INDICATIONS

ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone. Read More

ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function...Read More

US Psoriasis (PsO) Pivotal Trial

Recapture results after withdrawal and retreatment

US Psoriasis (PsO) Pivotal Trial

Recapture results after withdrawal and retreatment

Study Design

The US Psoriasis Pivotal Trial was a two-part, multicenter, phase 3 study consisting of a 24-week double-blind period followed by a 60-week withdrawal and retreatment period. A total of 652 patients with active but clinically stable plaque psoriasis involving at least 10% of body surface area (BSA) and a minimum Psoriasis Area and Severity Index (PASI) score of 10.1 Patients were randomized to receive ENBREL 50 mg twice weekly (BIW, n=164), ENBREL 25 mg BIW (n=162), ENBREL 25 mg weekly (QW, n=160), or placebo (n=166) for 12 weeks. After Week 12, patients in the placebo group began blinded treatment with ENBREL 25 mg BIW.1,2

At Week 24, patients with 50% PASI improvement from baseline discontinued ENBREL treatment until disease relapse (loss of the 50% PASI improvement that was obtained by Week 24). Upon relapse, patients resumed blinded ENBREL therapy at the same dose they had received from Weeks 13 to 24.1

A post hoc analysis was conducted for an open-label extension (OLE), including 439 patients from the US Psoriasis Pivotal Trial after completing a minimum of 60 weeks in the primary study. Patients in the OLE received ENBREL 50 mg QW for the first 12 weeks followed by a dose escalation to 50 mg BIW for patients with an inadequate clinical response.3,4

Additional Study Details and Study Schema

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  • Patients were limited to low- to moderate-strength topical corticosteroids in the axillary, groin, and scalp regions1
  • Primary endpoint: PASI 75 at Week 121
  • Select secondary endpoints: PASI 50, PASI 90, percent improvement from baseline PASI, static Physician's Global Assessment (sPGA) of clear or almost clear, and the patient’s global assessment of psoriasis at Weeks 12, 24, 48, and 721,2
  • OLE primary endpoints: The incidence of adverse events, infectious episodes, serious adverse events, serious infectious episodes, injection site reactions, changes from baseline in laboratory values, and presence/absence of an antibody response3
  • OLE select secondary endpoints: Percent PASI improvement relative to baseline in the parent study3

US Psoriasis Pivotal Trial1,2,4 (N=652)

US Psoriasis Pivotal Trial (N=652) US Psoriasis Pivotal Trial (N=652)

mITT = modified intent-to-treat.

Selected Baseline Demographics3,5

Age 45 years
Male 67%
Caucasian 87%
Weight (mean) 208 lb (86-437 lb)
Body mass index (mean) 31
BSA involvement (mean) 29%
PsO duration (mean) 19 years
PASI (mean) 18

References:

  1. 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.
  2. Data on file, Amgen; CSR 1639. October 8, 2003.
  3. 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.
  4. Data on file, Amgen; CSR 115. November 28, 2005.
  5. Data on file, Amgen; CSR 1639 3 Month. June 11, 2003.

Primary Endpoint

  • ~49% of patients achieved a PASI 75 score by Week 12 in the ENBREL 50 mg BIW group (n=164, LOCF) vs 4% with placebo (n-166)

Recapture Results Through 60 Weeks

  • For the 50 mg BIW dosing, 91% of the initial change in mean PASI was regained 12 weeks after retreatment3
  • For the 25 mg BIW dosing, 99% of the initial change in mean PASI was regained 12 weeks after retreatment3

Improvement in Mean PASI in the US Psoriasis Pivotal Trial3,5

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

a Patients who completed 12 weeks of retreatment.1

b Only patients with ≥50% PASI improvement from baseline at Week 24 discontinued ENBREL treatment and were enrolled in this part of the study.1

c Last observation carried forward (LOCF).

d As observed.

