PSORIATIC ARTHRITIS MEDICAL NEWS

AHP, IMMUNEX GET FDA APPROVAL TO MARKET ENBREL FOR PSORIATIC ARTHRITIS
WASHINGTON (Reuters Health) Jan. 2002

American Home Products Corp. subsidiary Wyeth-Ayerst Laboratories and Immunex
Corporation jointly said on Wednesday that they have received a supplementary
approval from the US Food and Drug Administration (FDA) to market the
arthritis therapy Enbrel (etanercept) for the treatment of psoriatic
arthritis.

Enbrel was first approved in 1998 for the treatment of rheumatoid arthritis
(RA). The supplementary application for psoriatic arthritis was filed in July
and was subsequently granted priority review by the FDA in August.
Roughly 1 million US adults have psoriatic arthritis, a number significantly
higher than previously believed, according to research released Wednesday by
the National Psoriasis Foundation (NPF).

The companies said that the supplementary FDA approval was based on
24-week-long phase III study involving 205 patients with psoriasis. Results
of the study were first released in November at a meeting of the American
College of Rheumatology in San Francisco. According to researchers, after 24
weeks about 59% of patients taking Enbrel had significant improvement in the
signs and symptoms of the disease compared with 15% of those on placebo.
Copyright © 2001 Reuters Ltd.

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LOW DOSE METHOTREXATE DOES NOT AFFECT BONE MINERAL DENSITY IN ARTHRITIS
PATIENTS

Bone density remains normal in patients treated with low-dose methotrexate,
Canadian researchers report. Dr. Ann B. Cranney from Ottawa Hospital, and
colleagues compared bone density in 30 rheumatoid arthritis (RA) patients and
30 patients with psoriasis/psoriatic arthritis receiving methotrexate with 57
similar patients who were not taking methotrexate.

The mean weekly dose of methotrexate was 10.1 mg in patients with RA and 12.4
mg in patients with psoriasis/psoriatic arthritis, according to the report in
the November issue of the Journal of Rheumatology.
The researchers measured bone mineral density at the radius, lumbar spine,
trochanter, and the neck of the femur. There was no significant difference at
any of the sites in patients taking methotrexate and controls. At the femoral
neck the mean difference in bone mineral density was 0.04 g/cm² for patients
with RA, and 0.06 for g/cm² for patients with psoriasis/psoriatic arthritis,
the researchers found.

RA patients receiving methotrexate had a higher absolute bone mineral density
at the lumbar spine than did controls (0.101 g/cm², p = 0.029), but this
significant difference was not seen in patients with psoriasis/psoriatic
arthritis.

Dr. Cranney's group concludes that "we did not find a negative effect on bone
density in arthritis patients taking low dose methotrexate in comparison to
those not taking methotrexate. However, we were not able to determine whether
higher doses of cumulative methotrexate may have a negative effect on bone
mineralization."

J Rheumatology 2001;28:2395-2399. Copyright © 2001 Reuters Ltd.

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Editors Note: The following press release (which has been abbreviated) is
extremely important reading for everyone. Go to the NPF website and view the
full text of the
press release and download all the survey information. Many thanks to those
members who participated in the Research Survey.

NEW RESEARCH SHOWS 1 MILLION U.S. ADULTS SUFFER
FROM PSORIATIC ARTHRITIS - ALSO OTHERS MAY BE AT
RISK BUT NOT KNOW IT PORTLAND, Ore., Jan. 16, 2002 -- Approximately 1
million U.S. adults have psoriatic arthritis, a number significantly higher
than previously believed, according to new research released today by the
National Psoriasis Foundation (NPF). The majority of people surveyed say the
disease seriously affects daily living, and many people are dissatisfied with
the medical treatment they have received.

The research also suggests many people with psoriasis, a related skin
disease, may have psoriatic arthritis and not know it.

