Major Clinical Trial For Children’s Arthritis

In Northern Ireland, a major clinical trial will focus on children suffering from arthritis — not only for the betterment of its treatment but also to reduce brittle bones (osteopenia) in this children as a result of steroid treatments.

The said clinical trial - funded by the Arthritis Research Campaign and is being lead by Consultant Rheumatologist Dr Madeleine Rooney - aims to recruit about 40 local youngsters aged between four and 18 and is being conducted at the Belfast’s Musgrave Park Hospital.

Many children develop osteopenia as a result of taking steroids to treat their diseases.

The team hope their research will lead to new guidelines on the treatment of steroid-induced osteopenia, which could improve the lives of the tens of thousands of children with arthritis who are affected throughout the world.

Also, later in the progress of the said clinical trial, it hopes to extend the study to 230 children and young people from throughout the UK — making this the first multi-centre trial involving children to be led from Northern Ireland.

More than 12,000 children and teenagers in the UK have childhood arthritis, known as juvenile idiopathic arthritis (JIV). Around 400 of them live in Northern Ireland.

Steroids are widely used in the treatment of childhood arthritis and other related conditions, such as lupus, juvenile dermatomyositis or vasculitis.

But the down side of these drugs is that they cause thinning of the bones. More than 50% of children who take steroids develop osteopenia within a year.

The said clinical trial will compare the effectiveness of risedronate (a bisphosphonate drug which protects against bone loss) against 1-Alpha (a more potent form of Vitamin D) on the bone density of the children over a year.

It becomes troubling that young children suffers from arthritis. Whoever said that arthritis is age related?! There are even more concern when children have arthritis because they are still growing.

As Dr. Rooney puts it:

“As a result of early onset arthritis, children develop growth abnormalities, joint damage and osteopenia.

This means they are at greater risk of developing osteoporosis in later life and are at increased risk of fractures, particularly vertebral collapse.

There are currently many studies showing the effectiveness of bisphosphonates in the treatment of osteoporosis in adults - including a significant reduction in fractures, and there are now clear guidelines on how it should be diagnosed and treated.”

But she said, there are no available data to support the effectiveness of bisphosphonates in children. At least now, that’s gonna be looked into, especially these days that early onset or juvenile arthritis has gotten rampant.

Find more details on this at Belfast Telegraph.

               

Roche’s Arthritis Drug Actemra™ Got Japanese Approval

Roche Holding AG’s arthritis drug Actemra™ just won Japanese approval, which will then be sold by Roche’s Chugai unit.

Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development program of five Phase III trials was designed to evaluate clinical findings of Actemra.

Four studies are completed and have reported meeting their primary endpoints. A fifth trial, a two-year study called LITHE (TociLIzumab safety and THE prevention of structural joint damage), is currently underway and is expected to report preliminary first-year data in 2008.

Actemra™ (tocilizumab) will be sold for rheumatoid arthritis and two types of the disease that affect children: namely juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis.

The therapy is aimed at patients who aren’t helped by older drugs marketed by Amgen Inc., Johnson & Johnson and Abbott Laboratories. Roche is seeking to expand its range of treatments with medicines for arthritis, diabetes and anemia.

Roche expects the market for rheumatoid arthritis to grow to 15.6 billion Swiss francs ($15.5 billion) by 2010 from 8.6 billion francs in 2005. The Swiss drugmaker has also asked U.S. and European regulators to approve the medicine.

While the Japanese approval is the first worldwide approval for Actemra™, the FDA in the United States has yet to approve this drug. The FDA’s decision is expected by September 21, 1008.

Actemra™ works by targeting a different protein — called interleukin-6 — which also causes inflammation and also other symptoms such as fever, pain and stiffness.

Actemra is the first of a new class of drug with a novel mechanism of action that brings new hope to RA patients. It is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, which works by suppressing the activity of IL-6, an important trigger of the inflammatory process. This novel mode of action reduces inflammation of the joints and relieves the systemic effects of RA.

Since 2005, Actemra has been marketed in Japan for the treatment of patients with a rare auto-immume condition known as Castleman’s disease. Actemra licence applications have also been filed for treatment of RA in the Unites States and the European Union in 2007, and are currently under review.

Rheumatoid arthritis (RA), as we all know is debilitating, it is an autoimmune disease. In fact (according to Roche), RA is a high unmet medical need!

Rheumatoid arthritis is a progressive autoimmune disease characterized by inflammation of the membrane lining in the joints throughout the body. This inflammation causes distortion of the joint and impaired function accompanied by pain, stiffness and swelling and ultimately leading to irreversible joint destruction and disability.

In addition, the systemic symptoms of RA include fatigue, anaemia, osteoporosis and may contribute to shortening life expectancy by affecting major organ systems. Sadly after 10 years, less than 50% of patients can continue to work or function normally on a daily basis.

Read the full report at Bloomberg and Roche PR.

               

Pediatric Arthritis: Prevalent and Burden in the U.S.

I already said that arthritis does not happen in adults alone. Young people can get arthritis as well.

In fact, an estimated 294,000 U.S. children and teenagers under age 18 (or one in 250 children) have been diagnosed with arthritis or another rheumatologic condition.

Such were the data uncovered by a study published in the December issue of Arthritis Care & Research.

Conducted by the Centers for Disease Control and Prevention (CDC), the said study provides (for the first time!) a more accurate estimate of the number of children diagnosed with arthritis and related conditions across the U.S. and within each state – thereby creating a benchmark against which to measure future changes in prevalence rates.

A provision of the proposed Arthritis Prevention, Control and Cure Act introduced in 2004 called for a better determination of the size of the childhood arthritis problem. As a result, the CDC, in collaboration with several other organizations, began an intensive review of options on how to estimate the number of children with arthritis and related conditions, as well as what conditions should be included in such a count.

In addition to providing these improved national estimates, the study also provides estimates for each state. “The CDC’s first-ever estimates of childhood arthritis- related diagnoses show a state-by-state range from a low of 500 children in Wyoming to a high of 38,000 children in California,” said Jeffrey Sacks, M.D., M.P.H., Captain in the U.S. Public Health Service at the CDC.

Study data also show that children diagnosed with arthritis and other rheumatologic conditions account for approximately 827,000 doctor visits each year, including an average of 83,000 emergency department visits.

Honestly I am surprised that this hasn’t been done before, considering that it’s the U.S. But then they might have not paid attention to pediatric arthritis because of the “notion” that arthritis is an age-related condition.

According to Patience White, M.D., Arthritis Foundation chief public health officer and a pediatric rheumatologist:

“This study finds that one in 250 children have been diagnosed with arthritis or related conditions. Due to the lack of availability of pediatric rheumatologists trained in the diagnosis and care of children with arthritis, we know that many children with inflammatory forms of arthritis are not diagnosed early enough to prevent disability.

New treatments are now available for children with inflammatory arthritis that decrease disability thus making early diagnosis essential. We know that 11 states do not have a practicing pediatric rheumatologist.

The need for more pediatric rheumatologists is critical for families and children with arthritis. Passage of the Arthritis Prevention, Control and Cure Act is necessary as it would encourage more physicians to enter the field and also would highlight the research needs for children with arthritis.”

Find more details from PR Newswire.

Furthermore, the Arthritis Foundation has a resource brochure for families affected by pediatric arthritis – the “Arthritis in Children” brochure which includes the latest information on treatments and self-management techniques.

To get a free copy of this brochure, contact the Arthritis Foundation at 1-800-283-7800 or visit the Arthritis Foundation website.