  • 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)3

Recapture Results Through 132 Weeks

Mean % of PASI Improvement From the US Psoriasis Pivotal Trial and the OLE3,6

Mean % of PASI Improvement From the US Psoriasis Pivotal Trial and the OLE Mean % of PASI Improvement From the US Psoriasis Pivotal Trial and the OLE
  • The following patients were not included in this OLE efficacy analysis:
    • Patients (n=37) in the ENBREL 50 mg BIW group on after Week 12 during the US Psoriasis Pivotal Trial who were randomized to the 50 mg QW group through 72 weeks of the OLE6
    • Patients (n=284) who increased their ENBREL dose to 50 mg BIW after Week 12 during the OLE4,7
    • Patients (n=75) in the ENBREL 50 mg QW continuous arm through 72 weeks who had >30 days off treatment between the US Psoriasis Pivotal Trial and the OLE8
    • Patients (n=5) met 2 of these exclusion criteria: received ENBREL 50 mg BIW who had >30 days off treatment
  • Patients included in the trial started with placebo, ENBREL 25 mg QW, ENBREL 25 mg BIW, and ENBREL 50 mg BIW for 12 weeks. After 12 weeks, placebo patients were switched to ENBREL 25 mg BIW3
  • OLE results are from post hoc analysis. These results are exploratory and no statistical conclusions can be drawn
  • Consider OLE study limitations when interpreting results. The OLE is not blinded, not controlled, and includes inherent self-selection bias. A total of 20 patients (2.2%) had adverse events that led to discontinuation of the study4

Global Psoriasis
Pivotal Trial

12-week and 120-week results

Global Psoriasis Pivotal Trial

12-week and 120-week results

Study Design

The Global Psoriasis Pivotal Trial was a 48-week, multicenter, double-blind, randomized, phase 3 trial of 611 adult patients with active but clinically stable PsO involving at least 10% of BSA and a minimum PASI score of 10. 583 patients received at least one dose of study drug and these were the 583 patients included in the primary analysis. Patients were randomized to receive ENBREL 50 mg (n=194), ENBREL 25 mg (n=196), or placebo (n=193) BIW over 12 weeks. After Week 12, all patients (n=583) received open-label ENBREL 25 mg BIW over 36 weeks. Patients were limited to low- to moderate-strength topical corticosteroids in the axillary, groin, and scalp regions. A post hoc analysis was conducted for an OLE, including 473 patients from the Global Psoriasis Pivotal Trial after completing a minimum of 36 weeks of open-label treatment. Patients in the OLE received ENBREL 50 mg QW.4,9,10

Additional Study Details and Study Schema

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  • Primary endpoint: PASI 75 at Week 121
  • Select secondary endpoints: PASI 50, PASI 90, percent improvement from baseline PASI, sPGA of clear or almost clear, and the patient’s global assessment of psoriasis at Weeks 12, 24, and 481,2
  • OLE primary endpoints: The incidence of adverse events, infectious episodes, serious adverse events, serious infectious episodes, injection site reactions, changes from baseline in laboratory values, and presence/absence of an antibody response3
  • OLE select secondary endpoints: Percent PASI improvement relative to baseline in the parent study3

Global Psoriasis Pivotal Trial1-3 (N=583)

Global Psoriasis Pivotal Trial (N=583)Global Psoriasis Pivotal Trial (N=583)

Selected Baseline Demographics1,4

Age (mean) 45 years
Male 66%
Caucasian 91%
Weight (mean) 194 lb
Body mass index (mean) 30
BSA involvement (mean) 28%
PsO duration (mean) 20 years
PASI (mean) 19

References:

  1. 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.
  2. Data on file, Amgen; CSR 1642. October 8, 2003.
  3. Data on file, Amgen; CSR 115. November 28, 2005.
  4. Data on file, Amgen; CSR 1642. May 29, 2003.

PASI Results at Week 12

  • Primary endpoint: Nearly half (46%) of patients saw 75% skin clearance in their moderate to severe plaque PsO in 12 weeks with ENBREL in the 50 mg BIW group (n=203) vs 3% with placebo (n=204, primary endpoint; intent-to-treat nonresponder imputation [ITT NRI] analysis)5
  • 66% mean PASI improvement at Week 12 in the ENBREL 50 mg BIW group (n=194) vs 0.1% with placebo (n=193, mITT LOCF analysis)11

PASI Results Through Week 120

Mean PASI Improvement (%) During the Global Psoriasis Pivotal Trial and the OLE6,9

