Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00708708

Collaborator

(none)

926

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This prospective observational cohort study will assess the average duration of the drug free interval between etanercept treatment cycles in usual care settings in Germany.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: etanercept (Enbrel®)

Detailed Description

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Study Design

Study Type:

Observational

Actual Enrollment :

926 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective Non-interventional Study (Nis) Of The Routine Use Of Etanercept In The Long-term Treatment Of Patients With Plaque-type Psoriasis In Everyday Practice: An Efficacy, Safety, And Health Economic Evaluation

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
A Patients with moderate to severe plaque psoriasis	Drug: etanercept (Enbrel®) The patients will be treated in accordance with the requirements of the labeling of etanercept in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

Arm

Intervention/Treatment

Patients with moderate to severe plaque psoriasis

Drug: etanercept (Enbrel®)

The patients will be treated in accordance with the requirements of the labeling of etanercept in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

Outcome Measures

Primary Outcome Measures

Duration of Drug-Free Interval Prior to Treatment Cycle 2 [Cycle 1 Week 24 up to Cycle 2 Week 0]
Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 3 [Cycle 2 Week 24 up to Cycle 3 Week 0]
Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 4 [Cycle 3 Week 24 up to Cycle 4 Week 0]
Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 5 [Cycle 4 Week 24 up to Cycle 5 Week 0]
Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 6 [Cycle 5 Week 24 up to Cycle 6 Week 0]
Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.

