FDA approves first drug for progressive MS

By Jonathan Delozier - jdelozier@civitasmedia.com

A new drug is being called a breakthrough for people living with multiple sclerosis, which is very good news for Wellington.

On March 29, the U.S. Food and Drug Administration approved Ocrevus, the first treatment it’s signed off on meant for both primary progressive multiple sclerosis, or PPMS, and relapsing forms of the disease.

In 2011, the National Resources Defense Council said one in 146 Wellington residents has been diagnosed with MS, classifying the village as a hot spot or “cluster” for the disorder.

Nationwide, MS affects one in 1,600 people.

It is a chronic, inflammatory, autoimmune disorder of the central nervous system. It affects the brain’s control over an individual’s body and occurs more frequently in women by a two to one margin.

“This is a big breakthrough for people with PPMS,” said Eileen Curran, senior director of communications and public relations at the National Multiple Sclerosis Society. “Right now, we have 14 treatments available for relapsing MS, but nothing for progressive MS. It’s not applicable to everyone with PPMS, but it’s a first step.”

About 85 percent of MS cases are classified as relapsing, meaning the patient has episodes of impaired function followed by periods of remission. Over time, however, recovery can become incomplete and lead to PPMS.

Those living with PPMS experience steadily worsening symptoms without remission or recovery.

According to the FDA, the effectiveness of Ocrevus in treating relapsing MS was shown in two 96-week clinical trials with 1,656 participants. In both studies, the patients who took Ocrevus saw lower rates of relapse and reduced progression of the disease compared to the effects of another MS drug, Rebif.

Among 732 PPMS patients in the study, those who took Ocrevus saw their symptoms’ progression to be noticeably slowed.

“Doctors had essentially been using medications for relapsing MS as treatment for PPMS,” said Curran. “That led to very temporary relief followed by the patient going right back into a decline. There’s never been anything showing real success until now. We’re very hopeful.”

Ocrevus is administered by IV twice a year. According to the FDA, it should not be used by patients with hepatitis B or a history of serious IV-related infection.

Side effects listed include itchy skin, rash, low blood pressure, fever, swelling of the throat, nausea, and accelerated heartbeat. Patients could also be at higher risk for malignancies, especially breast cancer.

For PPMS patients in the study, the most common side effects were respiratory and skin infections.

Wellington’s MS numbers were first brought to the federal government’s attention in 2003 when a village resident petitioned the the Agency for Toxic Substances and Disease Registry, drawing a possible link between cases of MS and emissions from Sterling Foundry, Forest City Technologies, and LESCO Inc.

An increased number of MS cases in Wellington was first identified in 1998 by the Ohio Department of Health and Lorain County health district.

Resulting investigations did not find a direct link between Wellington’s environment and MS cases, but concluded that chemical contaminants from those businesses did leak into the surrounding area.

The original petitioner also voiced concern over the Sterling Foundry landfill potentially affecting the village’s nearby water reservoir, according to a 2005 ATSDR report.

“We know there are environmental triggers but we don’t know the actual cause of MS,” said Curran. “The frustrating part is MS is different in every single person. It’s really hard to figure out the causes, the family ties, the outside factors.”

Jonathan Delozier can be reached at 440-647-3171 or @DelozierNews on Twitter.

By Jonathan Delozier