishes both of these. Our ret-
rospective analysis showed that initial treatment with
HD-DXM produced longer response duration compared
to a conventional dose of prednisone. Randomized clini-
cal trials are warranted to establish the optimal initial
steroid therapy for adult ITP.
5. Acknowledgements
We thank all members of the Department of Hematology,
Tokyo Women’s Medical University for their support.
We also thank Editage for providing editorial assistance.
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