Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab

Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Lost a Satisfactory Response to Adalimumab

This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.

Study Overview

• Status: Terminated
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Etanercept

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Research Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 0A2
      • Research Site
  • Ontario
    • Markham, Ontario, Canada, L3P 1X2
      • Research Site
    • Peterborough, Ontario, Canada, K9J 1Z2
      • Research Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Research Site
    • Mobile, Alabama, United States, 36609
      • Research Site
  • Arizona
    • Phoenix, Arizona, United States, 85044
      • Research Site
  • California
    • Bakersfield, California, United States, 93309
      • Research Site
    • Encino, California, United States, 91436
      • Research Site
    • Irvine, California, United States, 92697
      • Research Site
    • Los Angeles, California, United States, 90045
      • Research Site
    • Sacramento, California, United States, 95816
      • Research Site
    • San Francisco, California, United States, 94118
      • Research Site
    • San Ramon, California, United States, 94583
      • Research Site
    • Santa Monica, California, United States, 90404
      • Research Site
  • Colorado
    • Denver, Colorado, United States, 80220
      • Research Site
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Research Site
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Research Site
    • Miami, Florida, United States, 33136
      • Research Site
    • Saint Petersburg, Florida, United States, 33708
      • Research Site
    • Tampa, Florida, United States, 33607
      • Research Site
    • Tampa, Florida, United States, 33609
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Research Site
    • Macon, Georgia, United States, 31217
      • Research Site
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Research Site
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Research Site
    • Plainfield, Indiana, United States, 46168
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Research Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Research Site
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Research Site
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Research Site
    • Verona, New Jersey, United States, 07044
      • Research Site
  • New York
    • Rochester, New York, United States, 14625
      • Research Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Research Site
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Research Site
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Research Site
  • Tennessee
    • Bartlett, Tennessee, United States, 38134
      • Research Site
    • Knoxville, Tennessee, United States, 37917
      • Research Site
    • Nashville, Tennessee, United States, 37215
      • Research Site
  • Texas
    • Dallas, Texas, United States, 75231
      • Research Site
    • Houston, Texas, United States, 77004
      • Research Site
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Research Site
  • Washington
    • Walla Walla, Washington, United States, 99362
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Moderate to severe plaque psoriasis
• Loss of satisfactory response to adalimumab
• Currently receiving or recently discontinued treatment with adalimumab

Exclusion Criteria:

• Active skin conditions that would interfere with evaluations of the effect of investigational product on psoriasis
• Serious medical conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Etanercept 50 mg; Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.	Drug: Etanercept; Administered by subcutaneous injection; Other Names: Enbrel®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).	Week 12
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).	Weeks 4, 8, 16, 20 and 24
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).	Weeks 4, 8, 16, 20 and 24
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.	Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.	Weeks 4, 8, 12, 16, 20 and 24
Static Physician Global Assessment (sPGA) at Each Visit	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).	Weeks 4, 8, 12, 16, 20 and 24
Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).	Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With a PASI 50 Response at Each Visit	A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit	A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With a PASI 75 Response at Each Visit	A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit	A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With a PASI 90 Response at Each Visit	A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit	A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status	The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)	The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status	The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis	A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status	A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Patient Satisfaction With Treatment at Week 12	Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".	Week 12
Patient Satisfaction With Treatment at Week 24	Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".	Week 24
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score	The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.	Baseline and Weeks 12 and 24
Change From Baseline in Work Productivity and Activity Impairment (WPAI)	The impact of disease severity on the participant's ability to participate in work and other activities was evaluated using the WPAI. WPAI consists of six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.	Baseline and Weeks 12 and 24
Change From Baseline in Patient Assessment of Itch	The severity of the participants itch was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their itch, with 0 indicating "no itch at all" and 10 indicating "worst itch imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.	Baseline and Week 12 and 24
Change From Baseline in Patient Assessment of Pain	The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe how much their psoriasis hurts today, with 0 indicating "does not hurt at all" and 10 indicating "worst hurt imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.	Baseline and Week 12 and 24
Change From Baseline in Patient Assessment of Flaking	The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their flaking, with 0 indicating "no flaking at all" and 10 indicating "worst flaking imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.	Baseline and Week 12 and 24
Number of Participants With Adverse Events	A treatment-related adverse event is defined as an event that is deemed by the investigator to be related to investigational product.	From first dose of study drug until 30 days after the last dose (up to 28 weeks)

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Bagel J, Tyring S, Rice KC, Collier DH, Kricorian G, Chung J, Iles J, Stolshek BS, Kaliyaperumal A, Papp KA. Open-label study of etanercept treatment in patients with moderate-to-severe plaque psoriasis who lost a satisfactory response to adalimumab. Br J Dermatol. 2017 Aug;177(2):411-418. doi: 10.1111/bjd.15381. Epub 2017 Jul 19.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Actual): May 29, 2015
• Study Completion (Actual): May 29, 2015

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: February 27, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Actual): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: adalimumab; etanercept; plaque psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: 20101145