PSORIATIC ARTHRITIS NEWSLETTER NO. 112

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PSORIATIC ARTHRITIS NEWS AND VIEWS

VOLUME- 6 ISSUE- 13

November 15, 2006

PSORIATIC ARTHRITIS MEDICAL NEWS

CDC PAINTS PORTRAIT OF AMERICA IN PAIN

Chronic pain is a common complaint, affecting one in four Americans,

according to the CDC

By Neil Osterweil, MedPage Today Staff Writer - Reviewed by Zalman S. Agus,

MD; Emeritus Professor at the University of Pennsylvania School of Medicine.

- November 16, 2006

HYATTSVILLE, Md., -- Persistent pain is remarkably prevalent in America,

according to a CDC report. Pain from lower backs, knees, and migraine stood out

from the rest.

One-quarter of all Americans surveyed said they had at least one episode of

pain lasting more than 24 hours in the previous month, the survey found.

One in 10 of those surveyed said that their pain lasted more than a year,

found CDC investigators in their annual report on health trends in the United

States.

" We chose to focus on pain in this report because it is rarely discussed as

a condition in and of itself -- it is mostly viewed as a byproduct of another

condition, " said Amy Bernstein, Sc.D., the lead author. " We also chose this

topic because the associated costs of pain are posing a great burden on the

health care system, and because there are great disparities among different

population groups in terms of who suffer from pain. "

The report noted that that while pain serves an essential sentinel function,

signaling the presence of injury or inflammation, " when the damage has

healed and the pain remains, identifying either the cause of the remaining pain,

or how to treat it, can be frustrating, time-consuming, and expensive. "

Using data from National Health and Nutritional Exam Surveys (NHANES), which

accounted for more than 26,000 Americans, and other databases, the CDC

investigators found that from 1999 to 2002, 26% of all Americans age 20 and over

had some type of pain lasting more than 24 hours in the month prior to their

interview.

The most commonly reported sites of pain were the usual suspects, with low

back pain leading the way. Other leading sources of pain included migraine or

severe headache, joint pain, aching, and stiffness.

Knees caused more pain than any other joint, with hospitalization rates for

knee replacement procedures increasing by nearly 90% from 1992-93 to 2003-04

among Americans 65 and older.

Not surprisingly, the prevalence of joint pain increased with age, with

about one-fifth of adult’s ages 18 to 44, and one-half of people ages 65 and

over, reporting any joint pain in the previous 30 days.

Among adults ages 65 and older, nearly 60% of those who reported having pain

of any kind said it had lasted for a year or more, compared with 37% of 20-

to 44-year olds who reported having pain.

Women tended to report pain more often than men did, and non-Hispanic white

adults were more likely to complain about hurting than people of other racial

or ethnic backgrounds, the investigators noted.

Pain also appeared to make socioeconomic distinctions, with lower-income

adults reporting pain more than higher-income adults do.

The authors noted that chronic low back pain was associated with lower

health status among a substantial number of adults surveyed.

In 2004, adults who reported low back pain lasting more than 24 hours during

the past three months reported worse health status, using a number of

different measures, than people who did not report recent low back pain,

regardless

of age.

Overall, 28% of adults with low back pain said they had a limitation of

activity caused by a chronic condition, compared with 10% of adults who did not

report low back pain. Adults with recent low back pain were about three times

as likely to report fair or poor health status and more than four times as

likely to experience serious psychological distress as people without low back

pain.

In all, 21% of adult women reported having headaches or severe migraines,

compared with 10% of men; headaches were most common among women in 20s, 30s,

and 40s.

The investigators also found that the financial burden of pain was large and

growing, with hospitalizations for knee replacements more than doubling

among both men and women and in all age categories, and non-fracture hip

replacements also climbing, although not quite as dramatically.

In 2002-2003, ambulatory medical care or prescribed medicine expenses for

headaches averaged $566 per person for headache-related care among

non-institutionalized adults who reported a headache expense, " the CDC

researchers wrote,

" representing more than $4 billion in total expenses -- not including

self-treatment, over-the-counter drugs, and inpatient hospital expenses for

this

condition.

Primary source: U.S. Centers for Disease Control and Prevention, National

Center for Health Statistics

Source reference: National Center for Health Statistics. " Health, United

States, 2006 with Chartbook on Trends in the Health of Americans. " ©

2004-2006

MedPage Today, LLC. .