The complete National Psoriasis Foundation Press Kit on Psoriatic Arthritis
is available as a PDF file at the National Psoriasis Foundation Website:
http://www.psoriasis.org/ The kits includes the press release, a recap of the
benchmark survey results, a list of psoriatic arthritis spokespeople, a
psoriatic arthritis Q&A sheet and a psoriasis fact sheet.
Viewing and printing files in PDF format requires free Acrobat Reader
software. If you do not have this software installed on your computer, it is
available at the Adobe Web site.

"Psoriatic arthritis can be a disabling disease and can cause permanent
damage when left untreated," said Gail M. Zimmerman, NPF president and CEO.
"It's vital that we educate the public and medical community about the
disease and its effects. We want people who have psoriatic arthritis to seek
treatment in order to improve their quality of life."

The NPF Benchmark Survey for Psoriatic Arthritis is the first research to
establish the prevalence of psoriatic arthritis among U.S. adults, according
to the NPF. In surveys conducted in December 2001 of more than 27,000 adults,
one-half of 1 percent said they had been diagnosed with psoriatic arthritis.
That translates to about 1 million of the total U.S. adult population --
roughly double the number that the medical community previously suspected had
the disease. Children also are affected by psoriatic arthritis but data about
children is not reflected in these findings.

"We're hopeful this new data on the prevalence of psoriatic arthritis will
encourage the medical community to conduct further research and develop new
therapies," Zimmerman said.

About one in four people surveyed said they are dissatisfied with the medical
treatment they have received for their psoriatic arthritis.

The National Psoriasis Foundation is the only nonprofit organization in the
United States dedicated to improving the quality of life for those with
psoriasis and psoriatic arthritis and their families. It receives its
principal support from public donations. Its mission is to raise public
awareness about these diseases and their treatments and to support ongoing
research.

The organization is headquartered in Portland, Ore., and serves the millions
of men, women and children diagnosed with psoriasis and psoriatic arthritis.
For more information, please call the NPF at (800) 723-9166 or tour their Web
site at http://www.psoriasis.org/

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RAYNAUD'S PHENOMENON
By Robert H. Shmerling, M.D. - Harvard Medical School

If you experience cold and painful fingers in the winter, you are not alone.
After all, rushing out the door without your gloves or scraping the ice off
the windshield in the dead of winter can be a miserable experience for
anyone. But for many people with Raynaud's phenomenon -- at least 5 percent
of the population -- it is even worse: their fingers and sometimes their toes
or other areas actually turn blue and become extremely painful.

Raynaud's phenomenon, named after Maurice Raynaud who first described it in
1862, is a circulation problem that makes blood vessels in the coldest parts
of the body constrict (or "go into vasospasm"), reducing their blood supply.
Some people notice that their nail beds or finger tips turn white, then blue,
then red; others notice only one or two color changes, In almost all cases,
the episodes last only a few minutes and then resolve entirely. Thus,
Raynaud's phenomenon is often more annoying than dangerous.

Tiny nerves around the arteries control their size, allowing them to open up
or narrow. For example, when we exercise, the nerves instruct the arteries to
open up and allow more blood to flow to the muscles - in that way, more fuel,
such as oxygen, is delivered, and more waste products can be removed. When
exposed to cold, the smallest blood vessels near the skin surface constrict,
in part, to conserve body heat. It is this normal constriction of the small
arteries in the fingers and toes that is overactive in patients with
Raynaud's phenomenon.

Raynaud's phenomenon is more common in women than men. The underlying cause
is unknown, although patients with certain rheumatic diseases, such as
scleroderma and lupus, have Raynaud's more often than people without these
diseases. For persons with Raynaud's phenomenon, medical textbooks and many
physicians often suggest extensive evaluation for rheumatic conditions,
including antibody tests for lupus, scleroderma and related disorders.
However, these tests are not terribly accurate. (See related commentary. The
only reliable way to know if you have a rheumatic illness associated with
Raynaud's is through assessment of "the big picture:"

Are there symptoms that may suggest another illness (such as a rash or
arthritis)?
Are there abnormalities on the physical examination (including examination of
the skin, lungs and joints)?
Are there abnormal results on routine tests, such as the complete blood
count, evaluation of kidney function or urine tests?
Raynaud's phenomenon is highly treatable, although there is no single
treatment that reliably works for all patients. For most, no medication is
necessary: simply avoiding things that provoke the episodes (such as going
out in the cold without first bundling up) and turning up the thermostat a
few degrees are all that is necessary. Wearing a hat and scarf (to avoid
lowering the body's core temperature), as well as good gloves or mittens, is
recommended. Simple and technologically advanced hand and foot warmers are
available and can make a huge difference when cold exposure cannot be
avoided, such as during a ski trip.

Certain medications, such as beta-blockers (common heart or blood pressure
therapies) and over-the-counter vasoconstrictors (such as pseudo ephedrine,
an active ingredient in many decongestants), should be avoided if possible,
because they may worsen or increase the frequency of Raynaud's episodes. On
the other hand, alcoholic beverages (in moderation, of course) tend to dilate
blood vessels.

Sometimes, emotional stress can provoke Raynaud's episodes. Biofeedback, a
method of training the hands to warm up through imagery or meditation, is
occasionally useful.

When symptoms are severe, medications to dilate blood vessels may be helpful.
Commonly prescribed agents include diltiazem, nifedipine, hydralazine and
prazosin. They may only be necessary in the coldest weather. Rarely, a minor
surgical procedure to reduce nerve signals to the blood vessels -- known as a
"nerve block" -- may be warranted, especially in the rare circumstance when
infection, poor healing or even skin damage develop because of poor blood
supply.

For most people with Raynaud's phenomenon, the burden is real but is
fortunately limited to certain times of the year. By knowing what to avoid
and the options for treatment, patients can reduce their risk of serious
problems or severe symptoms. For many, the treatment of choice may be the
ultimate in natural remedies: springtime.

Robert H. Shmerling, M.D., is associate physician at Beth Israel Deaconess
Hospital and associate professor at Harvard Medical School.

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NERVE DAMAGE POSSIBLE WITH TWO ARTHRITIS DRUGS
Friday January 18 6:41 PM ET By Faith Reidenbach

NEW YORK (Reuters Health) - In a small number of cases, certain arthritis
drugs have been associated with serious nervous system problems, according to
a recent report from researchers at the US Food and Drug Administration (news
- web sites) (FDA) and elsewhere in Washington, DC.

They recommend that patients receiving Enbrel (etanercept) or Remicade
(infliximab) be monitored by their physicians for neurological symptoms such
as confusion, numbness, changes in vision and difficulty walking.

These symptoms are suggestive of demyelination, or the loss of myelin, the
fatty sheath that coats nerve fibers and helps nerves function. A familiar
example of a demyelinating disease is multiple sclerosis, in which
degeneration of nerve cells results in symptoms ranging from numbness and
muscle weakness to paralysis.

If neurologic symptoms appear in a patient taking Enbrel or Remicade, the
drug should be discontinued immediately, the researchers advise in a recent
issue of Arthritis & Rheumatism. The patient should be referred to a
neurologist for a thorough examination, they say.

In interviews with Reuters Health, spokespeople for Enbrel's maker Immunex,
and Centocor, the maker of Remicade, emphasized that demyelinating disease is
a rare complication of therapy with these two drugs. The companies have known
about this complication for over a year, and a warning about it appears on
their drug packaging and Web sites.

``Our current knowledge of this would suggest that (demyelinating disease) is
a very, very rare complication,'' Dr. John H. Klippel, medical director of
the Arthritis Foundation in Atlanta, Georgia, concurred in an interview with
Reuters Health.

``On the other hand, the authors of this study have asked for additional
studies to reassure ourselves that it is in fact quite rare, because it has
not been systematically studied,'' he said. ``The Arthritis Foundation would
certainly agree that additional studies are warranted.''

Dr. Niveditha Mohan of Georgetown University Medical Center and colleagues
first suspected a possible link between neurologic symptoms and the drugs
when a 48-year-old man was referred to them because of confusion and
difficulty walking. The man had rheumatoid arthritis and had been taking
Enbrel for 4 months.

A brain biopsy revealed some damage to nerve fibers, although no actual loss
of myelin was visible when the man underwent an MRI brain scan.

To investigate whether similar cases had ever been reported, the researchers
searched an FDA database. They found reports of 17 other patients taking
Enbrel and 2 taking Remicade who had developed neurologic symptoms suggestive
of demyelination.

Eighteen of those patients had undergone brain MRI. In all of them the scans
showed demyelination in one or more areas of the central nervous system, or
some other injury to nerve fibers.

The average length of therapy before neurologic symptoms developed was 5
months, the database showed. In all patients, symptoms improved completely or
partially after patients stopped using Enbrel or Remicade. When one patient
began taking Enbrel again, his symptoms returned.

``Reports to the (FDA) do not necessarily represent causal relationships
between adverse events and drugs,'' the researchers note. ``In addition,
underreporting of adverse events occurs, and the reports may be missing data.
Therefore these reports should be interpreted cautiously.''

In correspondence with Immunex, Mohan's group learned that Enbrel was
prescribed for 77,152 patients between November 1998 and May 2000. Symptoms
suggestive of a demyelinating disorder were reported for only nine patients
during this period.

That figure is similar, the researchers point out, to the natural rate of new
cases of multiple sclerosis: 4 to 6 cases for every 100,000 people per year.
The spokesman for Centocor also noted that the rate of demyelinating
disorders associated with Remicade is no higher than the expected rate of MS
in the general population.

The research team acknowledges that the patients they studied might have had
``a genetic propensity to develop MS.'' Four of the patients were known to
have had MS or an MS-like syndrome before they started taking the arthritis
drug.

``Clinicians should consider avoiding (Enbrel, Remicade, and similar drugs)
in those patients who have a preexisting diagnosis of MS,'' Mohan's group
recommends.

``I would be a little more emphatic,'' Klippel told Reuters Health. ``Instead
of giving consideration to avoiding, I think that the medical community would
be of the view that these drugs should not be used in people with known
demyelinating diseases like multiple sclerosis.'' SOURCE: Arthritis &
Rheumatism 2001;44:2862-2869.

*****************************************

Editors Note: This is our fourth in a series that describes other forms of
Arthritis. Realizing that many of our members have children already suffering
from Psoriatic Arthritis and Psoriasis, the following information can help
all of us better understand the devastation this disease can bring to a
family.

JUVENILE ARTHRITIS

Arthritis is not a single disease, but rather a descriptive term for
conditions in which there is inflammation of the joints that causes pain and
swelling. Although many people believe arthritis is a disease of old age,
various forms of arthritis can strike just about anyone at any age. When
arthritis occurs in children younger than age 16, it is called "juvenile
arthritis". It has been estimated that approximately 285,000 children in the
United States have some form of the disease.

Juvenile rheumatoid arthritis (JRA) also called Juvenile idiopathic arthritis
(JIA): This is the single most common form of juvenile arthritis. JRA is
thought to be an autoimmune disease, which means that, for unknown reasons,
the body reacts against some of its own tissue the same way it would react
against a foreign invader (such as a virus or bacteria), by launching an
immune attack. In the case of JRA, the lining of the joint (also called the
synovial membrane) becomes inflamed and enlarged, limiting movement and
causing pain and tenderness. Enzymes released by the inflamed membranes cause
further damage by eroding the bone and cartilage. This type of joint and bone
damage can cause special problems in a growing child: if the growth areas of
the bones are affected, the bones may grow at different rates so that one
bone may develop abnormally in shape or size. The result could be, for
example, that one leg might be permanently shorter than the other.

There are three subcategories of JRA:
Systemic onset type, which begins with a whole-body (systemic) reaction,
including high fevers (generally 103° F or higher); skin rash on the legs,
arms and trunk; joint inflammation; and signs of inflammation of other body
organs, such as enlarged lymph nodes or lining of the lungs (pleurisy). A
child may have one or more episodes of systemic onset JRA that eventually
disappear, or it may persist into adulthood. Any joint damage done during the
episode will be permanent.

