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Lemtrada is FDA approved for people with relapsing MS

On November 14, 2014, the U.S. Food and Drug Administration (FDA) approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS) who have responded inadequately to two or more MS drugs.  Lemtrada is already approved in over 40 countries around the globe including the EU, Canada and Australia.

The FDA approval of Lemtrada is a significant milestone for people living with relapsing MS.  Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in two pivotal randomized Phase III open-label rater-blinded studies in patients with relapsing remitting MS which were the basis for approval.  The clinical development program for Lemtrada involved nearly 1,500 patients including patients at the Swedish MS Center with more than ...

Breastfeeding, Disease Modifying Therapies (DMTs), and Postpartum Relapse in Multiple Sclerosis

Women with multiple sclerosis (MS) have higher risk of relapse during the postpartum period.  Can exclusive breastfeeding alone prevent relapses? How soon after delivery should disease modifying therapies (DMTs) be reintroduced? Are any DMTs safe to take while breastfeeding? 
 
While disease modifying therapies (DMTs) have been shown generally to reduce relapse rates, none of them are indicated for use during pregnancy and lactation. Therefore, the question of when to restart DMTs postpartum remains a difficult one for physicians counseling MS patients who wish to breastfeed their children.
 
Trying to predict the risk of relapse for any one individual is very difficult. The risk factors for postpartum attacks include ...

A (Slightly) New Medication for Multiple Sclerosis Comes Out in November

Interferons have been used for the treatment of multiple sclerosis (MS) since 1993. The existing line-up of interferons for MS (Avonex, Betaseron, Extavia and Rebif) will soon be joined by Plegridy, approved by the US Food and Drug Administration in August 2014. Plegridy will become commercially available in November 2014.

Plegridy is a pegylated form of interferon beta. Pegylation is a process, used by several other non-MS medications, whereby a long string of polyethylene glycol molecules is attached to the interferon beta molecule, to extend its half-life by reducing clearance via kidneys or other elimination pathways in the body. This modification allows less frequent dosing of Plegridy – once every two weeks – although it is still administered as an injection under the skin.

In the ADVANCE trial, Plegridy was ..

Gray Matter Myelin Loss Linked to Severity of Multiple Sclerosis Symptoms

In a recent collaborative study completed by the Swedish Multiple Sclerosis Center, University of Washington, and University of Wisconsin, doctors discovered through a more refined magnetic resonance imaging (MRI) process, the amount of myelin lost in the gray matter of multiple sclerosis (MS) patients’ brains may indicate a more severe form of the disease.
 
Multiple Sclerosis (MS) has long ...

Advances in Vision Assessment in Multiple Sclerosis

Over the past several years, the visual function of people living with multiple sclerosis (MS) has been increasingly recognized as an important marker of quality of life in MS, and as a useful indicator of the severity and activity of MS both clinically, and in MS research. Measurement of a person’s ability to see faded letters (low contrast acuity) has been found to be an excellent marker of MS visual function, and its change over time is related to MS disease activity. Optical coherence tomography (OCT), which measures the health of optic nerves and retinas in individuals with MS, is providing an explosion of data that has increased our insight into the extent, course, and pathology of multiple sclerosis.
 
At this year’s North American Neuro-ophthalmology Society meeting, data was presented on another technique that is being developed and refined for use in the MS population, a questionnaire about visual quality of life.  The ..

Statin Benefits Secondary Progressive MS

No treatments can currently abate the advanced stage of the disease, known as secondary progressive MS, which gradually causes patients to become more disabled. Statins are postulated to have immunomodulatory effects that appear to be independent of their effect on cholesterol. A benefit has been suggested in early multiple sclerosis (MS) based on reduction of magnetic resonance imaging brain lesions.  However, following trials have had inconsistent results.

In this multicenter, double-blind study, investigators randomized 140 participants with secondary progressive (SP) MS to 80 mg of simvastatin or placebo daily for 2 years. Participants were 18 to 65 years old, had active progression over the preceding 2 years, and had difficulties ambulating but were not wheelchair bound.  Whole brain atrophy was 43% slower annually in simvastatin recipients than in placebo recipients. The simvastatin group also had small clinical improvements over placebo on the disability scale and a patient-reported MS impact scale at 24 months.
 
These findings show that simvastatin reduced ...

Drug treatment and weight loss restores vision in a blinding disorder linked to obesity

As many as 100,000 Americans suffer from a disorder called pseudotumor cerebri or idiopathic intracranial hypertension that can cause permanent blindness and chronic headaches. The disease primarily strikes obese women of reproductive age with symptoms of daily headaches, visual symptoms including transient blurring or blindness, double vision, and pulsating noises in one’s head. Up to 5-10% of these patients may have permanent visual loss due to optic nerve damage.
 
A recent national trial funded by the National Institute of Health’s National Eye Institute has shown that a common water pill, acetazolamide, combined with a moderate but comprehensive dietary and lifestyle modification plan can restore and preserve vision in women with this disease. I was one of the local investigators for this trial along with Dr. Eugene May.
 
The symptoms of pseudotumor cerebri are thought to be due to high spinal fluid pressure around the optic nerves and brain due to impaired reabsorption of spinal fluid that is continuously being produced within the brain. This results in chronic headaches and swelling of the optic nerves that can lead to permanent blindness if left untreated. Patients typically are ...

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