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CONFLICTING REPORTS ON PAINKILLERS SAFETY

New study suggests naproxen, sold as Aleve, may pose heart dangers

Reuters - Nov 16, 2006

Researchers looking at the safety of various arthritis and headache remedies

said Thursday they had found some more evidence that the popular analgesic

naproxen may cause heart problems.

The researchers themselves cautioned about reading too much into their

findings, and outside experts discounted them.

Nonetheless, the researchers said they thought it was important to present

their evidence to help experts sort out what the real dangers are.

The issue is important because companies have been forced to withdraw

several drugs in a new class called COX-2 inhibitors because they may cause

strokes

and heart attacks, and drug makers face multi-million dollar liability suits.

And the U.S. Food and Drug Administration has ordered strict warnings to be

put on packages of painkillers known as non-steroidal anti-inflammatory drugs

or NSAIDS, including naproxen, a popular NSAID sold over-the-counter by Bayer

under the brand name Aleve.

Call for warning labels

The warning labels were ordered because of some studies that suggested

NSAIDS might also raise heart risks.

“Particularly for safety data, ’truth’ may come in small doses. We firmly

believe that results from trials should be published regardless of the

direction, magnitude, or statistical significance of the observed results,â€

said

Barbara of the Hopkins University School of Public Health, who

worked on the study.

Writing in the Public Library of Science journal PLoS Clinical Trials,

and colleagues said they looked at data from a trial designed to see if

Celebrex might help prevent Alzheimer’s disease in high-risk patients.

The 2,500 elderly volunteers were given either COX-2 inhibitor Celebrex,

naproxen or a placebo for up to 3-1/2 years. It was stopped when concerns rose

over the safety of COX-2 inhibitors.

The trial showed no increased or decreased heart risk for Celebrex, known

generically as celecoxib, compared to placebo.

However, it did show an increased risk for naproxen.

Over three years, 5.5 percent of the patients getting Celebrex had a stroke,

heart attack or were diagnosed with congestive heart failure, while 5.6

percent of those getting a placebo did.

In comparison, 8.25 percent of the naproxen patients had such a serious

cardiovascular incident or death.

Critics call study unreliable

Dr. Steve Nissen of the Cleveland Clinic in Ohio said the trial’s findings

were “completely unreliable.â€

“The stopping of the study early was improper and it led to erroneous

conclusions,†Nissen said in a telephone interview.

“We know from very large epidemiological (population) studies and all sorts

of studies that naproxen is a safe drug, perhaps the best of the NSAIDS,â€

added Nissen, an outspoken expert on the safety of NSAIDS and COX-2 inhibitors.

Just last week, a much smaller study led by Dr. Schiff of the Denver

Arthritis Clinic suggested that naproxen did not raise the risk of heart

attack and stroke.

“We don’t have the full answers,†Nissen said. He has a safety trial with

21,000 patients under way to compare naproxen with Celebrex and placebo. -

Copyright 2006 Reuters Limited. All rights reserved.

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MIXED REVIEWS FOR VIOXX SUCCESSOR - MSNBC.COM

Some doctors concerned about side effects of new Merck painkiller

The Associated Press - Nov 13, 2006

The first published studies of Arcoxia, the drug that Merck & Co. hopes will

take the place of its withdrawn painkiller Vioxx, are getting mixed reviews

from doctors, some of whom say the results do not make a case for the

medication’s approval.

The critics cite not just Arcoxia’s side effects but also that Merck tested

it against diclofenac, an older painkiller known to raise heart risks. A

fairer comparison would have been to a medicine that does not do that, such as

naproxen, sold as Aleve, they say.

“The development program for Arcoxia is fatally flawed,†said Dr.

Nissen, a Cleveland Clinic cardiologist who formerly headed the Food and Drug

Administration’s cardiac drug advisory panel. “My advice to the FDA is that

they should not approve this drug.â€

Dr. Graham, an FDA drug safety expert who has criticized his agency’s

handling of Vioxx, agreed.

“It’s my own suspicion that this study was intentionally designed to

minimize the possibility of their having a repeat of what happened with

VIGOR,†the

study that revealed Vioxx’s heart risks, he said.

The new research “raises red flags,†Graham said, and gave his personal

opinion that the drug should not be approved. “There’s every reason to think

it

suffers from the same problems†as Vioxx, he said.

Vioxx was a blockbuster arthritis drug when Merck pulled it from the market

in September 2004 over safety concerns. Like Arcoxia, it is a cox-2 inhibitor,

a class of drugs originally developed to be gentler on the stomach and

hopefully easier to take long-term than traditional pain relievers.

