RCGP’s Comment On The Chief Medical Officer Advice To GPs On Annual Flu Campaign, UK

Commenting on this announcement, the Royal College of General
Practitioners (RCGP) said:

“We want to praise the work of GPs who last year delivered the highest
ever flu vaccination rate of 75.3% in the over 65s. With this latest
announcement GPs will need to have a good idea of how long we will be
without full stocks of the flu vaccine. In the meantime, we would urge
GPs to intensify their arrangements to deliver the vaccine they have
over a shorter period. Ideally additional protection from flu should be
offered to the at-risk groups before November when flu often begins to
set in. We also support the CMO’s recommendations on which at-risk
groups to target with the vaccine first to avoid pressure on GP
vaccination systems.”

Dr Douglas Fleming, Director of the RCGP Flu Unit

rcgp

Perceived Control Improves Asthma Health Status

Patients with asthma who believe they have control of their condition are likely to report improved asthma-related health status and have a decreased risk of severe asthma attacks. In a new study out of the University of California, San Francisco, researchers followed 865 patients (mean age 60 years) hospitalized for asthma for a median of 1.9 years after hospital discharge. Researchers collected demographic information, asthma history, perceived asthma control, and measured emergency department (ED) visits and hospitalizations for asthma. Results indicated that greater perceived control was associated with better physical health status, better asthma-related quality of life, fewer days of restricted activity due to asthma, and lower asthma severity scores. A multivariate model also showed that greater perceived control was associated with significantly decreased prospective risk of ED visits and hospitalizations for asthma. This study appears in the November issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.

Newsbriefs from the journal Chest, November 2006

Contact: Jennifer Stawarz

American College of Chest Physicians

Common Reasons for Not Taking Asthma Meds Don’t Hold Up

Financial and access barriers to health care are frequently cited reasons for people not taking prescribed medications; however, a new study shows that many patients do not refill their medication, even when these barriers are removed.

When researchers from the University of Alabama at Birmingham and the Children’s Hospital of Alabama provided 296 children with asthma (ages 6 to 13) in Birmingham, AL, with free rescue and controller medication and instructed them to call in for a refill, the overwhelming majority did not.

To date, 213 children (72 percent), have never refilled their controller medication, and only 36 children (17 percent) have refilled their prescription at the expected rate.

CHEST 2005 abstract highlights

Jennifer Stawarz
jstawarzchestnet
American College of Chest Physicians
chestnet

Bronchial Thermoplasty Demonstrates Long Term Safety Benefits In Asthma Patients

Asthmatx Inc., presented positive five-year data from the Asthma Intervention Research (AIR) Trial, which evaluated the safety of bronchial thermoplasty (BT) with the Alair® System. The data demonstrated the absence of clinical complications and the maintenance of stable lung function over a five year period post-BT in patients with moderate to severe asthma. The data was presented in a poster at the annual meeting of the American Thoracic Society (ATS) in New Orleans.

“With the addition of this new long-term data, I can now confidently tell my patients whose disease is poorly controlled, despite receiving the highest doses of standard asthma medications, that the procedure has demonstrated a stable safety profile for at least five years,” stated Dr. Gerard Cox, Professor of Medicine, McMaster University (Ontario, Canada) and lead author of the poster. “The present findings from the AIR Trial echo data from other controlled trials that demonstrated BT is safe and beneficial for these patients in the first year after treatment.”

The data showed that over five years:

– The percent of patients reporting respiratory adverse events remained stable

– Hospitalizations and emergency room visits for respiratory symptoms remained stable

– Pulmonary function (FEV1) remained stable

– No incidences of pneumothorax, intubation, mechanical ventilation, cardiac arrhythmias or death as a result of BT treatment over the five year follow-up

BT, which is the first device-based asthma treatment approved by the U.S. Food and Drug Administration (FDA), is a novel outpatient procedure that delivers precisely controlled thermal energy to reduce excess airway smooth muscle that is associated with airway constriction in patients with asthma. By decreasing the ability of the airways to constrict, this new treatment has been shown to help patients with severe asthma gain substantially better control over their disease.

In the period immediately following BT, there was an expected transient increase in the frequency and worsening of respiratory-related symptoms, which were of the type expected following bronchoscopy in patients with asthma. These events typically occurred within a day of the procedure and resolved on average within seven days with standard care.

