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Abbott Presents Long-Term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission
Date:5/21/2008

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Worsening congestive heart failure (CHF) has been observed with TNF-blocking agents, including HUMIRA, and new onset CHF has been reported with TNF-blocking agents. Treatment with HUMIRA may result in the formation of autoantibodies and rarely, in development of a lupus-like syndrome.

In the placebo-controlled clinical studies of adult patients with rheumatoid arthritis, the most frequent adverse reactions vs. placebo were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11 percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo.

In HUMIRA clinical trials for ankylosing spondylitis, psoriatic arthritis, Crohn's disease and plaque psoriasis, the safety profile for adult patients treated with HUMIRA was similar to the safety profile seen in adult patients with rheumatoid arthritis. In the placebo-controlled clinical trials in plaque psoriasis, the incidence of arthralgia was 3 percent in HUMIRA-treated patients versus 1 percent in controls.

In general, adverse reactions in pediatric patients were similar in frequency and type to those seen in adult patients. Severe adverse reactions reported in the clinical trial of juvenile idiopathic arthritis (JIA) included neutropenia, streptococcal pharyngitis, increased aminotransferases, herpes zoster, myositis, metrorrhagia and appendicitis. Serious infections were observed in 4 percent of patients within approximately 2 years of initiation of treatment with HUMIRA and included cases of herpes simplex, pneumonia, urinary tract infection, pharyngitis, and herpes zoster. Safety of HUMIRA in pediatric patients for uses other than JIA has not been established.

As with any treatment program, the benefits and risks of HUMIRA should be carefully co
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