Moderate to severe plaque psoriasis (PsO) and psoriatic arthritis (PsA) can be long journeys

What unknowns may occur down the paths of plaque PsO and PsA?

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.1

PLAN for the road ahead

  • laque psoriasis may
    appear in different
    places from patient
    to patient2,3
  • apses and disruptions
    in treatment can occur
    for many patients
    using biologics4
  • ssessment
    of signs and
    symptoms of PsA
    is important5
  • eed for personalized
    patient support
    throughout
    treatment

Percent of plaque psoriasis patients with involvement in given area:

Areas where plaque psoriasis may appear

Plaque psoriasis may appear in different areas from patient to patient2,3

Plaque psoriasis can develop anywhere on the body, and the presentation of plaques can vary2,3,6

  • As skin involvement becomes more extensive (moderate to severe plaque psoriasis), patients become candidates for systemic therapy or phototherapy3,7

Results from a national survey of 784 plaque psoriasis patients.2

Percent of plaque psoriasis patients with involvement in given area:

Areas where plaque psoriasis may appear

Results from a national survey of 784 plaque psoriasis patients.2


In moderate to severe plaque psoriasis,
ENBREL provides consistent results from region to region8

Global Psoriasis Pivotal Trial

  • The ENBREL Global Psoriasis Pivotal Trial assessed mean percent changes in PASI. Patients were randomized to receive ENBREL 50 mg, ENBREL 25 mg, or placebo administered BIW over 12 weeks, followed by open-label ENBREL 25 mg BIW for an additional 12 weeks9
  • Nearly half of patients (46%; N = 203) achieved a PASI 75 score by week 12 in the ENBREL 50 mg BIW group (ITT NRI analysis)1,10
  • Statistically significant improvement in symptoms as early as 2 weeks (P < 0.0001)9-11
    • Median time for achieving a PASI 75 response was approximately 2 months1

View full study design

Mean % PASI improvement through 24 weeks from the Global Psoriasis Pivotal Trial Mean % PASI improvement through 24 weeks from the Global Psoriasis Pivotal Trial

Mean PASI improvement by region8†‡

Mean PASI improvement by region in week 12 and week 24 Mean PASI improvement by region in week 12 and week 24

* Rates as observed with no imputation for missing data.8
Post hoc analysis of the ENBREL Global Psoriasis Pivotal Trial. All patients who received at least one dose of investigational product were included. Patients received ENBREL 50 mg BIW for 12 weeks followed by ENBREL 50 mg QW through week 24.8
The efficacy and use of ENBREL are based on involvement across the entire body surface area and not from individual body regions.1,8

ENBREL patient testimonial - Shanan

“I remember wearing shorts in the middle of winter. I still had some patches, but I couldn’t wait to show off how much my skin had improved.”

Shanan—ENBREL patient

These testimonials represent individual patient experiences with ENBREL. Results may vary.

ENBREL patient testimonial - Shanan
Hikers

Over time, patients may stop and restart treatment4

1 in 4 moderate to severe plaque psoriasis patients who experienced a treatment gap restarted* their current biologic therapy within a year in a retrospective analysis4

Hikers
  • In a retrospective cross-sectional study, patients with moderate to severe plaque psoriasis who were enrolled in large employer-sponsored US health plans were analyzed via MarketScan Commercial Encounters Database4
  • This study was designed to examine the utilization patterns associated with the use of ENBREL, adalimumab, and ustekinumab among patients with moderate to severe psoriasis4

* Permissible treatment gaps were defined as 4 weeks for ENBREL, 8 weeks for adalimumab, and 18 weeks for ustekinumab, based on clinical expert opinion. Patients were considered to be persistent if they had no treatment gaps that exceeded the specified time thresholds. If a patient had a treatment gap that exceeded the specified time thresholds and subsequently reinitiated the same index biologic agent, the patient was deemed to have restarted therapy.4


Restart ENBREL treatment with recapturable efficacy12

Mean PASI improvement in the US Psoriasis Pivotal Trial Mean PASI improvement in the US Psoriasis Pivotal Trial

