> |
Researchers at the University
of Pennsylvania School of Medicine have found that
natalizumab (TYSABRI®) – a drug that slows disability
and reduces relapse rates in patients with multiple sclerosis
(MS) – also reduces vision loss in patients with relapsing
MS. |
> |
Researchers found vision loss – a worsening
of vision defined as a two-line (10-letter) reduction in letter
chart scores – was reduced by as much as 47% among people
taking natalizumab, compared to those taking placebo. |
> |
The study appears in the
April 17 issue of Neurology. |
(PHILADELPHIA) – According to a study that appears in the
April 17 issue of Neurology, researchers at the University
of Pennsylvania School of Medicine have found that natalizumab (TYSABRI®) – a drug that slows disability and reduces
relapse rates in patients with multiple
sclerosis (MS) – also
reduces vision loss in patients with relapsing MS. Vision
loss is one of the most common and disabling symptoms of MS.
“Not only does natalizumab prevent the worsening of vision
loss in people with relapsing MS, but it is also associated with
significant reductions in the likelihood of sustained vision loss
due to inflammatory demyelination of nerve fibers that connect
to the eye, a common cause of visual loss in MS,” says Laura
J. Balcer, MD, MSCE, Associate Professor of Neurology and Ophthalmology at Penn, and lead author of the paper.
|
Using low-contrast letter acuity charts,
researchers found vision loss - a worsening of vision defined
as a two-line (10-letter) reduction in letter chart scores - was
reduced by as much as 47% among people with MS taking natalizumab,
compared to those taking placebo.
Image Courtesy: Precision Vision, LaSalle IL |
The researchers analyzed data from two randomized,
double-blind, placebo-controlled, parallel group, phase 3 clinical
trials involving
2,138 men and women with relapsing MS from clinical centers in
Europe, North America, Australia, and New Zealand. More than
half of the participants received natalizumab every four weeks
for two years, while the remaining participants received placebo. Visits
were conducted every 12 weeks and visual function testing was performed
at each study visit. Low-contrast letter acuity was measured
using low-contrast letter charts (eye charts with gray letters
on a white background).
Researchers found vision loss – a worsening of vision defined
as a two-line (10-letter) reduction in letter chart scores – was
reduced by as much as 47% among people taking natalizumab, compared
to those taking placebo.
"Not only do the findings of the study add to our understanding
of the effects of natalizumab, but the results provide strong
validation for a simple, sensitive, cost-effective, and clinically
meaningful measure of visual function in MS," advises Dr.
Nicholas LaRocca, Associate Vice President, Health
Care Delivery and
Policy Research at the National
MS Society.
The researchers caution that, as with any therapy, the benefits
of natalizumab must be considered in the context of potential risks
or complications. In the case of natalizumab, three confirmed
cases of progressive
multifocal leukoencephalopathy (PML) – a
rare, often lethal brain disease – have been reported.
Despite the fact that vision loss is a common and important cause
of disability in MS, the natalizumab clinical trials were the first
to include a test of visual function. These trials showed
that low-contrast letter acuity eye chart testing is an effective
measure for assessing visual outcomes, and may be useful in future
clinical trials.
This study was supported by Biogen
Idec and Elan, makers of natalizumab. Dr.
Balcer has received support for consulting from Biogen Idec as
well as from other companies for work on developing visual outcome
measures for MS clinical trials.
###
PENN Medicine is a $2.9 billion enterprise
dedicated to the related missions of medical education, biomedical
research, and high-quality patient care. PENN Medicine consists
of the University of Pennsylvania School of Medicine (founded in
1765 as the nation's first medical school) and the University of
Pennsylvania Health System.
Penn's School of Medicine is ranked #2 in the nation for receipt
of NIH research funds; and ranked #3 in the nation in U.S. News
& World Report's most recent ranking of top research-oriented
medical schools. Supporting 1,400 fulltime faculty and 700 students,
the School of Medicine is recognized worldwide for its superior
education and training of the next generation of physician-scientists
and leaders of academic medicine.
The University of Pennsylvania Health System includes three hospitals,
all of which have received numerous national patient-care honors [Hospital
of the University of Pennsylvania; Pennsylvania Hospital, the nation's
first hospital; and Penn Presbyterian Medical Center]; a faculty practice
plan; a primary-care provider network; two multispecialty satellite
facilities; and home care and hospice.
Penn Medicine is one of the world’s leading academic medical centers, dedicated to the related missions of medical education, biomedical research, excellence in patient care, and community service. The organization consists of the University of Pennsylvania Health System and Penn’s Raymond and Ruth Perelman School of Medicine, founded in 1765 as the nation’s first medical school.
The Perelman School of Medicine is consistently among the nation's top recipients of funding from the National Institutes of Health, with $550 million awarded in the 2022 fiscal year. Home to a proud history of “firsts” in medicine, Penn Medicine teams have pioneered discoveries and innovations that have shaped modern medicine, including recent breakthroughs such as CAR T cell therapy for cancer and the mRNA technology used in COVID-19 vaccines.
The University of Pennsylvania Health System’s patient care facilities stretch from the Susquehanna River in Pennsylvania to the New Jersey shore. These include the Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, Chester County Hospital, Lancaster General Health, Penn Medicine Princeton Health, and Pennsylvania Hospital—the nation’s first hospital, founded in 1751. Additional facilities and enterprises include Good Shepherd Penn Partners, Penn Medicine at Home, Lancaster Behavioral Health Hospital, and Princeton House Behavioral Health, among others.
Penn Medicine is an $11.1 billion enterprise powered by more than 49,000 talented faculty and staff.