
PSORIATIC
ARTHRITIS NEWS AND VIEWS
VOL. 1 ISSUE 5 November 19, 2001
PSORIATIC
ARTHRITIS MEDICAL NEWS
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FDA
OK'S NEW RHEUMATOID ARTHRITIS DRUG - WASHINGTON (AP)
The first in a new class of therapy for rheumatoid arthritis won
federal
approval Wednesday, although studies show Kineret promises just
modest
effectiveness.
The
Food and Drug Administration said the new drug should be reserved
for
arthritis patients who have failed today's best treatments.
Still,
many doctors eagerly were awaiting Amgen Inc.'s drug because
there are
few options for the more than 2 million sufferers of rheumatoid
arthritis.
This
is not the common arthritis associated with the wear-and-tear of
aging.
With rheumatoid arthritis, the immune system goes awry and attacks
patients'
joints, causing swelling and stiffness as rogue immune cells eat away
cartilage and eventually erode bone. It mostly strikes women, usually
between
ages 25 and 50, and can disable them within 10 years.
Kineret,
known chemically as anakinra, works differently from other
treatments, blocking a protein called interleukin-1 that is one cause
of the
joint swelling.
Studies
show that after six months of treatment, about 38 percent of
Kineret
patients suffered less swelling and pain, compared with 22 percent
who got a
dummy shot.
In
contrast, about two-thirds of patients improve with the competing
drugs
Enbrel and Remicade, which block a different inflammatory immune
protein,
called tumor necrosis factor or TNF, said the FDA's Dr. Karen Weiss.
Prescription-only
Kineret will be on pharmacy shelves within two
weeks, and
will cost about $11,088 a year, said Thousand Oaks, Calif.-based
Amgen. That
is slightly lower than its anti-TNF competitors, which cost around
$12,000 a
year.
Kineret's
main side effect is irritation at the injection site.
Because it
suppresses the immune system, it also causes a small risk of serious
infection - 2 percent of Kineret patients versus less than 1 percent
of
placebo patients.
Patients
should stop taking Kineret if they develop an infection, but
can
resume the treatment once the infection clears, Amgen said.
The
anti-TNF drugs also cause the infection risk, so patients should
not use
Kineret together with either Enbrel or Remicade, Weiss said.
One
small study suggested that such combination therapy left 7
percent of
patients with a serious infection, and occasionally caused a severe
drop in
infection-fighting white blood cells. Copyright 2001 The Associated
Press.
******************************************
THE
FIGHT TO BE YOUR ARTHRITIS DRUG - Eric Sabo-CBS Healthwatch
Treating arthritis used to be like watching television before cable
came
along. There were few options, so you took what you could get. Now it
seems li
ke joint pain has its own satellite dish.
Tylenol
and other old standbys are being edged out by fancy new drugs
that
attack arthritis in ways never thought possible. Alternative
treatments, like
hyaluronan injections and the glucosamine-chondroitin duo, are
quickly
gaining ground as well. And expect more breakthroughs soon.
All
of this is certainly good news for those who suffer from sore
joints.
Even if the latest treatments only work as good as the old, they at
least
give patients another option to consider.
Yet
the success has also left doctors scrambling to figure out which
strategies work best. Looking at the same studies from their same
colleagues,
a number of experts have very different ideas on what treatments to
use and
when. Such disagreements are clearly healthy.
"It's
important to have robust debate," says Jack Klipple, MD,
scientific
advisor for the Arthritis Foundation.
But
working behind the scenes is a greater number of companies that
want to
make sure their drug comes out on top. As doctors try to figure it
out
themselves, pharmaceutical reps are helping to make up their minds
for them.
"The
marketing has never been as intense as it is now," says Klipple.
Show
Me the Money - The effort to persuade cuts deeper than the
glossy ads we
are all accustomed to. Study findings on a new treatment sound too
good to be
true? Check the source.
A
1994 review in the Archives of Internal Medicine found that when a
company
pitted its own anti-inflammatory painkiller against another, the home
team's
treatment proved safer 86% of the time. Evidence to support these
claims,
however, turned up in only 54% of the studies.
Skip
the fine print and more than your wallet is at risk: Similar
arthritis
drugs may cause different side effects in the process of helping your
joints.
Nowhere are these issues more complex--and the competition to sway
your
choice more intense-- than in the once-sedate world of nonsteroidal
anti-inflammatory drugs (NSAIDs).
