MS Pills Show Promise and Risk, Studies Say
From Associated Press (January 20, 2010)
ATLANTA_Tests of the first two oral drugs developed for treating
multiple sclerosis show that both cut the frequency of relapses and
may slow progression of the disease, but with side effects that
could pose a tough decision for patients.
Two experts not involved in the studies said the drugs appear
effective but with potentially dangerous side effects. It's too
soon to know if the pills will be approved by the government or
widely adopted by physicians, they said.
About 2.5 million people around the world have multiple sclerosis,
a neurological disease that can cause muscle tremors, paralysis and
problems with speech, memory and concentration. The studies involve
the most common form of the disease, in which people are well for a
while and then suffer periodic relapses.
Current treatments can reduce the duration and severity of symptoms
but require daily or regular shots or infusions.
The new studies tested two types of pills. Cladribine, made by
Merck Serono, is already sold to treat a rare blood cancer. For MS,
it would be taken eight to 10 days a year. Fingolimod is a daily MS
pill being developed by Novartis.
The research found that patients on the pills were about half as
likely to suffer relapses of symptoms as those who took dummy pills
or a commonly prescribed shot for MS.
But they also found both drugs significantly lowered immune
defenses that allowed latent herpes viruses to rage in some
patients _ in one study, two people died of unchecked herpes
infections.
The side effects detailed in the new studies are giving some
physicians pause.
"There is a price tag attached" to the new medications, said Dr.
Silva Markovic-Plese, an MS researcher at the University of North
Carolina.
The studies were being published in Thursday's New England Journal
of Medicine.
There is no cure for MS, but steroids can reduce the duration and
severity of symptoms in the short term, and seven treatments on the
market have had success in reducing recurrence of symptoms.
All involve daily or regular injections. So a pill is appealing:
Even healthy people can have trouble giving themselves shots, so it
can be a nightmare for patients with faltering coordination and
concentration.
"Right now I have to think very hard when I make coffee," said
Ivana Vuletic, a 49-year-old North Carolina. woman with MS. "I
would be greatly relieved if I didn't have to prick myself or be
pricked" with needles, she said.
Still, she said she wouldn't take the new pills if their side
effects were too dangerous.
Vuletic is on her third MS drug in about four years, and her
illness has gotten worse. The MS injections have led to pocked skin
and other problems so she is leery of new treatments' side
effects.
The new studies reveal the trade-offs:
_A two-year study gave 1,300 MS patients cladribine or dummy pills.
Patients on the drug were only half as likely to suffer relapse as
those on placebo, and were 30 percent less likely to have worsening
disability. However, 20 percent to 30 percent of the cladribine
patients developed low counts of infection-fighting white blood
cells, compared to just 2 percent of the others. And 20 cladribine
patients suffered herpes infections versus none in the dummy pill
group.
_A two-year study gave about 1,000 patients fingolimod or dummy
pills. Only 17 percent of fingolimod patients had worsening
disabilities from MS after three months, compared to 24 percent in
those on placebo. Herpes infections were about the same in the pill
and placebo groups, but respiratory infections like bronchitis and
pneumonia were nearly twice as common in the fingolimod
patients.
_A one-year study of 1,200 patients tested fingolimod against shots
of Avonex, a form of interferon. Those taking the pills had less
brain shrinkage _ a measure of progression of the disease. About 20
percent of patients on the pill had relapses versus 30 percent on
the dummy pills.
In that study, 9 percent of those on fingolimod had serious side
effects, compared to 6 percent of those on Avonex. Two people on
fingolimod died of herpes infections; six had eye swelling and
eight had skin cancers.
All three studies were funded by Novartis or Merck Serono, the pill
manufacturers.
Doctors are likely to turn first to current options until the
pills' side effects are better understood, said Dr. Neil Lava, the
director of Emory University's multiple sclerosis clinic.
Physicians are mindful of what happened with Tysabri, an MS drug
that was approved in November 2004 and pulled from the market the
next year after cases of a rare but lethal brain inflammation in
some patients. It was reintroduced in 2006, but doctors are still
monitoring for side effects, Lava said.
___
On the Net:
New England Journal: http://nejm.org
Posted: January 2010
