|
In placebo-controlled trials in RA, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis no increase in the incidence of serious infections was observed (approximately 1% in both placebo and ENBRELŪ-treated groups). In all clinical trials in RA, serious infections experienced by patients have included: pyelonephritis, bronchitis, septic arthritis, abdominal abscess, cellulitis, osteomyelitis, wound infection, pneumonia, foot abscess, leg ulcer, diarrhea, sinusitis, and sepsis. The rate of serious infections has not increased in open-label extension trials and is similar to that observed in ENBRELŪ- and placebo-treated patients from controlled trials. Serious infections,including sepsis and death, have also been reported during post-marketing use of ENBRELŪ.Some have occurred within a few weeks after initiating treatment with ENBRELŪ. Many of the patients had underlying conditions (e.g., diabetes, congestive heart failure, history of active orchronic infections) in addition to their rheumatoid arthritis (see WARNINGS). Data from a sepsisclinical trial not specifically in patients with RA suggest that ENBRELŪ treatment may increase mortality in patients with established sepsis.9 In patients who received both ENBRELŪ and anakinra for up to 24 weeks, the incidence of serious infections was 7%. The most common infections consisted of bacterial pneumonia (4 cases) andcellulitis (4 cases). One patient with pulmonary fibrosis and pneumonia died due to respiratoryfailure. Text Continues Below
In post-marketing experience in rheumatologic indications, infections have been observed with various pathogens including viral, bacterial, fungal, and protozoal organisms. Infections have beennoted in all organ systems and have been reported in patients receiving ENBRELŪ alone or incombination with immunosuppressive agents. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