In
about half the time it usually takes arthritis treatments to get
developed, Vioxx and Celebrex stormed out of research labs to become
the
latest craze in painkillers.
Company
officials say they have spent considerable time and money to
show
that their drugs are safer than older NSAIDs, which can cause serious
harm to
the stomach. These efforts have paid off big: The so-called super
aspirins
racked up nearly $6 billion in combined sales last year.
Super
Aspirins or Super Duds? -So far, however, this same research
has failed
to impress the FDA.
At
a crucial hearing last February, an advisory board for the FDA was
not
convinced that Celebrex proved any safer than diclofenac (Voltaren)
and
ibuprofen (Advil). They agreed that Vioxx caused fewer stomach
problems than
the NSAID it went up against, but the drug also left patients at
greater risk
for heart attacks.
"Basically
what we are saying is pick your poison," proclaimed
advisory board
member Michael Wolfe, MD, of Boston University.
Confused?
You're in good company. "I was convinced that the COX-2
inhibitors
[Vioxx and Celebrex] were safer," said another panel member, James
Williams,
MD, of the University of Utah."The data don't necessarily show that
today."
The
FDA is now mulling over what warnings to include on the drug's
label. But
some think it hardly seems to matter.
Despite
the FDA's uncertainty, plenty of experts say these drugs are
better
than traditional NSAIDs. Why even bother with a labeling change that
few seem
to pay attention to anyways?
"Many
patients and physicians already believe that Vioxx is safer,"
says
Christine Fanneli, a spokesperson for Merck, the company that makes
Vioxx.
"But it's not until the FDA accepts this hypothesis that we can
clearly state
that to patients and physicians."
Skipping
Past the FDA - Indeed, companies can only make specific
claims with
an FDA stamp of approval. But there are other ways to get your
message
across. At recent arthritis conference in Europe, company officials
announced
positive results from a Celebrex study that it hasn't presented to
the FDA
yet.
The
finding, according to a release, "further adds to the global body
of
evidence that Celebrex is comparable in efficacy to the two
traditional
NSAIDs studied while offering an improved GI [stomach] safety and
tolerability profile."
And
when the new kids on the block aren't going after older
treatments, they
are attacking each other. The companies that make Celebrex sponsored
two
studies that suggest Vioxx is more harmful to the heart than its
drug. Merck
shot back with a study of its' own and found that Vioxx was just as
safe as
Celebrex.
Lee
Simon, MD, of Beth Israel Deaconess Medical Center in Boston, was
curious
about any possible differences as well. He signed up for the
Celebrex-sponsored trial but withdrew after it became it apparent to
him that
the study would be used as a marketing gimmick.
"There
may be something there," he says about the potential for Vioxx
to
cause greater troubles for the heart. But it's hard to tell,
especially when
company officials spin the findings one way and scientists another,
he says.
"This
is all terribly complex," says Simon.
How
to Be a Smart Shopper - So how do you sort through the hype to
get a
treatment that's best for you? Consider these tips:
Don't
make up your mind before you see your doctor. An ad or article
you read
can be a good way to learn that a treatment exists. "Educating
consumers
about choices is always a good thing," says Klipple. "But what
you'll
find is
that consumers will demand drug X because they learned about it on
TV." That
miracle cure, however, may not always be right for you. With a
growing list
of treatments to choose from, doctors are paying increasing attention
to what
drugs keep you safe from other problems in addition to fighting
arthritis.
All
drugs come with a built-in risk. What seems safe in clinical
trials may
turn out to be dangerous once more people try it. Along with
outstanding
questions on Vioxx and Celebrex, the FDA has recently issued several
warnings
about rare and deadly problems found with rheumatoid arthritis drugs
known as
TNF (tumor necrosis factor) inhibitors. Make sure to stay up to date
on the
latest concerns.
Alternative
treatments are still drugs. Just because a treatment
is "natural"
does not mean its safe. And alternative remedy pushers can be equally
one-sided when comes to promoting their own findings. Recent studies
suggest
that both hyaluronan injections and the supplement glucosamine stave
off
osteoarthritis damage to the knees. Very exciting, but the X-ray
evidence
used to support these claims has been discounted by other research.
Don't
forget to exercise and eat healthy. Drugs can help, but even
the best
treatments will not do it alone. The American College of Rheumatology
recommends diet and exercise as part of an overall program to ease
joint
pain.