Secondary Outcome Measures

Psoriasis Area and Severity Index (PASI) Score [Week 0, 12, 24 of Cycle 1 to 6]
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent (%) area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. PASI score at Week 0 of each cycle signifies the disease activity at the time of resumption of etanercept therapy.
Percentage of Body Surface Area (BSA) Affected by Psoriasis [Week 0, 12, 24 of Cycle 1 to 6]
Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1% of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. The results of this outcome measure was summarized separately for participants without drug-free interval, participants with drug-free interval and remaining participants, as per planned analysis.
Static Physician Global Assessment (sPGA) of Disease Activity [Week 0, 12, 24 of Cycle 1 to 6]
Static physician global assessment (sPGA) of disease activity was assessed as 0 (no psoriasis) to 5 (severe disease) based on severity of induration, scaling, and erythema across all psoriatic lesions.
Physician Global Assessment of Efficacy [Week 24 of Cycle 1 to 6]
Physician assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.
Patient Global Assessment of Efficacy [Week 24 of Cycle 1 to 6]
Participant assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.
Number of Injections Per Year [Year 1, 2, 3, 4, 5]
Number of etanercept injections per year were calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.
Cumulative Dose of Etanercept Per Year [Year 1, 2, 3, 4, 5]
Cumulative dose of etanercept per year was calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.
Percentage of Time on Treatment in First Year [Year 1]
Percentage of time on etanercept treatment for first year was calculated. It was calculated as 100% * (365- sum of durations of drug-free intervals in the first year)/365. Analysis was not possible for participants with missing data of visit 1 (Week 0) of Cycle 1.
Percentage of Time on Treatment Over Entire Period [Cycle 1 up to Cycle 6]
Percentage of time on etanercept treatment over entire treatment period was calculated. It was calculated as 100% * ([Date of last application - Date of first application + 1] - Sum of duration of drug-free intervals [days])/(Date of last application - Date of first application + 1).
Patient's Global Assessment of Disease Activity (PatGA) [Week 0, 12, 24 of Cycle 1 to 6]
Participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity.
Dermatology Life Quality Index (DLQI) Score [Week 0, 12, 24 of Cycle 1 to 6]
DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) [Week 0, 12, 24 of Cycle 1 to 6]
EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state.
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) [Week 0, 12, 24 of Cycle 1 to 6]
EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.
Number of Participants With at Least 1 Concomitant Medication [Cycle 1 Week 0 up to Cycle 6 Week 24]
Number of participants taking any non-study medications which were administered during the period of etanercept treatment for the management of an adverse event or for the treatment of any other disease and not plaque psoriasis were reported.
Annual Costs for Treatment With Etanercept [Year 1, 2, 3, 4, 5]
Costs for treatment with etanercept per year up to 5 years was calculated in Euros. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.
Average Cost of Treatment by Disease Severity [Year 1, 2, 3, 4, 5]
Average costs for treatment with etanercept up to 5 years was calculated in Euros. Disease severity was categorized as mild (0 to 10 PASI score), moderate (10.1 to 20 PASI score) and severe (20.1 to 72 PASI score) at each year. PASI: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.
Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications [Prior to study, Year 1, 2, 3, 4, 5]
Annual costs for participants for treatment with etanercept due to out of pocket payments (included payments which were not reimbursed by the health insurance funds) and concomitant medications was reported per month for costs prior to study and per year for each year in the study up to 5 years. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.
Effect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA) [Week 0, 12, 24 of Cycle 1 to 6]
Effect of drug-free interval on PatGA was determined by comparing the PatGA scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". PatGA: participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity.
Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score [Week 0, 12, 24 of Cycle 1 to 6]
Effect of drug free interval on DLQI was determined by comparing the scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO) [Week 0, 12, 24 of Cycle 1 to 6]
Effect of drug free interval on EQ-5D was determined by comparing the scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state.
Participant Perception of Drug-Free Interval: Length of Drug-Free Interval [Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5]
A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "How long do you expect the drug-free interval to last for?" After the drug-free interval participants were asked, "How long did the drug-free interval last?" Results are reported for participant's perception of the length of drug-free interval.
Participant Perception of Drug-Free Interval: Reason for Returning to Practice [Before Cycle 2, 3, 4, 5, 6]
A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "Why did you return to the practice today?" Responses included unscheduled visit due to new occurrence of disease, scheduled visit or other reasons (included reasons like treatment of adverse event, get a prescription or examination after external treatment). Results are reported for reasons for returning to the practice.
Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval [Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5]
A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "Do you basically like the idea of a drug-free interval?" After the drug-free interval participants were asked, "How did you like the current drug-free interval?" Participants responded on a scale of 1 (not at all) to 5 (very good). Results are reported for participant's liking of the drug-free interval.
Participant Perception of Drug-Free Interval: Duration [Before Cycle 2, 3, 4, 5, 6]
A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How would you assess the length of the current drug-free interval?" Participants responded on a scale of 1 (too long) to 5 (too short). Results are reported for participant's perception of the duration of drug-free interval.
Participant Perception of Drug-Free Interval: Relapse of Symptoms [Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5]
A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "How much are you concerned about a relapse of symptoms?" After the drug-free interval participants were asked, "Were you concerned about a relapse of symptoms during the drug-free interval?" Participants responded on a scale of 1 (not concerned) to 5 (very much concerned). Results are reported for participant's perception of relapse of symptoms.
Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval [Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5]
A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "To what extend are you relieved by the fact that there is an effective therapy after the drug-free interval?" After the drug-free interval participants were asked, "To what extend were you relieved by the fact that there is an effective therapy after the drug-free interval?" Participants responded on a scale of 1 (not much relieved) to 5 (very much relieved). Results are reported for participant's perception of effective therapy after drug-free interval.
Participant Perception of Drug-Free Interval: Disease Activity [Before Cycle 2, 3, 4, 5, 6]
A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How would you assess the activity of your disease during the first half of the drug-free interval?" and "How would you assess the activity of your disease during the second half of the drug-free interval?" Participants responded on a scale of 1 (no activity) to 5 (strongest possible activity). Results are reported for participant's perception of disease activity during the first half and second half of drug-free interval.
Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition [Before Cycle 2, 3, 4, 5, 6]
A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How much were you satisfied with the condition of your skin during the first half of the drug-free interval?" and "How much were you satisfied with the condition of your skin during the second half of the drug-free interval?" Participants responded on a scale of 1 (very dissatisfied) to 5 (very satisfied). Results are reported for participant's satisfaction with their skin condition during the first half and second half of drug-free interval.
Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions [Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5]
A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "A drug-free interval reduces the risk for adverse drug reactions." Results are reported for participant's perception of risk of adverse drug reactions.
Participant Perception of Drug-Free Interval: Reminder of Disease [Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5]
A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "During drug-free interval I will not be reminded permanently of my disease." Results are reported for participant's perception of reminder of disease during the drug-free interval.
Participant Perception of Drug-Free Interval: Comfort in Everyday Life [Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5]
A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "A drug-free interval means more comfort in my everyday life." Results are reported for participant's perception of comfort of life during the drug-free interval.
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy [Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5]
A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, "If possible, would you prefer a continuous therapy without drug-free interval?" Participants responded as yes or no to the question. Results are reported for participant's preference towards continuous therapy.
Participant Perception of Drug-Free Interval: Recommendation of Therapy [Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5]
A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, "Would you recommend therapy with Enbrel to other patients with plaque-psoriasis?" Participants responded as yes or no to the question. Results are reported for participant's likeliness to recommend therapy.
Criteria for Treatment Resumption [Before Cycle 2, 3, 4, 5, 6]
Criteria for resumption of therapy for another cycle by the physician were specified after the 5 drug-free intervals as 1) new disease activity (NDA), 2) prevention of deterioration (POD), 3) other reasons (included reasons like end of adverse event, frequent occurrence of adverse event or pre-specified therapy scheme), 4) new disease activity and prevention of deterioration, 5) new disease activity and other reason, 6) prevention of deterioration and other reason, and 7) new disease activity, prevention of deterioration, and other reasons.
Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) [Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24)]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with AEs included participants affected with both SAEs and non-SAEs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects with moderate to severe plaque psoriasis on etanercept treatment according to the Summary of Product Characteristics (SmPC), and applicable local guidelines
Subjects for whom the decision has already been made to initiate treatment with etanercept

