Newsletter Edition No. 2

September 9, 2001

PSORIATIC ARTHRITIS NEWS AND VIEWS VOLUME 1 ISSUE 2 SEPTEMBER

2001

PSORIATIC ARTHRITIS MEDICAL NEWS

We reported in our first newsletter about the new psoriasis drug under test

called " Alefacept. " This issue begins with additional information as reported

in the New England Journal of Medicine.

Alefacept Reduces Severity of Chronic Plaque Psoriasis

WESTPORT, CT (Reuters Health) Jul 26 - Alefacept (Amevive; Biogen) appears to

be an effective and well-tolerated immunomodulatory treatment for chronic

plaque psoriasis, according to results of the multicenter Alefacept Clinical

Study, which appear in the July 26th issue of the New England Journal of

Medicine.

" Alefacept was designed to interfere with the co-stimulatory pathways that

occur when an antigen-presenting cell meets a memory T cell, " co-investigator

Dr. Gerald G. Krueger, of the University of Utah Health Sciences Center in

Salt Lake City, told Reuters Health. " We were hoping it would also hook onto

a natural killer cell and therewith eliminate the memory effector cell that

causes psoriasis. " " As we demonstrate in our paper, there is a direct

correlation between memory effector T cells and improvement in disease, " he

said.

Dr. Krueger and associates randomly assigned subjects to alefacept (170

patients) or placebo (59 patients). The treatment group received alefacept in

doses of 0.025, 0.075, or 0.150 mg/kg, administered IV once a week for 12

weeks. Five placebo group patients and three alefacept patients discontinued

treatment because of worsening of psoriasis.

Two weeks after completion of alefacept treatment, mean scores on the

psoriasis area-and-severity index were lower than baseline by 38%, 53%, and

53% in patients receiving 0.025, 0.075 and 0.150 mg/kg, respectively. These

scores were significantly lower than the 21% decline observed in the placebo

group (p < 0.001).

Twelve weeks after treatment, between 42% and 63% of patients treated with

alefacept had at least a 50% reduction in baseline score, compared with 32%

of those given placebo (p = 0.02). Between 19% and 33% of patients who

received alefacept exhibited at least a 75% reduction versus 11% in the

control group (p = 0.02).

These results were mirrored in the group's recently completed phase III

trial, Dr. Krueger told Reuters Health. In this trial, more than 1000

patients were treated with alefacept 0.075 mg/kg, either IM or IV.

" Again, we saw a delayed response, " he said. " If someone achieved 50% or 75%

improvement immediately post-treatment, they either stayed there or got

better during the next 12 weeks. At the end of 12 weeks, they were offered

another course. " Twenty-three percent of the psoriasis cases cleared after

the first course of treatment and 32% cleared after the second course.

The study group also looked for evidence of infections that would be

anticipated if T-cell counts declined in a generally immunosuppressive mode,

especially fungal infections, Pneumocystis, herpes simplex, and herpes zoster.

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

Editors note: The following article from the Southern Medical Journal makes

reference to the possible connection

between cigarette smoking and psoriasis. I have chosen to include only a very

small portion of the information because

of the length of the study. The following is the web site address should you

desire to read the entire publication.

http://www.medscape.com/SMA/SMJ/2001/v94.n06/smj9406.14.stra/smj9406.14.stra-0

1.html

Tobacco Use and Skin Disease

Melody Vander Straten, MD, Carrasco, MD, Martha S. Paterson, MD,

L. Mccrary, MD, Diane J. Meyer, MD, K. Tyring, MD, PhD,

Association]

Abstract

Background The primary objective of this review is to evaluate the

mucocutaneous manifestations of tobacco use.

Methods. Computerized literature searches were conducted for English language

articles related to skin/mucous membrane disease and use of tobacco. The

primary criterion for assessing data quality and validity was the

demonstration of a causal relationship between tobacco use and skin/mucous

membrane disease.

Results. This review of the literature shows that a number of disorders and

diseases of the skin and mucous

membranes are related to tobacco use.