* Patients included in this trial started with placebo, ENBREL 25 mg QW, ENBREL 25 mg BIW, or ENBREL 50 mg BIW for 12 weeks. After 12 weeks, placebo patients were switched to ENBREL 25 mg BIW.1,12
Patients who completed 12 weeks of retreatment.12
Only patients with ≥ 50% PASI improvement from baseline at week 24 discontinued ENBREL treatment and were enrolled in this part of the study.12

ENBREL recaptured almost all of its initial response following suspension of treatment for up to 5 months among these responders1,12

US Psoriasis Pivotal Trial

  • The US Psoriasis Pivotal Trial was designed to assess retreatment after withdrawal. Patients with ≥ 50% PASI improvement from baseline at week 24 (responders) discontinued ENBREL treatment. Upon relapse (loss of ≥ 50% PASI improvement obtained before week 24), patients resumed blinded ENBREL therapy at their dose from weeks 13 to 2411-13
  • The mean numerical difference for each patient (primary endpoint) between the PASI score at week 12 of retreatment and the PASI score at week 12 of initial treatment in the ENBREL 50 mg BIW group was –1.4 (± 0.5) and in the ENBREL 25 mg BIW group was –0.3 (± 0.5)12
  • According to this study conducted by Gordon et al, it is important to examine retreatment with ENBREL because a patient may need to discontinue treatment for a variety of logistical reasons, including “an interruption in insurance coverage or in preparation for a scheduled surgery”13
  • The primary endpoint of this multicenter, double-blind, US phase 3 trial was PASI 75 response rate at 12 weeks11
    • 49% of patients achieved a PASI 75 score by week 12 in the ENBREL 50 mg BIW group (n=164; LOCF)11

View full study design

Start with an established safety profile

The safety profile of ENBREL has been evaluated in 7 PsO trials that included 4,410 patients14

View the safety profile

Skin symptoms and joint damage - desktop

In Psoriatic Arthritis (PsA)

Most patients have skin symptoms prior to joint symptoms

Skin symptoms and joint damage - mobile

Depiction of joint damage that may be beneath the surface when skin symptoms are present. Note: pictures are not of the same patient and are shown for illustrative purposes.

  • PsO and PsA are not exclusive. As many as 30% of patients with psoriasis may have associated psoriatic arthritis15
  • In approximately 70% of patients, skin symptoms appear before joint pain and swelling15,16
  • Approximately 50% of patients with psoriatic arthritis have joint damage17*

Depiction of joint damage that may be beneath the surface when skin symptoms are present. Note: pictures are not of the same patient and are shown for illustrative purposes.

* Data from a prospective study of the clinical, laboratory, immunological, and radiological features of 180 patients diagnosed with psoriatic arthritis.17

“PsA can be a very severe disease with significant functional impairment. ... Therefore, we strongly encourage dermatologists to actively seek signs and symptoms of PsA at every patient visit.”5

—American Academy of Dermatology, 2008 Psoriatic Arthritis Guidelines


When patients are diagnosed with psoriatic arthritis,
start with ENBREL to help stop the progression of joint damage

Change in modified Total Sharp Score in Psoriatic Arthritis Pivotal Trial Change in modified Total Sharp Score in Psoriatic Arthritis Pivotal Trial

* Per protocol, in order to compare the radiographic images at year 2 with images from baseline, 6 months, and 1 year, all images were reread. Because of the known variability in evaluation of radiographic images in psoriatic arthritis, all radiographs were reread, blinded as to patients and time point, by 2 of 4 physicians. Radiographic scores were reported as an average from the 2 readers. Thus, the year 2 scoring of the radiographic images is considered a new reading of the year 1 time point.18,19
A modified Total Sharp Score (mTSS), which included distal interphalangeal joints, was used. All radiographic data are based on the radiographic ITT analysis, defined as all randomly assigned patients with acceptable baseline and postbaseline radiographs. Linear extrapolation methodology was used.1,20

