erapy alone [see Drug Interactions(7.3)].
5.12 Use with Anakinra or Abatacept
Use of Eticovo with anakinra or abatacept is not recommended [see Drug Interactions (7.2)].
5.13 Use in Patients with Moderate to Severe Alcoholic Hepatitis
In a study of 48 hospitalized patients treated with etanercept or placebo for moderate to severe alcoholic hepatitis, the
mortality rate in patients treated with etanercept was similar to patients treated with placebo at 1 month but
significantly higher after 6 months. Physicians should use caution when using Eticovo in patients with moderate to
severe alcoholic hepatitis.
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
• Serious Infections [see Boxed Warning and Warnings and Precautions (5.1)]
• Neurologic Reactions [see Warnings and Precautions (5.2)]
• Malignancies [see Boxed Warning and Warnings and Precautions (5.3)]
• Patients with Heart Failure [see Warnings and Precautions (5.4)]
• Hematologic Reactions [see Warnings and Precautions (5.5)]
• Hepatitis B Reactivation [see Warnings and Precautions (5.6)]
• Allergic Reactions [see Warnings and Precautions (5.7)]
• Autoimmunity [see Warnings and Precautions (5.9)]
• Immunosuppression [see Warnings and Precautions (5.10)]
6.1 Clinical Trials Experience
Across clinical studies and postmarketing experience, the most serious adverse reactions with etanercept wereinfections, neurologic events, CHF, and hematologic events [see Warnings and Precautions (5)].
The most commonadverse reactions with etanercept were infections and injection site reactions.
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinicaltrials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not predict the ratesobserved in clinical practice.
Adverse Reactions in Adult Patients with Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Plaque
Psoriasis
The data described below reflect exposure to etanercept in 2219 adult patients with RA followed for up to 80 months,in 182 patients with PsA for up to 24 months, in 138 patients with AS for up to 6 months, and in 1204 adult patientswith PsO for up to 18 months.
In controlled trials, the proportion of etanercept-treated patients who discontinued treatment due to adverse events was
approximately 4% in the indications studied.
Adverse Reactions in Pediatric Patients
In general, the adverse reactions in pediatric patients were similar in frequency and type as those seen in adult patients
[see Warnings and Precautions (5), Use in Specific Populations (8.4), and Clinical Studies (14.2 and 14.6)].In a 48-week clinical study in 211 children aged 4 to 17 years with pediatric PsO, the adverse reactions reported were
similar to those seen in previous studies in adults with PsO. Long-term safety profile for up to 264 additional weeks was assessed in an open-label extension study and no new safety signals were identified.
In open-label clinical studies of children with JIA, adverse reactions reported in those ages 2 to 4 years were similar toadverse reactions reported in olderchildren.
Infections
Infections, including viral, bacterial, and fungal infections, have been observed in adult and pediatric pati |