Conclusions. Since millions of persons use tobacco despite its well

publicized relationship to increased mortality, knowledge of the

mucocutaneous morbidity associated with tobacco use may help physicians in

counseling their patients.

Psoriasis (A paragraph taken from a section of the study)

Many researchers have shown a relationship between smoking and psoriasis,

especially palmopustular psoriasis. O'Doherty et al[21] showed that

palmopustular psoriasis was associated with a high prevalence of smoking. In

addition, Mills et al[22] showed that in plaque psoriasis, there was a

significantly higher prevalence of current smoking (46%) as compared with

matched controls (24%), and more patients with psoriasis had smoked before

the onset of psoriasis (55%) as compared with controls (32%). Finally, the

daily consumption of cigarettes correlated with the risk of developing

psoriasis, with the higher number of cigarettes smoked (more than 20

cigarettes per day) being associated with greater risk. This was confirmed by

Poikolainen et al,[23] who found that among psoriatic women the mean number

of cigarettes smoked was 8.6 compared with 4.7 for controls. It should be

noted that some treatments for psoriasis are flammable and therefore may pose

a danger to smokers.

Key Points

Dermatologic effects of cigarette smoking include facial wrinkling, facial

gauntness, complexion color changes, decreased skin moisture, yellowed nails,

harlequin nails, halitosis, nicotine stomatitis, and skin burns. Indirect

effects of cigarette smoking include poor wound healing; psoriasis;

atherosclerotic peripheral vascular disease; Buerger's disease; Raynaud's

disease; diabetic foot disease; oral yeast infections; condyloma acuminatum;

and cutaneous findings in HIV and AIDS, Crohn's disease, and malignancies.

Recognition of dermatologic signs of tobacco use can be a clue to many of the

serious underlying systemic diseases associated with smoking and also with

use of smokeless tobacco.

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

TB Test Required For Arthritis Patients Wishing To Take Remicade

August 16, 2001 WASHINGTON (AP) - Rheumatoid arthritis patients must be

tested for tuberculosis before they begin taking a treatment called Remicade,

the drug maker and the government announced.

Patients using Remicade are at least four times more likely than average

Americans to get active tuberculosis, the Food and Drug Administration

estimates. The problem: Apparently the drug suppresses users' immune systems

enough that if they unknowingly carry the TB germ, the respiratory illness

can suddenly flare up. The warning is serious because untreated, TB can kill

- and it's also an airborne illness that these patients could spread to

family and friends.

Worldwide, 88 cases of tuberculosis have been reported among the estimated

170,000 people who have tried Remicade, FDA's Dr. Bill Schwieterman said

Wednesday. Fifteen of those people died.

Some 2 billion people worldwide are infected with TB and risk developing an

active case of the disease. In the United States, TB cases dropped to a

record low of 16,377 last year. But the illness is a continuing threat here,

with increased foreign travel and immigration from countries where TB is

common.

Rheumatoid arthritis afflicts more than 2 million Americans when their immune

systems go awry and attack their joints, causing severe swelling, pain and

stiffness.

Remicade is a bioengineered drug that roams patients' blood to sop up an

immune system protein called tumor necrosis, a factor responsible for much of

the swelling.

But that immune suppression, so important in fighting rheumatoid arthritis,

can leave users at a higher risk for serious infections. Remicade's label has

long carried warnings about various infections, but it now will carry a boxed

warning in bold type about the TB risk - the strongest warning possible for a

prescription drug.

The warning doesn't say people should stop using Remicade. The risk of

activating latent TB appears highest in the first three to six months of use,

so doctors should carefully evaluate those patients, Schwieterman said.

But before prescribing Remicade to a first-time user, doctors should test for

TB - it's a simple skin test - and treat TB carriers, the FDA concluded.

Manufacturer Centocor Inc. will send letters to thousands of doctors who

prescribe Remicade, both for rheumatoid arthritis and the bowel ailment

ailment Crohn's disease, alerting them to the warning.

