Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis

• ClinicalTrials.gov Identifier: NCT00322439
• Recruitment Status: Completed
• First Posted: May 8, 2006
• Results First Posted: March 26, 2014
• Last Update Posted: June 28, 2018
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Study Description

Brief Summary:

This is an observational safety study tracking psoriasis patients on etanercept (Enbrel) for 5 years.

Condition or disease	Intervention/treatment
Psoriasis	Drug: Etanercept

Detailed Description:

This is a prospective, multi-center, observational surveillance registry to evaluate data on the long-term safety of etanercept (Enbrel) use in the treatment of psoriasis.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 2511 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Official Title: Observational Post-Marketing Safety Surveillance Registry of Enbrel (Etanercept) for Treatment of Psoriasis
• Actual Study Start Date: May 1, 2006
• Actual Primary Completion Date: December 11, 2012
• Actual Study Completion Date: February 8, 2013

Groups and Cohorts

Group/Cohort

Intervention/treatment

Etanercept; Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.

Drug: Etanercept; Observational study - no drug administered

Outcome Measures

Primary Outcome Measures :

1. Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events [ Time Frame: 5 years ]
   A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor's opinion on the relationship to a drug product. This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept. For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time).

Secondary Outcome Measures :

1. Five-year Cumulative Incidence for Events of Medical Interest (EMIs) [ Time Frame: 5 years ]
   Protocol defined EMIs included: • All malignancies, including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC); • Tuberculosis; • Opportunistic infections treated with intravenous therapy; • Histoplasmosis infections treated with oral antibiotics; • Coccidioidomycosis infections treated with oral antibiotics; • Central nervous system (CNS) demyelinating disorders; • Lupus disease; • Coronary artery disease; • Worsening of psoriasis as defined by change in psoriasis morphology and withdrawal of therapy; • Any event or laboratory abnormality that represents an event of medical significance. Cumulative incidences were calculated using Kaplan-Meier methods where time to event was defined as the time from the first dose of etanercept to the start date of the first occurrence of the event, regardless of exposure (ie, based on observation time). Estimates were adjusted using left truncation methodology to help address any bias due to participants with prior etanercept exposure.
2. Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) [ Time Frame: Baseline and at 3 and 5 years ]
   The sPGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).
3. Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1 [ Time Frame: Baseline and at 3 and 5 years ]
   The patient's global assessment of psoriasis is a self-administered numeric scale is designed to evaluate participants' perception of their psoriasis on a scale from 0 (good) to 5 (severe).
4. Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response [ Time Frame: Baseline, Year 3 and Year 5 ]
   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 answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A DLQI response is defined as a 5 point improvement from Baseline or a score of 0.
5. Euroqol-5D (EQ-5D) Total Score [ Time Frame: Baseline, Year 3 and Year 5 ]
   EQ-5D is a self-reported questionnaire that consists of five single-item health domains, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers are recorded as choices of 1, 2, or 3 for each question, with 1 signifying no problem, 2 signifying some problem, and 3 signifying major problem. Using the US scoring algorithm, the possible total EQ-5D score ranges from -0.11 (ie, answered '3' for all questions) to 1.0 (ie, answered '1' for all questions), where 1.0 represents perfect health.
6. Euroqol-5D (EQ-5D) Visual Analog Scale (VAS) [ Time Frame: Baseline, Year 3 and Year 5 ]
   The EQ-5D visual analog scale (VAS) is a 100 mm scale with 100 representing 'best imaginable health state' and 0 representing 'worst imaginable health state'. Participants were asked to indicate on this scale how good or bad their health was today.
7. Healthcare Resource Use [ Time Frame: Baseline, Year 3 and Year 5 ]

   This self-administered questionnaire is designed to measure the amount of healthcare resource utilization by the participant in the past 4 weeks. The average answers to the following questions are reported:

   1. How many times have you been to any physician's office or urgent care clinic, not including your dermatologist?
   2. How many times have you seen a nurse practitioner, physician assistant, psychologist, naturopath, acupuncturist, or chiropractor?
   3. How many times have you received care from a health professional (HP) in your home?
   4. How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)?
   5. How many times have you had a friend or family member take time off work to provide care or transportation?
8. Work Productivity and Activity Impairment (WPAI) [ Time Frame: Baseline, Year 3 and Year 5 ]
   The WPAI questionnaire has 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 (ie, worse outcomes).
9. Percentage of Body Surface Area Affected by Psoriasis [ Time Frame: Baseline, Year 3 and Year 5 ]
   Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.

Biospecimen Retention:   Samples With DNA

Whole blood, serum, plasma.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients with plaque psoriasis, who are currently receiving Enbrel or who are intending to start or restart Enbrel therapy at multi-centers.

Criteria

Inclusion Criteria:

• Patients with plaque psoriasis

Exclusion Criteria:

• Prior exposure to any tumor necrosis factor (TNF)-inhibitor
• Patients for whom Enbrel is contraindicated
• Patients currently enrolled in or has not yet completed at least 30 days since ending other investigational drug study.

Contacts and Locations

Sponsors and Collaborators

Amgen

Investigators

• Study Director: MD; Amgen

More Information

Additional Information:

AmgenTrials clinical trials website 

Publications:

Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Creamer K, McCroskery P, Kricorian G, Gelfand JM. OBSERVE-5, an Observational Post-Marketing SafetySurveillance Registry of Etanercept for the treatment of Psoriasis: A Model for Studying New Psoriasis Therapies. Psoriasis Forum. 2010;16(3):3-7.

Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Yong M, Creamer K, Hooper M, Aras G, Kricorian G, Gelfand JM. OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis. J Am Acad Dermatol. 2013 May;68(5):756-64. doi: 10.1016/j.jaad.2012.10.055. Epub 2013 Jan 26.

Kimball AB, Rothman KJ, Kricorian G, Pariser D, Yamauchi PS, Menter A, Teller CF, Aras G, Accortt NA, Hooper M, Rice KC, Gelfand JM. OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results. J Am Acad Dermatol. 2015 Jan;72(1):115-22. doi: 10.1016/j.jaad.2014.08.050. Epub 2014 Sep 26.

Kimball AB, Schenfeld J, Accortt NA, Anthony MS, Rothman KJ, Pariser D. Incidence rates of malignancies and hospitalized infectious events in patients with psoriasis with or without treatment and a general population in the U.S.A.: 2005-09. Br J Dermatol. 2014 Feb;170(2):366-73. doi: 10.1111/bjd.12744.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT00322439
• Other Study ID Numbers: 20040210
• First Posted: May 8, 2006
• Results First Posted: March 26, 2014
• Last Update Posted: June 28, 2018
• Last Verified: May 2018

Keywords provided by Amgen:

plaque Psoriasis patients; TNF-inhibitor naïve

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Etanercept; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Immunosuppressive Agents; Immunologic Factors