Exclusion Criteria:

Sepsis or risk of sepsis
Current or recent infections, including chronic or localized, e.g. tuberculosis (TB) infection
Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study
Pre-existing or recent onset CNS demyelinating disease.
Class III or IV congestive heart failure as defined by the New York Heart Association classification or uncompensated congestive heart failure.
Previous or ongoing treatment with etanercept
Participation in other clinical or observational studies.
Patients with psoriatic arthritis requiring continuous etanercept treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westfaelische Wilhelms-Universitaet Muenster, Zentr. f. Derm	Muenster	NRW	Germany	48149

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00708708

Other Study ID Numbers:

0881X1-4499
B1801081

First Posted:

Jul 2, 2008

Last Update Posted:

Jul 27, 2015

Last Verified:

Jul 1, 2015

Keywords provided by Pfizer

Plaque-type psoriasis

Additional relevant MeSH terms:

Psoriasis

Etanercept

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	A total of 955 participants were enrolled for documentation. Of these 955 participants enrolled, only 926 participants were included in analysis.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Period Title: Overall Study
STARTED	955
COMPLETED	213
NOT COMPLETED	742

Baseline Characteristics

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Overall Participants	926
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.4 (12.9)
Sex/Gender, Customized (participants) [Number]
Female	339 36.6%
Male	583 63%
Missing values	4 0.4%

Outcome Measures

1. Primary Outcome

Title	Duration of Drug-Free Interval Prior to Treatment Cycle 2
Description	Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Time Frame	Cycle 1 Week 24 up to Cycle 2 Week 0

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants greater than or equal to (>=) 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'N' (number of participants analyzed)= participants evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	120
Mean (95% Confidence Interval) [weeks]	12.6

2. Primary Outcome

Title	Duration of Drug-Free Interval Prior to Treatment Cycle 3
Description	Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Time Frame	Cycle 2 Week 24 up to Cycle 3 Week 0

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post-baseline documentations. Here 'N' (number of participants analyzed)= participants evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	39
Mean (95% Confidence Interval) [weeks]	10.5

3. Primary Outcome

Title	Duration of Drug-Free Interval Prior to Treatment Cycle 4
Description	Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Time Frame	Cycle 3 Week 24 up to Cycle 4 Week 0

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	9
Mean (95% Confidence Interval) [weeks]	25.0

4. Primary Outcome

Title	Duration of Drug-Free Interval Prior to Treatment Cycle 5
Description	Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Time Frame	Cycle 4 Week 24 up to Cycle 5 Week 0

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	5
Mean (95% Confidence Interval) [weeks]	20.6

5. Primary Outcome

Title	Duration of Drug-Free Interval Prior to Treatment Cycle 6
Description	Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Time Frame	Cycle 5 Week 24 up to Cycle 6 Week 0

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	2
Mean (95% Confidence Interval) [weeks]	14.2

