New Long-Term HUMIRA (adalimumab) Data Show Up To Seven-Year Efficacy With Combination Treatment For Rheumatoid Arthritis

HUMIRA® (adalimumab) resulted in clinical remission among long-standing RA patients when used in combination with methotrexate (MTX). The percentage of patients achieving clinical remission continued to increase after two or more years of continuous treatment with combination therapy. These data were presented at the European League Against Rheumatism (EULAR) annual meeting in Paris.

The seven-year HUMIRA data are a combined analysis of open-label extensions of the ARMADA, DE019, STAR, DE005 and DE037 trials. The open-label extension period of these studies assessed the measures of efficacy, remission and change over time in the safety profile in patients with long-standing RA treated for up to seven years with 40mg of HUMIRA every other week plus MTX.

“Rheumatoid arthritis is a chronic, progressive disease with no cure and usually requires long-term management for patients, so it is reassuring that HUMIRA has demonstrated up to seven years of efficacy in patients with this disease,” said Michael E. Weinblatt, M.D., Brigham and Women’s Hospital, Boston, and lead investigator.

Seven-Year Clinical Data Summary

A total of 1,469 patients with a history of RA who had continued on from randomized, controlled HUMIRA trials were treated with HUMIRA and MTX for greater than or equal to 30 days and up to seven years in open-label extension studies. The average length of exposure to treatment was 47 months.

The randomized controlled HUMIRA study included:

– The ARMADA trial: a Phase III study to evaluate efficacy and safety of HUMIRA in patients with moderate to severe RA who had failed at least one disease-modifying anti-rheumatic drug (DMARD).

– DE019: a Phase III study, which evaluated the efficacy and safety of HUMIRA in patients with moderate to severe RA with inadequate response to MTX, including assessment of inhibition of radiographic progression.

– The STAR trial: a Phase III study that evaluated the efficacy and safety of HUMIRA when added to a standard treatment regimen for RA in patients with inadequate response.

– DE005: a Phase I study evaluating the safety and efficacy of HUMIRA in combination with methotrexate in methotrexate partial responders.

– DE037: a Phase I roll-over study that evaluated the safety, pharmacokinetics and early signs of HUMIRA efficacy among RA patients in the United States and Japan.

Efficacy

– After six months of therapy, all efficacy measures showed significant improvements versus baseline.

– At year two, additional improvements were observed in American College of Rheumatology (ACR)

responses. ACR responses represent a percent improvement in tender joint count, swollen joint count and other relevant clinical measures.

– Improved response after year one was confirmed by examining sustained clinical remission (Disease Activity Score (DAS28) of less than 2.6) for at least three consecutive visits; sustained remission was achieved in 42 percent of all patients after a mean of 18 +/- 17 months. DAS28 is a composite index that includes variables such as the number of tender and swollen joints, specific laboratory values and other measures of disease activity.

Safety

– The treatment exposure-adjusted rate of serious adverse events (SAEs), and serious infections, declined progressively during seven years of observation.

– Rates and types of SAEs were consistent with randomized controlled trials, including the rate of serious infections. Two patients reported tuberculosis, one after three months and another after 13 months of exposure.

About Rheumatoid Arthritis

Unlike osteoarthritis, the most common form of arthritis, RA is an autoimmune disease where joints are inflamed, which may lead to damage of the joints’ interior and the surrounding bone. The joints most commonly affected during the beginning of the disease are the smaller joints of the fingers, feet and wrists. The elbows, knees, ankles and hips can be affected, but less often. Although there is no cure for RA, people continue to seek treatments that not only alleviate the pain and inflammation but also slow disease progression, thereby inhibiting the joint damage that can hinder patients from performing daily activities. Five million people worldwide are currently living with RA and most of them are between the ages of 25 and 55.

Important Safety Information

Globally, prescribing information varies; refer to the individual country product label for complete information.
Serious infections, sepsis, rare cases of tuberculosis (TB), and opportunistic infections, including fatalities, have been reported with the use of TNF antagonists, including HUMIRA. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease could predispose them to infections. Patients must be monitored closely for infections, including tuberculosis, before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.

TNF-blocking agents have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of the virus. Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating HUMIRA.

The combinations of HUMIRA and anakinra as well as HUMIRA and abatacept is not recommended.
TNF antagonists, including HUMIRA, have been associated in rare cases with demyelinating disease and serious allergic reactions. Rare reports of pancytopenia including aplastic anemia have been reported with TNF-blocking agents. Adverse events of the haematologic system, including medically significant cytopenia have been infrequently reported with HUMIRA.

More cases of malignancies including lymphoma have been observed among patients receiving a TNF antagonist compared with control patients in clinical trials. The size of the control group and limited duration of the controlled portions of studies precludes the ability to draw firm conclusions. Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation. During the long-term open-label trials with HUMIRA, the overall rate of malignancies was similar to what would be expected for an age, gender and race matched general population. With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF antagonist cannot be excluded. All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of Psoralen Ultra-Violet A (PUVA) treatment, should be examined for the presence of non-melanoma skin cancer prior to and during treatment with HUMIRA.

In clinical studies with another TNF antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events including worsening CHF and new onset CHF have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA. Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully. HUMIRA should not be used in patients with moderate or severe heart failure.

The most frequently reported adverse event (>1/10 patients) at least possibly causally related to HUMIRA is injection site reaction (including pain, swelling, redness or pruritus). Other common adverse events (reported by >1/100 patients) at least possibly causally related to HUMIRA include lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections), candidiasis, bacterial infection (including urinary tract infections), upper respiratory infection, dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias), cough, nasopharyngeal pain, diarrhea, abdominal pain, stomatitis and mouth ulceration, nausea, hepatic enzymes increased, rash, pruritus, musculoskeletal pain, pyrexia, fatigue (including asthenia and malaise).

About HUMIRA

HUMIRA is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis, ankylosing spondylitis (AS) and Crohn’s disease in the United States and Europe. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-?±), a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases. To date, HUMIRA has been approved in 75 countries and more than 250,000 people worldwide are currently being treated with HUMIRA. Clinical trials are also under way evaluating the potential of HUMIRA in ulcerative colitis.

In Europe, HUMIRA in combination with methotrexate, is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. HUMIRA is also indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. HUMIRA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. In the United States, HUMIRA is also approved for the treatment of juvenile idiopathic arthritis (JIA).

HUMIRA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. HUMIRA has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.

HUMIRA is indicated for the treatment of adults with severe, active ankylosing spondylitis who have had an inadequate response to conventional therapy.

HUMIRA is indicated for treatment of severe, active Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. For induction treatment, HUMIRA should be given in combination with corticosteroids. HUMIRA can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate.

HUMIRA is indicated for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA.

Abbott’s Commitment to Immunology

Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Mass., United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.
Abbott’s news releases and other information are available on the company’s Web site at abbott.

View drug information on Humira.

Indonesia Earthquake: Concerns About Post-operative Infections – WHO Sets Up Mechanism For Post- Operative Management

WHO is developing implementation plan of an emergency plan with the Ministry of Health to provide pre-emptive immunization of a booster dose of Tetanus-diphtheria (Td) to the entire over -15 population in the earthquake affected areas, totaling approximately 1.3 million people. Simultaneously, one dose of measles vaccine will also be administered to children 6-59 months in the same areas. This is extremely important as many have been exposed to minor cuts and open wounds, and also because communities have started clearing rubble from damaged houses which would expose many to cuts and injuries and possible exposure to tetanus. This immunization campaign has commenced in some districts and would be extended to all districts shortly. WHO is also stressing the importance of providing the standard three doses of tetanus-toxoid vaccine, as per national guidelines, for anyone who has suffered injuries.

The first suspected tetanus case, a 90-year-old patient has been referred to the Sardjito Hospital in Jogjakarta. The patient is under investigation and observation.

At the same time, WHO has sounded an alert for other possible post- surgical infections in patients in both the affected provinces of Yogyakarta and Central Java. Over 11000 patients have been treated for minor and major injuries, of whom, nearly 800 have been operated on, till 30th May. WHO’s concern is that, given the pressure of the sheer numbers of people who were provided emergency care, it is now important to screen all such patients for follow-up treatment and care both in hospitals and for those who have been discharged.

A WHO-led sub-group for hospitals is to mobilize all the medical and orthopaedic experts available to form teams for follow-up with reconstruction, correction and rehabilitation surgery.

WHO is advocating the use of established principles and guidelines for patient care which include high quality hospital care, good hospital management and good waste management to minimize the risk of hospital-based infections.

Ideally, to prevent hospital-based infections, WHO recommends that patients be discharged at the earliest, followed by post-operative care at home. However, for many of the affected patients there are no homes to return to.

The local culture is very strong in community self-help. Experts are advising that where possible, patients be provided community- based rehabilitation with support from the national health authorities, NGOs and international agencies.

The area around Bantul abounds in more elderly people as many of the younger generation have left to work in other cities, or other countries. Being more frail, they are more vulnerable and are prone to infections and to delayed healing. These persons would need greater care.

Among those with no home to return to is 80-year-old Pringo Utomo, who lives alone. She has an open fracture of the leg. Her home in Be be kaan village of Bantul province is a typical Javan house, with a tiled roof. She was injured when a wall of her single floor house collapsed. Pringo lives alone, while her daughter, who lives in Jakarta, rushed down to take care of her, she now has no home to return to.

Moliyo Dati, 60, who was operated for multiple fractures in his leg at a government mobile hospital in Bantul, is a farmer who also lives in the same village. While his 24 year old son and wife live with him, he is extremely anxious about leaving the hospital as his house has been totally destroyed.

who.int/en

Study Finds Bortezomib To Be Promising Treatment For Rheumatoid Arthritis

Proteasome Inhibitor Reduces Inflammation and Promotes Bone Healing in Arthritis Models.

A new study by Greek researchers suggests that the biologic drug bortezomib (Velcade), a proteasome inhibitor used to treat multiple myeloma (bone marrow cancer), may represent a promising treatment for rheumatoid arthritis (RA). In this study, bortezomib displayed favorable effects in an animal model of inflammatory arthritis that mimics RA, in reducing disease severity and inflammation, and promoting bone healing. Full findings of this study are published in the November issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology (ACR).

RA is a chronic, systemic, autoimmune disease characterized by inflammation and joint destruction. The newer biologics, such as the tumor necrosis factor (TNF) inhibitors and monoclonal antibodies, have increased the therapeutic options for patients with RA. However, studies have shown that more than 50% of patients treated with a TNF inhibitor do not meet the ACR 50 improvement criteria a standard set of measures developed by the college to determine efficacy of drugs in clinical trials.

“The definitive role of biologic agents in treating this difficult-to-cure population has yet to be defined in prospective trials comparing the available therapeutic options,” explained study leader Evangelia Yannaki, M.D, of George Papanicolaou Hospital in Thessaloniki, Greece. “Given the lack of options for poor responders and the increased risk of infections and malignancies with available biologic agents for RA, there is a great need for novel therapies that are safe and effective.”

The research team explored bortezomib as an optimal treatment for RA because the drug targets multiple pathways. In RA, the most important proinflammatory mediators are regulated by the transcription factor NF-???B proteins that control genes involved in inflammation and the immune response to infection. Where bortezomib inhibits NF-???B, researchers speculate that the drug may improve autoimmune conditions, such as RA, which are characterized by chronic inflammation.

The analysis demonstrated that in vitro, bortezomib significantly reduced proliferation and increased death of the inflammatory cells in rats with adjuvant induced arthritis (AIA), thereby reducing invasiveness of fibroblast-like cells that are responsible for the damage to the lining of the joints; it also modified the pattern of protein cell signaling (cytokine secretion) in T-lymphocytes that are involved in the immune system response. In vivo, bortezomib significantly improved clinical manifestations of arthritis in these animals, even when administered during the advanced disease phase. Researchers noted that joints in animals treated with the drug displayed limited damage and inflammation, and an obvious bone healing effect was observed.

“Our research showed that bortezomib is a useful treatment in targeting critical cell populations involved in the development of inflammation and autoimmunity in RA,” concluded Dr. Yannaki. “We believe that bortezomib should be further explored in a clinical setting, as it represents an attractive intervention for inflammatory conditions and a highly promising agent in the treatment of RA.”

Sources: Wiley – Blackwell, AlphaGalileo Foundation.

View drug information on Velcade.

New Medicare Reimbursement Code For Orthovisc For Patients With Osteoarthritis, USA

DePuy Mitek, Inc., a Johnson & Johnson company, today announced that the Centers for Medicare & Medicaid Services (CMS) has assigned a new reimbursement HCPCS (“J”) Code to ORTHOVISC®, an ultra pure hyaluronan injectable used to improve mobility and treat knee pain caused by osteoarthritis.

The HCPCS J Code, J7319, will take effect in January 2007 and will cover all hyaluronic acids.  Previously, ORTHOVISC was assigned a miscellaneous code that required manual billing and caused challenges and delays in processing claims. 
The new code should improve claim processing, reduce denials of coverage and reduce administrative costs for physicians’ offices.  Doctors should continue to use the current miscellaneous code until the new code is published in January.  Existing codes for hylaruonic acids are scheduled for deletion on December 31, 2006.

“This is good news for doctors and their patients who suffer from osteoarthritis of the knee,” said Michel Paul, President, DePuy Mitek.  “By assigning ORTHOVISC a permanent J Code, CMS has simplified the reimbursement process for doctors and improved patient access to this important treatment.  However, while ORTHOVISC will have the same code as other hyaluronic acids, important differences remain.”

ORTHOVISC is the only viscosupplementation product in this classification with a 30-mg per dose, 3-injection treatment regime that offers 26 weeks of pain relief.  ORTHOVISC contains no buffers or preservatives and no pseudoseptic reactions have been reported in more than 1 million injections.

More than 10 million people suffer from osteoarthritis of the knee, an often painful condition caused by the deterioration or loss of cartilage around the knee.  Treatment options include physical therapy and exercise, medications, corticosteroid or hyaluronic acid injections, and surgery.

Hyaluronan is a natural chemical found in the body that acts like a lubricant and shock absorber for the knee.  ORTHOVISC contains the highest concentration of ultra-pure hyaluronic acid per injection on the market today.  A doctor injects ORTHOVISC directly into the knee once a week, for a total of three injections, usually in the doctor’s office.  ORTHOVISC provides lubrication for the knee, helps to cushion the knee joint and can relieve knee pain for up to six months and improve mobility. 

DePuy Mitek markets ORTHOVISC to arthroscopists, orthopedic surgeons and rheumatologists.  Anika Therapeutics, Inc. (Nasdaq: ANIK) developed and manufactures ORTHOVISC.

ORTHOVISC is contraindicated in patients with known hypersensitivity to hyaluronate formulations or known avian or avian-derived allergies including eggs, feathers, or poultry.  ORTHOVISC should not be injected in patients with infections or skin diseases in the area of the injection site or joint.  Strict aseptic technique should be used.  The effectiveness of more than one course has not been established. 

For more information contact DePuy Mitek Customer Service at 800-382-4682 or visit orthovisc.  For reimbursement information visit orthoviscline or call 866-633-VISC (8472).

 
About DePuy Mitek, Inc.

DePuy Mitek, Inc., a Johnson & Johnson company, is a leading developer and manufacturer of a wide range of products and solutions that simplify procedures and “Restore the Anatomy”™.  Well known for its innovative surgical sports medicine and arthroscopic medical devices, DePuy Mitek currently operates in 58 countries.  Through an on-going process of improving upon and creating technologically advanced materials, instruments, implants and techniques for shoulder, knee and small joint pathologies, DePuy Mitek continues to advance arthroscopic procedural solutions in the field of sports medicine while expanding into viscosupplementation and biologics.  DePuy Mitek’s patient education efforts include websites such as managingosteoarthritis and shoulderpainsolutions/.  For more information, visit depuymitek.

 
About Anika Therapeutics, Inc.

Headquartered in Woburn, Mass., Anika Therapeutics, Inc. (anikatherapeutics) develops, manufactures and commercializes therapeutic products for tissue protection, healing and repair. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. ORTHOVISC is a registered trademark of Anika Therapeutics, Inc.

2nd International ‘Come To Your Senses’ Conference – For Those Who Work With Children & Adults With Various Disabilities

The 2nd International Come To Your Senses Conference will take place on May 23 – 27, 2007 at The Sheraton Centre Toronto. The focus of this conference is Opening the Sensory World to Children and Adults with Complex Disabilities.

