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Title: FDA Approves Adalimumab for the Treatment of Juvenile Idiopathic Arthritis

"FDA Approves Adalimumab for the Treatment of Juvenile Idiopathic Arthritis"

NEW YORK -- February 22, 2008 -- A new biologic therapy is now available for persons with polyarticular juvenile idiopathic arthritis (JIA). The US Food and Drug Administration has approved adalimumab (Humira) for the treatment of moderately to severely active JIA in persons aged 4 years and older. The approval was based on the results of a phase 3 study and a subsequent open-label extension that evaluated the effectiveness and safety of the drug in 171 patients (ages, 4-17 yr) with polyarticular JIA. The results of the 48-week study suggested that fewer children treated with adalimumab experienced disease flare compared with those assigned to placebo. Overall, children given adalimumab also experienced improvements in their disease symptoms. In the first part of the study, two groups of patients -- those taking methotrexate (MTX) and those not taking MTX -- were given open-label adalimumab, up to a maximum 40 mg every other week for 16 weeks. Patient responses were measured using the American College of Rheumatology Pediatric (ACR Pedi) 30 score. Children who showed a positive clinical response (n = 133) entered the second part of the study and were randomised to receive adalimumab or placebo for an additional 32 weeks or until disease flare. A disease flare was defined as a worsening of 30 percent or more in at least three of the six ACR Pedi response variables; a minimum of two active joints; and no more than one indicator that improved by 30 percent. Significantly fewer patients who received adalimumab demonstrated disease flare in the second part of the study compared with those assigned to placebo, both without MTX (43 percent vs 71 percent) and with MTX (37 percent vs 65 percent). Additionally, more patients treated with adalimumab continued to show ACR Pedi 30/50/70 responses at week 48 compared with patients who were given placebo. At the conclusion of the 48-week study, or at the time of disease flare during the double-blind phase, patients could enter the open-label extension period. Efficacy and safety were assessed at routine intervals throughout the study, and ACR Pedi responses were maintained for up to 2 years in patients who received adalimumab throughout the study. The most common adverse reactions that occurred in patients initially treated with adalimumab were injection site pain (19 percent) and injection site reaction (16 percent). "The pain and inflammation caused by JIA can be debilitating for some children, making it hard for them to run, jump, play, or participate in other activities with children their age," said Daniel J. Lovell, MD, MPH, Associate Director, Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. "[Adalimumab] is an important new treatment that gives physicians and families another option that can ease the symptoms of polyarticular JIA." Adalimumab, the first biologic to be approved for JIA since 1999, can be administered at home via an injection given every other week. JIA is the sixth disease indication for which adalimumab has received approval since 2002. SOURCE: Abbott

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