Serious and Opportunistic Infection Rates

Serious infection rates similar to MTX at 1 year, and consistent over 10 years¹

Serious infection rates (events/patient-year) from the ERA trial in the open-label extension*

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Understanding the Data^1-4:

An opportunistic infection is an infection typically seen only in a host whose resistance is lowered
In patients receiving TNF-blocking agents, opportunistic infections, including tuberculosis (TB), histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, legionella, listeriosis, and pneumocystosis, have been reported
No cases of opportunistic infections were reported in the COMET trial or Psoriatic Arthritis pivotal trial
Opportunistic infection rates^† were similar to controls in randomized controlled trials and overall clinical studies (RCT + OLE)^‡ in RA and psoriatic arthritis

In 38 ENBREL clinical trials and 4 cohort studies in the US and Canada (N=17,696), no histoplasmosis infections were reported among patients treated with ENBREL. Nonetheless, postmarketing cases of serious and sometimes fatal fungal infections, including histoplasmosis, have been reported with TNF blockers, including ENBREL. Empiric antifungal therapy should be considered for patients who develop severe systemic illness

Footnotes¹:

* 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 long-term therapy, serious infections were defined as all serious adverse events that were infectious.
† 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 RCTs, all events that occurred with onset dates between the first dose and the last dose were included. In the OLEs, 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.

Study Design

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THE EARLY RA TRIAL AND OPEN-LABEL EXTENSION^1-5:

Multicenter, double-blind, double-dummy, Phase 3 trial
632 MTX-naive patients with early moderately to severely active 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 to 12 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 the 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

THE LONGSTANDING RA OPEN-LABEL EXTENSION TRIAL^1,6:

714 adult patients with moderately to severely active RA (mean duration of disease: 12 years) who had a previous inadequate response to 1 or more DMARDs and had received ENBREL either as monotherapy or in combination with MTX in various clinical trials
Use of concomitant corticosteroids and/or NSAIDs was permitted during the study
Most patients received ENBREL 25 mg twice weekly. Because all patients did not enter clinical trials at the same time, length of follow-up varies
All 714 adult patients who received at least 1 dose of ENBREL were evaluated for safety. There was no active control or placebo arm in this open-label extension

ENBREL Support™ Malignancy Rates

Supportive data

Moderate to Severe Rheumatoid Arthritis

In medical studies, ENBREL was shown to be clinically effective in about 2 out of 3 adults with moderate to severe RA at 3 months. ENBREL has been shown to begin working in as few as 2 weeks, and most patients who benefit will do so within 3 months. In another medical study, 55% of patients who were evaluated 5 years after beginning ENBREL therapy had no further progression of joint damage.

Psoriatic Arthritis

In a medical study, ENBREL was shown to be effective in about 50% of psoriatic arthritis patients at 6 months. Clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.

Important Safety Considerations

Patient support every day

Help your patients start and stay on ENBREL with online videos and demos, services to keep patients on track, and live nurse support.

View our ongoing support

The experience of ENBREL

Evaluated in clinical studies over the past 19 years*

See our history of "1sts"

*Initial clinical research in RA patients began in 1993. Approved to treat moderate to severe RA in 1998.

Prescribing Information Medication Guide

Serious and Opportunistic Infection Rates

Serious infection rates similar to MTX at 1 year, and consistent over 10 years1

Understanding the Data1-4:

Footnotes1:

Study Design

THE EARLY RA TRIAL AND OPEN-LABEL EXTENSION1-5:

THE LONGSTANDING RA OPEN-LABEL EXTENSION TRIAL1,6:

Patient support every day

The experience of ENBREL

Serious infection rates similar to MTX at 1 year, and consistent over 10 years¹

Understanding the Data^1-4:

Footnotes¹:

THE EARLY RA TRIAL AND OPEN-LABEL EXTENSION^1-5:

THE LONGSTANDING RA OPEN-LABEL EXTENSION TRIAL^1,6: