CLINICAL NEWS
High-Dose Dexamethasone Preferable to
Corticosteroids for Patients with Immune
Thrombocytopenia
While ASH’s 2011 practice
guidelines recommend first-line
treatment with corticosteroids
(typically prednisone) for adult
patients with immune thrombocytopenia (ITP) only two-thirds
of patients are likely to have an
initial response, with a limited
number of patients experiencing
long-term remission. In addition, side effects associated with
corticosteroids can outweigh the
benefits of their long-term use.
Previous studies have found
encouraging results in treating
ITP with high-dose dexamethasone, but there have not been any
head-to-head trials comparing
high-dose dexamethasone with
prednisone.
In an article published in
Blood, Yu Wei, MD, from the
Department of Hematology
at Qilu Hospital of Shandong
University in Jinan, China, and
colleagues reported the results
of a prospective, multicenter,
open-label, randomized, controlled trial to compare the
efficacy and safety of high-dose
dexamethasone and conventional
prednisone as a first-line therapy
for newly diagnosed, treatmentnaïve, primary ITP in adult
patients.
Patients were screened for
eligibility at nine centers in China
from January 2011 to May 2014,
with 195 patients included in the
study. All patients had primary
ITP and a baseline peripheral
platelet count of <30x109/L or
the presence of bleeding symptoms at enrollment. Patients
with life-threatening bleeds were
not included, nor were patients
who had been previously treated
with medication for ITP or had
malignancy, active infection,
hypertension, cardiovascular disease, or liver and kidney function
impairment.
Patients were randomized 1:1
to receive:
• Dexamethasone: 40 mg per
day for four days (n=95;
nonresponders received an
additional four-day course of
treatment)
• Prednisone: 1 mg/kg per day
for four weeks then tapered
(n=97)
ASHClinicalNews.org
Each patient underwent a safety
follow-up one month after therapy
was stopped.
Across both arms, 155
patients (80.2%) presented with
bleeding symptoms, generally
mild to moderate. The majority
of patients (116; 60.4%) had a
baseline platelet count of ≤10 x
109/L; these patients also presented with significantly more severe
bleeding manifestations than
patients with a baseline platelet
count of <10 x 109/L (p<0.001).
Dr. Wei and colleagues
found that one or two courses
of high-dose dexamethasone
resulted in a higher incidence of
overall initial response (IR) and
sustained response (SR), compared with prednisone (TABLE 6).
Response was defined as having a
TABLE 6.
dose dexamethasone experienced
fewer bleeding events than those
treated with prednisone: 12 versus
25, respectively (p=0.028). Those
patients also had lower bleeding
scores (p=0.030).
Forty percent of patients in the
high-dose dexamethasone cohort
achieved a sustained response,
compared with 41.2 percent
of patients receiving prednisone (p=0.884) – indicating no
significant difference in response
between treatment groups.
The researchers noted that
gender, age, and baseline platelet
counts had no significant association with treatm [