Mean PASI Improvement (%) During the Global Psoriasis Pivotal Trial and the OLEMean PASI Improvement (%) During the Global Psoriasis Pivotal Trial and the OLE
  • The following patients were not included in the OLE efficacy analysis:
    • Patients who increased their ENBREL dose to 50 mg BIW after Week 12 during the OLE (n=307)4,7
    • Patients in the ENBREL 50 mg QW continuous arm through 72 weeks who had >30 days of treatment between Global Psoriasis Pivotal Trial and the OLE8
  • Patients included in this trial started with placebo, ENBREL 25 mg BIW, or 50 mg BIW for 12 weeks. All patients received ENBREL 25 mg BIW after 12 weeks9
  • OLE results are from post hoc analysis. These results are exploratory and no statistical conclusions can be drawn
  • Consider OLE study limitations when interpreting results. The OLE is not blinded, not controlled, and includes inherent self-selection bias. A total of 20 patients (2.2%) had adverse events that led to discontinuation of the study4

Photos of Patients From the Global Psoriasis Pivotal Trial

  • These photos depict only a select area of the patient’s skin involvement. Included below the photos are the patients’ actual PASI scores at baseline, Week 12, and Week 2412,13
Photos of Patients From the Global Psoriasis Pivotal TrialPhotos of Patients From the Global Psoriasis Pivotal Trial

Additional Phase 3 Study

Patient-reported outcomes for pain and itch

Additional Phase 3 Study

Patient-reported outcomes for pain and itch

Study Design

The Phase 3 Study was a 12-week, randomized, double-blind, placebo-controlled, parallel-group study of 618 patients with active and clinically significant plaque psoriasis involving ≥10% BSA and a minimum PASI score of 10. Patients received ENBREL 50 mg BIW (n=311) or placebo BIW (n=307).14

  • Primary endpoint: PASI 75 at Week 1215
  • Select secondary endpoints: Patient assessment of itching at Week 12, patient assessment of improvement from baseline in skin pain at Week 12, patient-reported outcomes of itching and improvement from baseline in skin pain at Week 1215
  • The severity of skin pain and itch was assessed by patients based on a single-item questionnaire* rating it on a scale of 0 (none) to 10 (severe) for pain and 0 (none) to 5 (severe) for itch15

* Subjects were asked to rate their skin pain and itch as a component of a psoriasis clinical trial, so it can be reasonably assumed that the subjects answered this question attributing the skin pain and itch to their moderate to severe plaque psoriasis.

Additional Study Details and Study Schema

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Phase 3 StudyPhase 3 Study

Reference:

  1. Tyring S, Gordon KB, Poulin Y, et al. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol. 2007;143:719-726.

Primary Endpoint Result

  • 47% of patients achieved PASI 75 with ENBREL (mean baseline PASI=18.3)14

Itch Scores

Itch Scores Reported by ENBREL Patients at Baseline and at Week 12 (LOCF)15

Itch Scores Reported by ENBREL Patients at Baseline and at Week 12 (LOCF)Itch Scores Reported by ENBREL Patients at Baseline and at Week 12 (LOCF)

Pain Scores

Improvement in Mean Skin Pain Score at Week 12 (LOCF)15

Improvement in Mean Skin Pain Score at Week 12 (LOCF)Improvement in Mean Skin Pain Score at Week 12 (LOCF)

Apremilast Failure Trial

ENBREL results in patients who previously failed apremilast

Apremilast Failure Trial

ENBREL results in patients who previously failed apremilast

Study Design

The Apremilast Failure Trial was a 24-week, multicenter, open-label, single-arm, phase 4 estimation study in 80 patients with BSA ≥10%, PASI ≥10, and sPGA ≥3 who had failed apremilast. Patients received ENBREL 50 mg BIW for 12 weeks. After Week 12, patients received ENBREL 50 mg QW.16

  • Primary endpoint: PASI 75 at Week 1216
  • Select secondary endpoints: PASI 75 response at Week 24, PASI 50 and 90 response at Weeks 12 and 24, Psoriasis Symptom Inventory (PSI) total and component score at Weeks 12 and 2416

Failed therapy with apremilast (at least 4 weeks of treatment) for chronic moderate to severe plaque PsO was defined as: (1) failure to achieve adequate clinical response in the opinion of the investigator, (2) loss of adequate clinical response in the opinion of the investigator, or (3) intolerability to apremilast in the opinion of the investigator. Patients were excluded from the study if they had used a biologic for PsO and did not have a satisfactory response (sPGA clear or almost clear) or had used a biologic for PsO and had a clinically significant adverse event.16

Additional Study Details and Study Schema

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PsO Apremilast Failure Trial 204-Aprimistal-AddStudy

Selected Baseline Demographics2

Age, mean 50 years
Male 59%
Caucasian 75%
Weight (mean) 192 lb (106-265 lb)
PsO duration (mean) 16 years
PASI (mean) 16
Apremilast efficacy failures 60 patients
Apremilast tolerability failures 20 patients

a Patients received at least 4 weeks of apremilast.

b Approximately 30 days after the last dose of ENBREL, patients received a safety follow-up phone call to confirm the status of any ongoing and/or new disease-related events or serious adverse events.

References:

  1. Data on file, Amgen; CSR 20150252. February 5, 2016.
  2. Data on file, Amgen; Summary of Results. February 19, 2018.

PASI Results

  • Primary endpoint: 42% of patients achieved PASI 75 with ENBREL at 12 weeks16,17
  • Select secondary endpoints: PASI 75 response at Week 24, PASI 50 and 90 response at Weeks 12 and 24, Psoriasis Symptom Inventory (PSI) total and component scores at Weeks 12 and 2416,17

Mean % PASI Improvement Through 24 Weeks From the PsO Apremilast Failure Trial (50 mg BIW/50 mg QW)17

Mean % PASI Improvement Through 24 Weeks From the PsO Apremilast Failure Trial (50 mg BIW/50 mg QW) Mean % PASI Improvement Through 24 Weeks From the PsO Apremilast Failure Trial (50 mg BIW/50 mg QW)
  • Open-label results from estimation study are exploratory in nature and no statistical conclusions can be drawn

Psoriasis Symptom Inventory Scores

  • PSI is a validated PsO-specific Patient Reported Outcomes (PRO) measure that reflects a patient’s perception of symptom severity for 8 key signs and symptoms: itch, redness, scaling, burning, stinging, cracking, flaking, pain18,19
  • Patients use the PSI questionnaire to assess the severity of each symptom (not at all, mild, moderate, severe, or very severe)19
  • The healthcare professional then scores the severity of each symptom19,20

PSI Total Score With ENBREL (LOCF)17

PSI Total Score With ENBREL (LOCF) PSI Total Score With ENBREL (LOCF)

PSI Component Scores

  • All PSI signs and symptoms reduced by 40% to 50% with ENBREL at Week 1217

PSI Component Scores With ENBREL (LOCF)17

PSI Component Scores With ENBREL (LOCF) PSI Component Scores With ENBREL (LOCF)

a Weeks 12 and 24 are based on data from patients that were available for follow-up.

PSI Tool

Use the PSI Tool with your patients who have moderate to severe plaque psoriasis
  • This PSI questionnaire allows patients to assess their nonobservable symptoms at each appointment: itch, sensations of burning, stinging, and pain18-20
  • Healthcare professionals then score the severity of each symptom on a scale of 0 (not at all) to 4 (very severe)19,20
Example PSI Tool when filled out by patient
Example PSI Tool when filled out by patient Example PSI Tool when filled out by patient
Example score calculation when evaluated by a healthcare professional

Example score calculation when evaluated by healthcare professional

Example score calculation when evaluated by healthcare professional

Scalp Involvement Study

Psoriasis Scalp Severity Index (PSSI) results for patients with PsO scalp involvement

Scalp Involvement Study

Psoriasis Scalp Severity Index (PSSI) results for patients with PsO scalp involvement

Study Design

The ENBREL Scalp Involvement Study was a 24-week, multicenter, double-blind, randomized, placebo-controlled trial of 124 patients with active but clinically stable plaque PsO involving BSA ≥10%, a minimum PASI score of 10, ≥30% involvement of the scalp surface area (SSA), and a minimum PSSI score of 15.21 Patients received ENBREL 50 mg BIW (n=62) or placebo BIW (n=62) over 12 weeks. After Week 12, patients received ENBREL 50 mg QW (if initially randomized to ENBREL 50 mg BIW, n=58) or ENBREL 50 mg BIW (if initially randomized to placebo, n=54).22