A similar rheumatoid arthritis treatment called Enbrel also suppresses the

immune system and carries warnings that users face the risk of serious

infections. But so far, Enbrel users don't seem to face a special TB risk,

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

FDA Advisers Endorse Arthritis Drug

August 17, 2001 WASHINGTON (AP) - An experimental treatment for rheumatoid

arthritis moved a step closer to the market, although studies show it

promises just modest effectiveness. Advisers to the Food and Drug

Administration recommended on a 6-2 vote that Amgen Inc.'s Kineret be

approved. Studies found that about 15 percent more patients who took Kineret

than who received a dummy shot saw improvement in joint swelling and pain.

Other treatments sold today come with higher effectiveness rates. But experts

note that those drugs don't help everyone so additional options are needed.

Kineret, known chemically as anakinra, works differently than other

therapies, by blocking a protein called interleukin-1 that is one cause of

the swelling associated with arthritis.

Side effects included irritation at the drug's injection site and a small

risk of serious infection.

The FDA is not bound by its advisers' recommendations but typically follows

them.

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

Editors Note: Because some of our members also fight the battle of coronary

artery disease, (besides psoriasis and psoriatic arthritis), I have included

the following article about antioxidants and lipid lowering medications. My

own

intimate involvement with the subject began in 1989. I had a heart attack,

discovered I have CAD which runs in the family, had my last cigarette after

35 years, experienced 7 angioplasties and 4 stents over 8 years, lost 25

pounds through diet and exercise, started daily vitamin therapy and lipid

lowering medications, and made some other lifestyle changes too. So this

subject is very near and dear to my heart. No pun intended of course.

Antioxidant Supplements Reduce Benefits of Lipid-Lowering Drugs

MedscapeWire August 10, 2001 By Hong Mautz New York - Taking antioxidant

vitamin supplements with 2 substances commonly prescribed to lower

cholesterol can sharply diminish a key beneficial effect of the therapy,

warns a new study. Some experts say these latest negative findings about the

popular supplements strongly suggest that the vitamins should not be used to

treat or prevent heart disease.

Researchers examined nearly 150 people who had both coronary artery disease

(CAD) and low levels of high-density lipoprotein (HDL) cholesterol. They were

given niacin (vitamin B3) and simvastatin.

Close to half of the subjects also were given a cocktail of antioxidant

supplements that included vitamins E and C, beta-carotene, and selenium.

Rather than helping patients with CAD, however, the antioxidants limited the

effectiveness of the niacin-simvastatin combination.

" We found that there was an adverse interaction between the antioxidant

cocktail and the lipid-lowering therapy, " says Greg Brown, MD, PhD, co-author

of the study, which is published in the August issue of Atherosclerosis,

Thrombosis, and Vascular Biology. " The adverse effect on HDL appeared

specific for the HDL2 component, which is responsible for most of the

risk-reducing benefits of HDL. "

After a year of treatment, the combination of simvastatin and niacin with the

antioxidant vitamin supplements increased HDL2 by 15% compared with 60% in

patients who did not receive the supplements.

" There is a substantial reduction in the rise of HDL2, the most protective

component of HDL, " says Brown, a professor of medicine in the cardiology

division of the University of Washington in Seattle. " The effect is

detrimental when antioxidant vitamins are taken with the lipid-lowering

drugs. "

In an editorial accompanying the study, Kuller, MD, DrPH, professor and

chairman of the Department of Epidemiology in the School of Public Health at

the University Of Pittsburgh, Pennsylvania, says that physicians should be

cautious about promoting antioxidant vitamins in patients with CAD.

" All the hype about antioxidant vitamins being a big winner in preventing

heart disease is totally unproven, " says Kuller. " For people who are on

lipid-lowering drugs such as niacin, a combination with vitamin E is not a

good choice. " Only a diet rich in antioxidants has been proved to be

associated with a low risk of CAD, he says.

" People who take vitamins are a highly selected group of individuals who are

interested in their health, so they often don't smoke, they exercise and

weigh less, and they are often better educated, " explains Kuller. " That may

be one of the reasons they are healthier: It doesn't have anything to do with

taking vitamins. "

The American Heart Association does not recommend using antioxidant vitamin

supplements to maintain or increase cardiovascular health; instead it

recommends eating a variety of foods daily from all of the basic food groups.

