Written in Blood
Low-Molecular-Weight Heparin Fails to
Boost Live Birth Rates in Women with
Recurrent Miscarriage
percent of the enoxaparin group and 23.7 percent of the placebo group had another
miscarriage (RR = 1.28, 95% CI 0.85 to 1.93), with the majority (84.3%) occurring before
ten weeks’ gestation.
“Prophylactic doses of LMWH do not improve the chance of a live birth in nonthrombophilic women with unexplained recurrent miscarriage and should consequently
no longer be routinely prescribed in this clinical setting,” the researchers stated.
Asked if aspirin may prove more effective in this patient population, Dr. Pasquier
explained that the Scottish Pregnancy Intervention (SPIN) study, which assessed LWMH
and low-dose aspirin in women with recurrent miscarriage, “showed no efficacy of openlabel LMWH plus aspirin versus intense pregnancy surveillance alone.”
Antithrombotic medications are often prescribed to women with histories of unexplained recurrent miscarriages , although there is little evidence of the efficacy of this
approach. But the use of low-molecular-weight heparin (LMWH) in non-thrombophilic
women with unexplained recurrent miscarriages did not improve live birth rates, according to a report in Blood.
Given these results, clinicians
should stop prescribing LMWH in
this particular patient population,
lead investigator Elisabeth Pasquier,
MD, of Brest University Hospital
in Brest, France, told ASH Clinical
News.
N O W AVA I L A B L E
The theory that women with recurrent miscarriages and negative tests
F O R T H E T R E A T M E N T O F P h - N E G A T I V E R E L A P S E D / R E F R A C T O RY
for antiphospholipid antibodies (or
B - C E L L A C U T E LY M P H O B L A S T I C L E U K E M I A ( A L L )
negative tests for inherited thrombophilia) may have some other blood
clotting disorder resulted in the use
of LMWH therapy among these
patients, Dr. Pasquier explained.
Dr. Pasquier and colleagues conducted a randomized, double-blind,
placebo-controlled trial of enoxaparin in 256 women with a history
Discover the first and only FDA-approved Bispecific CD19-directed CD3 T-cell Engager
of two or more consecutive miscarriages before 15 weeks gestation and
In a phase 2, open-label, multicenter,
a negative thrombophilia work-up
single-arm clinical trial:
at 13 French hospital centers from
April 2007 to October 2012. About
(95% CI: 64.2-84.4)
• The primary endpoint was the complete
70 percent of the women had three or
remission/complete remission with partial
with CR/CRh* also had an
hematological recovery (CR/CRh*) rate
more consecutive miscarriages.
MRD response (defined
within 2 cycles of treatment with BLINCYTO™.
Most of the patients were early
as MRD by PCR < 1 x 10-4)
in their pregnancy, between 5 to
• Eligible patients were ≥ 18 years of age with
(n=58/77)1
(95% CI: 34.4-49.1)
Philadelphia chromosome-negative relapsed
6 weeks’ gestation, at the time of
of R/R ALL evaluable
or refractory B-precursor ALL.
study enrollment. After training
patients achieved a
• Relapsed or refractory was defined as relapsed
for self-injection, the participants
with first remission duration of ≤ 12 months
CR/CRh* (n=77/185)1
were randomly assigned to receive
of patients who achieved
in first salvage or relapsed or refractory after
enoxaparin 40 mg or saline-solution
CR/CRh* went on to receive
first salvage therapy or relapsed within
placebo daily. Baseline characteristics
allogeneic transplant
12 months of allogeneic hematopoietic stem
were similar among the groups.
(n=30/77)1
cell transplantation (HSCT), and had ≥ 10%
Therapy began on the enrollment
blasts in bone marrow.
visit and continued until 35 weeks’
gestation. Patients maintained a log
INDICATION
of their injection site and treatment
BLINCYTO™ is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor
time on a daily basis to ensure protoacute lymphoblastic leukemia (ALL).
col compliance.
Nearly 70 percent of all women in
This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon
the study had a live and viable birth,
verification of clinical benefit in subsequent trials.
the study’s primary outcome: 66.6
IMPORTANT SAFETY INFORMATION
percent of the enoxaparin patients
and 72.9 percent of the placebo
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES
patients.
• Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving
The rates of live and viable births
BLINCYTO™. Interrupt or discontinue BLINCYTO™ as recommended.
did not differ significantly between
• Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO™.
groups (absolute difference in liveInterrupt or discontinue BLINCYTO™ as recommended.
birth rates = –6% [95% CI −17.1 to
5.1; p = 0.34]), the researchers noted.
Contraindications
There were also no significant differBLINCYTO™ is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the
ences in secondary outcomes (rates
product formulation.
of miscarriage, obstetric complications, maternal thrombocytopenia,
Warnings and Precautions
bleeding episodes, and skin reaction)
• Cytokine Release Syndrome (CRS): Life-threatening or fatal CRS occurred in patients receiving BLINCYTO™. Infusion
among the groups.
reactions have occurred and may be clinically indistinguishable from manifestations of CRS. Closely monitor patients
Over the course of the study, 30.4
75.3%
41.6%
39%
for signs and symptoms of serious events such as pyrexia, headache, nausea, asthenia, hypotension, increased alanine
aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), disseminated
intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic lymphohistiocytosis/macrophage
activation syndrome (HLH/MAS). Interrupt or discontinue BLINCYTO™ as outlined in the Prescribing Information (PI).
20
ASH Clinical News