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(DIR) Return to: PLEGRIDY (pegylated interferon beta-1a)
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#Post#: 623--------------------------------------------------
PLEGRIDY approved for RRMS by Scottish Medicines Consortium
By: agate Date: January 18, 2015, 11:08 pm
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From Medical News Today, January 15, 2015:
[quote]PLEGRIDY (peginterferon beta-1a) receives SMC approval
for the treatment of relapsing remitting multiple sclerosis
PLEGRIDYŽ (peginterferon beta-1a) has been approved by the
Scottish Medicines Consortium (SMC) as a treatment for adults
with relapsing- remitting multiple sclerosis (RRMS).
Peginterferon beta-1a is the only approved pegylated treatment
for MS. Utilising the pegylation process allows patients to
receive the benefits of an interferon treatment with fewer
injections, which may be an attractive option for patients with
RRMS seeking such a benefit. Less frequent dosing is one of the
factors which have been associated with improved adherence to
disease- modifying therapies in patients with
relapsing-remitting multiple sclerosis.
As well as pegylation allowing less frequent dosing, it also
allows peginterferon beta-1a to be stored outside a refrigerator
at room temperature (up to 25°C) for up to 30 days (but it must
be kept away from light) offering flexibility to patients in
terms of how they store their medication.
Peginterferon beta-1a has demonstrated an efficacy and safety
profile consistent with the established interferon class. It is
dosed fortnightly and is administered subcutaneously with the
PLEGRIDY PEN, a new, ready-to-use autoinjector. Other disease
modifying treatments for multiple sclerosis are dosed between
one and seven times a week.4 Data from patients treated up to 2
years with peginterferon beta-1a suggests that less than 1%
(5/715) developed persistent- neutralising antibodies (which can
reduce clinical efficacy) to the interferon beta-1a portion of
peginterferon beta-1a.
Dr James Overell, Consultant neurologist, South General
Hospital, Glasgow said, "PLEGRIDY offers a strong efficacy and
safety profile, with the additional benefits of a fortnightly
dosing schedule and a convenient method of administration where
patients don't need to see the needle.
It represents a suitable option for appropriate newly diagnosed
patients or patients with tolerability and compliance issues
considering a switch from other injectable or oral agents."
The SMC approval of peginterferon beta-1a is based on results
from one of the largest pivotal studies of a beta interferon
conducted, ADVANCE5, which involved more than 1,500 patients
with RRMS.
In the ADVANCE clinical trial, peginterferon beta-1a, dosed once
every two weeks, significantly reduced annualised relapse rate
(ARR) at one year by 36 percent compared to placebo (p=0.0007).
Peginterferon beta-1a reduced the risk of sustained disability
progression confirmed at twelve weeks by 38 percent (p=0.0383)
and at twenty four weeks by 54 percent (p=0.0069, post-hoc
analysis). In addition, the number of gadolinium-enhancing [Gd+]
lesions was significantly reduced by 86 percent (p<0.0001)
compared to placebo.
Results over two years of ADVANCE confirm that its efficacy was
maintained beyond the placebo-controlled first year of the
study.
"Biogen Idec wholeheartedly welcomes the SMC decision" said
Terry O' Regan, Vice President and Managing Director of Biogen
Idec in the UK & Ireland. "We are committed to improving the
lives of people with MS by developing innovative therapies and
providing greater choice and flexibility in terms of disease
management. Today's recommendation for Plegridy is supportive of
this aspiration."
The safety and tolerability profile of peginterferon beta-1a
observed in ADVANCE was consistent with that of established MS
interferon therapies. The most commonly reported adverse drug
reactions with peginterferon beta-1a treatment (incidence
≥10% and at least 2% more frequent on peginterferon
beta-1a than on placebo) were injection site reaction, flu-like
illness, fever, headache, muscle pain, chills, injection site
pain, weakness, injection site itching, and joint pain.
Peginterferon beta-1a is the fifth therapy to be offered by
Biogen Idec to people living with MS, expanding on a
comprehensive portfolio that addresses individual patient needs
at every stage of their disease.
About PLEGRIDY (peginterferon beta-1a)
Peginterferon beta-1a is a subcutaneous injectable therapy for
RRMS, in which interferon beta- 1a is pegylated to permit a less
frequent dosing schedule. It is a pegylated interferon beta-1a.
According to the Summary of Product Characteristics (SmPC), the
recommended starting dose of peginterferon beta-1a is 63
micrograms at dose 1, increasing to 94 micrograms at dose 2,
reaching the full dose of 125 micrograms by dose 3 and
continuing with the full dose (125 micrograms) every 2 weeks
thereafter.
The safety and tolerability profile of peginterferon beta-1a
observed in ADVANCE was consistent with that of established MS
interferon therapies. It should be administered with caution to
patients with previous depressive disorders, seizures, severe
hepatic impairment and In addition, the EU SmPC indicates that
the use of interferon beta products is associated with cases of
nephrotic syndrome, thrombotic microangiopathy manifested as
thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic
syndrome (HUS), hyper and hypothyroidism, hepatitis, autoimmune
hepatitis, rare cases of severe hepatic failure, and decreased
peripheral blood counts, including rare pancytopenia.
About Pegylation
Pegylation prolongs the circulation time of the molecule in the
body by increasing its size, thus enabling a longer half-life,
stabilising the molecule by improving its solubility and
shielding the molecule from enzymes in the body that try to
break it down into smaller particles. Pegylation is a
well-established scientific process for medicinal use.
[/quote] [References omitted]
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