We invite professionals, parents, caregivers, persons with disabilities, researchers, and students to attend the conference and participate in discussions covering a wide array of topics within the realm of Sensory Field and people with disabilities. The goal is to share and disseminate knowledge and experience from around the world so that we can better understand the Sensory Reality of people with disabilities and the many forms of treatment that exist.

Take advantage of this opportunity and REGISTER NOW by visiting sensoryconference

To become an exhibitor and be given a chance to demonstrate your services and products to conference participants, please visit the Exhibitors section of the conference webpage. To help make this unique event a huge success visit the Sponsors section and review the Sponsorship Package for a number of exciting opportunities!

To find out more information about MukiBaum Treatment Centres, visit mukibaum.

MukiBaum Treatment Centres
209 – 265 Rimrock Road
Toronto, ON, M3J 3C6
P: 416-630-2222 ext 230
F: 416-630-2236
eyyubmukibaum
mukibaum

House Appropriations Committee Passes Bill Allowing Contraceptive Donations To International Groups Barred From Funding

The House Appropriations Committee on Tuesday by voice vote approved a foreign aid spending bill that would allow the federal government to give contraceptives but not money to international groups barred from receiving U.S. aid because of their abortion policies, the AP/Forbes reports (Taylor, AP/Forbes, 6/13).

The so-called “Mexico City” policy bars U.S. funding from going to international groups that support abortion, even with their own money, through direct services, counseling or lobbying activities. The policy was originally implemented by former President Reagan at a population conference in Mexico City in 1984, removed by former President Clinton and reinstated by President Bush during the first days of his presidency. Bush in September 2003 issued an executive order that prevents the State Department from giving family planning grants to international groups that provide abortion-related counseling.

Rep. Nita Lowey (D-N.Y.), chair of the House Appropriations Subcommittee on State, Foreign Operations and Related Programs, recently said the legislation leaves the Mexico City policy intact, but Republicans disagreed and cited a threat by Bush to veto legislation that would change current abortion-related policies and laws. Bush last month in a letter to House Speaker Nancy Pelosi (D-Calif.) and Senate Majority Leader Harry Reid (D-Nev.) said he will veto any legislation that would weaken federal policies or laws on abortion, including measures that would “allow taxpayer dollars to be used for the destruction of human life” (Kaiser Daily Women’s Health Policy Report, 6/6).

Rep. Frank Wolf (R-Va.) said the amended Mexico City policy “is a guaranteed veto if it stays in.” Lowey said the policy retains all the current prohibitions on abortion and “simply allows for the provision of lifesaving contraceptives” (Kivlan, CongressDaily, 6/13).

The provisions included in the $34.2 billion spending bill for fiscal year 2008 must still be debated by the full House and Senate, Reuters reports (Cowan, Reuters, 6/12).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Bacteria’s Glue Valve Surprises Scientists

St Louis, USA – To stick to cells in the respiratory tract and start an infection, the bacterium Haemophilus influenza has to secrete a glue-like protein. Researchers at Washington University School of Medicine in St. Louis report this week that a study of the valve that lets out the glue has produced some surprising information.

Scientists are studying the valve to better understand how bacteria interact with host cells. Insights into these interactions could lead to new targets for drugs to treat H. influenzae infection, which is a common cause of respiratory tract disease and in some parts of the world is responsible for most cases of childhood bacterial meningitis.

The study is available online in the Proceedings of the National Academy of Sciences and will appear October 5 in the print edition of the journal. The first author is Neil K. Surana, an M.D./Ph.D. student at Washington University.

Washington University researchers determined that the protein that makes up the valve, HMW1B, is structurally similar to other proteins found in a wide variety of life forms ranging from humans to plants to single-celled organisms and bacteria. Those proteins, which create openings that move substances from one side of a cell membrane to another, are collectively known as Omp85-like proteins.

In addition to the similarities, though, researchers also found that HMW1B has some unexpected quirks.