Eric
Sabo is a staff writer for CBSHealthWatch by Medscape.
Copyright: © 2001
Medscape, Inc.
*****************************
Editors
Note: Beginning with this issue, I will be providing
information on
less common forms of arthritis, as part of our ongoing educational
process.
ANKYLOSING
SPONDYLITIS
What
Is It? - The word "spondylitis" refers to inflammation of the
spine;
"ankylosis" means fusion or the melding of two bones into one.
Taken
together, ankylosing spondylitis describes a chronic, inflammatory
rheumatic
disease involving the sacroiliac joint (the joint between the spine
and the
pelvis), as well as other regions of the spine primarily affecting
the lower
back with a tendency to fuse inflamed spine joints. It is a member of
a
family of arthritic conditions, called spondyloarthropathies, which
share
many features: the spine and/or other joints may be inflamed, blood
antibody
tests (such as rheumatoid factor or antinuclear antibody, often
present in
rheumatoid arthritis and lupus, respectively) tend to be normal, and
a
genetic marker, HLA-B27, is more commonly present than in the other
arthritic
conditions.
Although
relatively rare, ankylosing spondylitis is significant
because it
primarily strikes young men who are otherwise healthy. It causes pain
and
stiffness in the torso -- the back, neck, hips, ribs and shoulders.
As the
spine and its supporting structures stiffen, people with ankylosing
spondylitis tend to assume a bent-forward posture. Over time, if left
unchecked, the bones of the spine can fuse or grow together,
producing what
is called a poker spine -- an extremely stiff, rigid backbone. It can
impair
functioning in the limbs and chest.
If
you have ankylosing spondylitis, you might feel pain or stiffness
in the
lower back, especially in the morning or after periods of inactivity.
Usually, the back pain begins in the sacroiliac joint and works its
way up
the lower (lumbosacral) spine and eventually may involve the entire
spine
(thoracic, or midportion; and cervical, or that portion at the top of
the
spine including the neck). The knee or ankle may be inflamed as well,
although usually no more than three or four nonspinal joints are
involved.
Stiffness often improves with activity, so that persons with
ankylosing
spondylitis worsen if they do not exercise regularly; many other
causes of
back pain tend to worsen with exercise. Because the joints between
the bones
of the ribs may also be involved, patients may find it uncomfortable
to
breathe deeply or cough.
Although
the symptoms may wax and wane, the disease tends to be
progressive
and chronic. Bones, joints and cartilage (disks) in or around the
spine
deteriorate and become fused, constricting the spaces. Bony spurs
(syndesmophytes) frequently develop. When this happens, the joints
become
unyielding and almost any movement can be extremely painful. The pain
and
rigidity in lower back can cause problems walking. In most cases, the
disease
is mild. In fact, for many it goes undiagnosed for years. In rare
cases, the
lungs, heart and eyes can become affected, in which case the disease
is more
serious.
The
cause of ankylosing spondylitis is not known. However, genetic
factors
seem to play an important role.
Ankylosing
spondylitis strikes most often between the ages of 20 and
40, but
it can begin in children younger than 10. It affects one in 10,000
people,
mostly males. In fact, men are affected 10 times more frequently than
are
women.
Symptoms
- Pain and tenderness in the back, thighs, hips and other
joints of
the torso
Stiffness and limited flexibility in the back that is worse in the
morning
but improves with exercise
Chest discomfort
Pain and swelling in the knees, ankles or other joints
Fatigue, fever
Loss of appetite, weight loss
Eye inflammation.
Stooped or rigid posture
Prevention
- Ankylosing spondylitis is easier to live with if you do
regular
exercises to improve posture and breathing. In fact, physical therapy
and
exercise are often the focal points of treatment. A physical
therapist can
help develop a proper exercise routine that in all likelihood will
include
range-of-motion and stretching exercises to counteract the possible
loss of
spinal flexibility. Certain abdominal and back exercises can help you
maintain good posture and compensate for the tendency to stoop. In
addition,
breathing exercises can enhance lung capacity.
Swimming
is an especially good way to exercise because your buoyancy
in the
water will improve your ability to move stiff, painful areas more
easily.
At
the same time, avoid any activities that could put undue stress on
your
back, and by all means, avoid contact sports or other activities in
which
there may be a risk of spinal injury.