  • The objective of the ENBREL Scalp Involvement Study was to examine the efficacy of ENBREL in patients with moderate to severe plaque PsO with scalp involvement, primarily through PSSI assessments that evaluate plaque involvement of the scalp alone21
  • PSSI is a scalp-specific modification of PASI that evaluates the extent of involvement and severity of erythema, infiltration, and desquamation of the scalp in a single score (0-72)21
  • Primary endpoint: Percent improvement from baseline caps on PSSI at Week 1221
  • Select secondary endpoint: PSSI 75 at Week 12, percent change in PSSI from Week 12 to Week 24 in subjects switching from placebo to ENBREL at Week 1221

bagel

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Dr. Jerry Bagel discusses the efficacy of ENBREL in treating PsO scalp involvement

Additional Study Details and Study Schema

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Scalp Involvement Trial Scalp Involvement Trial

a 124 patients were randomized; 121 received at least one dose.

Selected Baseline Demographics1

Age (mean) 42 years
Male 56%
Caucasian 73%
Weight (mean) 197 lb (92-337 lb)
Body mass index (mean) 31
BSA involvement (mean) 22%
Scalp improvement (mean) 64%
PsO duration (mean) 18 years
PASI (mean) 18
PSSI (mean) 35

Reference:

  1. Data on file, Amgen; CSR 20080014. July 22, 2010.

PSSI Results

  • 91% mean PSSI improvement at Week 2421

Mean Percent Improvement in PSSI Score at Weeks 12 and 24 in the ENBREL Scalp Involvement Study21,a

Mean Percent Improvement in PSSI Score at Weeks 12 and 24 in the ENBREL Scalp Involvement Study Mean Percent Improvement in PSSI Score at Weeks 12 and 24 in the ENBREL Scalp Involvement Study

a ITT analysis with LOCF imputation.

b P<0.0001 vs placebo.

  • Among PSSI 75 achievers, the median time to PSSI 50 and PSSI 75 was approximately 4 weeks and approximately 8 weeks, respectively23

PASI Results

Mean Percent Improvement in PASI Score at Weeks 12 and 24 in the ENBREL Scalp Involvement Study21,22,a

Mean Percent Improvement in PASI Score at Weeks 12 and 24 in the ENBREL Scalp Involvement Study Mean Percent Improvement in PASI Score at Weeks 12 and 24 in the ENBREL Scalp Involvement Study

a ITT analysis with LOCF imputation.

Photos of Patients in Scalp Involvement Study

  • These are actual photos from ENBREL clinical trial patients and depict only a select area of the patients' scalp involvement. Included below the photos are the patients' actual PSSI scores at baseline, Week 12, and Week 2422,24-26
Photos of Patients in Scalp Involvement Study Photos of Patients in Scalp Involvement Study

Scalp Itch Scores

Patients experienced less scalp itch with ENBREL
  • The severity of scalp pain was assessed by patients based on a single-item questionnaire rating it on a scale of 0 (none) to 5 (severe)22,27
  • Scalp pain was assessed as an exploratory endpoint in this study and no statistical conclusions can be drawn22

Improvement in Mean Itch Score Through Week 2422,27,a,b

Improvement in Mean Itch Score Throughout Week 24 Improvement in Mean Itch Score Throughout Week 24

a Subjects were asked to rate their scalp itch as a component of a psoriasis clinical trial, so it can be reasonably assumed that the subjects answered this question attributing the scalp itch to their moderate to severe plaque psoriasis.

b ITT analysis with LOCF imputation.

Scalp Pain Scores

Patients experienced less scalp pain with ENBREL

Improvement in Mean Pain Score Through Week 2422,27,a,b

Improvement in Mean Pain Score Through Week 24 Improvement in Mean Pain Score Through Week 24

a Subjects were asked to rate their scalp itch as a component of a psoriasis clinical trial, so it can be reasonably assumed that the subjects answered this question attributing the scalp itch to their moderate to severe plaque psoriasis.

b ITT analysis with LOCF imputation.

