New multiple sclerosis medications offer options
12/13/2012 0 Comments Contact Our News Editors
By Karen Weintraub
Twenty years ago, there were no drugs at all for M.S. Now there are nine, with more coming.
When Jennifer Leon Hill walked down the aisle in October , she didn't feel clumsy, she didn't limp, and she didn't use the cane she sometimes needs for support.
Sure, the excitement of her wedding helped. But so have the lifestyle changes she's made since her diagnosis with multiple sclerosis, and the medication she's been able to take for it.
Three years ago, when Hill, 42, of Chandler, Ariz., was diagnosed with multiple sclerosis, there were only a few drugs available to treat it — and none was very appealing. The drugs were delivered by daily or weekly injection, often didn't help much, and had potentially devastating side effects.
Instead of prescribing one of them, Hill's neurologist enrolled her in a research study testing a once-a-day pill that promised fewer side effects and equal or better effectiveness.
The drug, Aubagio, was approved in September for general use — the second of a new generation of medications. For the first time, doctors and M.S. patients have a range of drugs to chose from.
Twenty years ago, there were no drugs at all for M.S., a disease in which the immune system attacks nerve cells in the brain and spinal cord, slowly robbing people of their physical coordination and mental sharpness. Now there are nine, with more on the way.
"This has been the field that has seen the most dramatic therapeutic changes in all of neurology, and perhaps all of medicine, for the last 15 years, accelerating in the last few years," says Aaron E. Miller, medical director of the Mount Sinai School of Medicine's multiple sclerosis center, in New York.
Basic research has helped scientists better understand how the immune system damages the insulation that speeds signals from one nerve cell to another. The newer drugs block this damage — and though data is still thin, there is hope that this will make a huge difference for patients long term, says Gordon Francis, a vice president at Novartis, which makes the M.S. drug Gilenya.
But life with M.S. is still a challenge, and the drugs are far from a cure.
Hill had a relapse last March — about the same time as America's most famous M.S. patient, Ann Romney, wife of former presidential candidate Mitt Romney, relapsed. Ann Romney has said in interviews that she overdid it in the days before the Super Tuesday primaries. She recovered after some time spent resting.
Hill ended up in the hospital after her attack, but has been better since. With the changes in diet — no more junk food that can trigger immune flare-ups — a dedicated exercise routine, a break from her middle school teaching job, and her new drug regimen, she says she generally feels much better. The fatigue, which used to make it a challenge for her to get out of bed four or five days a week, is now limited to one or two days.
For patients who got discouraged by the previous generation of drugs, now is a good time to check out treatment options again, says Bill Sibold, a senior vice president at Genzyme, the maker of Aubagio.
Each of the multiple sclerosis drugs, which run $30,000-$50,000 a year, has strengths and weaknesses, says neurologist Ellen Lathi, director of the Multiple Sclerosis Center at St. Elizabeth's Medical Center in Boston.
"One is not better or worse than the next," she says. The advantage is that by having so many, there's bound to be one drug that meets every patient's need for disease stabilization and bearable side effects, she says. Trial and error is currently the only way to figure out which is best for which patient.
There are a number of drug companies interested in M.S., suggesting that more options will be available soon, doctors say.
So far, the focus has been on the 85% of patients who have the remitting-relapsing form of the disease. Scientists still need to figure out how to provide some relief to the other 15%, whose disease either skipped that stage or has advanced beyond it, says Timothy Coetzee, chief research officer for the National Multiple Sclerosis Society.
For Hill, the biggest symptoms remain the fatigue, and the diarrhea and nausea that are occasional side effects of her medication. On her recent honeymoon, she divided her time one day between the couch and the bathroom, she says, after she waited too long between popping her pill and eating breakfast.
Overall, though, she's feeling optimistic.
"M.S. is not a death sentence," Hill says. "It is difficult. It is a struggle. It will wear on you. But the future is bright."
Newer drugs for multiple sclerosis:
• Tysabri, from Biogen Idec, delivered by monthly injection, is considered extremely effective, but carries a small risk of lethal brain infection. A year-old test can identify patients at somewhat higher risk of the infection.
• Gilenya, from Novartis, has been on the market for about two years and was the first M.S. treatment delivered by a pill. It has been shown to reduce relapses by 50% and brain shrinkage by 30%-40%.
• Aubagio, a pill developed by Sanofi-Aventis, but now run by its subsidiary, Genzyme, is similar to a drug that has been used by rheumatoid arthritis patients for years, so its safety profile is well known.
• BG-12, a pill developed by Biogen Idec, is expected to win FDA approval before the end of the year. Studies have shown that it reduces relapse rates by 50% and slows progression of the disease, compared with a placebo.
• Lemtrada, also from Genzyme, is not yet approved, but company executives say it is expected to show an actual reversal of disability, instead of just delaying progression. It is delivered by injection five days in a row and then three days in a row a year later.