The AIR Trial was a multicenter, randomized, controlled clinical study that evaluated the safety and effectiveness of BT in patients with moderate to severe asthma. Positive safety and effectiveness data at one year post-BT were published in the New England Journal of Medicine (NEJM) in March 2007. BT-treated patients have been followed for five years post-procedure to evaluate longer-term safety.

“This demonstration of long-term safety, combined with the therapeutic benefits demonstrated in a series of three randomized controlled clinical studies, is extremely uncommon for a medical device at the time of FDA approval,” said Glen French, CEO of Asthmatx. “It provides strong support for the adoption of BT as a new therapeutic option for the treatment of severe asthma in adults.”

About Asthma

Asthma is one of the most common and costly diseases in the world. The prevalence of asthma has grown in recent decades, and there is no cure. According to the Asthma and Allergy Foundation of America (AAFA), more than 20 million Americans have asthma, and managing asthma consumes over $18 billion of healthcare resources each year. In the U.S. each year, asthma attacks result in approximately 10 million outpatient visits, 2 million emergency rooms visits, 500,000 hospitalizations, and 4,000 deaths.

About Bronchial Thermoplasty Delivered by the Alair System

The Alair® Bronchial Thermoplasty System is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists. The Alair® System is not for use in patients with an active implantable electronic device or known sensitivity to medications used in bronchoscopy. Previously treated airways of the lung should not be retreated with the Alair® System. Patients should be stable and suitable to undergo bronchoscopy. The most common side effect of BT is an expected transient increase in the frequency and worsening of respiratory-related symptoms.

Bronchial thermoplasty is performed through the working channel of a standard flexible bronchoscope that is introduced through a patient’s nose or mouth, and into their lungs. The tip of the small diameter Alair catheter is expanded to contact the walls of targeted airways. Controlled thermal energy is then delivered to the airway walls to reduce the presence of excess airway smooth muscle that narrows the airways in patients with asthma. The minimally invasive procedure, like many other flexible endoscopy procedures, is done under moderate sedation, and the patient returns home the same day.

About Asthmatx

Based in Sunnyvale, Calif., Asthmatx is a privately-held medical device company that designs, develops and manufactures catheter based medical devices incorporating thermal energy for patients with severe asthma. Asthmatx’s first offering, bronchial thermoplasty delivered by the Alair System, is a novel device-based treatment option for patients with severe asthma. The Alair System has been approved for use in the U.S. by the FDA and has received a CE Mark for use in the European Union.

Alair, Asthmatx and the Asthmatx logo are registered trademarks of Asthmatx, Inc.

Source: Asthmatx Inc

Adams Respiratory Therapeutics Completes Repurchase Of Manufacturing Assets And Operations In Fort Worth, Texas, From Cardinal Health

Adams Respiratory
Therapeutics, Inc. (Nasdaq: ARxT) today announced that it has completed its
previously announced repurchase of the manufacturing assets and operations
in Fort Worth, Texas, from Cardinal Health.

As disclosed in an SEC filing on Aug. 2, Adams consummated the
acquisition from Cardinal Health on July 31, 2006. Under the terms of the
Asset Purchase Agreement, the Company paid Cardinal $24 million upfront, as
part of the $28 million in total cash payments, as previously disclosed.
The remaining $4 million will be paid on a quarterly basis during fiscal
year 2007.

Investor Conference Call and Webcast

Adams management will conduct an investor conference call and webcast
on Tuesday, Aug. 8, 2006, at 8:30 a.m. (EDT), to review financial and other
information related to the plant buyback. Michael J. Valentino, president
and CEO, and David P. Becker, executive vice president, CFO and treasurer,
will host the conference call. A slide presentation to accompany the audio
webcast of the conference call will be available by going to the Investor
Relations web site, investor.adamsrt.

To listen live to the call, dial 1-877-669-8882 or 1-706-758-9391. A
replay of the call will be available starting at approximately 11:30 a.m.
on Aug. 8 through 5 p.m. on Aug. 15. To listen to the replay, dial
1-800-642- 1687 or 1-706-645-9291 and enter the conference ID# 4040380.