Psoriatic Arthritis (PsA)

 

Psoriatic Arthritis (PsA)

1 out of 3 PsO patients may develop PsA

kircik

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Dr. Leon Kircik discusses the efficacy of ENBREL in treating psoriatic arthritis

Pediatric Psoriasis Pivotal Study

Results in patients ages 4-17

Pediatric Psoriasis Pivotal Study

Results in patients ages 4-17

Study Design

The Pediatric Psoriasis Pivotal Study was a 48-week, randomized, double-blind, placebo-controlled US and Canadian study (parent study) in 211 patients with moderate to severe plaque PsO between 4 and 17 years of age. Patients were randomized in double-blind treatment to receive ENBREL once weekly (QW, dosing of 0.8 mg/kg up to a maximum dose of 50 mg, n=106) or placebo (n=105) over 12 weeks. After Week 12, all patients (n=208) received open-label ENBREL QW for 24 weeks. After Week 36, patients were re-randomized in double-blind treatment to receive ENBREL QW (n=69) or placebo (n=69) for 12 weeks. The primary study was followed up by a 264-week (5-year; n=182) OLE. All patients in the OLE received ENBREL QW.5,29,30

eichenfield

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Dr. Larry Eichenfield discusses the Pediatric PsO efficacy data

Additional Study Details and Study Schema

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  • No loading dose or dose adjustments were made except for those based on weight1
  • Primary endpoint: PASI 75 at Week 122
  • Select secondary endpoints: PASI 50, PASI 90, sPGA of clear or almost clear2
  • OLE primary endpoints: Subject incidence of adverse events, including infectious episodes, serious adverse events, and serious infectious episodes3
  • OLE secondary endpoints: PASI 50/75/90 and sPGA of clear or almost clear3
  • 42% of all patients (n=89/211) had a baseline weight of >62.5 kg (>138 lb)1
  • Of the 89 patients, 47 received the maximum dose of ENBREL 50 mg QW and 42 received placebo QW during the 12-week, randomized, double-blind treatment phase2

Pediatric Pivotal Study

Pediatric Pivotal Study

a If PASI score worsened >50% at or after Week 4, patients could receive open-label ENBREL.

b Patients who did not reach PASI 50 at Week 24 or PASI 75 at Week 36 could discontinue or add low to moderate topical corticosteroids.

c Patients who lost PASI 75 resumed open-label ENBREL treatment.

d At Week 312, n=69.

Inclusion Criteria2,4

4-17 years old
Moderate to severe plaque PsO defined as:
  • PASI ≥12
  • Involvement of ≥10% pf BSA
  • sPGA ≥3
Disease duration ≥6 months
Had a history of receiving phototherapy or systemic therapy, or were inadequately controlled on topical therapy

Selected Baseline Demographics2,5

Age, mean
  • 4-11 years
  • 12-17 years

13 Years

36%

64%

Weight, mean (range) 136.3 lb (37.9-371.0 lb)
Height, mean (range) 61.2 in (40.9-75.0 in)
BSA involvement, mean (range) 25% (10.0-95.0)
Previously treated with systemic therapy or phototherapy 57%
Male 51%
Caucasiana 75%
Duration of PsO, mean 6.0 years
PASI, mean (range) 18.5 (12.0-56.7)
PASI, median 16.4

a 25% were Black or African American, Hispanic or Latino, Asian, Native Hawaiian or Other Pacific Islander, or Other5

References:

  1. Data on file, Amgen; Number of Subjects with Baseline Weight Over Certain Threshold. September 20, 2016.
  2. Paller AS, Siegfried EC, Langley RG, et al; for the Etanercept Pediatric Psoriasis Study Group. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med. 2008;358:241-251.
  3. Data on file, Amgen; CSR 20050111 Pediatric Psoriasis Open-Label Extension. June 1, 2012.
  4. ENBREL (etanercept) Prescribing Information. Thousand Oaks, CA: Immunex Corporation; 6/2019.
  5. Data on file, Amgen; CSR 20030211 Pediatric Psoriasis Double-Blind. September 18, 2006.

Primary Endpoint and Additional Efficacy Results

  • Primary endpoint: 57% of patients achieved PASI 75 with ENBREL vs 11% with placebo (P<0.001) at Week 1230
  • 52% of patients treated with ENBREL had an sPGA of clear or almost clear vs 13% of patients treated with placebo at Week 125,30
  • Prespecified exploratory endpoint: 69% mean PASI improvement with ENBREL vs 32% with placebo at Week 1231†
  • OLE primary endpoint: Long-term safety profile for up to 264 additional weeks was assessed in an open-label extension study; no new safety signals were identified5

† ITT NRI analysis.

