In adult chronic moderate to severe plaque psoriasis

Malignancy rates

Adverse event rates from pivotal clinical trials1

Adverse event rates through 3 years of treatment1‡§

Rates above do not include nonmelanoma skin cancers. Cases of nonmelanoma skin cancer have been reported in clinical trials and postmarketing experience.
These data come from 7 controlled and uncontrolled psoriasis studies.
Safety data include patients who received continuous 50 mg BIW ENBREL therapy.

Events/patient-year:

  • A rate of 0.007 events/patient-year is equivalent to observing 0.7 malignancies among 100 patients taking study drug continuously for 1 year1

Other serious adverse events from these 7 studies:

  • 2 cases demyelination were observed (0.0004 events/pt-yr)1
  • 7 cases of congestive heart failure were observed (0.001 events/pt-yr)1
  • 11 cases of myocardial infarction were observed (0.002 events/pt-yr)1

Malignancy rates were comparable to the general population (SIR: 1.15; 95% CI: 0.78, 1.64)1||


Important Safety Considerations

  • Cases of acute and chronic leukemia have been reported in association with postmarketing TNF-blocker use in RA and other indications. Even in the absence of TNF-blocker therapy, the risk of leukemia in RA patients may be higher (approximately 2-fold) than the general population2
  • For malignancies other than lymphoma and nonmelanoma skin cancer, there was no difference in exposure-adjusted rates between the ENBREL and control arms in the controlled portions of clinical studies for all indications. Analysis of the malignancy rate in combined controlled and uncontrolled portions of studies has demonstrated that types and rates were similar to what is expected in the general US population based on the SEER database and suggested no increase in rates over time. Whether treatment with ENBREL might influence the development and course of malignancies in adults is unknown. Cases of lymphoma and other malignancies have been reported in postmarketing studies2
  • Nonmelanoma skin cancer has been reported in patients treated with TNF antagonists including ENBREL. Among adult psoriasis patients treated with ENBREL (n = 1,245) in controlled clinical trials, the observed rate of nonmelanoma skin cancer was 0.04 events/pt-yr vs 0.01 events/pt-yr among control-treated patients (n = 720)2
In adult chronic moderate to severe plaque psoriasis

Lymphoma rates

Adverse event rates from pivotal clinical trials1

Adverse event rates through 3 years of treatment1§

These data come from 7 controlled and uncontrolled psoriasis studies.
Safety data include patients who received continuous 50 mg BIW ENBREL therapy.

Important Safety Considerations

  • In clinical trials of all TNF inhibitors, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA patients; the role of TNF inhibitors in the development of malignancies is unknown2-4
In adult chronic moderate to severe plaque psoriasis

Serious infection rates

Adverse event rates from pivotal clinical trials1

Adverse event rates through 3 years of treatment1§

These data come from 7 controlled and uncontrolled psoriasis studies.
Safety data include patients who received continuous 50 mg BIW ENBREL therapy.

Important Safety Considerations

  • Infections, including serious infections, some fatal, have been observed in patients treated with ENBREL. Discontinue ENBREL if a patient develops a serious infection or sepsis. Patients are at increased risk for developing serious infections when taking ENBREL that may lead to hospitalization or death. Most patients who developed these serious infections were taking concomitant immunosuppressants2
  • ENBREL is contraindicated in patients with sepsis. In clinical trials, the most common (> 5%) adverse events were infections and injection site reactions2
  • Patients with active infection should not initiate therapy. Use ENBREL with caution in patients: with chronic or recurrent infections; who are greater than 65 years of age or are immunocompromised; 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
In adult chronic moderate to severe plaque psoriasis

Opportunistic infection rates#**

Adverse event rates from pivotal clinical trials1

Adverse event rates through 3 years of treatment1§

These rates do not include tuberculosis.
These data come from 7 controlled and uncontrolled psoriasis studies.
Safety data include patients who received continuous 50 mg BIW ENBREL therapy.

Important Safety Considerations

  • In patients receiving TNF-blocking agents, opportunistic infections, including tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis, have been reported2
  • 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 illness2
  • Cases of reactivation of TB or new TB infections have been observed in patients receiving ENBREL. Patients should be evaluated for TB risk factors and be tested for latent TB infection prior to initiating ENBREL and during treatment2
  • In 66 global clinical trials of 17,505 patients with 21,015 patient-years of therapy, 4 cases of TB were reported (approximately 0.02% of patients). Patient totals include 9,895 from 38 clinical trials in the US and Canada and 7,610 from clinical trials outside the US and Canada, but do not include 7,801 in 4 cohort studies in the US and Canada. Adding 17,505 and 7,801 totals 25,306 patients studied globally1,2
  • In 38 clinical trials of 9,895 patients and 4 cohort studies of 7,801 patients in the US and Canada, among 17,696 total patients with 27,169 patient-years of treatment, 1 case of TB was reported (approximately 0.006% of patients). Patients should be evaluated for TB risk factors and be tested for latent TB infection prior to initiating ENBREL and during treatment1,2

 The duration of the double-blind, randomized, controlled portion of the trials was 24 weeks in the US Pivotal Trial and 12 weeks in the Global Pivotal Trial.
 Data are from clinical trials and include all 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. SEER (Surveillance, Epidemiology, and End Results) is a database compiled by the National Cancer Institute to collect information on cancer incidence, prevalence, and survival from specific geographic areas representing 26% of the US population and compile reports on all of these plus cancer mortality for the entire country.
 §Study drug exposure was calculated as the duration from the first dose of study drug to the last dose of study drug.
 ||The Standardized Incidence Ratio (SIR) is an estimate of the occurrence of cancer in the ENBREL population relative to what might be expected in a larger comparison population designated as "normal" or average, such as the general population.5
 Serious infections are infectious events that are classified as serious when any of the following outcomes were associated with the event: hospitalization or intravenous antibiotic therapy use.6
 #An opportunistic infection is an infection typically seen only in a host whose resistance is lowered.7
 **In etanercept clinical trials, the following types of opportunistic infections were observed: Aspergillus (invasive forms only), Candida species (excluding oral or vaginal candidiasis: also includes Torulopsis glabrata), Herpes zoster (only systemic or disseminated), Listeria monocytogenes, Mycobacterium tuberculosis, nontuberculosis Mycobacterium, and 1 unknown opportunistic infection. Serious and sometimes fatal infections due to opportunistic pathogens have been reported in patients receiving TNF-blocking agents, including ENBREL.1,2

 
INDICATIONS

ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be initiated in combination with methotrexate (MTX) or used alone.

ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.

ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.

ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Supportive data

Moderate to Severe Plaque Psoriasis
In medical studies, nearly half of patients saw 75% skin clearance in their moderate to severe plaque psoriasis in 3 months with ENBREL. Overall, 3 out of 4 patients saw 50% skin clearance in 3 months. ENBREL can work fast; many patients saw improvement within 2 months. Your results may vary.

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

For many adult patients with moderate to severe plaque psoriasis, ENBREL has meant clearer skin.1

1. Data on file, Amgen.

Our clinical experience

ENBREL has been prescribed by nearly 11,000 dermatology professionals in the US.1*

Learn more about our experience arrow

* Dermatologists, nurse practitioners, physician's assistants in dermatology offices, and dermatology subspecialists, which include D, DS, DMP, PDD and some NP, PA, and IM/PCPs. Based on cumulative data from 2003 through May 2011.

After being dissatisfied with other treatments, Bill decided to try ENBREL.

Bill started to see improvements in his skin within 2 weeks of starting treatment; his friends were surprised at how much his skin had improved.

"Psoriasis covered 20% of my body and now my symptoms are much improved."