6. Secondary Outcome

Title	Psoriasis Area and Severity Index (PASI) Score
Description	Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent (%) area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each sectionarea scoreweight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. PASI score at Week 0 of each cycle signifies the disease activity at the time of resumption of etanercept therapy.
Time Frame	Week 0, 12, 24 of Cycle 1 to 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	720
Cycle 1 Week 0 (n=675)	21.0 (12.1)
Cycle 1 Week 12 (n=605)	8.8 (8.5)
Cycle 1 Week 24 (n=538)	5.9 (6.6)
Cycle 2 Week 0 (n=435)	6.7 (6.5)
Cycle 2 Week 12 (n=394)	4.9 (5.0)
Cycle 2 Week 24 (n=368)	4.8 (5.2)
Cycle 3 Week 0 (n=234)	4.9 (6.1)
Cycle 3 Week 12 (n=226)	4.2 (5.5)
Cycle 3 Week 24 (n=202)	3.6 (4.5)
Cycle 4 Week 0 (n=120)	3.9 (3.9)
Cycle 4 Week 12 (n=117)	4.2 (3.6)
Cycle 4 Week 24 (n=105)	4.1 (4.8)
Cycle 5-week 0 (n=77)	3.6 (3.0)
Cycle 5 Week 12 (n=79)	4.2 (4.1)
Cycle 5 Week 24 (n=63)	3.6 (3.2)
Cycle 6 Week 0 (n=60)	3.9 (3.6)
Cycle 6 Week 12 (n=54)	3.0 (3.4)
Cycle 6 Week 24 (n=48)	2.8 (2.7)

7. Secondary Outcome

Title	Percentage of Body Surface Area (BSA) Affected by Psoriasis
Description	Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1% of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. The results of this outcome measure was summarized separately for participants without drug-free interval, participants with drug-free interval and remaining participants, as per planned analysis.
Time Frame	Week 0, 12, 24 of Cycle 1 to 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points for each arm, respectively.

Arm/Group Title	Participants Without Drug-Free Interval	Participants With Drug-Free Interval	Remaining Participants
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
Measure Participants	298	147	275
Cycle 1 Week 0 (n=293,145,267)	28.2 (20.8)	36.7 (21.3)	35.1 (23.2)
Cycle 1 Week 12 (n=293,142,235)	14.0 (13.6)	20.1 (18.0)	21.6 (19.8)
Cycle 1 Week 24 (n=294,143,168)	9.4 (10.3)	13.6 (15.1)	15.9 (17.6)
Cycle 2 Week 0 (n=293,143,66)	9.4 (10.3)	18.7 (15.0)	11.6 (13.1)
Cycle 2 Week 12 (n=280,127,62)	8.4 (9.8)	12.6 (14.3)	11.1 (13.4)
Cycle 2 Week 24 (n=263,117,53)	7.7 (9.4)	10.3 (11.0)	9.2 (10.1)
Cycle 3 Week 0 (n=212,44,47)	7.3 (9.5)	13.9 (13.3)	10.7 (13.0)
Cycle 3 Week 12 (n=201,40,43)	6.6 (8.0)	9.9 (12.8)	9.7 (13.5)
Cycle 3 Week 24 (n=181,38,36)	6.3 (7.2)	6.8 (9.1)	8.8 (11.0)
Cycle 4 Week 0 (n=144,8,21)	6.0 (6.0)	16.5 (13.8)	8.2 (9.8)
Cycle 4 Week 12 (n=128,8,20)	5.9 (5.6)	7.9 (5.2)	8.2 (11.4)
Cycle 4 Week 24 (n=121,7,18)	6.2 (6.4)	10.3 (8.2)	5.4 (6.6)
Cycle 5 Week 0 (n=100,4,10)	6.1 (5.8)	19.8 (8.8)	7.2 (8.1)
Cycle 5 Week 12 (n=98,2,9)	6.0 (6.7)	17.5 (10.6)	4.8 (4.5)
Cycle 5 Week 24 (n=88,1,5)	6.0 (7.3)	5.0 (NA)	3.4 (1.5)
Cycle 6 Week 0 (n=82,1,3)	6.2 (7.5)	5.0 (NA)	4.0 (3.5)
Cycle 6 Week 12 (n=75,0,2)	5.7 (6.8)	NA (NA)	3.0 (1.4)
Cycle 6 Week 24 (n=68,0,2)	5.2 (7.4)	NA (NA)	2.0 (0.0)

