Two studies recently presented at the American College of Rheumatology's annual meeting in Washington showed that Orencia and Humira, drugs approved for treating adults with RA and other diseases, are also effective for treating RA in children. It should be noted that the researchers reported receiving consulting fees from Amgen, Centocor, Bristol Myers Squibb, Abbott, Regeneron, Xoma, Hoffman-La Roche, and Novartis. Humira is marketed by Abbott Laboratories.
Bristol-Myers Squibb Co.'s drug Orencia, which is approved for adult use, appeared to be effective in treating children as well. The study's goal was to assess the efficacy and safety of Orencia in children ages 6 to 17 who previously had not responded well to one or more disease-modifying antirheumatic drugs. Children who were taken off the drug and given a placebo were more likely to experience a flare-up of symptoms than those who kept taking Orencia. Twenty percent of the children in the Orencia group experienced flare-ups, compared to 53.2 percent of children in the placebo group who experienced disease flare-ups.
The study showed that the same mechanism that works in adults also works for children, so doctors will have one more alternative for treating children who do not respond to TNF inhibitor drugs like Humira or Remicade. Children in both groups had received Orencia for four months before being divided into the placebo and drug parts of the study. Those in the placebo group who experienced disease flare-ups were able to resume taking the drug for a longer-term open label safety and efficacy portion of the study.
Children in the Orencia group had a higher rate of adverse side effects than the placebo group, but no child receiving Orencia during the six-month double-blind phase of the trial had a serious adverse event. However, the researchers cautioned that larger and longer term studies are needed to confirm safety of Orencia and any drug that modifies the immune response of children.
In another study, Humira (adalimumab) was found to significantly benefit children with juvenile rheumatoid arthritis. The study also found that children tolerated the drug well. The finding was based on a prospective 48-week clinical trial and 88 weeks of an extension study. According to the researchers, more than one in five children in the study achieved a benefit of ACR Ped 90 for the first time -- meaning that of six elements of the disease deemed important for children by the ACR, at least three improved by more than 90%.
The study, involving 171 children aged four to 17, began with a 16-week open-label phase, in which all children were given Humira. During this phase, 83% of children achieved an ACR Ped 30 result, which, according to the study, is a typical measure of response to a drug for children with RA. However, 52% met the criteria for an ACR Ped 70 result, which is a much greater degree of improvement. Children with an ACR Ped 30 response moved on to the blinded phase of the trial, in which they were divided into those on a background of methotrexate and those not taking the older drug, and randomized to either Humira or placebo.
The study's goal was to find the rate of flare-ups for children taking methotrexate with either Humira or placebo and those not taking methotrexate but taking either Humira or placebo. Among those not taking methotrexate, 71% of those on placebo experienced a flare, compared to 43% of those on Humira. Among those taking methotrexate, 65% of those on placebo had a flare-up, compared with 37% of those getting Humira.
Adverse events reported in the children were mainly mild upper respiratory infections. Patients on placebo were pulled from the trial when they experienced a flare and were entered into the extension study on Humira, while the remaining patients entered the extension when the double-blind phase ended. During the extension, 80% of the patients reached an ACR Ped 30 level and 70% reached ACR Ped 70.
The researchers concluded that while Humira and Orencia appear to be effective in treating children with JRA, because these drugs and others are being developed for use with children, there is little guidance for physicians about which medications should be used in which cases. Further research on safety and efficacy with children will be needed.
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Published On: November 21, 2006