“Previous studies of Omp85-like proteins on other bacterial surfaces had suggested that they are monomers, proteins active when only a single copy of the protein is present,” says senior investigator Joseph W. St. Geme, M.D., a Washington University pediatrician at St. Louis Children’s Hospital and a professor of molecular microbiology and pediatrics. “But we found that four copies of HMW1B come together in a structure known as a tetramer to form an active pore.”

Discovery of the tetramer led researchers to expect that the four copies of HMW1B would form a ring-like structure with a single central opening. But based on data still under review, they now suspect that each copy of HMW1B may have an opening in its center that lets the glue-like proteins, called adhesins, cross the cell membrane.

“We were already curious about why the tetramer exists instead of a monomer,” says St. Geme. “Now we need to see if we can confirm whether each copy creates its own opening.”

St. Geme speculates that the tetramer may be more stably positioned in the bacteria’s outer membrane than a monomer. Alternatively, the tetramer may facilitate interaction among multiple copies of the glue, perhaps allowing the glue to become activated as it emerges onto the surface of the bacteria.

Scientists previously have found other proteins similar to HMW1B and the glues it secretes in infectious agents like Bordetella pertussis, the bacteria that causes whooping cough. According to St. Geme, it’s too early to tell if these similarities make this group of proteins good targets for drug development.

“The similarities to other Omp85-like proteins could make it difficult to develop drugs that block HMW1B without adversely affecting Omp85-like proteins normally active in humans,” he explains. “But another major part of this paper is the discovery that there are some unique aspects to the interaction between HMW1B and the adhesin it exports. We may be able to focus our efforts on this interaction. ”

Surana NK, Grass S, Hardy GG, Li H, Thanassi DG, St. Geme JW III. Evidence for conservation of architecture and physical properties of Omp85-like proteins throughout evolution. Proceedings of the National Academy of Sciences, early online edition.

Funding from the National Institutes of Health and the Medical Scientist Training Program at Washington University School of Medicine.

Washington University School of Medicine’s full-time and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked second in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.

Contact: Michael C. Purdy
purdymwustl
314-286-0122
Washington University School of Medicine

NHLBI Asthma Clinical Research Networks And ALA ACRC Network Presenedt At ATS 2007

Researchers studying inhaled steroids and children with asthma, as well as asthma and obesity, presented new findings from the National Heart, Lung, and Blood Institute (NHLBI) Asthma Clinical Research Networks at the American Thoracic Society 2007 International Conference in San Francisco.

Researchers from the American Lung Association Asthma Clinical Research Centers (ACRC) presented substudies and subgroup analyses for three ACRC studies, plus an overview of ongoing and future ACRC studies.

NHLBI Asthma Clinical Research Networks

Two of the presentations included new research findings from the Prevention of Early Asthma in Kids (PEAK) study, which is investigating the effect of inhaled-corticosteroid therapy on children with asthma. In May 2006, PEAK researchers published findings in The New England Journal of Medicine that showed that preschool children at high risk for asthma had decreased asthma-like symptoms while on two years of inhaled-corticosteroid therapy; however, this therapy did not change the development of asthma symptoms or lung function during a third, treatment-free year.

Since then, the researchers have continued to observe the 285 children in the study, to get a more in-depth look at the changes in the lungs, including inflammation, in these children. The new PEAK results will look at the follow-up of the study, with more in-depth information about the predictors of response to inhaled steroids and long-term changes in the physiology of the lung.

Wayne Morgan, M.D., of the University of Arizona Health Sciences Center in Tucson, who presented new data at the ATS meeting, comments, “The question was, can you protect the airways by using inhaled steroids early in life in high-risk kids to modify the development of wheezing and protect lung function” The bottom line is no. You can control asthma, but you can’t make it go away.” In this study, children considered to be at high risk of asthma include those with recurrent wheezing in the first three years of life, as well as those with eczema or a parent with asthma.

A second presentation on the PEAK studylooked at whether there are ways to predict which high-risk children will do poorly with their asthma. “Some children outgrow their asthma and some maintain their asthma, and PEAK found that inhaled steroids didn’t change that course. However, these high-risk children do respond to inhaled steroids, but if you take them off, they tend to do worse,” says researcher Theresa Guilbert, M.D., Assistant Professor of Pediatrics at the University of Wisconsin-Madison and lead author of The New England Journal of Medicine article. “We know that if children have certain characteristics such if they’re male, have allergy, or have eczema that they tend to do poorly over time.”

