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#Post#: 1398--------------------------------------------------
(ECTRIMS) Ocrelizumab (Ocrevus) may be endorsed soon for PPMS
By: agate Date: October 2, 2016, 8:14 pm
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From MedPage Today, September 20, 2016:
[quote]European MS Guidance Taking Shape
ECTRIMS teases the first-ever MS drug guideline
by Kristina Fiore
Associate Editor, MedPage Today
LONDON -- European researchers are putting finishing touches on
the first-ever clinical guideline for drug treatment of multiple
sclerosis, with a preview presented here in advance of its final
release.
The guideline will discuss the considerations involved with each
of the dozen available drugs but with little specific advice on
how to choose among them, said Susana Otero-Romero, MD, of the
Multiple Sclerosis Center of Catalonia in Barcelona, speaking at
the European Committee for Treatment and Research in Multiple
Sclerosis meeting here.
Selecting a drug will depend on patient characteristics, disease
severity, drug safety profile, and accessibility – in
combination with a conversation with the patient about their
preferences, she said.
"The evidence thus far does not allow us to prioritize drugs,"
Otero-Romero told MedPage Today. "We're lacking head-to-head
comparisons."
The guideline will also endorse ocrelizumab (tentative brand
name Ocrevus) for primary progressive MS if the drug is approved
before publication, Otero-Romero said.
Many expect the drug to be approved in the U.S. before the end
of the year, and Otero-Romero said the guideline will likely be
published by the beginning of next year.
"The guideline will come out whenever it's ready, but if in the
meantime we have approval of ocrelizumab, we will recommend it,"
she said. "It has been tested in PPMS and is the first to show
some effect."
The guideline was developed jointly by ECTRIMS and the European
Academy of Neurology, via a committee chaired by Xavier
Montalban, MD, of Vall d'Hebron Hospital in Barcelona, and Ralf
Gold, MD, of Ruhr University Bochem in Germany, and coordinated
by Otero-Romero, and follows the GRADE methodology for assessing
evidence.
During a platform presentation here at a late-breaker session,
Otero-Romero offered "a taste" of what the full-length guideline
will say about MS drug therapies when it is finalized and
published.
It will generally recommend that the "entire spectrum of
disease-modifying drugs should only be prescribed in centers
where there is adequate infrastructure" to provide proper
monitoring, comprehensive assessment, and detection of side
effects and ability to promptly address them, Otero-Romero said.
That does not mean that treatment should only take place in
highly specialized centers, Montalban explained, in response to
an audience member's objection that the guideline appeared to
exclude community-based neurology clinics.
"If you can follow the patient and be aware of side effects and
manage them, that's perfectly okay," he said. "It does not have
to be done at specific MS centers."
Otero-Romero noted that treatment is "getting especially
complicated, and you need to make sure you have all the tools to
properly monitor patients and address side effects."
"For instance, you need to make sure you're really complying
with all the safety monitoring required for a drug like
natalizumab (Tysabri), which is one of the most complex ones,"
she said. "Do you have access to MRI? Do you have MS nurses? ...
If the patient says, 'I want to become pregnant,' can you handle
that? And if you can't take care of that, can you refer the
patient when necessary?"
For clinically isolated syndrome (CIS) patients who have an
abnormal MRI but don't fulfill MS criteria, the guidance
recommends consideration of interferon or glatiramer acetate
(Copaxone). Otero-Romero noted that these are the only agents
for which there is specific, published evidence of effectiveness
in CIS.
In relapsing-remitting MS (RRMS), physicians should offer
treatment early to those with relapses and/or MRI activity,
Otero-Romero said.
Choosing between a the range of "modestly to highly effective"
drugs will depend on several factors, including patient
characteristics and comorbidities, disease activity/severity,
drug safety profile, and it accessibility, in conjunction with a
dialogue with the patient as to his or her preferences.
For monitoring, doctors should consider using MRI combined with
clinical measures to assess disease evolution in patients on
disease-modifying drugs.
When monitoring patient response to DMDs, consider performing a
standard reference brain MRI within six months of the start of
therapy, and compare that with further brain MRI, typically
performed 12 months later.
In the case of a poor response to therapy interferon or
glatiramer acetate, physicians should offer a more efficacious
drug, and if a highly efficacious drug is stopped for inefficacy
or safety, consider another highly efficacious drug, the
guidance states.
When switching between highly efficacious drugs, take into
account disease activity, half-life and biological activity of
the previous drug, and the potential for disease activity to
resume or rebound, particularly with natalizumab, Otero-Romero
said.
Among other potential treatments not mentioned in the guideline
at this point: vitamin D screening and supplementation, and stem
cell therapy.
There are currently no other comprehensive guidelines for MS
treatment, Otero-Romero said. There has only been some consensus
on specific topics like treatment of attacks, and the use of
particular treatments like mitoxantrone and natalizumab.
The American Academy of Neurology is taking comments on a draft
version of its evidence-based guidelines for MS
disease-modifying therapies through Oct. 8.
Otero-Romero said the guidelines may also be helpful in terms of
making certain treatments available for more patients. In the
U.K., for instance, regulators have declined to pay for
off-label rituximab for MS patients.
"If these guidelines could be used to change some local
regulations, that would be fine," she said.
_____________________
Co-authors disclosed financial relationships with several MS
drugmakers.[/quote]
The article can be seen here
HTML http://www.medpagetoday.com/MeetingCoverage/ECTRIMS/60307?xid=nl_mpt_DHE_2016-09-20&eun=g345846d0r&pos=0.
#Post#: 1478--------------------------------------------------
More about Ocrevus (ocrelizumab) from MS Focus Magazine
By: agate Date: December 7, 2016, 7:02 pm
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More information about Ocrevus (ocrelizumab) is available in the
"Doctor's Notes" section of the latest (Fall 2016) issue of MS
Focus Magazine, page 51. The article includes remarks by Dr.
Ben Thrower:
[quote]FDA grants priority review for ocrelizumab
The U. S. Food and Drug Administration accepted for review
Genentech's Biologics License Application for Ocrevus
(ocrelizumab) for the treatment of relapsing and primary
progressive multiple sclerosis, and granted the application
Priority Review designation with a Dec. 28 targeted action date.
If approved, Ocrevus would be the first and only treatment
indicated for both forms of MS, which affect approximately 95
percent of people at diagnosis.
Priority Review designation is granted to medicines that the FDA
has determined to have the potential to provide significant
improvements in the safety and effectiveness of the treatment of
a serious disease.
[Dr. Ben Thrower, Senior Medical Adviser for MS Focus]: More
options for managing MS are always welcome. Zinbryta's
(daclizumab) approval this summer introduces a treatment option
with a unique mechanism of action. It would also seem to be
convenient, with once monthly subcutaneous injections. As with
any therapy, the benefits must be weighed against the risks.
Zinbryta can be associated with serious liver damage and monthly
lab testing is a must. In addition, mostly mild skin reactions
can be seen. ... It's expected that Zinbryta will be mainly used
as a second-line option when other therapies have not worked
out.
Ocrevus (ocrelizumab) will likely be FDA-approved for both RMS
and PPMS. As stated, this will be our first approved treatment
option for PPMS. Ocrelizumab works similarly to rituximab. This
drug has been used off-label for both MS and its cousin,
neuromyelitis optica. The drug is given intravenously every six
months and seems to be generally well-tolerated. The infusion
itself is slow, running about six hours on average.
[/quote]
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