A live audio webcast of the conference call also will be available by
going to the Calendar of Events section of Adams’ Investor Relations web
site, investor.adamsrt. A replay of the webcast will be
available starting at approximately 10:30 a.m. on Aug. 8 through 5 p.m. on
Sept. 8.

About Adams Respiratory Therapeutics, Inc.

Adams is a specialty pharmaceutical company focused on the late-stage
development, commercialization and marketing of over-the-counter and
prescription pharmaceuticals for the treatment of respiratory disorders.

Forward-Looking Statements

This press release may contain certain “forward-looking” statements.
Such forward-looking statements can be identified by the words “expect,”
“plan,” “seeks,” “believe,” “intend,” and similar expressions and are
subject to risks and uncertainties that could cause actual results to
differ materially from those in the forward-looking statements. Factors
that could cause actual results to differ materially include risk factors
set forth under the headings “Cautionary Note Regarding Forward-Looking
Statements”, “Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” in Adams’ Rule 424(b)(4)
Prospectus filed with the SEC on December 9, 2005 and under Item 1A. Risk
Factors in Adams’ Quarterly Report on Form 10- Q for the period ended March
31, 2006. Except to the extent required by applicable securities laws,
Adams is not under any obligation to (and expressly disclaims any such
obligation to) update its forward-looking statements, whether as a result
of new information, future events, or otherwise. All statements contained
in this press release are made only as of the date of this presentation.

Adams Respiratory Therapeutics, Inc.
adamsrt

Possible Vaccine For Mesothelioma Proven Safe

Researchers have demonstrated the safety of a potential vaccine against mesothelioma, a rare cancer associated primarily with asbestos exposure. The vaccine, which infuses uses a patient’s own dendritic cells (DC) with antigen from the patient’s tumor, was able to induce a T-cell response against mesothelioma tumors.

“[This] is the first human study on DC-based immunotherapy in patients with mesothelioma,” wrote Joachim G Aerts M.D., Ph.D., a pulmonary physician at Erasmus Medical Center in the Netherlands.

The findings have been published online ahead of print publication in the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.

The U.S. and other developed countries have prohibited the use of asbestos for decades, but the time between asbestos exposure and diagnosis of mesothelioma can up to 50 years. The incidence of mesothelioma, therefore, is still on the rise and expected to continue to increase until 2020. Once diagnosed, mesothelioma has a median survival time of 12 months. The standard chemotherapeutic treatment only improves survival time by about three months.

The anticipated increase in the incidence of mesothelioma, together with the paucity of treatment options, has spurred considerable interest in the development of new therapies. Immunotherapy, which uses the body’s own immune system to target and destroy cancer cells, has been shown to have some promise.

“The possibility to harness the potency and specificity of the immune system underlies the growing interest in cancer immunotherapy,” said Dr. Aerts. “One such approach uses the patient’s own DC to present tumor-associated antigens and thereby generate tumor-specific immunity.”

Building upon their previous research which demonstrated that DC vaccinations induced anti-tumor immunity and conferred a survival benefit in mice, Dr. Aerts and colleagues sought to test the clinical relevance of their finding. After recruiting 10 human patients recently diagnosed with malignant pleural mesothelioma of the epithelial subtype, they cultured immature DC from their blood and exposed the DC to the antigen produced by the patients’ tumors. The DC were also exposed to keyhole limpet hemocyanin (KLH), which was used as a surrogate marker to show an immune response. The DC were then matured and injected back into the patients in three doses over a two-week interval.

Serum samples from all patients showed a significant increase of pre- versus post-vaccine antibodies to KLH. In the four patients whose tumor material was sufficient for testing, there was clear induction of cytotoxicity against their own tumors after vaccination. Three patients showed signs of tumor regression, though this could not be conclusively or directly attributed to the vaccine.

Encouragingly, while eight of the patients developed flu-like symptoms in response to the vaccinations, the symptoms normalized after one day in all but one of the patients. There were no signs of autoimmune diseases in the patients provoked by the vaccination, nor other serious side effects.

“The major problem in mesothelioma is that the immunosuppressive environment caused by the tumor will negatively influence our therapy so we are now working on a method to lower this immunosuppressive environment,” said Dr. Aerts. “We hope that by further development of our method it will be possible to increase survival in patients with mesothelioma and eventually vaccinate persons who have been in contact with asbestos to prevent them from getting asbestos related diseases.”

