ENBREL Safety Profile in Psoriatic Arthritis

In psoriatic arthritis, serious adverse events (SAEs) and serious infection (SI) rates were comparable to placebo. In the double-blind portion of the Psoriatic Arthritis Pivotal Trial:

• There were no infections requiring hospitalization or intravenous antibiotics in ENBREL patients.¹
• Injection site reactions were the only adverse event significantly more common than in the placebo group.¹
• As in our randomized controlled trials for other indications, the rates of malignancies were similar to those seen with placebo.^1,23
  • Infections, including serious infections, some fatal, have been observed in patients treated with ENBREL. TB has been observed in patients receiving TNF-blocking agents, including ENBREL.³
  • In clinical trials of all TNF inhibitors, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA and psoriasis patients, particularly those with highly active disease. The potential role of TNF inhibitors in the development of lymphoma is unknown.³
  • SAEs and SIs were defined as events that were Grade 3 or Grade 4 in severity.¹
  • Cases of acute and chronic leukemia have been reported in associations with post-marketing anti-TNF use. Even in the absence of anti-TNF patients with RA may be at higher risk than the general population.