Safety

Once weekly injections of efalizumab, 1 mg/kg, were generally well tolerated for 12 weeks to 15 months. In published clinical trials, between 3% and 6% of subjects withdrew due to adverse events of efalizumab compared to 1-3% in the placebo groups. The most common adverse events seen in clinical trials included a first dose complex consisting of headache, nausea, myalgia, fever, and chills that typically developed within 2 days after the first two injections. After the third dose, these reactions diminished, with similar incidence in both efalizumab and placebo groups. These reactions were typically well managed with acetaminophen or nonsteroidal anti-inflammatory drugs. Serious adverse events were uncommon. In the three 12-week studies, 2% of efalizumab-treated patients (1 mg/kg/ week) had a serious adverse event during treatment. Withdrawals from the studies due to these adverse events were rare as well, with a total of 3.5 % of efalizumab (1 mg/kg/week) treated patients withdrawing from treatment due to adverse events in these same studies, whereas 2.1 % of placebo treated patients withdrew because of adverse events.

Long-term treatment with efalizumab, examined in the study by Gottlieb and colleagues, was not associated with an overall increased incidence of adverse events. Those events noted were similar in nature to those documented in short-term trials. There was no evidence of cumulative toxicity noted. Two serious adverse events that were determined by the investigator to be drug related included arthritis and gastrointestinal carcinoma.

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Treating Rheumatoid Arthritis With Herbs Spices Roots

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