Source
American Thoracic Society (ATS)

American Red Cross Issues One-Month Progress Report For Haiti Earthquake

The American Red Cross issued a one-month progress report on its efforts to provide food, water, relief supplies, shelter, healthcare, family services and other assistance since the January 12 earthquake in Haiti.

“Every day since the earthquake, we have been focused on getting aid into the hands of those who need it most,” said Gail McGovern, president and CEO with the American Red Cross. “The American people have entrusted us with this responsibility, and we remain committed to helping the people of Haiti cope with their losses.”

Since the earthquake, the American Red Cross has raised approximately $255 million for the Haiti relief and recovery efforts. To date, it has spent or committed $80 million, with approximately 69 percent of the funds spent or committed for food and water; 20 percent for shelter; and 11 percent for health and family services. As the response progresses and recovery begins, the Red Cross will continue to support these priority areas and longer-term assistance initiatives.

Food, Water and Other Relief Items

The American Red Cross has provided 3 million pre-packaged meals to the United Nations World Food Programme as well as $30 million in funding to help feed an additional 1 million people for a month. To meet the dire need for clean water, it has also distributed more than 1 million water-purification sachets as well as containers that allow people to clean and carry water. The American Red Cross is also providing supplies for 130,000 people and working with Red Cross teams from other nations distributing relief items, such as blankets, kitchen supplies, hygiene kits and buckets.

Shelter

More than 1 million people in Haiti are in need of shelter. Leaders representing more than 20 Red Cross and Red Crescent societies, including the American Red Cross, gathered this week in Montreal, Canada for a two-day summit to develop and coordinate a comprehensive approach to respond to Haiti’s immediate and long-term needs.

“The challenges to quickly develop and deliver appropriate transitional shelters, and to do so prior to the rainy season, are immense,” said David Meltzer, senior vice president of international services with the American Red Cross. “This week’s meetings establish both a commitment and process to quickly shelter tens of thousands of survivors.”

In coordination with other relief agencies, the Red Cross aims to address the complex shelter situation in Haiti through a combination of strategies, including:

- Providing local families with solutions that will encourage them to rebuild safely near their pre-disaster homes

- Supporting host families who are housing displaced people

- Supporting people in post-quake settlements by providing both tarps and tents

Health and Family Services

Since the earthquake, American Red Cross has provided nearly 750 units of blood for earthquake survivors, more than 50 Creole-speaking interpreters for the USNS Comfort hospital ship, and $600,000 worth of food for the mobile clinics and hospitals operated by other Red Cross teams in Haiti.

In the United States, the American Red Cross has been providing welcoming services, shelter and other support for repatriated citizens and medical evacuees who arrived home following the earthquake. In addition, the American Red Cross is helping people find and reestablish contact with their loved ones in Haiti through its international family tracing service ??????” a form of assistance that is also being provided by the Red Cross in Haiti.

Looking Ahead

It is clear that what took minutes to destroy will take many years and the collective support from governments and relief agencies across the globe to help rebuild. Because of extraordinary support from the American public, the American Red Cross will continue to play an important role in relief efforts in the months ahead.

“The needs are great, but the generous support of the American people is making a difference every day,” said McGovern.

To learn more and read the complete report, please visit redcross/haiti.

You can help the victims of countless crises, like the recent earthquake in Haiti, around the world each year by making a financial gift to the American Red Cross International Response Fund, which will provide immediate relief and long-term support through supplies, technical assistance and other support to help those in need. The American Red Cross honors donor intent. If you wish to designate your donation to a specific disaster, please do so at the time of your donation by mailing your donation with the designation to the American Red Cross, P.O. Box 37243, Washington, D.C. 20013 or to your local American Red Cross chapter. Donations to the International Response Fund can be made by phone at 1-800-REDCROSS or 1-800-257-7575 (Spanish) or online at redcross.

Source
American Red Cross

Popular Stomach Acid Reducer Triples Risk Of Developing Pneumonia

A popular stomach-acid reducer used to prevent stress ulcers in critically ill patients needing breathing machine support increases the risk of those patients contracting pneumonia threefold, according to researchers at Wake Forest University School of Medicine.

