Moderate to SeverePlaque Psoriasis

Efficacy Data

Review ENBREL’s clinical study designs and results in treating patients with moderate to severe plaque psoriasis (PsO)

US Psoriasis 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. 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 of 50 mg BIW for patients with an inadequate clinical response.^3,4

Additional Study Details and Study Schema

Primary Endpoint

~49% of patients achieved a PASI 75 score by Week 12 in the ENBREL 50 mg BIW group (n=164, last observation carried forward (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
- 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
Improvement in Mean PASI in the US Psoriasis Pivotal Trial^3,6
*Patients who completed 12 weeks of retreatment.¹

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

^‡Last observation carried forward (LOCF).

^§As observed.

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Recapture Results Through 132 Weeks
94% of the Week 24 response was recaptured at Week 60⁷

Mean % of PASI Improvement From the US Psoriasis Pivotal
Trial and the OLE^3,7
- The following patients were not included in this OLE efficacy analysis:
–Patients (n=37) in the ENBREL 50 mg BIW group after Week 12 during the US Psoriasis Pivotal Trial who were randomized to the 50 mg QW group through 72 weeks of the OLE⁷

–Patients (n=284) who increased their ENBREL dose to 50 mg BIW after Week 12 during the OLE⁸

–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 OLE⁹

–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
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sPGA, static Physician's Global Assessment.

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.^4,10,11

Additional Study Details and Study Schema

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)⁶
- 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)¹³
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PASI Results Through Week 120
Mean PASI Improvement (%) During the Global Psoriasis
Pivotal Trial and the OLE^7,10
- 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)⁸

–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 OLE⁹
- 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 weeks¹⁰
- 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
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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 24^14,15
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ITT, intent-to-treat; LOCF, Last observation carried forward; mITT, modified intent-to-treat; NRI, nonresponder imputation; RCT, randomized controlled trial.

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).¹⁶

Primary endpoint: PASI 75 at Week 12¹⁷
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 12¹⁷
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 itch¹⁷

*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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Primary Endpoint Result

47% of patients achieved PASI 75 with ENBREL (mean baseline PASI=18.3)¹⁶

Itch Scores

58% improvement in mean itch score relative to the mean baseline score.¹⁷

Improvement in Mean Itch Score at Week 12 (LOCF)¹⁷

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Pain Scores

68% improvement in mean skin pain score relative to the mean baseline score¹⁷

Improvement in Mean Skin Pain Score at Week 12 (LOCF)¹⁷

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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. 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).^18,19

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 alone¹⁸
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)¹⁸
Primary endpoint: Percent improvement from baseline PSSI at Week 12¹⁸
Select secondary endpoints: PSSI 75 at Week 12, percent change in PSSI from Week 12 to Week 24 in subjects switching from placebo to ENBREL at Week 12¹⁸

Additional Study Details and Study Schema

PSSI Results
- 91% mean PSSI improvement at Week 24¹⁸
- Among PSSI 75 achievers, the median time to PSSI 50 and PSSI 75 was approximately 4 weeks and approximately 8 weeks, respectively²⁰
Mean Percent Improvement in PSSI Score at Weeks 12 and 24
in the ENBREL Scalp Involvement Study^18*
*ITT analysis with LOCF imputation.

^†P<0.0001 vs placebo.

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PASI Results

78% mean PASI improvement at Week 24¹⁹

Mean Percent Improvement in PASI Score at Weeks 12 and 24 in the ENBREL Scalp Involvement Study^18,19*

*ITT analysis with LOCF imputation.

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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 24²¹
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Scalp Itch Scores
Patients experienced less scalp itch with ENBREL
- The severity of scalp itch was assessed by patients based on a single-item questionnaire rating it on a scale of 0 (none) to 5 (severe)¹⁹
- Scalp itch was assessed as an exploratory endpoint in this study and no statistical conclusions can be drawn¹⁹
Improvement in Mean Itch Score Through Week 24^19*†
*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.

^†ITT analysis with LOCF imputation.

