Malignancy Rates

Malignancy rates similar to MTX at 1 year, and consistent over 10 continuous years*1,2

Malignancy rates (events/patient-year) from the ERA study in the open-label extension
ERA SIR 0.99 (95% CI: 0.67-1.42)
  • The malignancy rates in the LRA, COMET, TEMPO, and PsA trials were consistent with the rates shown above1,3-10
  • The most common malignancies included: lymphoma, prostate carcinoma, lung carcinoma, and breast carcinoma1
  • In adult clinical studies of all TNF blockers, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA and psoriasis patients. The role of TNF blocker therapy in the development of malignancies is unknown
  • Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and other indications. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general population
Understanding the Data:
  • The ERA SIR§ was 0.99 (95% CI: 0.67-1.42), indicating that malignancy types and rates in the ERA study were consistent with the general US population1
    • Analysis of overall malignancy rates in ENBREL studies has demonstrated types and rates similar to those expected in the SEER database and suggests no increase over time11
  • * Data are from clinical studies and include all Surveillance, Epidemiology, and End Results (SEER)-defined cancers (excluding nonmelanoma skin cancers, in situ carcinomas except bladder, and recurrent cancers) and comparisons are based on age and sex-matched cohorts.1
  • Observed on study or within 30 days after the last ENBREL dose. The population for each year reflects all adult patients at the time of analysis who received at least 1 dose of study drug.1
  • In Year 1 of the COMET study, safety was analyzed using the ITT population (N=542), which was defined as all enrolled subjects in the study who received at least 1 dose of the study drug. In Year 2, the ITT population (N=411) was defined as all subjects who received at least 1 dose of study drug during Period 2.6,7
  • § SIR=standardized incidence ratio.1
  • Malignancy data excludes NMSC.

Study Design


  • Multicenter, double-blind, double-dummy, Phase 3 study1,2
  • 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 months1,2,4
  • This study 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 subcutaneously1,2,5,6
  • Subjects could re-enroll in the continuing open-label portion of the study upon meeting specific predefined re-enrollment inclusion criteria2
  • Primary endpoints were area under the curve (AUC) for the numeric ACR score over 6 months and modified Total Sharp Score (mTSS) over 12 months4
  • In the OLE of ERA trial, MTX could be added to ETN if, after 1 year in the RCT, there was lack of efficacy
  • Of the 207 patient initially randomized to receive ENBREL 25 mg BIW at baseline, 79 patients did not receive MTX at any point during the OLE through 5 years3


  • Six-month, randomized, double-blind, placebo-controlled trial of patients with moderately to severely active RA (mean duration of disease: 12 years) who had a previous inadequate response to 1 or more DMARDs1,2
  • Open-label phase included 714 patients who had received ENBREL either as monotherapy or in combination with MTX in one of seven adult clinical trials: three placebo-controlled, randomized double-blind phase 2 or 3 trials; two phase 1 randomized dose-finding trials; two open-label trials. Exposure during the randomized controlled trial (RCTs) was included in the OLE1,2
  • Use of concomitant corticosteroids and/or NSAIDs was permitted during the study1,2
  • Most patients received ENBREL 25 mg twice weekly. Because all patients did not enter clinical studies at the same time, length of follow-up varies1,2
  • 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 extension1,2
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

ENBREL is the #1 prescribed biologic by rheumatologists*

See why

*6-month average of IMS monthly NPA prescription data by rheumatologists.

IMS NPA prescription data does not include products administered by infusion.

Simplify the reimbursement process

We can help take the confusion out of insurance verifications and prior authorizations for ENBREL.

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Rapid, Sustained Efficacy of ENBREL
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Achieving Clinical Remission
Efficacy of ENBREL Monotherapy for RA
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