Hospital-acquired pneumonia is the leading cause of infection-related deaths in critically ill patients. It increases hospital stays by an average of seven to nine days, cost of care, and the risk of other complications.

“As best we can tell, patients who develop hospital-acquired pneumonia or ventilator-acquired pneumonia have about a 20 to 30 percent chance of dying from that pneumonia,” said senior study author David L. Bowton, M.D., professor and head of the Section on Critical Care in the Department of Anesthesiology. “It’s a significant event.”

The study, published in a recent issue of CHEST, compared treatment with two drugs that decrease stomach acid: ranitidine, marketed under the name ZantacTM, and pantoprazole, marketed under the name ProtonixTM or PrilosecTM.

Both drugs decrease stomach acid, but the newer pantoprazole is considered more powerful and has become the drug of choice in many hospitals.

However, in the analysis of 834 patient charts, the researchers found that hospitalized cardiothoracic surgery patients treated with pantoprazole were three times more likely to develop pneumonia.

“We conducted this study, in part, because we thought we were seeing more pneumonias than we were used to having,” said study co-author Marc G. Reichert, Pharm.D., pharmacy coordinator for surgery at Wake Forest University Baptist Medical Center.

Both acid-reducing drugs can make the stomach a more hospitable place for bacteria to colonize. Patients on breathing machines sometimes develop pneumonia when stomach secretions reflux into the lungs.

Current treatment guidelines to prevent pneumonia recommend raising the head of the bed for patients on breathing machines, which reduces the risk of stomach secretions getting into the lungs.

But the study’s findings suggest some other steps could keep critically ill patients from developing ventilator-associated pneumonia.

Doctors should consider whether an acid reducer is needed at all, Bowton said. The occurrence of stress ulcer bleeding has gone down in recent years, perhaps because patients with breathing tubes are fed earlier, and food in the stomach may neutralize or reduce the effects of stomach acid.

Bowton added that in cases where an acid reducer is needed, ranitidine is recommended, given the apparent decreased risk in developing pneumonia.

Doctors should stop using the drug as soon as the risk of bleeding passes – once the patient is off the breathing machine and eating, either on his/her own or through a feeding tube.

“Stopping the drugs earlier appears to be the best thing for patients,” Reichert said.

Todd A. Miano, Pharm.D., formerly of Wake Forest University Baptist Medical Center and now with the Hospital of the University of Pennsylvania, is the study’s lead author. Co-authors, all from Wake Forest University School of Medicine, are Timothy T. Houle, Ph.D., and Drew A. MacGregor, M.D., of the Department of Anesthesiology; and Edward H. Kincaid, M.D., of the Department of Cardiothoracic Surgery.

Source:
Shannon Koontz

Wake Forest University Baptist Medical Center

View drug information on Ranitidine Capsules.

Asthma Treatment Claims May Mislead As Drug Trials Open To Industry Manipulation

The lack of agreed standard measurements of effectiveness in trials for asthma drugs means that drug companies can pick and choose the outcomes that best matches their products, according to Drug and Therapeutics Bulletin (DTB).

Dr Ike Iheanacho, editor of DTB said:

“Clinical trials vary greatly in the types of measures they use to assess the effects of asthma drugs, and this makes it difficult to compare different trials or to assess whether new treatments offer a genuine benefit for patients.”

There are many potential outcomes or endpoints to choose from when designing trials to look at effectiveness of a particular drug, and DTB believes this can lead to confusion.

The lack of agreed benchmarks to test asthma drugs in trials means that endpoints chosen might have little to do with how well the drug performs compared to other treatments; instead, the choice might be influenced more by the promotional objectives of the drug company.

Dr Iheanacho explains:

“A trial may, for example, define an endpoint as the change in asthma symptoms such as cough, wheeze and breathlessness and measure these during the day and night.

“The symptoms can be assessed in terms of severity and frequency, but there is no universally accepted standard for scoring them, and different studies record different sets of symptoms and use different scales.”

Likewise, lung function measures on their own can be an inadequate or misleading measure of treatment effect and so need to be considered with other outcomes such as symptoms, exacerbations or quality of life.