Vioxx was a blockbuster arthritis drug when Merck pulled it from the market

in October 2004 over safety concerns. Like Arcoxia, it is a cox-2 inhibitor, a

class of drugs originally developed to be gentler on the stomach and

hopefully easier to take long-term than traditional pain relievers.

Arcoxia already is widely used in other countries, and Merck has been

seeking approval to sell it in the United States. In August, the company said

preliminary data from unpublished studies showed that Arcoxia did not increase

heart risks more than diclofenac, sold as Cataflam and Voltaren by

Switzerland-based Novartis AG.

On Monday, pooled results of three studies of Arcoxia were to be published

in the British journal The Lancet and presented at an American Heart

Association conference in Chicago.

They involved 34,701 arthritis patients, average age 63, in the United

States and 37 other countries. One-third had heart disease or multiple risk

factors for it.

After an average of 18 months on either drug, clot-related heart problems

were statistically similar — 320 among the 17,412 who started the study on

Arcoxia, and 323 among the 17,289 on diclofenac, said lead author Dr.

Cannon of Brigham and Women’s Hospital in Boston.

About one percent of each group suffered a heart attack, stroke or death

within a year of starting on their drug. That rose to about 2.5 percent three

years later.

Arcoxia users were 30 percent less likely to have ulcers, stomach bleeding

or other gastrointestinal problems (176 cases versus 246 on diclofenac), but

the rate of serious problems was similar.

“Most of the GI bleeding in this study was probably microscopic, meaning it

wasn’t clinically important,†the FDA’s Graham said.

Heart risks

Slightly more than half of each group stopped taking whichever drug they had

been assigned. Side effects were the reason for 20 percent of the

discontinuations. More people quit Arcoxia because of high blood pressure; more

stopped

diclofenac because of stomach or liver problems. Congestive heart failure

was rare but more common among those receiving a higher dose of Arcoxia than

among those on a lower dose or diclofenac.

Cannon consults for Merck and other drug makers. Nissen currently heads a

large study funded by Merck’s chief rival in this field, Pfizer Inc., though

he

said he gets no salary from it and that all research revenue goes to the

Cleveland Clinic Foundation.

The Arcoxia study “isn’t the answer to everything†about painkillers, but

it provides one piece of the puzzle, Cannon said.

“A picture is emerging here,†said co-author Garret FitzGerald, a

University of Pennsylvania scientist who believes that all cox-2 drugs bring

additional heart and stroke risks because they work through a common mechanism.

“If you have people that are at risk of heart disease ... you stay away from

these drugs at the cox-2 end of the spectrum and tilt towards the other end,

where naproxen lies,†he said.

Conversely, if someone’s risk of ulcer or stomach bleeding is high, a cox-2

might make more sense, he said. Pfizer’s Celebrex is the only one still on the

market in the U.S. © 2006 The Associated Press. All rights reserved.

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DOCTORS RARELY DISCUSS DRUG COSTS WITH PATIENTS

Nov. 8 (HealthDay News)

U.S. doctors often fail to discuss costs, prescription drug insurance

coverage and other related issues when they give new prescriptions to patients,

a

new study finds.

These are all important issues because they're linked to whether patients

will continue taking their medications, the researchers note.

" Though cost discussions are not always necessary, especially if physicians

know a patient's financial situation and the best formulary choice for a

medication, physicians must have a high level of awareness about medication cost

and issues impeding acquisition to medication, because these can be important

barriers to patient medication adherence, " lead author Dr. Derjung Tarn,

assistant professor of family medicine at the University of California, Los

Angeles, Geffen School of Medicine, said in a prepared statement.

His team's published their findings in the November issue of the American

Journal of Managed Care.

The study included 185 patients who had outpatient visits with 15 family

doctors, 18 internists and 11 cardiologists. In total, about 243 new medications

were prescribed during these visits.

In only 33 percent of the cases did the doctors talk with patients about

issues related to medication cost, insurance, generic or name brand, logistics,

supply and refills. Cost and insurance were addressed 12 percent of the time,

the logistics of obtaining medications 18 percent of the time, and medication

supply 9 percent of the time.

Patients initiated discussions about medication costs or insurance in only 2

percent of the cases.

The study found that discussions about drug costs were more likely to occur

if a patient earned less than $20,000 per year than if they earned more than

$60,000 a year.

Family doctors and internists were less likely than cardiologists to talk

with patients about costs, and all doctors were less likely to do so when

prescribing medications to older patients, the study said.

Preidt - SOURCE: University of California, Los Angeles, news release,

Nov. 8, 2006

Copyright © 2006 ScoutNews LLC. © 1996-2005 MedicineNet, Inc. All rights

reserved. Copyright and Legal Disclaimer.

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HUMIRA APPROVED IN CANADA FOR TREATMENT OF ANKYLOSING SPONDYLITIS Canada

Approval Marks Third for Humira in Treating Autoimmune Diseases - CCNs

-

Nov. 7, 2006

Abbott announced that it has received approval from Health Canada to market

HUMIRA® (adalimumab) as a treatment for active ankylosing spondylitis (AS) in

Canada. AS is a chronic disease of the spinal skeleton and large peripheral

joints that causes inflammatory back pain and stiffness, but can also be

associated with other inflammatory diseases of the skin, eyes and intestines. In

its severe form, AS over time can result in complete spinal fusion, causing

extreme physical limitation. It is estimated that AS affects between 150,000

and 300,000 Canadians (as many as one in 100).

This is the third in a series of autoimmune diseases targeted for HUMIRA

therapy. HUMIRA is also approved in Canada for the treatment of moderately to

severely active rheumatoid arthritis and active psoriatic arthritis.

" This approval of HUMIRA in Canada is important in the treatment of

ankylosing spondylitis, a debilitating disease that strikes young, mostly male

patients in their thirties and forties, " said Walter P. Maksymowych, M.D.,

Professor of Medicine at the University of Alberta. " Treatments like HUMIRA are

changing how we can treat AS. HUMIRA has been shown to significantly reduce the

pain and inflammation caused by AS and substantially improve function and reduce

disability. "

HUMIRA will be available immediately to patients with ankylosing spondylitis

in Canada.

Unlike many other rheumatic conditions, AS affects mostly young men, and

commonly begins before the age of 35. AS is difficult to diagnose in its early

stages and is one of the most overlooked causes of persistent back pain in

young adults.

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MARKER IDENTIFIES HIGH-RISK ANKYLOSING SPONDYLITIS PATIENTS

By , MedPage Today Staff Writer -Reviewed by Jasmer, MD;

Associate Clinical Professor of Medicine, University of California, San

Francisco November 15, 2006

A simple lab test can predict most of the patients at risk for progression

of ankylosing spondylitis and should be part of clinical practice, a Canadian

researcher said here.

Serum matrix metalloproteinase-3 (MMP-3) -- a biomarker associated with

damage to joint matrix -- is elevated in two-thirds of ankylosing spondylitis

patients who go on to the more severe forms of the disease, according to Walter

Maksymowych, M.D., of the University of Alberta in Edmonton.

" Testing for MMP-3 is cheap and readily available, " Dr. Maksymowych told a

press conference at the American College of Rheumatology meeting.

" This is a test that should be done in patients with ankylosing

spondylitis, " he said. " It is essentially our only predictor. "

The finding emerged from a continuing study of ankylosing spondylitis

patients at four centers on Europe. Researchers analyzed blood samples from 100

patients for a panel of eight biomarkers associated with other forms of

inflammatory disease, including rheumatoid arthritis.

Of the eight, only MMP-3 was significantly associated (P=0.004) with

two-year radiological progression in ankylosing spondylitis, as measured by the

modified Stoke Ankylosing Spondylitis Spinal Score, Dr. Maksymowych said.

He said the finding might make it easier for physicians to decide which

patients should get new biologic treatments for the disease, which are both more

toxic and more expensive than standard anti-inflammatory medications.

Also, he said, the result may help improve the design of clinical trials.

Physicians now have " highly effective " treatments for the disease, he said,

but resource constraints in many countries mean that the medications aren't

easily available. Being able to target the drugs to specific patients at high

risk may break down such barriers, Dr. Maksymowych said.

That's not a serious concern in the U.S., said Ruderman, M.D., of

Northwestern University in Chicago, who was not involved in the study. By and

large, he said, U.S. payers are covering biologics for ankylosing spondylitis if

physicians make a case for the drugs on the basis of on clinical signs and

symptoms.

He said the " missing piece of the puzzle " is evidence that early treatment

of patients with high levels of MMP-3, using biologics such as Remicade

(infliximab), would prevent future damage. Currently, a patient with minimal

clinical symptoms probably would not be offered the drugs because of the expense

and toxicity.

On the other hand, " if I knew that I could give a patient something that is

going to prevent damage, even in the absence of clinical signs right now, I

would encourage that, " he said. " And that's where this is going. "

Primary source: Arthritis & Rheumatism Supplement

Source reference: Maksymowych WP et al. " Serum Matrix Metalloproteinase 3 is

an Independent Predictor of Structural Damage Progression in Patients with

Ankylosing Spondylitis (AS) " Arthritis & Rheumatism 2006; 54(9): © 2004-2006

MedPage Today, LLC. .

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HUMIRA SHOWS PROFOUND BENEFIT FOR KIDS WITH RHEUMATOID ARTHRITIS - By

, MedPage Today Staff Writer - Reviewed by Zalman S. Agus, MD;

Emeritus Professor at the University of Pennsylvania School of Medicine.

November

14, 2006

Humira (adalimumab) has a " quite profound " benefit for children with

juvenile rheumatoid arthritis and is well tolerated, a researcher reported

here.

The finding was based on a prospective 48-week clinical trial and 88 weeks

of an extension study, according to Lovell, M.D., of the Cincinnati

Children's Hospital Medical Center. The results mean " we can now make the

disease almost a non-issue " for children.

Some benefit was expected, because the drug is approved for rheumatoid

arthritis in adults, but the magnitude and speed of action was a surprise, Dr.

Lovell told a press conference at the American College of Rheumatology meeting.

He said more than one in five children in the study " for the first time

ever " achieved a benefit of ACR Ped 90 -- meaning that of six elements of the

disease deemed important for children by the ACR, at least three improved by

more than 90%.

The study, involving 171 children aged four to 17, began with a 16-week

open-label phase, in which all children were given the drug, an

immunosuppressant

that blocks the action of tumor necrosis factor-alpha.

During this phase, 83% of children achieved an ACR Ped 30 result, which is

the usual measure of response to a drug for children with this disease, Dr.

Lovell said.

At the same time, however, 52% met the criteria for an ACR Ped 70 result,

which he said was " an extraordinarily robust degree of improvement. "

" To put it in common usage, " Dr. Lovell said, " if you have an ACR 70, there

are only a few days a month when you even remember you have arthritis. "

Children with an ACR Ped 30 response moved on to the blinded phase of the

trial, in which they were divided into those on a background of methotrexate and

those not taking the older drug, and randomized to either Humira or placebo.

The primary endpoint was the rate of flare-ups of the arthritis, Dr. Lovell

said. The researchers found:

Among those not taking methotrexate, 71% of those on placebo experienced a

flare, compared to 43% of those on Humira. Among those taking methotrexate, 65%

of those on placebo had a flare-up, compared with 37% of those getting

Humira. The differences were statistically significant at P=0.03 and P=0.01,

respectively.

Adverse effects were mainly mild upper respiratory infections, he said.

Patients on placebo came out of the trial when they experienced a flare and

were

entered into the extension study on Humira, while the remaining patients

entered the extension when the double-blind phase ended, he said.

During the extension, Dr. Lovell said, 80% of the patients reached an ACR

Ped 30 level and 70% reached ACR Ped 70.

" These kids continued to show the benefit, " he said.

The results are " extremely promising, " commented Stanley Cohen, M.D., of the

University of Texas Southwestern Medical Center at Dallas, who was not

involved with the study. With these biologics, he said " we are in a whole new

era "

of treatment for juvenile arthritis, he added.

" We used to have rehab centers with kids in wheelchairs, " Dr. Cohen said.

Those are gone because of new medications such as methotrexate. The next

generation of targeted treatments, such as Humira, means " those crippled

children

that we used to see will be gone. It will be a rare, rare patient who gets to

that stage. "

The problem now facing clinicians, he said, is that several biologic therap

ies are in development and there is little guidance as to which medications

should be used in which cases.

Dr. Lovell reported receiving consulting fees from Amgen, Centocor, Bristol

Myers Squibb, Abbott, Regeneron, Xoma, Hoffman-La Roche, and Novartis. The

drug is marketed by Abbott Laboratories.

Primary source: Arthritis & Rheumatism Supplement

Source reference: Lovell DJ et al. " Long-Term Efficacy and Safety of

Adalimumab in Children with Juvenile Rheumatoid Arthritis (JRA): 48-Week

Results. "

Arthritis & Rheumatism 2006; 54(9): © 2004-2006 MedPage Today, LLC. All

Rights Reserved.

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HUMIRA RECEIVES FDA APPROVAL FOR INHIBITING JOINT DAMAGE AND IMPROVING

PHYSICAL FUNCTION IN PATIENTS WITH ARTHRITIS

Abbott announced today that the U.S. Food and Drug Administration (FDA)

approved an expanded indication for HUMIRA® (adalimumab) that includes

inhibiting

structural joint damage and improving physical function in patients with

psoriatic arthritis (PsA). The expanded indication is in addition to the

psoriatic arthritis approval granted in October 2005.

HUMIRA is also approved in the U.S. for use in moderate to severe rheumatoid

arthritis (RA) and active ankylosing spondylitis (AS).

PsA is a chronic disease that combines symptoms of arthritis, including

joint pain and inflammation, and those of psoriatic skin disease, such as

painful, raised red lesions covered by silvery white scales. Approximately one

million men and women suffer from PsA in the United States and, when left

untreated, the disease can be potentially disabling. Early recognition,

diagnosis and

treatment of PsA can relieve pain and inflammation and possibly help inhibit

extensive joint involvement and damage in later stages of the disease.

" Psoriatic arthritis can be debilitating for many people, hindering everyday

activities. For these people, and others, the new indication for HUMIRA is

welcome news to our community, " said Gail Zimmerman, president and CEO of the

National Psoriasis Foundation.

Progression of Structural Joint Damage

Patients taking HUMIRA experienced significantly less joint damage than

patients taking placebo. Joint damage was assessed with X-rays taken at

baseline

and weeks 24 and 48, using the modified total Sharp score (mTSS), a measure

of joint damage progression. A smaller change in mTSS reflects less

progression of joint damage, with a positive score indicating worse

radiographic

damage. At week 24, the co-primary endpoint (the average change in joint

damage, as

measured by a mean change in mTSS) was 10 times greater in the placebo arm

than in the HUMIRA arm (0.9 and -0.1, respectively; p<0.001). More than three

times as many patients on placebo (29 percent) experienced joint damage

compared to patients taking HUMIRA (9 percent) at week 24. Results in the

HUMIRA

group were maintained through 48 weeks, the mean change in mTSS compared to

baseline was -0.2 at 48 weeks.

Physical Function

Patients taking HUMIRA showed significant improvement in physical function

as assessed by the Health Assessment Questionnaire Disability Index (HAQ)

score and the Short Form-36 Health Status Survey (SF-36). HAQ scores assess a

patient's ability to perform daily activities such as getting dressed, walking

and climbing stairs. Statistically significant improvements in HAQ were

achieved by patients in the HUMIRA group compared to placebo at week 24

(p<0.001).

Patients taking HUMIRA also showed statistically significant improvement

compared to placebo in the SF-36 Physical Component Score (p<0.001). The SF-36

is

a broad questionnaire that examines the physical and mental impact on

patients. Improvements in physical function were maintained through week 84.

Joint results were maintained for patients in the HUMIRA group through week

48. Patients in the placebo group achieved similar results after receiving

HUMIRA from week 24 through week 48. Skin results were also maintained in the

HUMIRA group through week 48, when nearly three out of five patients achieved

PASI 75 skin clearance and nearly one out of two patients achieved PASI 90

skin clearance response at week 48. Patients in the placebo group achieved

similar results after receiving HUMIRA in the 24-week, open-label extension.

" Psoriatic arthritis is a multifaceted disease in which patients can

experience joint and skin symptoms that may lead to disability and decreased

quality

of life, " said Eugene Sun, M.D., vice president, Global Pharmaceutical

Clinical Development, Abbott. " HUMIRA effectively treats multiple aspects of the

disease, making it a promising comprehensive treatment for these patients. "

HUMIRA is the only fully human monoclonal antibody approved for the

treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and

ankylosing

spondylitis (AS) in the U.S. and Europe. HUMIRA resembles antibodies normally

found in the body. It works by blocking tumor necrosis factor alpha (TNF-α), a

protein that plays a central role in the inflammatory responses of autoimmune

diseases. To date, HUMIRA has been approved in 67 countries and more than

160,000 people worldwide are currently being treated with HUMIRA. Clinical

trials are currently under way evaluating the potential of HUMIRA in other

autoimmune diseases.

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NO CANCER LINK FOUND WITH NEW RHEUMATOID ARTHRITIS AGENTS

By , MedPage Today Staff Writer -

Reviewed by Emeritus Professor at the University of Pennsylvania School of

Medicine. November 15, 2006

WASHINGTON, Nov. 15 -- There is no link of significance between major

cancers and new biologic therapies for rheumatoid arthritis, FDA-mandated

warnings

not withstanding, a researcher said here.

