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Side Effects & Drug Interactions
ADVERSE REACTIONS
Adverse Reactions in Adult Patients with RA, Psoriatic Arthritis, Ankylosing Spondylitis, or Plaque Psoriasis ENBRELŪ has been studied in 1442 patients with RA, followed for up to 80 months, in 157 patients with psoriatic arthritis for 6 months, in 222 patients with ankylosing spondylitis for up to10 months, and 1261 patients with plaque psoriasis for up to 15 months. In controlled trials, the proportion of ENBRELŪ-treated patients who discontinued treatment due to adverse events was approximately 4% in the indications studied. The vast majority of these patients were treated with25 mg SC twice weekly. In plaque psoriasis studies, ENBRELŪ doses studied were 25 mg SC oncea week, 25 mg SC twice a week, and 50 mg SC twice a week. Text Continues Below
Injection Site Reactions In controlled trials in rheumatologic indications, approximately 37% of patients treated withENBRELŪ developed injection site reactions. In controlled trials in patients with plaque psoriasis,14% of patients treated with ENBRELŪ developed injection site reactions during the first 3 monthsof treatment. All injection site reactions were described as mild to moderate (erythema and/oritching, pain, or swelling) and generally did not necessitate drug discontinuation. Injection site reactions generally occurred in the first month and subsequently decreased in frequency. The mean duration of injection site reactions was 3 to 5 days. Seven percent of patients experienced redness at a previous injection site when subsequent injections were given. In post-marketing experience, injection site bleeding and bruising have also been observed in conjunction with ENBRELŪtherapy. Infections In controlled trials, there were no differences in rates of infection among RA, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis patients treated with ENBRELŪ and those treated with placebo (or MTX for RA and psoriatic arthritis patients). The most common type of infection was upper respiratory infection, which occurred at a rate of approximately 20% among both ENBRELŪ-and placebo-treated patients in RA, psoriatic arthritis, and AS trials, and at a rate of approximately12% among both ENBRELŪ- and placebo-treated patients in plaque psoriasis trials in the first 3months of treatment. Page: 1 | 2 | 3 | 4 | 5 | Next >>
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