Serious and Opportunistic ENBREL Infection Rates
Serious infection (SI) rates* in the double-blind portions of randomized controlled trials across adult indications1,2
SI rates* (events/patient-year) from the ERA trial1
Opportunistic infection rates† from RA and PsA trials‡
*In the controlled portion, event rates were based on the definition of medically important infections (infections associated with hospitalization or intravenous [IV] antibiotics). For the open-label extension, serious infections were defined as all serious adverse events that were infectious.1
†These rates do not include TB.
‡Included in this analysis were all adult patients (RA and psoriatic arthritis) who had received at least 1 dose of ENBREL in double-blind and open-label trials. For the double-blind portion of the randomized controlled trials, all events that occurred with onset dates between the first dose and the last dose were included. In the open-label extensions, all events with onset dates between the first dose and within 30 days after the last dose were included (within 15 days for some ex-US studies). Data as of May 2006. Data from the COMET trial and PRESTA study were not included in these pooled analyses.
- In 38 ENBREL clinical trials and 4 cohort studies in all approved indications representing 27,169 patient-years of exposure from the US and Canada, no histoplasmosis infections were reported among patients treated with ENBREL. Postmarketing cases of serious and sometimes fatal infections due to opportunistic pathogens have been reported. Empiric anti-fungal therapy should be considered for patients at risk for invasive fungal infections who develop severe systemic illness.2
- No cases of opportunistic infections were reported in the COMET trial, PRESTA study, or psoriatic arthritis pivotal trial3
- No overall safety or efficacy differences were seen between patients >65 years and younger patients in RA and plaque psoriasis clinical trials2
- In general, there is a higher incidence of infections in the elderly population; therefore, caution should be used when treating this population2
- Patients with active infection should not initiate therapy. Use ENBREL with caution in patients: with chronic or recurrent infections; who have been exposed to TB; who have resided or traveled in areas of endemic TB or mycoses; with underlying conditions that predispose them to infections2
Understanding the Data
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- An opportunistic infection is an infection typically seen only in a host whose resistance is lowered.4
- In patients receiving TNF-blocking agents, opportunistic infections, including tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis, have been reported.2
Study Descriptions
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The Early RA Trial and Open-label Extension Trial1-5:
- Multicenter, double-blind, double-dummy, phase 3 trial
- 632 MTX-naive patients with moderate to severe early RA (≤3 years' duration) were randomized to receive twice-weekly ENBREL 25 mg (n = 207), twice-weekly ENBREL 10 mg (n = 208), or MTX (n = 217). The mean duration of disease for these patients was 11 months
- This trial became open-label and unblinded after all patients had completed 1 year of evaluation. Patients continued through 1 year of follow-up on the treatment to which they had been randomized. At end of year 2, patients switched to or continued twice-weekly ENBREL 25 mg subcutaneously
- Subjects could re-enroll in the continuing open-label portion of the study upon meeting specific predefined re-enrollment inclusion criteria
References
- Enbrel® (etanercept) Prescribing Information. Thousand Oaks, CA: Immunex Corporation; February 2011.
- Data on file, Amgen.
- Bathon JM, Martin RW, Fleischmann RM, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med. 2000;343:1586-1593.
- Genovese MC, Bathon JM, Martin RW, et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two year radiographic and clinical outcomes. Arthritis Rheum. 2002;46:1443-1450.
- Genovese MC, Bathon JM, Fleischmann RM, et al. Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol. 2005;32:1232-1242.