Pauciarticular onset disease, in which fewer than five joints are affected,
is the most common form of JRA. The large joints -- such as knees, elbows,
and ankles -- are often affected, usually in an asymmetrical pattern (for
example the knee on one side, the ankle on the other). Symptoms include pain,
swelling, stiffness, redness, and warmth at the affected joint. Children with
this type of JRA are particularly susceptible to an eye inflammation called
iridocyclitis. Frequent evaluations by an ophthalmologist, perhaps as often
as every three months, are critical because there may be no symptoms and
permanent eye damage can occur even if other symptoms of JRA are under
control. Fortunately, treatment for iridocyclitis is highly effective. Many
or even most children with pauciarticular onset JRA will outgrow the disease
with no ongoing arthritis.

Polyarticular disease, in which five or more joints are affected, usually
involves the small joints, such as those in fingers and toes, although large
joints can also be affected. Symptoms include the same inflammatory symptoms
as other types of JRA, along with low-grade fever and bumps or "rheumatoid
nodules" near the affected joints. Typically, it follows a symmetrical
pattern, with matching joints on both sides of the body affected.
Polyarticular JRA is more common in girls than in boys, is usually more
severe than the other two types, and often leads to long-term joint problems.
In 5 to 10 percent of cases, the antibody called "rheumatoid factor" can be
detected in a blood test, which further classifies the JRA as seropositive.
Seropositive JRA is most like adult rheumatoid arthritis, and often continues
into adulthood.

Juvenile ankylosing spondylitis. Affecting boys more often than girls, this
disease involves the large joints of the lower body, particularly the lower
back and hips. Key symptoms are lower back pain or stiffness, especially in
the morning, and improvement with exercise.

Reiter's syndrome. Weeks to months after a child has been exposed to certain
infectious agents -- in particular shigella, salmonella, or yersinia
associated with diarrhea -- he or she may develop this type of arthritis.
Because it follows as a type of reaction to an infectious agent well after
the infection has subsided, the arthritis is often called "reactive." Onset
is usually sudden. Key symptoms are fever along with pain and inflammation in
several joints, conjunctivitis and painful urination.

Juvenile psoriatic arthritis. This type of chronic arthritis sometimes
strikes people with psoriasis, and seems to have a genetic component. Along
with joint pain and inflammation, key symptoms are pitted fingernails and
psoriasis and a raised, scaly rash behind the ears, in the area of the navel,
along the scalp or other body areas.

Juvenile systemic lupus erythematosus. Although lupus generally does not
appear before adolescence, when it occurs in children it is very similar to
lupus in adults. This disease has symptoms that can appear anywhere in the
body, and often affects more than one organ system. It can cause inflammation
or damage to the skin, joints, blood vessels, brain, heart, muscles or
kidneys. The disease often appears in episodes, with flares that come and go
for no particular reason. Key symptoms include a rash on the cheeks,
sensitivity to sunlight, mouth or nose sores, joint pain, seizures or other
signs of neurological problems, and chest pain.

Although the type and severity of symptoms will vary depending on the child
and the disorder diagnosed, common symptoms to watch for include:
One or more joints that are persistently swollen and tender, or possibly red
and warm to the touch. Pain, when moving joints, although many young children
never complain of pain. Stiffness or decreased joint mobility, especially
upon waking. Limping.
Joints that look knobby or deformed. Bent posture or limbs, which the child
may adopt to alleviate pain but which can become permanent if enough joint
damage is done.

Other symptoms can include: Asymmetric growth patterns (one leg longer than
the other, for example). Blurry vision, eye pain or redness, Low-grade fever,
Skin rash, Fatigue,
Irritability, Chest pain, Generalized complaints of pain

Juvenile arthritis is difficult to diagnose because there are so many
different diseases, and because there is no single test that definitively
points to a diagnosis of juvenile arthritis. If your child shows signs of
juvenile arthritis or other rheumatic disease, you will likely be referred to
a pediatric rheumatologist for diagnosis. The rheumatologist will look at the
medical history of the child to try to find clues to the disease. For
example, one of the primary diagnostic criteria for juvenile rheumatoid
arthritis is joint inflammation that has persisted for at least six weeks.
Blood tests may be performed to look for antibodies common to some forms of
arthritis, such as rheumatoid factor (RF) or antinuclear antibodies (ANA's),
although they are often absent in children. X-rays may be performed to look
for damage to cartilage or, in severe cases, bone. Other tests may also be
performed to rule out other conditions.