Hot
baths, heat and massage may help to relieve pain. Proper sleep
and
walking positions will also help with your posture. If you are able,
sleep on
your back on a firm mattress and use a small pillow or none at all.
Ankylosing
spondylitis can affect the bones of the rib cage, and
therefore
your lung capacity can be restricted to begin with. If you smoke,
quitting
should be a priority.
Even
with the best treatment, some people will develop a fused
or "ankylosed"
spine, but most remain functional. At some points, a back brace or
other
devices may be necessary.
Treatment
- Treatment will address joint pain and will try to
prevent, delay
or correct any deformities of the spine.
Medications
- Nonsteroidal anti-inflammatory drugs (NSAIDs), such as
aspirin,
ibuprofen or naproxen, are used to reduce chronic pain, stiffness and
inflammation associated with the condition. These medications may
help you to
maintain normal activities. Moreover, they can control the pain
sufficiently
to allow you to include exercises as part of your treatment strategy.
In some
patients for whom NSAIDs alone are not adequate, more powerful
medications
such as sulfasalazine or methotrexate may be recommended, although
these have
a higher risk of side effects and require regular monitoring.
Surgery
- Surgery is performed only if the disease has caused nerve
damage in
the spine or if joint damage is severe.
Prognosis
- This disease is currently not curable. Because ankylosing
spondylitis is a lifelong problem, you will need continuing care.
Symptoms
usually progress unpredictably with periods of improvement and
worsening.
With or without treatment, you may develop permanent posture and
mobility
problems. With treatment, symptoms can be relieved or controlled so
that in
all likelihood, you can lead a normal, productive life.
********************************************
OTHER
CAUSES OF JOINT PAIN
o Bursitis - Bursitis, the inflammation of the bursa, commonly
results when a
specific joint is overused. In most all cases, the condition is
related to
such repeated physical activity as throwing a baseball or swinging a
tennis
racket.
o Carpal Tunnel Syndrome - Carpal tunnel syndrome happens because
tendons
and nerves to the hand have become irritated as they thread through
the
carpal tunnel (a passage between bones and ligaments in the wrist).
o Fibromyalgia - Fibromyalgia is a chronic condition of pain,
stiffness and
usually fatigue.
o Myositis (Polymyositis And Dermatomyositis) - The term myositis
means
inflammation of the muscles. A connective tissue disease,
characterized by
inflammation and degeneration of the body's muscles, myositis is
experienced
in tender and weak muscles.
o Sarcoidosis - Sarcoidosis -- a disorder associated with a variety
of
symptoms -- occurs in up to 65 per 100,000 persons, yet the cause is
unknown.
o Scleroderma - Scleroderma is a chronic autoimmune disorder, an
illness in
which it is believed that the body's immune defenses mistakenly
attack the
body's own cells rather than protecting them from outside invaders.
o Tendonitis - Tendonitis is the inflammation, irritation or
microscopic
tearing of a tendon -- a band of tough, flexible, fibrous tissue that
connects muscle to bone.
*********************************
ARTERY
DISEASE MAY BE UNDERTREATED CHICAGO (AP) - An artery disease
that is
strongly linked to heart attacks and strokes is underdiagnosed and
undertreated, despite widespread availability of a simple test, a
study says.
The
research in Wednesday's Journal of the American Medical
Association
suggests that peripheral arterial disease or PAD, previously
estimated to
affect about 8 million to 12 million Americans, may be more common
than
previously thought.
It
also suggests that doctors are overlooking the disease in part
because leg
pain - considered a classic symptom - may be present in just 10
percent of
patients.
Compared
with healthy patients, those with PAD face at least four
times the
risk of developing a heart attack or stroke. But the study indicates
primary-care doctors may be underestimating the disease's severity
and are
not giving patients appropriate treatment that could reduce their
risk, the
researchers said.
"PAD
is equally important to American health as heart disease
itself," said
Dr. Alan T. Hirsch, a vascular medicine specialist at the University
of
Minnesota and the study's lead author.
The
condition, also known as peripheral vascular disease, is a
narrowing of
blood vessels and arteries in the legs and sometimes arms. It usually
stems
from the same type of fatty plaque buildup that causes hardening of
the
arteries leading to the heart.
