Serious adverse events (SAE) rates in moderate to severe RA¹
ENBREL Has 10 Years of Continuous Safety Data

A serious adverse event was defined as any adverse event that resulted in death, was life-threatening (ie, any adverse event that placed the patient at immediate risk of death from the event as it occurred), required or prolonged inpatient hospitalization, resulted in a permanent or significant disability or incapacity, or resulted in a congenital anomaly or birth defect.¹

Serious Adverse Event (SAE) rates^*

SAE rates (events/pt-yr) from the Early RA (ERA) trial¹^*

^*Observed on study or within 30 days of the last ENBREL dose. The population for each year reflects all adult patients at the time of analysis who received at least one dose of study drug.

The rates observed in the Long-Standing RA (LRA) 10-year trial were consistent with the ERA trial. The overall SAE rate for the LRA trial (n=7,838) was 0.18 (events/patient-year)¹
The SAE rates in the COMET Trial were consistent with the rates in the Early RA 10-year trial^1,2
In the Psoriatic Arthritis pivotal trial, rates per patient-year of adverse events observed in the open-label period were similar to those observed during the 24-week double-blind period of the study¹

See Important Safety Information below for additional information.

Understanding the Data Expand/Collapse

Early RA = Moderate to severe RA patients with disease duration of ≤3 years.

Long-standing RA = Moderate to severe RA patients who had failed at least 1 DMARD.

Study Descriptions Expand/Collapse

The Early RA Trial and Open-label Extension Trial^1-5:

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.

Explanation of Non-Prespecified Data Analysis

The COMET trial: A very early non-prespecified analysis

The COMET trial was not prospectively designed to compare patients with very early RA to those with early RA. Data from the non-prespecified analysis should be viewed in context with the results from the prospective analysis of the COMET trial. The interpretation of the results of non-prespecified analyses is limited. For instance, these analyses were performed following the unblinding of the data when all patient responses were known
A non-prespecified analysis of COMET trial observed data was done to determine if very early (≤4 months' disease duration) compared with early (>4 months' to 2 years' duration) treatment of moderate to severe RA was associated with a higher percentage of patients achieving DAS 28 clinical remission at 52 weeks (DAS 28 ≤2.6)
This analysis included only patients with a DAS 28 score at 52 weeks and those who discontinued for lack of efficacy and who were assumed to be non-responders
- Of 274 randomized to ENBREL + MTX, 220 were included in this analysis: 63 in the very early group and 157 in the early group
- Of 268 randomized to MTX only, 197 were included in this analysis: 49 in the very early group and 148 in the early group
Subjects who achieved the following outcomes at Week 52 were assessed by treatment group for baseline disease duration effect
- Clinical remission
- LDA
- HAQ ≤0.5
- Radiographic nonprogression (Δ mTSS ≤0.5)

View Study Designs and Descriptions

Learn about the ENBREL Safety Profile

Psoriatic Arthritis and ENBREL Diagnosis and Referral

Important Safety Information Prescribing Information Medication Guide

Indications

Moderate to Severe Rheumatoid Arthritis Supportive Data

ENBREL Support™ offers financial support to new or continuing eligible patients*

No out-of-pocket costs for 6 months for new ENBREL Support™ card members.

Learn about our program

*Eligibility: Open to patients with commercial prescription insurance. Not open to uninsured patients or patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare including Medicare Part D, Medicaid, etc.) or patients who live in Massachusetts (or where prohibited by law). Restrictions, including monthly maximums, may apply. Offer subject to change or discontinuation without notice.

Injection demos for your patients

View step-by-step videos that demonstrate 4 convenient options for self-injecting ENBREL.

Watch injection demos

ENBREL has helped Darla manage her moderate to severe RA symptoms.

Darla R., ENBREL RA patient since 2000

Prescribing Information Medication Guide

Serious adverse events (SAE) rates in moderate to severe RA1ENBREL Has 10 Years of Continuous Safety Data

Serious Adverse Event (SAE) rates*

The Early RA Trial and Open-label Extension Trial1-5:

References

Explanation of Non-Prespecified Data Analysis

ENBREL Support™ offers financial support to new or continuing eligible patients*

Injection demos for your patients

Serious adverse events (SAE) rates in moderate to severe RA¹
ENBREL Has 10 Years of Continuous Safety Data

Serious Adverse Event (SAE) rates^*

The Early RA Trial and Open-label Extension Trial^1-5: