FDA approves new drug to fight juvenile arthritis

For those patients six-years-old-and-up battling Polyarticular Juvenile Idiopathic Arthritis (JIA), the FDA has now approved a new weapon in the fight, in the form of Orencia.

Meant for those children and teens no longer responding to current treatments, Orencia is an abatacept injection, "used alone or in combination with other medications to reduce the pain, swelling, difficulty with daily activities, and joint damage" caused by arthritis, according to MedlinePlus. The medication functions by blocking the activity of T-cells, thereby reducing inflammation and damage.

The relief cannot come quickly enough. "JIA is the most common chronic rheumatic disease in children, with onset before age 16 years," Yael Waknine writes for medscape.com.

Orencia has been approved for those with moderately-to-severely active JIA. As for the medications with which it can combine, Waknine writes that "patients with JIA may receive abatacept alone or in combination with methotrexate (MTX); tumor necrosis factor antagonists should not be used, and concomitant use of biologic therapies (e.g., anakinra) is not recommended."

The approval announcement was made on April 8 by Bristol-Myers Squibb Co., makers of Orencia. This comes after the findings of the "Abatacept Withdrawal study to Assess efficacy and safety in Key Endpoints in juvenile idiopathic arthritis Not responding to current treatment," or "AWAKEN."

In a press release, Bristol-Myers writes that the Awaken trial "evaluated the efficacy and safety of ... abatacept in patients six-to-17 years of age ... who had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as MTX or TNF antagonists."

Orencia was approved for use in adults back in December 2005.

Blogger and person with arthritis Christine Miller writes on healthcentral.com:

The news makes me think about the limited options that were available for me as a child (in the late 70s, early 80s). When I was a child, plaquenil was common, as well as other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), gold shots and then methotrexate. For years, I took a combination of plaquenil and NSAIDs. While I was spared the gold shots, I did add methotrexate to the combination for one year. Every time I read news like this, I am amazed at how, in the last 5 years or so, it seems that the newest drugs are tested and made available to children so quickly. The FDA approved Orencia for use in adults just over two years ago.

Side effects were found to be consistent in "type and frequency" with those of adults. Miller writes, "The overall frequency of adverse events in [the first four-month period] was 70 percent (36 percent had infections). The most common infections were upper respiratory tract infection and nasopharyngitis. Serious side effects included leukemia, chickenpox, ovarian cyst, disease flare, and joint deterioration."

For a news article on the announcement, Miller's sifting through the statistics, the U.S. National Library of Medicine's Abatacept Injection informational page, or a news article detailing Orencia's 2005 approval for adults, click on any of the links below:

Article References
FDA Approval: Orencia, site accessed on 04/21/08

Christine Miller's SharePosts: FDA Approves Orencia (abatacept) for Children with JIA, site accessed on 04/21/08

MedlinePlus Drug Information: Abatacept Injection, site accessed on 04/21/08

FDA Approvals: Orencia and Revlimid (Dec. 29, 2005), site accessed on 04/21/08