own.
In pediatric PsO studies, approximately 10% of subjects developed antibodies to etanercept by Week 48 andapproximately 16% of subjects developed antibodies toetanercept by Week 264. All of these antibodies werenon-neutralizing. However, because of the limitations of the immunogenicity assays, the incidence of binding and
neutralizing antibodies may not have been reliably determined.
The data reflect the percentage of patients whose test results were considered positive for antibodies to etanercept inan ELISA assay, and are highly dependent on the sensitivity and specificity of the assay.
Autoantibodies
Patients with RA had serum samples tested for autoantibodies at multiple time points. In RA Studies I and II, thepercentage of patients eva luated for antinuclear antibodies (ANA) who developed new positive ANA (titer ≥ 1:40)was higher in patients treated with etanercept (11%) than in placebo-treated patients (5%). The percentage of patientswho developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% ofpatients treated with etanercept compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% ofpatients treated with etanercept compared to none of placebo-treated patients). The proportion of patients treated withetanercept who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients. InRA Study III, no pattern of increased autoantibody development was seen in etanercept patients compared to MTXpatients [see Warnings and Precautions (5.9)].
6.3 Postmarketing Experience
Adverse reactions have been reported during post approval use of etanercept products in adults and pediatric patients.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible toreliably estimate their frequency or establish a causal relationship to etanercept exposure.
Adverse reactions are listed by body system below:
Blood and lymphatic system disorders:
Cardiac disorders:
Gastrointestinal disorders:
General
disorders:
Hepatobiliary disorders:
Immune disorders:
Musculoskeletal and connective
disorders:
tissue
Neoplasms benign, malignant, and unspecified:
Nervous system disorders:
Ocular disorders:
Respiratory, thoracic and mediastinal disorders:
Skin and subcutaneous tissue disorders:
pancytopenia, anemia, leukopenia, neutropenia,
thrombocytopenia, lymphadenopathy, aplastic anemia [see
Warnings and Precautions (5.5)]
congestive heart failure [see Warnings and Precautions (5.4)]
inflammatory bowel disease (IBD)
angioedema, chest pain
autoimmune hepatitis, elevated transaminases, hepatitis B
reactivation
macrophage activation syndrome, systemic vasculitis,
sarcoidosis
lupus-like syndrome
melanoma and non-melanoma skin cancers, Merkel cell
carcinoma [see Warnings and Precautions (5.3)]
convulsions, multiple sclerosis, demyelination, optic
neuritis, transverse myelitis, paresthesias [see Warnings and
Precautions (5.2)]
uveitis, scleritis
interstitial lung disease
cutaneous lupus erythematosus, cutaneous vasculitis
(including leukocytoclastic vasculitis), erythema multiforme,
Stevens- Johnson syndrome, toxic epidermal necrolysis,
subcutaneous nodule, new or worsening psoriasis (all s |
