Reuters.com—July 15, 2008
Bristol-Myers Squibb Co's Orencia can help children with rheumatoid arthritis who do not respond to other drugs, Italian researchers said on Tuesday.
The findings showed the drug, known generically as abatacept, cut flare-ups in children by a third compared to those in the trial who received a placebo, Nicolino Ruperto of the Gaslini Children's Hospital in Genoa and colleagues wrote.
"Abatacept treatment induced improvement and was well tolerated in patients with active juvenile idiopathic arthritis, who responded to this treatment in the open-label phase," they wrote in the journal Lancet.
But other researchers questioned the findings, saying the results were clouded because everyone in the study initially received the drug during a so-called open label phase.
Writing in a Lancet commentary, Dr. Thomas Lehman, Chief of Pediatric Rheumatology at Hospital for Special Surgery in New York, said well-designed studies should account for a placebo effect by randomly assigning patients to a placebo or Orencia at the start of a trial.
"Combined with carryover effects, these factors can overestimate any potential benefit in clinical practice and underestimate side-effects, obscuring our knowledge of the drug's true risks and benefits," he wrote.
About 20 million people worldwide have rheumatoid arthritis, an autoimmune disease caused when the body confuses healthy tissues for foreign substances and attacks itself.
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