A third study from NHLBI’s Asthma Clinical Research Network looks at the impact of overweight and obesity on asthma severity and response to asthma therapy. The study is using data from the NHLBI on approximately 1,200 people with asthma.

“This type of study provides extremely rich data in terms of the participants’ height, weight and asthma severity, allowing us to more precisely evaluate the relationship between body mass and asthma severity,” says researcher E. Rand Sutherland, M.D., M.P.H., Assistant Professor of Medicine at the National Jewish Medical and Research Center in Denver. “We can also look at how obesity modifies the response to therapy.”

Dr. Sutherland’s findings suggest that in patients with mild-to-moderate asthma, increased weight does not substantially worsen physiologic and inflammatory markers of asthma. “However, overweight and obese patients with asthma do appear to respond less well to traditional asthma therapies than do their lean counterparts,” he says.

ACRC Trials

The American Lung Association Clinical Research Centers’ (ACRC) purpose is to conduct clinical trials with practical importance to both adults and children with asthma. Researchers will present new data from substudies and subgroup analysis of the following three studies:

Leukotriene Modifier or Corticosteroids or Corticosteroid-Salmeterol Trial (The LOCCS Trial) aimed to determine the optimal “step down” therapy for mild-moderate persistent asthma that was controlled on inhaled corticosteroids

The Sinusitis and Rhinitis in Asthma Study (SIRNA) trial developed a clinical tool to reliably diagnose rhinosinusitis in people with poorly controlled asthma

Contact: Suzy Martin

American Thoracic Society

Asthma in Northern Ireland – the true picture revealed

Admissions to hospital for asthma in Northern Ireland remain significantly higher than the rest of the UK, says a report
launched today by Asthma UK Northern Ireland.

‘A Moving Picture – Asthma in Northern Ireland Today’ reveals the true extent of how asthma affects people in Northern
Ireland and describes the standards of care that they receive.

The report also details that people’s confidence in how Health and Social Services handles asthma emergencies is low.

Marjory Burns, Executive Director of Asthma UK Northern Ireland said: ‘Asthma is a condition that should be controllable with
modern treatments and specialist training yet we still see an unacceptable level of hospital admissions for asthma
emergencies. 75% of hospital admissions and 90% of asthma deaths are preventable. We would like to see every person with
asthma have a personal action plan to help them take control of their asthma.’

One shocking statistic from the report shows that asthma has a real and all-pervading effect on people’s lives with only 1 in
4 people with asthma in Northern Ireland expecting their medicines to control their asthma. The survey also revealed that
people with asthma in Northern Ireland have low expectations – four out of five are still experiencing daily asthma symptoms
and yet their confidence in local health care practitioners and routine care is higher than anywhere else in the UK.

Dr Vincent McGovern, GP and part-time Medical Officer in Respiratory Medicine, Belfast City Hospital added: ‘It is important
to ensure that people with asthma understand that for the majority of people, their condition can be effectively controlled
and that there is no reason why they should be experiencing symptoms every day. Their GP or practice nurse should be giving
advice about how their asthma might change over time and what they can do to control their symptoms. Using a reliever inhaler
three times a week or more or even waking up once a week, indicates that they should discuss their symptoms with their GP or
nurse. Healthcare professionals have a responsibility to monitor who is due for an asthma review and to check that their
symptoms are not taking over their lives.’

Ms Burns further commented: ‘Healthcare professionals in Northern Ireland need to review the way people with asthma are cared
for. Asthma UK Northern Ireland is calling for healthcare professionals to put Asthma UK’s ten-point Asthma Charter into
practice. The Charter outlines the standards of care that a person with asthma should expect. GPs and practice nurses should
also be following the BTS/SIGN Guideline on the management of asthma to improve care, save lives and keep people out of
hospital.’

As part of Asthma UK’s commitment to working with healthcare professionals, the charity is providing all GPs and practice
nurses in Northern Ireland with new tools for controlling asthma – the Be in Control pack, which includes an asthma action
plan and a guide to carrying out an asthma review as well as basic information for people with asthma.

ENDS
For media queries about this story, call Will Chambr? on 028 9066 1006 or 07736 230585.