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Scalp Pain Scores
Patients experienced less scalp pain with ENBREL
- The severity of scalp pain was assessed by patients on a scale of 0 (none) to 10 (severe)¹⁹
- Scalp pain was assessed as an exploratory endpoint in this study and no statistical conclusions can be drawn¹⁹
Improvement in Mean Pain Score Through Week 24^19*†
*Subjects were asked to rate their scalp pain as a component of a psoriasis clinical trial, so it can be reasonably assumed that the subjects answered this question attributing the scalp pain to their moderate to severe plaque psoriasis.

^†ITT analysis with LOCF imputation.

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Psoriatic Arthritis (PsA)

Learn about the psoriatic arthritis trial with Enbrel® (etanercept)

1 out of 3

PsO patients may develop PsA²²

Learn about the PsA Trial with ENBREL

Pediatric Psoriasis Pivotal Study

Evaluated patients with plaque PsO between 4 and 17 years of age over 48 weeks

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.^6,23,24

Additional Study Details and Study Schema

No loading dose or dose adjustments were made except for those based on weight²⁵
Primary endpoint: PASI 75 at Week 12²⁴
Select secondary endpoints: PASI 50, PASI 90, sPGA of clear or almost clear²⁴
OLE primary endpoints: Subject incidence of adverse events, including infectious episodes, serious adverse events, and serious infectious episodes²⁶
OLE secondary endpoints: PASI 50/75/90 and sPGA of clear or almost clear²⁶
42% of all patients (n=89/211) had a baseline weight of >62.5kg (>138lb)²⁵
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 phase²⁴

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

^†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.

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

^§At Week 312, n=69.

Inclusion Criteria^6,24

4-17 years old

Moderate to severe plaque PsO defined as:

PASI ≥12
Involvement of ≥10% of 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 Demographics²⁷

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%
Caucasian**	75%
Duration of PsO, mean	6.0 years
PASI, mean (range)	18.5 (12.0-56.7)
PASI, median	16.4

**25% were Black or African American, Hispanic or Latino, Asian, Native Hawaiian or Other Pacific Islander, or Other.²⁷

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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 12²⁴
52% of patients treated with ENBREL had an sPGA of clear or almost clear vs 13% of patients treated with placebo at Week 12⁶
Prespecified exploratory endpoint: 69% mean PASI improvement with ENBREL vs 32% with placebo at Week 12²⁸
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 identified⁶

PASI Results Through 36 Weeks
- 23%, 11%, and 7% of patients treated with placebo achieved PASI 50, PASI 75, and PASI 90, respectively, at 12 weeks (n=105)²⁸
- 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)²⁴
Patients Who Achieved a PASI 50/75/90 Response at Week 12 and
Through Week 36 While Taking ENBREL Throughout^28*†
*Open-label period or incomplete-responder arm; patients could enter the incomplete-responder arm at Week 24 or Week 36.

^†ITT NRI analysis.

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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 Weeks^23,29* (ITT as Observed)

*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%).²⁹

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.²⁸

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sPGA Results Through 36 Weeks
- Approximately half of pediatric ENBREL patients were clear or almost clear at 12 through 36 weeks²⁴
- 52% of patients were clear or almost clear with ENBREL vs 13% with placebo at 12 weeks⁶
sPGA of Clear or Almost Clear at Week 12 and
Through 36 Weeks^6,24,28*
*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.

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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 weeks³⁰*
*ITT NRI analysis.

sPGA of Clear or Almost Clear Through 312 Weeks (as Observed)^23,30
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.²⁸

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Results by Body Mass Index (BMI) Post Hoc Analysis
Post Hoc BMI Subgroup Analysis: Patients Who Achieved PASI 75 at Week 12³¹*
*Healthy weight = body mass index (BMI) 5th-84th percentile; overweight = BMI 85th-94th percentile; obese = BMI ≥95th percentile.³²
- Post hoc analysis is exploratory and no statistical conclusions can be drawn
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References:

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.
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; CSR 1639. October 8, 2003.
Data on file, Amgen; CSR 115. November 28, 2005.
Data on file, Amgen; CSR 1639 3 Month. June 11, 2003.
Enbrel^® (etanercept) Prescribing Information. Thousand Oaks, CA: Immunex Corporation.
Data on file, Amgen; CSR 115 Subanalysis. December 21, 2009.
Elewski B, Leonardi C, Gottlieb A, et al. Sustained long-term clinical efficacy and safety for up to 2.5 years of etanercept in patients with psoriasis. Poster presented at: 64th Annual Meeting of the American Academy of Dermatology; March 3-7, 2006; San Francisco, CA.
Data on file, Amgen; CSR 115 Biostats Memo. October 18, 2011.
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; CSR 1642. October 8, 2003.
Data on file, Amgen; CSR 1642. May 29, 2003.
Data on file, Amgen; CSR 1642 Subanalysis. May 31, 2007.
Data on file, Amgen; 1642 Subanalysis Patient PASI Data. May 25, 2007.
Data on file, Amgen; 1642 Subanalysis Patient PASI Data Photos. May 25, 2007.
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.
Data on file, Amgen; CSR 20030117 Week 12 Readout. June 17, 2004.
Bagel J, Lynde C, Tyring S, Kricorian G, et al. Moderate to severe plaque psoriasis with scalp involvement: a randomized, double-blind, placebo-controlled study of etanercept. J Am Acad Dermatol. 2012;67:86-92.
Data on file, Amgen; CSR 20080014. July 22, 2010.
Data on file, Amgen; Biostats Memorandum Psoriasis Flares in Pivotal Studies. May 11, 2016.
Data on file, Amgen; CSR 20080014 Scalp Photos. July 22, 2010.
National Psoriasis Foundation Website. About Psoriatic Arthritis. https://www.psoriasis.org/about-psoriatic-arthritis. Accessed August 28, 2019.
Paller AS, Siegfried EC, Pariser DM, et al. Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis. J Am Acad Dermatol. 2016;74:280-287.
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.
Data on file, Amgen; Number of Subjects with Baseline Weight Over Certain Threshold. September 20, 2016.
Data on file, Amgen; CSR 20050111 Pediatric Psoriasis Open-Label Extension. June 1, 2012.
Data on file, Amgen; CSR 20030211 Pediatric Psoriasis Double-Blind. September 18, 2006.
Data on file, Amgen; CSR 20030211 Pediatric Final Report. July 16, 2007.
Data on file, Amgen; CSR 20050111 Pediatric Psoriasis Open-Label Extension PASI 50, 75, 90 Baseline to Week 264.
Data on file, Amgen; CSR 20050111 Pediatric Psoriasis Open-Label Extension sPGA Baseline to Week 264. April 21, 2017.
Data on file, Amgen; Pediatric CSR 20030211 PsO PASI 75 and Weight.
Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007;120(suppl 4):S164-S192.

Age (mean)	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

Age (median)	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

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

INDICATIONS

Moderate to SeverePlaque Psoriasis

Efficacy Data

US Psoriasis Pivotal Trial

Study Design

US Psoriasis Pivotal Trial^2-4 (N=652)

Selected Baseline Demographics^1,5

Primary Endpoint

Improvement in Mean PASI in the US Psoriasis Pivotal Trial^3,6

Mean % of PASI Improvement From the US Psoriasis Pivotal
Trial and the OLE^3,7

Global Psoriasis Pivotal Trial

Study Design

Global Psoriasis Pivotal Trial^4,10,11 (N=583)

Selected Baseline Demographics^9,12

Mean PASI Improvement (%) During the Global Psoriasis
Pivotal Trial and the OLE^7,10

Additional Phase 3 Study

Study Design

Primary Endpoint Result

Improvement in Mean Itch Score at Week 12 (LOCF)¹⁷

Improvement in Mean Skin Pain Score at Week 12 (LOCF)¹⁷

Scalp Involvement Study

Study Design

Selected Baseline Demographics¹⁹

Mean Percent Improvement in PSSI Score at Weeks 12 and 24
in the ENBREL Scalp Involvement Study^18*

Mean Percent Improvement in PASI Score at Weeks 12 and 24 in the ENBREL Scalp Involvement Study^18,19*

Improvement in Mean Itch Score Through Week 24^19*†

Improvement in Mean Pain Score Through Week 24^19*†

Psoriatic Arthritis (PsA)

Pediatric Psoriasis Pivotal Study

Study Design

Inclusion Criteria^6,24

Selected Baseline Demographics²⁷

Primary Endpoint and Additional Efficacy Results

Patients Who Achieved a PASI 50/75/90 Response at Week 12 and
Through Week 36 While Taking ENBREL Throughout^28*†