ENBREL provided sustained inhibition of joint damage through 2 years18,21

  • 86% of ENBREL patients showed no radiographic progression from baseline to year 2 (Δ in mTSS ≤ 0.0) compared to 63% of patients who switched from placebo to ENBREL at year 118,21

Psoriatic Arthritis Pivotal Trial

  • The Psoriatic Arthritis Pivotal Trial was a multicenter, double-blind, phase 3 study of 205 patients with active psoriatic arthritis18,22
  • The study evaluated the reduction in signs and symptoms, improvement in physical function, and inhibition of radiographic progression in patients with PsA21
  • At week 12, 59% of ENBREL-treated patients achieved the primary endpoint of an ACR 20 response vs 15% of placebo-treated patients (P < 0.0001)20
  • In a subset of psoriatic arthritis patients with body surface area (BSA) involvement ≥ 3% (n = 128), 23% of patients on ENBREL achieved PASI 75 at 24 weeks compared to 3% of placebo patients18
  • Results were similar for patients on ENBREL with or without methotrexate21

View full study design
 

ENBREL patient testimonial - Tom

“When I first started ENBREL for my psoriatic arthritis, my joints started to loosen up and I could move more freely than I had in the past.”

Tom—ENBREL patient

These testimonials represent individual patient experiences with ENBREL. Results may vary.

ENBREL patient testimonial - Tom
ENBREL Professional Resources

Additional support your patients may need between office visits

ENBREL Professional Resources

ENBREL professional resources

Whether it's streamlining the insurance verification process or getting advice from a registered nurse, your practice and your patients can take advantage of the following tools and resources:

  • Insurance specialists
  • Exclusive access to forms
  • Nurse hotline
  • Financial and reimbursement support*
  • Treatment and administration tips

See the full list of support tools and materials

* Eligibility criteria apply.
ENBREL Nurse Partner™ provides injection training and educational support supplemental to what is provided by the office.

Prescription Enbrel® (etanercept) is administered by injection.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
SERIOUS INFECTIONS

Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with ENBREL should be carefully considered prior to initiating therapy in patients 1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) who have resided or traveled in areas of endemic TB or endemic mycoses, or 4) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of TB in patients who tested negative for latent TB prior to initiating therapy.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including ENBREL.

In adult clinical trials 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.

Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer.

Pediatric Patients

In patients who initiated therapy at ≤ 18 years of age, approximately half of the reported malignancies were lymphomas (Hodgkin’s and non-Hodgkin’s lymphoma). Other cases included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.

NEUROLOGIC EVENTS

Treatment with TNF-blocking agents, including ENBREL, has been associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with ENBREL therapy. Prescribers should exercise caution in considering the use of ENBREL in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.

CONGESTIVE HEART FAILURE

Cases of worsening congestive heart failure (CHF) and, rarely, new-onset cases have been reported in patients taking ENBREL. Caution should be used when using ENBREL in patients with CHF. These patients should be carefully monitored.

HEMATOLOGIC EVENTS

Rare cases of pancytopenia, including aplastic anemia, some fatal, have been reported. The causal relationship to ENBREL therapy remains unclear. Exercise caution when considering ENBREL in patients who have a previous history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. Consider discontinuing ENBREL if significant hematologic abnormalities are confirmed.

HEPATITIS B REACTIVATION

Reactivation of hepatitis B has been reported in patients who were previously infected with hepatitis B virus (HBV) and received concomitant TNF-blocking agents, including ENBREL. Most reports occurred in patients also taking immunosuppressive agents, which may contribute to hepatitis B reactivation. Exercise caution when considering ENBREL in these patients.

ALLERGIC REACTIONS

Allergic reactions associated with administration of ENBREL during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of ENBREL should be discontinued immediately and appropriate therapy initiated.

IMMUNIZATIONS

Live vaccines should not be administered to patients on ENBREL. JIA patients, if possible, should be brought up to date with all immunizations prior to initiating ENBREL. In patients with exposure to varicella virus, consider temporary discontinuation of ENBREL and prophylactic treatment with Varicella Zoster Immune Globulin.