8. Secondary Outcome

Title	Static Physician Global Assessment (sPGA) of Disease Activity
Description	Static physician global assessment (sPGA) of disease activity was assessed as 0 (no psoriasis) to 5 (severe disease) based on severity of induration, scaling, and erythema across all psoriatic lesions.
Time Frame	Week 0, 12, 24 of Cycle 1 to 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	720
Cycle 1 Week 0 (n=718)	3.1 (0.9)
Cycle 1 Week 12 (n=683)	1.9 (1.0)
Cycle 1 Week 24 (n=615)	1.6 (1.0)
Cycle 2 Week 0 (n=514)	1.7 (1.0)
Cycle 2 Week 12 (n=482)	1.5 (0.9)
Cycle 2 Week 24 (n=444)	1.5 (1.0)
Cycle 3 Week 0 (n=307)	1.5 (1.0)
Cycle 3 Week 12 (n=291)	1.4 (1.0)
Cycle 3 Week 24 (n=259)	1.3 (0.9)
Cycle 4 Week 0 (n=174)	1.4 (0.9)
Cycle 4 Week 12 (n=158)	1.5 (0.9)
Cycle 4 Week 24 (n=147)	1.5 (0.9)
Cycle 5 Week 0 (n=114)	1.5 (0.8)
Cycle 5 Week 12 (n=109)	1.6 (0.9)
Cycle 5 Week 24 (n=95)	1.5 (0.8)
Cycle 6 Week 0 (n=88)	1.5 (0.9)
Cycle 6 Week 12 (n=78)	1.3 (0.8)
Cycle 6 Week 24 (n=71)	1.3 (0.8)

9. Secondary Outcome

Title	Physician Global Assessment of Efficacy
Description	Physician assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.
Time Frame	Week 24 of Cycle 1 to 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	720
Cycle 1: very good (n=606)	304 (0.9) 32.8%
Cycle 1: good (n=606)	214 (1.0) 23.1%
Cycle 1: moderate (n=606)	68 (1.0) 7.3%
Cycle 1: insufficient (n=606)	20 (1.0) 2.2%
Cycle 2: very good (n=440)	242 (0.9) 26.1%
Cycle 2: good (n=440)	151 (1.0) 16.3%
Cycle 2: moderate (n=440)	39 (1.0) 4.2%
Cycle 2: insufficient (n=440)	8 (1.0) 0.9%
Cycle 3: very good (n=259)	153 (0.9) 16.5%
Cycle 3: good (n=259)	92 (0.9) 9.9%
Cycle 3: moderate (n=259)	13 (0.9) 1.4%
Cycle 3: insufficient (n=259)	1 (0.9) 0.1%
Cycle 4: very good (n=147)	81 (0.8) 8.7%
Cycle 4: good (n=147)	59 (0.9) 6.4%
Cycle 4: moderate (n=147)	4 (0.8) 0.4%
Cycle 4: insufficient (n=147)	3 (0.9) 0.3%
Cycle 5: very good (n=96)	53 (0.8) 5.7%
Cycle 5: good (n=96)	40 (0.8) 4.3%
Cycle 5: moderate (n=96)	3 0.3%
Cycle 5: insufficient (n=96)	0 0%
Cycle 6: very good (n=70)	49 5.3%
Cycle 6: good (n=70)	18 1.9%
Cycle 6: moderate (n=70)	3 0.3%
Cycle 6: insufficient (n=70)	0 0%

10. Secondary Outcome

Title	Patient Global Assessment of Efficacy
Description	Participant assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.
Time Frame	Week 24 of Cycle 1 to 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	720
Cycle 1: very good (n=605)	297 (0.9) 32.1%
Cycle 1: good (n=605)	216 (1.0) 23.3%
Cycle 1: moderate (n=605)	65 (1.0) 7%
Cycle 1: insufficient (n=605)	27 (1.0) 2.9%
Cycle 2: very good (n=444)	229 (0.9) 24.7%
Cycle 2: good (n=444)	165 (1.0) 17.8%
Cycle 2: moderate (n=444)	40 (1.0) 4.3%
Cycle 2: insufficient (n=444)	10 (1.0) 1.1%
Cycle 3: very good (n=258)	145 (0.9) 15.7%
Cycle 3: good (n=258)	98 (0.9) 10.6%
Cycle 3: moderate (n=258)	10 (0.9) 1.1%
Cycle 3: insufficient (n=258)	5 (0.9) 0.5%
Cycle 4: very good (n=147)	77 (0.8) 8.3%
Cycle 4: good (n=147)	61 (0.9) 6.6%
Cycle 4: moderate (n=147)	7 (0.8) 0.8%
Cycle 4: insufficient (n=147)	2 (0.9) 0.2%
Cycle 5: very good (n=96)	39 (0.8) 4.2%
Cycle 5: good (n=96)	50 (0.8) 5.4%
Cycle 5: moderate (n=96)	7 0.8%
Cycle 5: insufficient (n=96)	0 0%
Cycle 6: very good (n=71)	47 5.1%
Cycle 6: good (n=71)	21 2.3%
Cycle 6: moderate (n=71)	3 0.3%
Cycle 6: insufficient (n=71)	0 0%