Percent of ENBREL Patients Who Achieved a PASI 50/75/90 Response
Through 312 Weeks^23,29* (ITT as Observed)

sPGA of Clear or Almost Clear at Week 12 and
Through 36 Weeks^6,24,28*

sPGA of Clear or Almost Clear Through 312 Weeks (as Observed)^23,30

Post Hoc BMI Subgroup Analysis: Patients Who Achieved PASI 75 at Week 12³¹*

Moderate to SeverePlaque Psoriasis

Efficacy Data

US Psoriasis Pivotal Trial

Study Design

US Psoriasis Pivotal Trial2-4 (N=652)

Selected Baseline Demographics1,5

Primary Endpoint

Improvement in Mean PASI in the US Psoriasis Pivotal Trial3,6

Mean % of PASI Improvement From the US Psoriasis Pivotal Trial and the OLE3,7

Global Psoriasis Pivotal Trial

Study Design

Global Psoriasis Pivotal Trial4,10,11 (N=583)

Selected Baseline Demographics9,12

Mean PASI Improvement (%) During the Global Psoriasis Pivotal Trial and the OLE7,10

Additional Phase 3 Study

Study Design

Primary Endpoint Result

Improvement in Mean Itch Score at Week 12 (LOCF)17

Improvement in Mean Skin Pain Score at Week 12 (LOCF)17

Scalp Involvement Study

Study Design

Selected Baseline Demographics19

Mean Percent Improvement in PSSI Score at Weeks 12 and 24 in the ENBREL Scalp Involvement Study18*

Mean Percent Improvement in PASI Score at Weeks 12 and 24 in the ENBREL Scalp Involvement Study18,19*

Improvement in Mean Itch Score Through Week 2419*†

Improvement in Mean Pain Score Through Week 2419*†

Psoriatic Arthritis (PsA)

Pediatric Psoriasis Pivotal Study

Study Design

Inclusion Criteria6,24

Selected Baseline Demographics27

Primary Endpoint and Additional Efficacy Results

Patients Who Achieved a PASI 50/75/90 Response at Week 12 and Through Week 36 While Taking ENBREL Throughout28*†

Percent of ENBREL Patients Who Achieved a PASI 50/75/90 Response Through 312 Weeks23,29* (ITT﻿ as﻿ Observed)

sPGA of Clear or Almost Clear at Week 12 and Through 36 Weeks6,24,28*

sPGA of Clear or Almost Clear Through 312 Weeks (as﻿ Observed)23,30

Post Hoc BMI Subgroup Analysis: Patients Who Achieved PASI 75 at Week 1231*

US Psoriasis Pivotal Trial^2-4 (N=652)

Selected Baseline Demographics^1,5

Improvement in Mean PASI in the US Psoriasis Pivotal Trial^3,6

Mean % of PASI Improvement From the US Psoriasis Pivotal
Trial and the OLE^3,7

Global Psoriasis Pivotal Trial^4,10,11 (N=583)

Selected Baseline Demographics^9,12

Mean PASI Improvement (%) During the Global Psoriasis
Pivotal Trial and the OLE^7,10

Improvement in Mean Itch Score at Week 12 (LOCF)¹⁷

Improvement in Mean Skin Pain Score at Week 12 (LOCF)¹⁷

Selected Baseline Demographics¹⁹

Mean Percent Improvement in PSSI Score at Weeks 12 and 24
in the ENBREL Scalp Involvement Study^18*

Mean Percent Improvement in PASI Score at Weeks 12 and 24 in the ENBREL Scalp Involvement Study^18,19*

Improvement in Mean Itch Score Through Week 24^19*†

Improvement in Mean Pain Score Through Week 24^19*†

Inclusion Criteria^6,24

Selected Baseline Demographics²⁷

Patients Who Achieved a PASI 50/75/90 Response at Week 12 and
Through Week 36 While Taking ENBREL Throughout^28*†

Percent of ENBREL Patients Who Achieved a PASI 50/75/90 Response
Through 312 Weeks^23,29* (ITT as Observed)

sPGA of Clear or Almost Clear at Week 12 and
Through 36 Weeks^6,24,28*

sPGA of Clear or Almost Clear Through 312 Weeks (as Observed)^23,30

Post Hoc BMI Subgroup Analysis: Patients Who Achieved PASI 75 at Week 12³¹*