AUTOIMMUNITY

Autoantibodies may develop with ENBREL, and rarely lupus-like syndrome or autoimmune hepatitis may occur. These may resolve upon withdrawal of ENBREL. Stop ENBREL if lupus-like syndrome or autoimmune hepatitis develops.

WEGENER’S GRANULOMATOSIS PATIENTS

The use of ENBREL in patients with Wegener’s granulomatosis receiving immunosuppressive agents (eg, cyclophosphamide) is not recommended.

MODERATE TO SEVERE ALCOHOLIC HEPATITIS

Based on a study of patients treated for alcoholic hepatitis, exercise caution when using ENBREL in patients with moderate to severe alcoholic hepatitis.

ADVERSE EVENTS

The most commonly reported adverse events in RA clinical trials were injection site reaction, infection, and headache. In clinical trials of all other adult indications, adverse events were similar to those reported in RA clinical trials.

In a JIA study, adverse reactions in pediatric patients were generally similar in frequency and type as those seen in adult patients. The types of infections reported in pediatric patients were generally mild and consistent with those commonly seen in the general pediatric population.

DRUG INTERACTIONS

The use of ENBREL in patients receiving concurrent cyclophosphamide therapy is not recommended. The risk of serious infection may increase with concomitant use of abatacept therapy. Concurrent therapy with ENBREL and anakinra is not recommended. Hypoglycemia has been reported following initiation of ENBREL therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.

Please see Prescribing Information and Medication Guide.

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 (PsA). ENBREL can be used with or without MTX.

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.

References:

  • Enbrel® (etanercept) Prescribing Information, Immunex Corporation, Thousand Oaks, Calif. March 2015.
  • van de Kerkhof PCM. Clinical features. In: van de Kerkhof PCM, ed. Textbook of Psoriasis. Oxford, England: Blackwell Science Ltd; 2008:3-29.
  • Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58:826-850.
  • Feldman SR, Zhao Y, Navaratnam P, Friedman HS, Lu J, Tran MH. Patterns of medication utilization and costs associated with the use of etanercept, adalimumab, and ustekinumab in the management of moderate-to-severe psoriasis. J Manag Care Spec Pharm. 2015;21:201-209.
  • Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008;58:851-864.
  • van de Kerkhof PCM, Steegers-Theunissen RPM, Kuipers MV. Evaluation of topical drug treatment in psoriasis. Dermatology. 1998;197:31-36.
  • Pariser DM, Bagle J, Gelfand JM, et al. National Psoriasis Foundation Clinical Consensus on Disease Severity. Arch Dermatol. 2007;143:239-242.
  • Data on file, Amgen; 20021642 PASI Components Memo: February 28, 2014.
  • Papp KA, Tyring S, Lahfa M, et al; for the Etanercept Psoriasis Study Group. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005;152:1304-1312.
  • Data on file, Amgen; 1642 Subanalysis: May 31, 2007.
  • Leonardi CL, Powers JL, Matheson RT, et al; for the Etanercept Psoriasis Study Group. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003;349:2014-2022.
  • Data on file, Amgen; CSR1639: October 8, 2003.
  • Gordon KB, Gottlieb AB, Leonardi CL, et al. Clinical response in psoriasis patients discontinued from and then reinitiated on etanercept therapy. J Dermatolog Treat. 2006;17:9-17.
  • Pariser DM, Leonardi CL, Gordon K, et al. Integrated safety analysis: short- and long-term safety profiles of etanercept in patients with psoriasis. J Am Acad Dermatol. 2012;67:245-256.
  • Mease P, Goffe BS. Diagnosis and treatment of psoriatic arthritis. J Am Acad Dermatol. 2005;52:1-19.
  • Mease PJ. Cytokine blockers in psoriatic arthritis. Ann Rheum Dis. 2001;60:iii37-iii40.
  • Torre Alonso JC, Rodriguez Perez A, Arribas Castrillo JM, et al. Psoriatic arthritis (PA): a clinical, immunological and radiological study of 180 patients. Br J Rheumatol. 1991;30:245-250.
  • Data on file, Amgen; CSR1630: August 5, 2004.
  • van der Heijde DM. How to read radiographs according to the Sharp/van der Heijde method. J Rheumatol. 2000;27:261-263.
  • Mease PJ, Kivitz AJ, Burch FX, et al. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum. 2004;50:2264-2272.
  • Mease PJ, Kivitz AJ, Burch FX, et al. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol. 2006;33:712-721.
  • Mease PJ, Woolley JM, Singh A, Tsuji W, Dunn M, Chiou CF. Patient-reported outcomes in a randomized trial of etanercept in psoriatic arthritis. J Rheumatol. 2010;37:1221-1227.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
SERIOUS INFECTIONS

Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with ENBREL should be carefully considered prior to initiating therapy in patients 1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) who have resided or traveled in areas of endemic TB or endemic mycoses, or 4) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of TB in patients who tested negative for latent TB prior to initiating therapy.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including ENBREL.

In adult clinical trials 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.

Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer.

Pediatric Patients

In patients who initiated therapy at ≤ 18 years of age, approximately half of the reported malignancies were lymphomas (Hodgkin’s and non-Hodgkin’s lymphoma). Other cases included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.

NEUROLOGIC EVENTS

Treatment with TNF-blocking agents, including ENBREL, has been associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with ENBREL therapy. Prescribers should exercise caution in considering the use of ENBREL in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.

CONGESTIVE HEART FAILURE

Cases of worsening congestive heart failure (CHF) and, rarely, new-onset cases have been reported in patients taking ENBREL. Caution should be used when using ENBREL in patients with CHF. These patients should be carefully monitored.

HEMATOLOGIC EVENTS

Rare cases of pancytopenia, including aplastic anemia, some fatal, have been reported. The causal relationship to ENBREL therapy remains unclear. Exercise caution when considering ENBREL in patients who have a previous history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. Consider discontinuing ENBREL if significant hematologic abnormalities are confirmed.

HEPATITIS B REACTIVATION

Reactivation of hepatitis B has been reported in patients who were previously infected with hepatitis B virus (HBV) and received concomitant TNF-blocking agents, including ENBREL. Most reports occurred in patients also taking immunosuppressive agents, which may contribute to hepatitis B reactivation. Exercise caution when considering ENBREL in these patients.

ALLERGIC REACTIONS

Allergic reactions associated with administration of ENBREL during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of ENBREL should be discontinued immediately and appropriate therapy initiated.

IMMUNIZATIONS

Live vaccines should not be administered to patients on ENBREL. JIA patients, if possible, should be brought up to date with all immunizations prior to initiating ENBREL. In patients with exposure to varicella virus, consider temporary discontinuation of ENBREL and prophylactic treatment with Varicella Zoster Immune Globulin.

AUTOIMMUNITY

Autoantibodies may develop with ENBREL, and rarely lupus-like syndrome or autoimmune hepatitis may occur. These may resolve upon withdrawal of ENBREL. Stop ENBREL if lupus-like syndrome or autoimmune hepatitis develops.

WEGENER’S GRANULOMATOSIS PATIENTS

The use of ENBREL in patients with Wegener’s granulomatosis receiving immunosuppressive agents (eg, cyclophosphamide) is not recommended.

MODERATE TO SEVERE ALCOHOLIC HEPATITIS

Based on a study of patients treated for alcoholic hepatitis, exercise caution when using ENBREL in patients with moderate to severe alcoholic hepatitis.

ADVERSE EVENTS

The most commonly reported adverse events in RA clinical trials were injection site reaction, infection, and headache. In clinical trials of all other adult indications, adverse events were similar to those reported in RA clinical trials.

In a JIA study, adverse reactions in pediatric patients were generally similar in frequency and type as those seen in adult patients. The types of infections reported in pediatric patients were generally mild and consistent with those commonly seen in the general pediatric population.

DRUG INTERACTIONS

The use of ENBREL in patients receiving concurrent cyclophosphamide therapy is not recommended. The risk of serious infection may increase with concomitant use of abatacept therapy. Concurrent therapy with ENBREL and anakinra is not recommended. Hypoglycemia has been reported following initiation of ENBREL therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.