11. Secondary Outcome

Title	Number of Injections Per Year
Description	Number of etanercept injections per year were calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.
Time Frame	Year 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable at the specified time points for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	720
Year 1 (n=675)	47.0 (22.2)
Year 2 (n=418)	30.8 (22.4)
Year 3 (n=167)	32.1 (20.3)
Year 4 (n=53)	15.6 (12.9)
Year 5 (n=7)	11.8 (10.3)

12. Secondary Outcome

Title	Cumulative Dose of Etanercept Per Year
Description	Cumulative dose of etanercept per year was calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.
Time Frame	Year 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n' = participants evaluable at the specified time points for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	720
Year 1 (n=664)	2249.2 (1100.6)
Year 2 (n=418)	1474.7 (1104.6)
Year 3 (n=167)	1565.5 (1027.3)
Year 4 (n=53)	729.1 (589.9)
Year 5 (n=7)	399.5 (354.5)

13. Secondary Outcome

Title	Percentage of Time on Treatment in First Year
Description	Percentage of time on etanercept treatment for first year was calculated. It was calculated as 100% * (365- sum of durations of drug-free intervals in the first year)/365. Analysis was not possible for participants with missing data of visit 1 (Week 0) of Cycle 1.
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	677
Mean (Standard Deviation) [percentage of first year]	96.5 (10.6)

14. Secondary Outcome

Title	Percentage of Time on Treatment Over Entire Period
Description	Percentage of time on etanercept treatment over entire treatment period was calculated. It was calculated as 100% * ([Date of last application - Date of first application + 1] - Sum of duration of drug-free intervals [days])/(Date of last application - Date of first application + 1).
Time Frame	Cycle 1 up to Cycle 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	400
Mean (Standard Deviation) [percentage of entire treatment period]	94.8 (10.9)

15. Secondary Outcome

Title	Patient's Global Assessment of Disease Activity (PatGA)
Description	Participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity.
Time Frame	Week 0, 12, 24 of Cycle 1 to 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set included all participants >=18 years of age, confirmed diagnosis of plaque psoriasis, had not received treatment with etanercept previously and had post baseline documentations. Here, 'n'=number of participants evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	720
Cycle 1 Week 0 (n=673)	3.7 (1.2)
Cycle 1 Week 12 (n=629)	2.2 (1.2)
Cycle 1 Week 24 (n=554)	1.9 (1.2)
Cycle 2 Week 0 (n=349)	2.2 (1.3)
Cycle 2 Week 12 (n=455)	1.7 (1.1)
Cycle 2 Week 24 (n=395)	1.7 (1.2)
Cycle 3 Week 0 (n=191)	1.8 (1.2)
Cycle 3 Week 12 (n=261)	1.6 (1.1)
Cycle 3 Week 24 (n=224)	1.6 (1.2)
Cycle 4 Week 0 (n=89)	1.8 (1.1)
Cycle 4 Week 12 (n=145)	1.7 (1.1)
Cycle 4 Week 24 (n=132)	1.8 (1.1)
Cycle 5 Week 0 (n=63)	1.9 (1.1)
Cycle 5 Week 12 (n=103)	1.7 (1.0)
Cycle 5 Week 24 (n=92)	1.8 (0.9)
Cycle 6 Week 0 (n=43)	2.2 (0.9)
Cycle 6 Week 12 (n=76)	1.6 (1.1)
Cycle 6 Week 24 (n=68)	1.6 (1.0)

