nown whether ENBREL® is excreted in human milk or absorbed systemically after ingestion. Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ENBREL®, a decision should be made whether to discontinue nursing or to discontinue the drug.
Geriatric Use
A total of 480 RA patients ages 65 years or older have been studied in clinical trials. In plaque psoriasis randomized clinical trials, a total of 138 out of 1965 subjects treated with ENBREL® or placebo were age 65 or older. No overall differences in safety or effectiveness were observed between these patients and younger patients, but the number of geriatric psoriasis subjects is too small to determine whether they respond differently from younger subjects. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
Pediatric Use
ENBREL® is indicated for treatment of polyarticular-course juvenile idiopathic arthritis in patients ages 2 and older. For issues relevant to pediatric patients, in addition to other sections of the label, see also WARNINGS;PRECAUTIONS: Immunizations; and ADVERSE REACTIONS: Adverse Reactions in Patients with JIA. ENBREL® has not been studied in children < 2 years of age.
The safety and efficacy of ENBREL® in pediatric patients with plaque psoriasis have not been studied.
ADVERS REACTIONS
Adverse Reactions in Adult Patients with RA, Psoriatic Arthritis, Ankylosing Spondylitis, or Plaque Psoriasis
ENBREL® has been studied in 1442 patients with RA, followed for up to 80 months, in 169 patients with psoriatic arthritis for up to 24 months, in 222 patients with ankylosing spondylitis for up to 10 months, and 1261 patients with plaque psoriasis for up to 15 months. In controlled trials, the proportion of ENBREL®-treated patients who discontinued treatment due to adverse events was approximately 4% in the indications studied. The vast majority of these patients were treated with 25 mg SC twice weekly. In plaque psoriasis studies, ENBREL® doses studied were 25 mg SC once a week, 25 mg SC twice a week, and 50 mg SC twice a week.
Injection Site Reactions
In controlled trials in rheumatologic indications, approximately 37% of patients treated with ENBREL® developed injection site reactions. In controlled trials in patients with plaque psoriasis, 14% of patients treated with ENBREL® developed injection site reactions during the first 3 months of treatment. All injection site reactions were described as mild to moderate (erythema and/or itching, 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 ENBREL® therapy.
Infections
In controlled trials, there were no differences in rates of infection among RA, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis patients treated with ENBREL® and those treated with placebo (or MTX for RA and psoriatic arthritis patients). The most common type of infection was upper respiratory infection |