Please see Prescribing Information and Medication Guide.

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 (PsA). ENBREL can be used with or without MTX.

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.

  • Close
IMPORTANT SAFETY INFORMATION AND INDICATIONS: SERIOUS INFECTIONS

Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with ENBREL should be carefully considered prior to initiating therapy in patients 1) with chronic or recurrent infection, 2) who have been exposed to TB, 3) who have resided or traveled in areas of endemic TB or endemic mycoses, or 4) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of TB in patients who tested negative for latent TB prior to initiating therapy.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including ENBREL.

In adult clinical trials 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.

Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, including ENBREL. Periodic skin examinations should be considered for all patients at increased risk for skin cancer.

Pediatric Patients

In patients who initiated therapy at ≤ 18 years of age, approximately half of the reported malignancies were lymphomas (Hodgkin’s and non-Hodgkin’s lymphoma). Other cases included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.

NEUROLOGIC EVENTS

Treatment with TNF-blocking agents, including ENBREL, has been associated with rare (< 0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders. Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketing experience with ENBREL therapy. Prescribers should exercise caution in considering the use of ENBREL in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.

CONGESTIVE HEART FAILURE

Cases of worsening congestive heart failure (CHF) and, rarely, new-onset cases have been reported in patients taking ENBREL. Caution should be used when using ENBREL in patients with CHF. These patients should be carefully monitored.

HEMATOLOGIC EVENTS

Rare cases of pancytopenia, including aplastic anemia, some fatal, have been reported. The causal relationship to ENBREL therapy remains unclear. Exercise caution when considering ENBREL in patients who have a previous history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. Consider discontinuing ENBREL if significant hematologic abnormalities are confirmed.

HEPATITIS B REACTIVATION

Reactivation of hepatitis B has been reported in patients who were previously infected with hepatitis B virus (HBV) and received concomitant TNF-blocking agents, including ENBREL. Most reports occurred in patients also taking immunosuppressive agents, which may contribute to hepatitis B reactivation. Exercise caution when considering ENBREL in these patients.

ALLERGIC REACTIONS

Allergic reactions associated with administration of ENBREL during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of ENBREL should be discontinued immediately and appropriate therapy initiated.

IMMUNIZATIONS

Live vaccines should not be administered to patients on ENBREL. JIA patients, if possible, should be brought up to date with all immunizations prior to initiating ENBREL. In patients with exposure to varicella virus, consider temporary discontinuation of ENBREL and prophylactic treatment with Varicella Zoster Immune Globulin.

AUTOIMMUNITY

Autoantibodies may develop with ENBREL, and rarely lupus-like syndrome or autoimmune hepatitis may occur. These may resolve upon withdrawal of ENBREL. Stop ENBREL if lupus-like syndrome or autoimmune hepatitis develops.

WEGENER’S GRANULOMATOSIS PATIENTS

The use of ENBREL in patients with Wegener’s granulomatosis receiving immunosuppressive agents (eg, cyclophosphamide) is not recommended.

MODERATE TO SEVERE ALCOHOLIC HEPATITIS

Based on a study of patients treated for alcoholic hepatitis, exercise caution when using ENBREL in patients with moderate to severe alcoholic hepatitis.

ADVERSE EVENTS

The most commonly reported adverse events in RA clinical trials were injection site reaction, infection, and headache. In clinical trials of all other adult indications, adverse events were similar to those reported in RA clinical trials.

In a JIA study, infection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adult RA patients in placebo-controlled trials. The types of infections reported in JIA patients were generally mild and consistent with those commonly seen in outpatient pediatric populations.

DRUG INTERACTIONS

The use of ENBREL in patients receiving concurrent cyclophosphamide therapy is not recommended. The risk of serious infection may increase with concomitant use of abatacept therapy. Concurrent therapy with ENBREL and anakinra is not recommended. Hypoglycemia has been reported following initiation of ENBREL therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.

Please see Prescribing Information and Medication Guide.

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.

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IMPORTANT SAFETY INFORMATION AND INDICATIONS:
SERIOUS INFECTIONS

Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use, 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.