Author Topic: (CMSC) Ocrevus maintains superiority in OPERA analysis  (Read 115 times)

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Offline agate

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(CMSC) Ocrevus maintains superiority in OPERA analysis
« on: May 30, 2017, 09:30:15 am »
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:
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.

MS Speaks--online for 17 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.


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