Different endpoints do not necessarily correlate with each other. Interpreting and comparing data from different trials can therefore be difficult.

Dr Iheanacho concludes:

“It is also important to beware of the potential for over interpretation of the secondary results of a trial: these may just add to the confusion about what is actually being measured and the drug’s true effectiveness.”

1 Exacerbations are associated with major morbidity, lifestyle disruption, hospital
admission, increased cost of care and risk of death. However there is no agreed
definition of a mild, moderate or severe exacerbation, and there is a wide variation
in the definitions used in trials.

2 Recorded or recalled use of inhaled short acting beta2 agonists is often used as a marker of asthma control. But some patients habitually take two puffs of bronchodilator before using an inhaled corticosteroid, and some use a bronchodilator before exercise to prevent symptoms. Such use must be distinguished from use of a bronchodilator for acute symptom relief.

3 For over 40 years Drug and Therapeutics Bulletin (DTB) has provided rigorous and independent evaluations of, and practical advice on, individual treatments and the management of disease for doctors, pharmacists and other healthcare professionals.

4 DTB also produces Treatment Notes – award-winning, evidence-based, practical information for patients that complements that available to healthcare professionals.

5 For further information about DTB and Treatment Notes or to subscribe, please go to dtb

6 Annual subscription ?49. Retired doctors, pharmacists and students ?24.50. All orders to DTB, Which? Castelmead, Gascoyne Way, Hertford X, SG14 1LH

Which?
2 Marylebone Road
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NW1 4DF
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T: 020 7770 7562
F: 020 7770 7666

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Plexxikon Initiates Phase 1 Clinical Trial For Oral Rheumatoid Arthritis Agent PLX5622

Plexxikon Inc. announced that dosing began in the first of two Phase 1 clinical trials with PLX5622, a novel, oral and highly selective Fms inhibitor, targeted for the treatment of rheumatoid arthritis (RA). PLX5622 has been shown in preclinical arthritis models to reduce inflammation, reduce cartilage damage and prevent bone resorption. Fms-related inflammatory mediators and cells, including macrophages, osteoclasts and T-cells, have been validated as key players in RA, other autoimmune diseases and osteoarthritis.

The initial Phase 1 trial is a single-ascending dose study in 32 healthy volunteers. The second trial is a multiple-ascending dose study in 32 RA patients that will begin once the first cohort of healthy volunteers has been cleared for safety, with continued enrollment in a staggered fashion relative to the single-ascending dose study.

“PLX5622 is an important and differentiated candidate among Plexxikon’s portfolio of Fms inhibitors that are being developed for multiple indications, and yet another first-in-class compound from Plexxikon,” said K. Peter Hirth, CEO of Plexxikon. “By targeting key drivers of the inflammatory process, we are hopeful that PLX5622 may provide relief to patients with rheumatoid arthritis and other autoimmune disorders, with the convenience of a pill.”

PLX5622 is expected to provide therapeutic benefit by modulating macrophage proliferation, inhibiting production of pro-inflammatory cytokines, and preventing the formation of osteoclasts. Osteoclasts’ bone resorptive activity is responsible for excessive bone destruction in several diseases.

In preclinical models of arthritis, PLX5622 demonstrated substantial disease suppression, including in advanced models of collagen-induced arthritis. PLX5622 significantly improved grip strength and clinical scores, as well as improved knee joint range-of-motion scores.

Plexxikon is completing a Phase 1 trial with PLX3397, another Plexxikon Fms inhibitor that selectively targets Fms, Kit and the Flt-3-ITD mutation. This study has provided validation of Fms-specific biomarkers, which will be directly applicable to the development of PLX5622 in defining a dose response. The company plans to initiate several proof-of-concept clinical trials with PLX3397, including in Hodgkin lymphoma, glioblastoma, acute myelogenous leukemia (AML) and metastatic breast cancer in 2011.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic disease that causes pain, stiffness, and swelling primarily in the joints, and affects more than 1.3 million Americans.

RA occurs when the body’s immune system malfunctions and attacks healthy tissue. This malfunction causes inflammation which leads to pain, swelling in the joints and may eventually cause permanent joint damage, bone erosion and deformation, and painful disability.

Source:

Plexxikon