Bristol's Orencia can ease juvenile arthritis: study
LONDON (Reuters) - 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 the 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.
It is the most common chronic rheumatic disorder in children and a major cause of disability and impaired quality of life in childhood, the Italian team said.
U.S. regulators in April approved Orencia for use in children with moderate to severe juvenile rheumatoid arthritis.
The Italian researchers found that Orencia benefited children who were not helped by the older medicine methotrexate or drugs that block an inflammatory protein called tumor necrosis factor, or TNF.
Orencia is given along with methotrexate and works in a different way to anti-TNF medicines -- which include Amgen Inc's Enbrel, Johnson & Johnson's Remicade and Abbott Laboratories Inc's Humira -- by modulating the action of immune cells called T-cells.
In their study of 190 children aged 6 to 17 in 45 centers in the United States and Europe, the researchers found that the risk of flare-ups was less than a third of that for placebo. Rates of severe side effects such as headaches and nausea were high in both groups.
"Our data showed that abatacept had clinical benefits for patients, irrespective of juvenile idiopathic arthritis subtype," Ruperto and team wrote.
(Reporting by Michael Kahn; editing by Maggie Fox and Sue Thomas)
