ents.
Infections have been noted in all body systems and have been reported in patients receiving etanercept alone or incombination with other immunosuppressive agents.
In controlled portions of trials, the types and severity of infection were similar between etanercept and the respectivecontrol group (placebo or MTX for RA and PsA patients) in RA, PsA, AS and PsO patients. Rates of infections in RAand adult PsO patients are provided in Table 3 and Table 4, respectively. Infections consisted primarily of upperrespiratory tract infection, sinusitis and influenza.
In controlled portions of trials in RA, PsA, AS and PsO, the rates of serious infection were similar (0.8% in placebo,3.6% in MTX, and 1.4% in etanercept/etanercept + MTX-treated groups). In clinical trials in rheumatologic indications, serious infections experienced by patients have included, but are not limited to, pneumonia, cellulitis,septic arthritis, bronchitis, gastroenteritis, pyelonephritis, sepsis, abscess and osteomyelitis. In clinical trials in adultPsO patients, serious infections experienced by patients have included, but are not limited to, pneumonia, cellulitis,gastroenteritis, abscess and osteomyelitis. The rate of serious infections was not increased in open-label extensiontrials and was similar to that observed in etanercept- and placebo-treated patients from controlled trials.
In 66 global clinical trials of 17,505 patients (21,015 patient-years of therapy), tuberculosis was observed inapproximately 0.02% of patients. In 17,696 patients (27,169 patient-years of therapy) from 38 clinical trials and 4cohort studies in the U.S. and Canada, tuberculosis was observed in approximately 0.006% of patients. These studiesinclude reports of pulmonary and extrapulmonary tuberculosis [see Warnings and Precautions (5.1)].
The types of infections reported in pediatric patients with PsO and JIA were generally mild and consistent with thosecommonly seen in the general pediatric population. Two JIA patients developed varicella infection and signs andsymptoms of aseptic meningitis, which resolved without sequelae.Injection Site Reactions
In placebo-controlled trials in rheumatologic indications, approximately 37% of patients treated with etanerceptdeveloped injection site reactions. In controlled trials in patients with PsO, 15% of adult patients and 7% of pediatricpatients treated with etanercept developed injection site reactions during the first 3 months of treatment. All injectionsite reactions were described as mild to moderate (erythema, itching, pain, swelling, bleeding, bruising) and generallydid not necessitate drug discontinuation. Injection site reactions generally occurred in the first month andsubsequently decreased in frequency. The mean duration of injection site reactions was 3 to 5 days. Seven percent ofpatients experienced redness at a previous injection site when subsequent injections were given.
Other Adverse Reactions
Table 3 summarizes adverse reactions reported in adult RA patients. The types of adverse reactions seen in patientswith PsA or AS were similar to the types of adverse reactions seen in patients with RA.
Table 3. Percent of Adult RA Patients Experiencing Adverse Reactions in Controlled Clinical Trials
Reaction
Placebo Controlleda
(Studies I, II, and a Phase 2 Study)
Active Controlledb
(Study III)
Placebo
(N=152)
Etanerceptc
(N=349)
MTX
(N=217)
Etanercept |
