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#Post#: 1934--------------------------------------------------
NEJM's article on Ocrevus/MS one of top 10 articles in 2017
DIR By: agate
Date: December 26, 2017, 7:47 pm
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The New England Journal of Medicine Neurology's article
(January 19, 2017) on Ocrevus for PPMS is one of the 10 articles
of 2017 that the journal considers most significant. This is a
review of the article as it appeared in NEJM Neurology on
January 27, 2017:
--- Quote ---
> January 27, 2017
>
> Positive Clinical Trial Results for Ocrelizumab in Primary
Progressive Multiple Sclerosis
>
> Robert T. Naismith, MD reviewing Montalban X et al. N Engl J
Med 2017 Jan 19.
>
> This B-cell depleting therapy reduced worsening disability by
24%.
>
> Effective treatments for primary progressive multiple
sclerosis (PPMS) have remained a major unmet need. A phase II
study of rituximab in PPMS was overall negative, but subgroup
analyses suggested possible benefit in younger and less disabled
patients. Similar to rituximab, the investigational drug
ocrelizumab depletes B cells via binding by CD20. For this
multicenter, randomized, double-blind, placebo-controlled,
manufacturer-sponsored phase 3 study, investigators recruited
732 patients with PPMS (age range, 18–55; Expanded Disability
Status Scale score 3.0– 6.5 [i.e., mild disability through
walker dependent]; disease duration <15 years) who met
diagnostic criteria plus the presence of abnormal cerebrospinal
fluid. Ocrelizumab or placebo was administered as two 300-mg
doses separated by 2 weeks, repeated every 6 months.
>
> Disability worsening confirmed at 3 months (the primary
outcome) occurred for 33% on ocrelizumab versus 39% on placebo,
a 24% relative risk reduction. The 25-foot timed walk worsened
from baseline by 39% on treatment versus 55% on placebo.
Ocrelizumab also had favorable effects on T2 lesion volume and
change in brain volume. Mild infusion reactions occurred in 40%
on ocrelizumab and led to discontinuation in 0.4%. Common
infections were slightly increased with ocrelizumab. Neoplasms
were identified in 2.3% on ocrelizumab versus 0.8% on placebo.
>
> COMMENT
>
> The MS field welcomes favorable study results for PPMS.
Ocrelizumab is reasonably well tolerated, and the infrequent
dosing is convenient. One third of patients still progressed
while taking ocrelizumab, so clinicians should balance optimism
with expectations when discussing this treatment with patients.
Patients who are older than 55, wheelchair bound, and with
disease duration >15 years were not studied; benefits in that
population remain unknown. To assess the risk for neoplasms and
infectious complications, long-term evaluation of data from
clinical trial populations and postmarketing investigations will
be needed. For patients with PPMS who fit study criteria,
treatment at this time seems recommendable, pending FDA
approval.
>
> Dr. Naismith has received honoraria for consulting with
Genentech, manufacturer of ocrelizumab.
>
> EDITOR DISCLOSURES AT TIME OF PUBLICATION
>
> Disclosures for Robert T. Naismith, MD at time of publication
>
> Consultant / Advisory board
Bayer HealthCare; Biogen Idec; EMD Serono; Genzyme Corp./Sanofi;
Genentech; Malinckrodt Pharmaceuticals; Pfizer; Novartis
> Speaker’s bureau
Corp./Sanofi
> Grant / Research support
National Institutes of Health
--- End Quote ---
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