A New Era: New Drugs, New Options, New Risks for Multiple Sclerosis medications

In the Spring edition of MOMENTUM Magazine – By Martha King

Melissa Losasso had her first MS symptom 12 years ago, but wasn’t diagnosed until an attack paralyzed her right side in 2004. It didn’t take much for the Maryland resident with two young kids at home to opt for treatment. In fact, she volunteered for a clinical trial comparing two standard MS meds head to head. For three years she took both a daily and a weekly injection. For research purposes, she had no clue if one or both of the drugs she took were real, and, in fact, she doesn’t know today. But she certainly experienced side effects.

“The daily injection left my skin tough and dimpled. I’d have swollen red marks that itched and burned,” she said in testimony before an FDA advisory committee considering a new MS drug. Her weekly shot was worse. The “flu-like” side effects that abate in time for many others ruined every single weekend for three years.

“I would start to become agitated and depressed I long before I needed to take it. I would sit holding » the needle for 30 minutes or more trying to make 2 myself inject, knowing I was going to have body £ aches, fever and pain within hours. Mentally, I was wearing down, angry at my disease and angry with myself for putting my family through this.”

She soldiered on and completed the trial as promised but then couldn’t bring herself to continue on either of the two drugs. “I had to have a break,” she said. Although many people stop their MS med with no obvious effect, Losasso had an attack just a few weeks later.

Unlike others who have dropped treatment—and gone without protection from mostly silent MS damage—Losasso was offered an out. She was eligible for a clinical trial of an MS medication in a capsule. The trial was designed to explore the best dosages, so all the volunteers were given active medication. The weekend bouts of aches and fever were gone, and with them her depression, anxiety and fear. And her MS was controlled. The experimental drug was fingolimod, approved last September under the brand name, Gilenya.

“Having the option of an oral drug has truly made a difference in my outlook on life,” she told the FDA advisory committee.

An oral MS disease modifier has been urgently sought ever since the first injectables were approved in the early 1990s. We listed 14 oral drugs “in the pipeline” in the Summer 2009 issue of Momentum. Some have since been ejected as ineffective, a few others are stalled at this writing, one has emerged into the marketplace and several seem headed for an FDA review sometime this year. In addition to tablets and capsules, some are “infrequent dosing” treatments delivered as periodic IV infusions or as a short series of injections every few months or only once a year.

We now have a powerful game changer for people like Losasso whose lives have been marred by unrelenting side effects. We will have some new options for people who have continued to have MS attacks despite conscientiously taking injections. And there is new hope for people with needle fear so severe that they cannot consider self-injection.

But more options mean it’s going to be complicated—because of the sheer number of drugs and because of a new level of serious risk.

Almost all the coming new drugs, including the just approved Gilenya, carry risks that are fairly new in the MS world. Tysabri could be considered a harbinger of this new situation. Tysabri is powerfully effective but has produced a relatively rare but very serious “adverse event”—PML (progressive multifocal leukoencephalopathy) caused by JC virus infection. PML has caused severe disability and some deaths in Tysabri users, despite careful clinical monitoring.

We asked Dr. Richard Ransohoff, a leading MS researcher at the Cleveland Clinic Foundation and a member of the Society’s board of clinical advisors, about drug safety.

“When a new medicine arrives, typically only a few thousand people will have received it for no more than a couple of years. That doesn’t tell you what you really need to know about safety. As for efficacy, it’s taken forever to get solid data supporting the idea that our standard MS drugs do help some people in a meaningful way, by lowering their likelihood of disability,” he said.

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