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#Post#: 1707--------------------------------------------------
(CMSC) Ocrevus maintains superiority in OPERA analysis
By: agate Date: May 30, 2017, 1:30 pm
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Ocrevus improves cognitive functioning in MS, according to
this--a presentation at the 2017 annual meeting of the CMSC
(Consortium of Multiple Sclerosis Centers) in New Orleans.
From MedPage Today, May 30, 2017:
[quote]CMSC: New MS Drug Maintains Superiority in OPERA Analysis
Bests interferon for improvements in cognitive function
by Ed Susman
Contributing Writer, MedPage Today
NEW ORLEANS -- Treatment with ocrelizumab (Ocrevus) improved
cognitive functioning in multiple sclerosis (MS) in comparison
with interferon therapy, researchers reported here.
In a pooled analysis of the OPERA studies, patients treated with
ocrelizumab versus subcutaneous interferon beta-1a had a greater
improvement from baseline on the Symbol Digit Modalities Test
(SMDT) at week 96, according to Aaron Miller, MD, of Mount
Sinai's Corinne Goldsmith Dickinson Center for Multiple
Sclerosis at Mount Sinai in New York City, and colleagues.
There also was trend for improved of cognition as assessed by
the Paced Auditory Serial Addition Test (PASAT), the authors
reported in a poster at the Consortium of Multiple Sclerosis
Centers (CMSC).
"Using published thresholds of clinical meaningfulness for the
Symbol Digit Modalities Test, a significantly greater percentage
of patients achieved improvement with ocrelizumab than with
interferon beta-1a," they noted. "This was true for both the
overall population, and for patients with at lest mild cognitive
impairment at baseline. Among patients with at least mild
cognitive impairment at baseline, ocrelizumab was associated
with greater improvements in cognitive functioning on both the
PASAT and the Symbol Digit Modalities Test."
Cognitive impairment is a common symptom manifestation of MS,
and may occur throughout the clinical course and in all subtypes
of the disease, Miller explained. Frequently affected cognitive
domains include learning, information processing speed, memory,
sustained attention and execute functioning. Impairments in
these domains have significantly impacted quality of life and
daily functioning, he added.
Patients were eligible for the overall OPERA studies if they
were ages 18-55, and had a diagnosis of relapsing MS, according
to the 2010 McDonald criteria. They had to have two or more
relapses in the past 2 years or at least one relapse in the
previous year.
They were randomized to receive ocrelizumab 600 mg every 24
weeks as two intravenous infusions of 300 mg on day 1 and day
15, and single 600 mg infusion thereafter. Alternatively, they
were assigned to receive interferon beta-1a at a dose of 44
μg in a subcutaneous injection three times a week for 96
weeks.
Ocrelizumab was approved by the FDA in March 2017 for the
treatment of both relapsing-remitting and primary progressive
MS. Earlier this week, drug developer Genentech notified
physicians of the first case of progressive multifocal
leukoencephalopathy (PML) in a patient taking ocrelizumab.
The pooled population from OPERA I and OPERA II consisted of 812
MS patients who were treated with interferon beta-1a and 819
patients who received ocrelizumab. The baseline demographics
were well matched as patients were about age 37.5; two-thirds
were women. The Extended Disability Status Scale score across
the the groups was a mean of 2.5. About 97% of the patients in
the study completed the two cognitive functioning tests.
The PASAT and SDMT tests were given at baseline and every 12
weeks, and analyses were conducted for the individual OPERA
trials and the pooled population.
In the pooled population, mean baseline PASAT scores were 42.58
with ocrelizumab and 41.70 with interferon, the authors
reported. Baseline SDMT scores were 47.34 and 47.31,
respectively. SDMT and PASAT scores were modestly correlated,
they noted (0.36, P<0.0001).
At week 96 in the pooled population, a greater improvement from
baseline in mean PASAT score was seen with ocrelizumab (6.520,
95% CI 5.84-7.20) than with interferon (5.651, 95% CI 4.95-6.35,
P=0.0531).
There also was a greater improvement from baseline in mean SDMT
score with ocrelizumab (5.430, 95% CI 4.41-6.46) versus
interferon (4.046, 95% CI 3.00-5.10, P=0.0422) at week 96 in the
pooled population.
"These results are quite impressive and are consistent with the
mechanism of action of the medication," commented June Halper,
MSN, APN, CEO of CMSC, to MedPage Today. "It is very exciting."
Halper noted that the reliability of PASAT for assessing
cognitive impairment has been questioned. On the other hand,
SDMT has been endorsed by the neuropsychological community.
"I would certainly suggest that a longer study be done, and
maybe use some other testing, perhaps the 9-hole peg test, which
also looks at cognitive processing and upper extremity
function," she said.
Halper cautioned the study was short at 96 weeks, but that the
results were still "quite significant...ocrelizumab showed
superiority over subcutaneous interferon beta-1a."
The study was supported by F. Hoffmann-La Roche and Genentech.
Miller disclosed relevant relationships with Accordant Health
Services, Acorda, Alkermes, Biogen Idec, EMD Serono,
Genzyme/Sanofi, Mallinckrodt, Novartis, and Roche/Genentech.
Halper disclosed no relevant relationships with
industry.[/quote]
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