Download ‘A Moving Picture’ (PDF 380KB)

Notes to Editors:

1. Asthma UK is the charity dedicated to improving the health and well-being of the 5.2 million people with asthma in the UK.
Asthma UK works with people with asthma, healthcare professionals and researchers to develop and share expertise to help
people increase their understanding and reduce the effect of asthma on their lives.

2. For independent and confidential advice on asthma, call the Asthma UK Adviceline, which is staffed by asthma nurse
specialists. It is open weekdays from 9am to 5pm on 08457 01 02 03. Or email an asthma nurse at asthma/adviceline.

3. For up-to-date news on asthma, information and publications, visit the Asthma UK website asthma

Contact
Media Office
T: 020 7704 5841
F: 020 7704 5933
E: mediaofficeasthma
asthma/news/press100.php

New Autism Association Centre Expands Services For WA, Australia

The Premier of Western Australia officially marked the commencement of construction of
the Autism Association of Western Australia’s new Service Headquarters and state of the art
Early Intervention Centre in Shenton Park.

The new facilities will expand the Association’s delivery of services in all areas and enable
clinical and training staff to connect with organisations, professionals and families throughout
Western Australia.

Autism Association of WA Chief Executive Officer, Joan McKenna Kerr, said the new Service
Headquarters was the result of a true partnership between the Autism Association, the
community and the public sector.

The Government and Lotterywest have supported the development of the centre with a
$4million grant with the balance of the funding coming largely from community fundraising and
other activities.

“Our new Service Centre will provide the infrastructure to expand services for both children and
adults, and will include a state of the art early intervention centre for newly diagnosed children
under the age of six years,” Ms McKenna Kerr said.

“It will provide the Association’s multi-disciplinary teams with the capacity to work with over 400
pre-school children with Autism each year. In addition to the Early Intervention Centre, the new
complex will also provide facilities for all of the Autism Association’s community based Children
and Adult Services as well as Family Support Programs.

“It will also have a medical consultancy suite for adolescents and adults with complex needs.”
Ms McKenna Kerr said importantly the new facilities would assist clinical and training staff to
connect with organisations, professionals and families in regional Western Australia.

“This will be a place where any member of the public can come to find out more about Autism; a
place where the achievements of people with Autism will be on show; and facilities where
families can come to meet with staff and with each other”.

Lisa Cocks, mother of two children with Autism, said early intervention was critical in helping
develop life-long skills for her children and strategies to cope in different situations.

“This is about teaching them many of things we all take for granted, such as how to play with
other children, to share, to understand emotions and facial expressions and to interact with
children their own age” Ms Cocks said.

“My eldest son Aaron was diagnosed with Asperger’s Syndrome at six years of age, while Bryce
received his diagnosis of Autism Spectrum Disorder (ASD) at three. While they both have very
different autistic tendencies they both need special support. Aaron would have benefited greatly
from early intervention if we’d had an earlier diagnosis,” she said.

“The work the Autism Association does is amazing. At three years old Bryce had no language
and communicated through ‘melt downs’. He still has trouble with eye contact but he is a
different child.

“I can’t wait to see the new centre operating. Having all the facilities located in one place rather
than being spread across different locations will certainly make it logistically better for both staff
and for families.”

Designed by Architects Cameron Chisholm Nicol and being constructed by Diploma Group, the
building is expected to be completed in early 2012.

Autism Association of WA Background

Autism is a complex, life-long developmental disability which is neurobiological in origin.
Approximately one in every 160 children in Australia is diagnosed with an Autism Spectrum
Disorder (ASD).

The Autism Association of Western Australia is a large not-for-profit organisation providing
services from diagnosis in infancy and throughout the life of person with Autism.
Our mission is to advance the personal development, equality of opportunity and community
participation of people with Autism.

The Association is the only specialist Autism organisation in Australia providing the full range of
services to meet the needs of people with Autism from early childhood into adulthood; and is the
second largest specialist organisation providing services to people with Autism and their families
in Australia.

The Association also works with a range of service providers in Western Australia and is one of
only five agencies worldwide providing specialist programs to assist job-seekers with Autism to
find and maintain employment.

Source:

Autism Association