Although juvenile arthritis is generally a chronic, life-long condition, many
patients note that their symptoms gradually lessen or disappear as they enter
adulthood. Because no one knows what causes juvenile arthritis, there is no
known way to prevent it.

The main goal of treatment is to get the symptoms under control so that no
further damage to the joints is done, and so that the child can maintain a
good function and quality of life. Nonsteroidal anti-inflammatory drugs
(NSAIDs) are usually the first medications tried to relieve joint
inflammation. They work by decreasing the amount of an enzyme found in
affected joints that promotes inflammation. This same enzyme, however, has a
protective effect in the stomach, so NSAIDs often cause stomach irritation
and ulcers. Low doses of NSAIDs are available over-the-counter, including
ibuprofen and naproxen. Newer prescription drugs, the COX-2 inhibitors
(including celecoxib and rofecoxib), more selectively inhibit the enzyme
involved in joint inflammation, so they are thought to be safer for the
stomach. Although COX-2 inhibitors have not been well-studied or approved for
use in children, they may become a useful medication for juvenile arthritis
in the future. NOTE: Do not attempt to treat your childï¾'s joint pain with
medication without the advice of a physician. Children can be very sensitive
to the effects of NSAIDs, and serious side effects can occur if too high a
dosage is given.

In severe cases, children with juvenile arthritis may be treated with more
powerful medications. Corticosteroids (such as prednisone) are fast-acting,
anti-inflammatory agents that may be used to stop dangerous inflammation,
such as when the lining of the heart has become inflamed (pericarditis), or
to stabilize a child in an acute stage of the disease. These drugs can have
very serious side effects, including interference with growth, weight gain,
weakened bones, and an increased susceptibility to infections. They are
usually prescribed for only a short time. If a child is prescribed
corticosteroids, they must be taken exactly as directed. Disease-modifying
anti-rheumatic drugs (DMARDs), such as methotrexate, act more slowly, but
often provide relief if other medications have failed. Liver damage or other
complications are well-recognized risks, so physicians will carefully monitor
blood levels of the drug in patients taking DMARDs. Newer agents are under
active investigation for juvenile arthritis. Surgery is sometimes required if
joint damage is severe or joint deformity has developed.

Children with juvenile arthritis should be encouraged to maintain as normal a
life as possible. Although there may be pain, exercise is important to
maintain range of motion and function in the affected joints. Usual play and
sports activities are beneficial once symptoms are under control. In severe
cases, physical therapy may be recommended to keep the joints moving as
freely as possible. Tutoring or special attention from teachers may be needed
if the child misses many weeks of school due to illness; and counseling might
be recommended to help the child deal with the emotional aspects of having a
chronic illness. Call a health-care provider if the child develops fever or
rash along with symptoms of arthritis such as persistent joint pain, swollen
joints, and limited motion.

Because the symptoms and damage caused by juvenile arthritis can vary
greatly, the prognosis is also highly variable. Some types of arthritis have
flares that can recur after periods of remission, whereas other types are
more chronic. The majority of patients have good symptom control with
treatment, and many children "outgrow" the illness. However, severe forms of
the disease may cause growth problems if the growth plates in the long bones
are damaged, long periods of missed school if the child is very ill, and/or
long-term functional problems resulting from joint damage. In addition, the
medications used to treat juvenile arthritis may cause other problems,
including stomach ulcers, weakened bones, and liver damage.

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Due to the extraordinary amount of current medical information available, I
will be publishing the next newsletter this weekend.

I always welcome your comments and good health to all.

Jack Nicholas - Editor
Cornishpro@aol.com
Issue 2002-01/24/02-2