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

Cholesterol Drug Warnings Urged

August 21, 2001 WASHINGTON (AP) - Nearly two weeks after a popular

cholesterol-lowering drug was pulled off the market for causing deadly muscle

destruction, a consumer group charged Monday that five similar medications

have killed an additional 81 people.

Public Citizen petitioned the government to force manufacturers to give

special warning brochures to the millions of Americans who take those

medicines - statins - telling them to quit the pills at the first sign of

muscle pain or weakness.

Statins dramatically lower cholesterol and reduce patients' risk of heart

attacks.

" Most people taking these drugs aren't aware that they could sustain serious

muscle damage and could even die, " said Dr. Sidney Wolfe of Public Citizen's

Health Research Group.

" Serious muscle and kidney damage, and potentially death, may be averted only

if the patients taking statins stop the drugs at the first sign of muscle

pain or weakness, " Wolfe wrote the Food and Drug Administration Monday.

The FDA disputed Wolfe's death count, saying its own investigation last year

uncovered just 18 deaths that could be linked to the five statins on the U.S.

market - Lipitor, Mevacor, Pravachol, Zocor and Lescol.

But the agency will consider Wolfe's request for stiffer warnings.

Pfizer Inc. already has asked the FDA to approve a brochure written in

layman's language that would accompany every bottle of the top-selling statin

Lipitor, explaining the risk.

Wolfe's petition comes almost two weeks after one statin, Baycol, was pulled

off the market when the FDA linked it to 31 U.S. deaths from a side effect

called rhabdomyolysis. That's a rare but life-threatening condition in which

muscle cells are destroyed. In severe cases, it leads to kidney failure.

Every statin has been linked to rare reports of a muscle side effect, and

their labels carry that warning.

Wolfe analyzed FDA records to uncover 772 cases of rhabdomyolysis since 1997

among the six statins sold in this country. Half - 387 cases - were caused by

Baycol alone, explaining why Bayer pulled it off the market.

But Wolfe said he found another 385 rhabdomyolysis cases among users of the

other five statins still sold, including 81 deaths dating back to 1987, when

the first of those drugs hit the market.

That's still a rare risk, considering 8 million Americans are estimated to

use statins. But Wolfe argues that severe muscle destruction and death are

preventable if patients are aware of the early warning signs.

He urged the FDA to put stronger warnings on the statins' labels, to write

every U.S. physician telling them about the risk, and to mandate that every

patient get a brochure with each bottle telling them to stop the pills and

call a doctor if they suffer muscle symptoms.

A closer look at the FDA's reports shows duplicates and patients who actually

died of other causes, leading federal health officials to link just 18

rhabdomyolysis deaths to statins during an investigation last year, said

FDA's Dr. .

Merck & Co., maker of Zocor and Mevacor, says it provides Zocor users a

layman's explanation of the muscle side effect on its Internet site.

Bristol-Myers Squibb is seeking to capitalize on Baycol's departure with

full-page newspaper ads of Pravachol that mention the muscle risk, but

company spokesmen didn't return calls seeking comment Monday.

Lescol-maker Novartis maintained the risk is small and that patients are

reserved.

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

Communication Needed to Prevent Statin and Other Drug Side Effects, AHA Says

August 24, 2001 By Deborah Flapan - from Medscape News & MedscapeWireNew York

-

The American Heart Association (AHA) said this week that more open dialogue

between doctors and patients is needed to head off the appearance of

dangerous drug side effects, such as rhabdomyolysis from statin therapy. The

statement came in response to a recent petition filed with the US Food and

Drug Administration (FDA) to require " black box " warnings, the strongest

warning the FDA can mandate, on all of the cholesterol-lowering drugs. Public

Citizen, a consumer advocacy group, filed the petition earlier this week,

soon after the statin Baycol (cerivastatin) was pulled from the market

because of reports of rhabdomyolysis and deaths related to the muscle

disorder.

