Adult Arthritis Drug Also Effective in Children

July 15, 2008

Abatacept, a drug effective for adults with rheumatoid arthritis, is also effective compared with placebo in children with juvenile idiopathic arthritis who had already shown an initial response to the drug and failed other treatments, according to an article published online July 15 in The Lancet.

TUESDAY, July 15 (HealthDay News) -- Abatacept, a drug effective for adults with rheumatoid arthritis, is also effective compared with placebo in children with juvenile idiopathic arthritis who had already shown an initial response to the drug and failed other treatments, according to an article published online July 15 in The Lancet.

Nicolino Ruperto, M.D., from IRCCS Instituto G. Gaslini Pediatria II-PRINTO in Genoa, Italy, and colleagues randomly assigned 122 children with a history of active juvenile idiopathic arthritis who were unresponsive or intolerant to at least one disease-modifying antirheumatic drug, and who had initially responded to abatacept during an open-label period and then withdrawn, to 10 mg/kg abatacept or placebo every 28 days. Patients were treated for six months or until an arthritis flare.

The researchers found that significantly fewer patients taking abatacept had arthritis flares (20 versus 53 percent, hazard ratio 0.31). The median time to flare was six months for the placebo group and could not be assessed in the abatacept group due to an insufficient number of events. The frequency of adverse events was similar in the placebo and abatacept groups (55 versus 62 percent).

"Failure to appropriately measure placebo response by selecting only children who responded during the open-label phase for randomization confuses rather than enhances our understanding of the safety, efficacy, and appropriate role of abatacept in children with juvenile idiopathic arthritis," Thomas J.A. Lehman, M.D., from the Hospital for Special Surgery in New York City, writes in an accompanying editorial.

The study was funded by Bristol-Myers Squibb. Several of the study authors report a relationship to the pharmaceutical industry.

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