The
research involved 6,979 high-risk patients - over age 70 or
between ages
50 and 69 but with a history of smoking or diabetes. The authors
evaluated
how well the disease would be diagnosed in 350 primary-care doctors'
offices
in 25 cities, using a simple test that compares blood pressure in the
arms
and ankles.
Overall,
1,865, or 29 percent of the nearly 7,000 patients tested,
had PAD -
823 whose disease was diagnosed by the physicians during the study
and about
1,000 whose diseases had already been diagnosed.
Among
those already diagnosed, the study found, only about half of
the
doctors treating them said they knew of the previous diagnosis - even
though
the patients' charts contained documentation about it.
Doctors
had either forgotten about their own diagnoses or - more
likely -
were unaware of diagnoses made by others, said co-author Dr. Michael
Criqui
of the University of California-San Diego School of Medicine. Either
way, he
said, the results suggest doctors weren't paying attention to a
serious
condition that should have been suspected because of the patients'
risk
factors.
Among
already-diagnosed patients, more than 40 percent had not been
prescribed aspirin or other blood-thinning medications, and 12
percent were
not on blood pressure drugs.
Criqui
said many doctors think of the disease as a leg problem, even
though
the study found that only about 10 percent of patients have classic
leg pain.
Doctors
should be using the ankle-arm blood pressure measurement to
routinely
screen high-risk patients, Criqui said.
"If
you rely on leg pain alone to catch PAD, you miss 90 percent of
PAD
patients," Criqui said.
Dr.
Kenneth Ouriel of Cleveland Clinic Foundation, wrote a JAMA
editorial
calling the study "an important reminder for primary care clinicians
to be
cognizant of PAD and its associated signs and symptoms."
Identifying
patients earlier will lead to earlier treatment that "can
be
expected to improve the overall health status and life expectancy of
elderly
patients with athersclerosis," Ouriel said. Copyright 2001 The
Associated
Press. All rights reserved.
*************************************
ASPIRIN
MAY EXTEND LIVES - CHICAGO (AP) - People who take aspirin
regularly
to reduce their short-term heart attack risk may also be
substantially
extending their lives, new research suggests.
The
study of 6,174 adults with suspected heart disease found that
regular
aspirin users faced a 33 percent lower risk of dying during a follow-
up
period averaging three years than patients who didn't take aspirin.
The
findings extend the known benefits for heart patients in taking
aspirin
at least every other day, which previous studies have shown can
reduce the
risk of heart attack and the short-term risk of death in heart attack
sufferers, said the authors, led by Dr. Patricia Gum of The Cleveland
Clinic.
"Up
until now it really had not been very well established" that
aspirin had
long-term survival benefits for heart patients, said co-author Dr.
Michael
Lauer, clinical research director in the clinic's cardiovascular
medicine
department.
The
study appeared in Wednesday's Journal of the American Medical
Association.
Dr.
Lynn Smaha, a cardiologist at Guthrie Clinic in Sayre, Pa., said
patients
often ask him if they should regularly take aspirin, which improves
blood
flow through the arteries by making it less sticky and less likely to
clot.
For
those who've had previous heart attacks, "it's pretty clear that
that's
an appropriate recommendation," said Smaha, past president of the
American
Heart Association.
The
new study "lends credence to the possibility that long-term
aspirin
therapy may be of significant benefit" even for patients with no
previous
heart attacks, Smaha said.
Lauer
stressed that patients should consult with their doctors about
whether
to start taking aspirin on a regular basis.
Study
participants were male and female patients who underwent
ultrasounds
called echocardiograms and stress tests to evaluate suspected heart
problems.
Included were 2,310 people who were taking about one aspirin daily or
every
other day at test time and 3,864 nonusers.
There
were 276 deaths during about three years of follow-up. While
there were
about equal numbers of deaths in both groups, the aspirin users were
older
when they were tested - aged 62 on average compared with 56 for the
nonusers
and had more diagnosed heart disease. Adjusting for those factors,
the
authors found aspirin users were 33 percent less likely to die than
nonusers.
The
greatest benefits were seen in patients who were physically
unfit, over
age 50 or who had known heart disease. Lauer said most of the deaths
likely
were heart-related, though exact causes weren't available. Copyright
2001 The
Associated Press. All rights reserved.
************************************
I
wish everyone a great Thanksgiving and hope you have a joyous day
with
family and friends.
Good health to all.
Jack Nicholas
Cornishpro@a...
Issue 2001 11/18/01-5
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