" The bottom line is that, in general, these drugs are safe, " said Fred

Wolfe, M.D., of the National Databank for Rheumatic Disease (NDBRD) in Wichita,

Kan., at the American College of Rheumatology meeting.

The FDA, prompted by reports of an increased risk of lymphoma seen in some

clinical trials of the medications, added a warning on the labels of Remicade

(inflixumab), Enbrel (etanercept), and Humira (adalimumab).

" In contradistinction, " Dr. Wolfe said, " we found no overall increase in the

rate of cancer associated with biologic therapies. "

Skin cancer was an exception, with melanoma and non-melanoma skin cancers

both slightly increased among users of biologic therapies, Dr. Wolfe said.

The findings come from an analysis of 13,000 participants in the rheumatic

disease database between 1998 and 2005, who reported all medication use as well

as all cancers semi-annually.

The rates seen in those with rheumatic disease were compared to those seen

in the general population and reported to National Cancer Institute's

Surveillance, Epidemiology and End Results (SEER) database, Dr. Wolfe reported.

The comparison found:

Nearly half of the rheumatoid disease patients (48%) used one of the

biologic therapies.

Over the study period, there were 623 incident cases of non-melanoma skin

cancer and 537 other cancers, including 32 cases of melanoma.

The standardized incidence rate for all cancers was 1.0, with a 95%

confidence interval from 0.9 to 1.0.

There was a slightly increase risk of non-melanoma skin cancer. The odds

ratio was 1.5, with a 95% confidence interval from 1.2 to 1.8, which was

statistically significant at P<0.001.

The risk of melanoma showed the highest rise (with an odds ratio of 2.3) but

the increase was not statistically significant (P=0.07), Dr. Wolfe said.

There were no other statistically significant increases in risk, he said.

" The data from the clinical trials do not provide adequate guidance for the

safety of these drugs, " he said.

The link had been biologically plausible, he said, because the therapies

alter the function of the immune system, and changes in the immune system are

known to render a person more vulnerable to a malignancy.

Cancer is a " significant concern because patients today are very

well-informed, " commented Cush, M.D., of Presbyterian Hospital of Dallas,

who was

not part of the study. The issue has to be put in perspective by physicians,

he said.

" I think this is reassurance " both for patients and for doctors who may not

have extensive experience with the biologic medications, Dr. Cush said.

Some of the odds ratios for cancer are high -- notably those for skin cancer

-- but " the risk to any one individual is still very low, " he said.

Dr. Wolfe said he has had research support from several pharmaceutical

companies, including Amgen, Aventis, Bristol-Myers-Squibb, and Centocor.

Primary source: Arthritis & Rheumatism Supplement

Source reference: Frederick Wolfe and Kaleb Michaud. " The Association of New

Cases of Cancer with Biologic Therapy. " Arthritis & Rheumatism 2006; 54(9):

© 2004-2006 MedPage Today, LLC. .

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HUMIRA DOES NOT AFFECT FLU VACCINATIONA EFFICACY

By , MedPage Today Staff Writer - Reviewed by Zalman S. Agus,

MD; Emeritus Professor at the University of Pennsylvania School of Medicine.

Nov. 16 - Vaccination against influenza or pneumococcal disease is safe and

effective in patients with rheumatoid arthritis who are taking Humira

(adalimumab), a researcher said here.

The finding, which emerged from a large randomized placebo-controlled study,

should provide reassurance for both patients and their doctors that the

vaccinations remain a valuable tool against infection, said Alan Kivitz, M.D.,

of

the Altoona Center for Clinical Research in Duncansville, Pa., at the

American College of Rheumatology meeting here.

There had been some concern about the efficacy of the vaccines inferred from

clinical trial data of Humira, which suggested a higher rate in infections,

said Dr. Kivitz.

Some patients and physicians had worried that the TNF-alpha inhibitors might

interfere with the immune response, rendering a vaccination useless and

possibly even dangerous, he said. " I had a patient just last week who wanted to

receive a flu shot and wondered if it was safe and effective, " Dr. Kivitz said.

At least in the case of Humira, he said, those worries can be laid to rest.

Both for pneumococcal disease and influenza, vaccines produced protective

immune responses in patients taking the drug and those taking placebo at

roughly

the same levels, Dr. Kivitz reported. He said other, smaller trials have

shown similar results for other biologic therapies.

