FDA Approves Orencia (abatacept) for Children with JIA

Christine Miller Health Guide
  • As of last week, parents will have one more option to help their children battle Juvenile Idiopathic Arthriti (JIA). The FDA has approved Orencia (abatacept) for the treatment of moderate to severe polyarticular JIA. This may be a very welcome treatment option for children who have not responded to TNF-inhibitors or other drugs already approved for kids.

     

    It has now been approved for use in children 6 years and older, either alone or in conjunction with methotrexate. However, it should not be used with tumor necrosis factor (TNF-a) inhibitors and is not recommended for use with other biologic therapies, such as anakinra.

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    The news makes me think about the limited options that were available for me as a child (in the late 70's, early 80's). 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 (December 2005).

     

     

    A one-year, three part clinical trial studied the safety and efficacy of Orencia in children 6 to 17 years of age who had one of several subtypes of JIA and had insufficient response to one or more Disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate or TNF inhibitors. The study was called AWAKEN (Abatacept Withdrawal study to Assess efficacy and safety in Key Endpoints in juvenile idiopathic arthritis Not responding to current treatment).

     

    Most of the children in the study had polyarticular JIA (64% and of those, 20% were RF-positive. Sixteen percent of the children had oligoarticular JIA and 20% had systemic JIA with a polyarticular course. Abatacept was given by IV infusion at 10 mg/kg; maximum 1,000 mg, on days one, 15, 29 and then once per month. The study began with 190 children, and during that 4 month period, researchers found that children with each subtype of JIA showed similar improvement. Children with RF-positive polyarticular RA had the highest rate of evaluation score improvement (68.4%) with similar responses across all JIA subtypes, while the other two subtypes had improvement rates of 59-64%. The study used the standard of improvement called the ACR Pediatric 30. This means greater than or equal to 30 percent improvement in at least three of the six JIA core set variables and greater than or equal to 30 percent worsening in not more than one of the JIA core set variables.

     

    Patients who achieved this level of improvement in the first phase were eligible to enter the phase two, six-month trial, in which they were randomized to remain on abatacept or be given placebo for six months. That portion of the trial found that patients treated with abatacept had a longer period between disease flares and had significantly fewer disease flares compared to placebo-treated patients (20% versus 53% respectively). Finally, the third part of the study found. In an open-label extension (part C), the proportion of ACR Pedi 30, 50, and 70 responders remained consistent through one year.

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    The study found that the adverse reactions in pediatric patients were similar in type and frequency to those seen in adult patients. The overall frequency of adverse events in Period A was 70 percent (36% 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.

Published On: April 14, 2008