PASI Results Through 36 Weeks

Patients Who Achieved a PASI 50/75/90 Response at Week 12 and Through Week 36 While Taking ENBREL Throughout30,31,a,b

Patients Who Achieved a PASI 50/75/90 Response at Week 12 and Through Week 36 While Taking ENBREL Throughout

Patients Who Achieved a PASI 50/75/90 Response at Week 12 and Through Week 36 While Taking ENBREL Throughout

  • 23%, 11%, and 7% of patients treated with placebo achieved PASI 50, PASI 75, and PASI 90, respectively, at 12 weeks (n=105; P<0.0001)31,b
  • 86%, 65%, and 38% of patients who switched from placebo to ENBREL achieved PASI 50, PASI 75, and PASI 90, respectively, at 36 weeks (Weeks 0-12: n=105; Weeks 16-36: n=103)30

a Open-label period or incomplete-responder arm; patients could enter the incomplete-responder arm at Week 24 or Week 36.

b ITT NRI analysis.

PASI Results Through 312 Weeks

Results through 312 weeks in the combined primary study and open-label extension

Percent of ENBREL Patients Who Achieved a PASI 50/75/90 Response Through 312 Weeks29,32,a (ITT as Observed)

Percent of ENBREL Patients Who Achieved a ASI 50/75/90 Response Through 312 Weeks (ITT as Observed)

Percent of ENBREL Patients Who Achieved a ASI 50/75/90 Response Through 312 Weeks (ITT as Observed)

a Patients were treated and evaluated for 5 years or until they turned 18, whichever came last. Seven patients discontinued due to disease progression (3.8%).33

Consider OLE study limitations when interpreting the above results. The OLE study is not blinded, not controlled, and includes inherent self-selection bias. A total of 6 patients (3.3%) had adverse events that led to discontinuation of ENBREL and 5 patients (2.7%) had adverse events that led to discontinuation of the study.33

sPGA Results Through 36 Weeks

  • Approximately half of pediatric ENBREL patients were clear or almost clear at 12 through 36 weeks30

sPGA of Clear or Almost Clear at Week 12 and Through 36 Weeks5,30,31,a

sPGA of Clear or Almost Clear at Week 12 and Through 36 Weeks

sPGA of Clear or Almost Clear at Week 12 and Through 36 Weeks

ENBREL: n=106 through Week 12 and n=105 through Week 36. Placebo/ENBREL: n=105 through Week 12 and n=103 through Week 36.

52% of patients were clear or almost clear with ENBREL vs 13% with placebo at 12 weeks5,30

sPGA Results Through 312 Weeks

Results through 312 weeks in the combined primary study and open-label extension
  • ~4 out of 10 patients treated with ENBREL consistently experienced clear or almost clear skin through 312 weeks34‡

‡ ITT NRI analysis.

sPGA of Clear or Almost Clear Through 312 Weeks (as Observed)29,34

sPGA of Clear or Almost Clear Through 312 Weeks (as Observed)

sPGA of Clear or Almost Clear Through 312 Weeks (as Observed)

Consider OLE study limitations when interpreting the above results. The OLE study is not blinded, not controlled, and includes inherent self-selection bias. A total of 6 patients (3.3%) had adverse events that led to discontinuation of ENBREL and 5 patients (2.7%) had adverse events that led to discontinuation of the study.33

Results by BMI Post Hoc Analysis

Post Hoc BMI Subgroup Analysis:
Patients Who Achieved PASI 75 at Week 1235,a

Post Hoc BMI Subgroup Analysis: Patients Who Achieved PASI 75 at Week 12

Post Hoc BMI Subgroup Analysis: Patients Who Achieved PASI 75 at Week 12

a Healthy weight = body mass index (BMI) 5th-84th percentile; overweight = BMI 85th-94th percentile; obese = BMI ≥95th percentile.36

  • Post hoc analysis is exploratory and no statistical conclusions can be drawn

MODERATE TO SEVERE PLAQUE PSORIASIS

Learn about the PsO safety resultsfooter-cta-icon

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 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 REACTIONS

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 REACTIONS

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. Pediatric patients, if possible, should be brought up to date with all immunizations prior to initiating ENBREL. In patients with exposure to varicella virus, temporarily discontinue ENBREL and consider 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 REACTIONS

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

In general, the adverse reactions in pediatric patients were 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 (RA). ENBREL can be initiated in combination with methotrexate (MTX) or used alone.

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 the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

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

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

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.