Dr. Kivitz and colleagues enrolled 226 volunteers with rheumatoid arthritis

who had not been taking any biologic therapy for at least two months, although

they were allowed to be taking methotrexate or prednisone.

They were randomized to either Humira or placebo, during the 2004-2004 flu

season, and those in the active arm were given an initial dose of 80 mg of the

drug, followed by 40-mg injections at two-week intervals.

At day eight of the 36-day study, the researchers took baseline antibody

titers and vaccinated the volunteers against either the flu or pneumococcal

disease.

Some volunteers already had protective antibody levels, the study found,

but:

Among those who were vulnerable to pneumococcal disease, 57% of the placebo

group and 67% of the Humira group had a protective response at day 36. The

difference was not statistically significant.

Among those who were vulnerable to the flu, 87% of the placebo group and

97.6% of the Humira group had a protective response at day 36. The difference

was not statistically significant.

The bottom line, Dr. Kivitz said, is that " our RA patients can be safely and

effectively vaccinated. "

He said the finding would probably not change clinical practice, because

most rheumatologists are already recommending vaccination. " I think this gives

us reassurance that for adalimumab patients with RA, we now have confirmation

that we are inducing an appropriate immune response, " Dr. Kivitz said.

" Hopefully this type of study will remind doctors (to offer vaccination) and

also let patients know that it's safe and they're not going to get worse, "

commented Cush, M.D., of Presbyterian Hospital of Dallas, who was not part

of the study.

" If the average person gets the flu, he's down for five days, feels lousy,

misses work, " Dr. Cush said. In rheumatoid arthritis patients, " it's not

unreasonable to expect a more serious disease course, including hospitalization

and even death. "

The great part of Dr. Kivitz's study, he said, is that it tells both doctors

and patients that the vaccinations produce an immune response without

adverse effects.

One of the authors reported receiving consulting fees from Abbott and

another one of the authors is an employee at Abbott.

Primary source: Arthritis & Rheumatism Supplement

Source reference: Kaine J et al. " Abilities to Develop Protective Antibodies

to Pneumococcal and Influenza Vaccine are Maintained in Rheumatoid Arthritis

(RA) Patients Treated with Adalimumab (Humira®) " Arthritis & Rheumatism

2006; 54(9): © 2004-2006 MedPage Today, LLC. .

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ICE YOU CELLPHONE FOR EMERGENCY CONTACTS

Medical Author: Conrad Stöppler, MD - medical Editor: C.

Shiel Jr, MD, FACP, FACR

No one likes to think about the possibility of being seriously injured in an

accident, but take a moment to consider what might happen if you’re rendered

unconscious in an accident or other disaster. How would authorities or

emergency personnel notify your loved ones? By tracing your car’s license

number or

looking at your driver’s license, it may be possible to obtain your home

phone number, but your loved ones may not be there to receive the call.

Because of this difficulty in locating family members of accident victims,

the ICE idea was born. The ICE concept is simple- simply program your cellular

phone memory with the acronym ICE (“in case of emergencyâ€) followed by the

names and phone numbers of those whom you would wish to be notified in an

emergency. For example, “ICE-1 †as a saved contact entry in your

phone would alert emergency response personnel to contact Mr. at the

number listed. You can program as many numbers as you like using ICE-2, ICE-3,

etc. so that your emergency contact person’s office and/or cellular phone

numbers are also recorded.

Launched in the U.K. in May 2005, ICE was the idea of East Anglian Ambulance

Service paramedic Bob Brotchie. The idea has been promoted in a nationwide

campaign in the U.K. and is gaining in popularity in the U.S. and other

countries. Stickers are commercially available (or you can make your own) to

affix

to your cell phone to alert emergency personnel to the fact that you have

emergency contact information stored in your cell phone’s memory. You can

also

put a sticker on the back of your driver’s license or other form of

identification so that rescuers will know where to look for emergency contact

information.

Programming your cell phone takes only minutes to accomplish, yet it may

save you and your loved ones hours of anguish in the event of an emergency.

Rapid access to your next of kin, who will be able to provide your medical

history and any background information needed, can also enhance the success of

your

emergency treatment.

Last Editorial Review: 11/1/2006 1996-2005 MedicineNet, Inc. All rights

reserved. Copyright and Legal Disclaimer.

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Good Health to All,

Jack

Newsletter Editor

_Cornishpro@..._ (mailto:Cornishpro@...)

Issue 2006- 13

11/15/06