" We know that the FDA looks carefully at adverse drug reactions to determine

if special warnings or labels are warranted, " said Sidney , MD, Chief

Science Officer of the American Heart Association. " After careful review of

the available information on the statin class of drugs, the FDA should be in

the best position to determine whether special labeling will be effective. "

encouraged open communication between physicians and their patients.

" Doctors should warn their patients to be on the watch for potential side

effects of any medication. And patients need to take the initiative and call

their physician if they experience an unusual side effect. Appropriate labels

can also be a valuable tool in patient education. "

In the case of statins, patients should watch for muscle aches and pains,

dark urine and other signs and symptoms as noted by the FDA and the package

insert included with the medicine.

The AHA emphasizes that lifestyle decisions such as diet and exercise should

be the foundation for strategies to lower cholesterol, although statins and

other cholesterol-lowering drugs can play an important role in overall

cholesterol management.

" In general, we don't think that patients should stop taking medications

without talking to their physician. If a patient is experiencing side

effects, the physician can often switch the patient to a different statin or

other medicine that will continue to manage their cholesterol without the

side effects, " said .

Editors Note: In the last two weeks there have been an extraordinary number

of medical articles on my web sites, about cholesterol lowering medications

and possible side effects. I would personally encourage you to discuss this

information with your own physician. I most certainly will be, at my next

cardiologist and rheumatologist appointments.

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

Health News to Love: Chocolate Is Good for You

By Reaney-Reuters - GLASGOW, Scotland (Sept. 3)

Good news for chocoholics. The treat favored by millions not only tastes

delicious but is healthy for you, American researchers said on Monday.

Chocolate contains compounds called flavonoids that can help maintain a

healthy heart

and good circulation and reduce blood clotting -- which can cause heart

attacks and strokes. " More and more, we are finding evidence that consumption

of chocolate that is rich in flavonoids can have positive cardiovascular

effects, " Carl Keen, a nutritionist at the University of California, ,

told a science conference. " We not only have observed an increase in

antioxidant capacity after chocolate consumption, but also modulation of

certain compounds which affect blood vessels. "

Antioxidants are substances that help reduce the damage of cancer-causing

charged particles in the body. Fruits, vegetables, nuts and whole grains are

high in antioxidant vitamins such as C and E.

NOT ALL CHOCOLATE CREATED EQUAL

Flavonoids in chocolate are derived from cocoa, which is rich in the

compounds. Research has shown that a small bar of dark chocolate contains as

many flavonoids as six apples, 4.5 cups of tea, 28 glasses of white wine and

two glasses of red. But Dr. Harold Schmitz said there were variations in the

levels of flavonoids in chocolate and cocoa products depending on the

production process, in which many flavonoids are destroyed. " All chocolates

are not created equal in regards to flavonoid content, " Schmitz, a scientist

with confectionery maker Mars Inc., told a news conference.

Flavonoids are thought to reduce the risk of cardiovascular disease, the

number one killer in many industrialized countries, by reducing platelet

aggregation -- when blood platelets combine into a sticky mass and form

clots.

Keen and his colleagues measured the impact of chocolate on platelets in the

blood in 25 volunteers. They presented their findings to the British

Association for the Advancement of Science conference in Glasgow. The

researchers collected blood samples from volunteers who ate 25 grams (0.9

ounces) of chocolate with a high flavonoid content and other volunteers who

ate bread. They took blood samples from both groups two and six hours after

they ate the chocolate and bread to measure their platelet activation.

Volunteers who consumed the chocolate had lower levels of platelet activity,

which would reduce the probability of having a blood clot. The scientists

found no change in the group that ate the bread.

Keen said the results of the study support earlier research showing that

cocoa acts like low-dose aspirin which helps to reduce blood clotting. But he

warned that eating chocolate should not be substituted for taking low dose

aspirin because they work through different mechanism in the body. " These

results lead us to believe that chocolate may contribute to a healthy,

well-balanced diet, " Keen added.

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

Thanks again, and please send your comments and suggestions.

Jack - Cornishpro@... (A Big Fan of Chocolate)

Issue 2001 9/08-2

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