pepsia 1 4 10 11
Sinusitis 2 3 3 5
Vomiting - 3 8 5
Mouth ulcer 1 2 14 6
Alopecia 1 1 12 6
Pneumonitis (“MTX lung”) - - 2 0
In controlled trials of RA and psoriatic arthritis, rates of serious adverse events were seen at a frequency of approximately 5% among ENBREL®- and control-treated patients. In controlled trials of plaque psoriasis, rates of serious adverse events were seen at a frequency of < 1.5% among ENBREL®- and placebo-treated patients in the first 3 months of treatment. Among patients with RA in placebo-controlled, active-controlled, and open-label trials of ENBREL®, malignancies (see WARNINGS: Malignancies, ADVERSE REACTIONS: Malignancies) and infections (see ADVERSE REACTIONS: Infections) were the most common serious adverse events observed. Other infrequent serious adverse events observed in RA, psoriatic arthritis, ankylosing spondylitis, or plaque psoriasis clinical trials are listed by body system below:
Cardiovascular: heart failure, myocardial infarction, myocardial ischemia, hypertension, hypotension, deep vein thrombosis, thrombophlebitis
Digestive: cholecystitis, pancreatitis, gastrointestinal hemorrhage, appendicitis
Hematologic/Lymphatic: lymphadenopathy
Musculoskeletal: bursitis, polymyositis
Nervous: cerebral ischemia, depression, multiple sclerosis (see WARNINGS: Neurologic Events)
Respiratory: dyspnea, pulmonary embolism, sarcoidosis
Skin: worsening psoriasis
Urogenital: membranous glomerulonephropathy, kidney calculus
In a randomized controlled trial in which 51 patients with RA received ENBREL® 50 mg twice weekly and 25 patients received ENBREL® 25 mg twice weekly, the following serious adverse events were observed in the 50 mg twice weekly arm: gastrointestinal bleeding, normal pressure hydrocephalus, seizure, and stroke. No serious adverse events were observed in the 25 mg arm.
Adverse Reactions in Patients with JIA
In general, the adverse events in pediatric patients were similar in frequency and type as those seen in adult patients (see WARNINGS and other sections under ADVERSE REACTIONS). Differences from adults and other special considerations are discussed in the following paragraphs.
Severe adverse reactions reported in 69 JIA patients ages 4 to 17 years included varicella (see also PRECAUTIONS: Immunizations), gastroenteritis, depression/personality disorder, cutaneous ulcer, esophagitis/gastritis, group A streptococcal septic shock, Type 1 diabetes mellitus, and soft tissue and post-operative wound infection.
Forty-three of 69 (62%) children with JIA experienced an infection while receiving ENBREL® during three months of study (part 1 open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy. The types of infections reported in JIA patients were generally mild and consistent with those commonly seen in outpatient pediatric populations. Two JIA patients developed varicella infection and signs and symptoms of aseptic meningitis which resolved without sequelae.
The following adverse events were reported more commonly in 69 JIA patients receiving 3 months of ENBREL® compared to the 349 adult RA patients in placebo-controlled trials. These included headache (19% of patients, 1.7 events per patient-year), nausea (9%, 1.0 events per patient-year), abdominal pain (19%, 0.74 events per patient-y |