16. Secondary Outcome

Title	Dermatology Life Quality Index (DLQI) Score
Description	DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Time Frame	Week 0, 12, 24 of Cycle 1 to 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'n'=number of participants evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	720
Cycle 1 Week 0 (n=654)	14.0 (7.3)
Cycle 1 Week 12 (n=598)	6.4 (5.8)
Cycle 1 Week 24 (n=536)	4.9 (5.7)
Cycle 2 Week 0 (n=334)	6.2 (6.3)
Cycle 2 Week 12 (n=440)	4.3 (5.1)
Cycle 2 Week 24 (n=378)	4.2 (5.3)
Cycle 3 Week 0 (n=186)	4.9 (5.9)
Cycle 3 Week 12 (n= 258)	3.9 (5.1)
Cycle 3 Week 24 (n=221)	3.7 (5.0)
Cycle 4 Week 0 (n=90)	4.7 (6.4)
Cycle 4 Week 12 (n=146)	3.6 (4.4)
Cycle 4 Week 24 (n=132)	3.8 (5.1)
Cycle 5 Week 0 (n=64)	4.5 (5.4)
Cycle 5 Week 12 (n=104)	3.8 (4.8)
Cycle 5 Week 24 (n=91)	3.7 (4.3)
Cycle 6 Week 0 (n=43)	5.0 (5.1)
Cycle 6 Week 12 (n=75)	3.5 (4.6)
Cycle 6 Week 24 (n=69)	3.9 (4.4)

17. Secondary Outcome

Title	Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state.
Time Frame	Week 0, 12, 24 of Cycle 1 to 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'n'=number of participants evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	720
Cycle 1 Week 0 (n=666 )	0.817 (0.236)
Cycle 1 Week 12 (n=628)	0.915 (0.149)
Cycle 1 Week 24 (n=549)	0.930 (0.145)
Cycle 2 Week 0 (n=344)	0.915 (0.154)
Cycle 2 Week 12 (n=451)	0.933 (0.142)
Cycle 2 Week 24 (n=393)	0.939 (0.140)
Cycle 3 Week 0 (n=190)	0.932 (0.149)
Cycle 3 Week 12 (n= 257)	0.949 (0.094)
Cycle 3 Week 24 (n=222)	0.928 (0.154)
Cycle 4 Week 0 (n=89)	0.912 (0.169)
Cycle 4 Week 12 (n=144)	0.935 (0.121)
Cycle 4 Week 24 (n=129)	0.927 (0.153)
Cycle 5 Week 0 (n=63)	0.914 (0.157)
Cycle 5 Week 12 (n=104)	0.932 (0.103)
Cycle 5 Week 24 (n=91)	0.950 (0.099)
Cycle 6 Week 0 (n=43)	0.930 (0.097)
Cycle 6 Week 12 (n=75)	0.938 (0.098)
Cycle 6 Week 24 (n=69)	0.939 (0.127)

18. Secondary Outcome

Title	Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.
Time Frame	Week 0, 12, 24 of Cycle 1 to 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'n'=number of participants evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	720
Cycle 1 Week 0 (n=666 )	73.8 (20.5)
Cycle 1 Week 12 (n=628)	85.1 (16.7)
Cycle 1 Week 24 (n=549)	87.7 (16.9)
Cycle 2 Week 0 (n=344)	85.6 (17.7)
Cycle 2 Week 12 (n=451)	88.6 (15.9)
Cycle 2 Week 24 (n=393)	89.5 (16.3)
Cycle 3 Week 0 (n=190)	88.3 (17.0)
Cycle 3 Week 12 (n= 257)	90.3 (14.0)
Cycle 3 Week 24 (n=222)	88.5 (17.7)
Cycle 4 Week 0 (n=89)	85.7 (18.9)
Cycle 4 Week 12 (n=144)	88.8 (15.4)
Cycle 4 Week 24 (n=129)	87.8 (17.9)
Cycle 5 Week 0 (n=63)	85.0 (18.8)
Cycle 5 Week 12 (n=104)	87.1 (15.4)
Cycle 5 Week 24 (n=91)	89.4 (14.9)
Cycle 6 Week 0 (n=43)	85.1 (16.2)
Cycle 6 Week 12 (n=75)	87.8 (13.8)
Cycle 6 Week 24 (n=69)	89.0 (14.9)

19. Secondary Outcome

Title	Number of Participants With at Least 1 Concomitant Medication
Description	Number of participants taking any non-study medications which were administered during the period of etanercept treatment for the management of an adverse event or for the treatment of any other disease and not plaque psoriasis were reported.
Time Frame	Cycle 1 Week 0 up to Cycle 6 Week 24

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants with available post-baseline safety data.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	926
Number [participants]	368 (10.6) 39.7%

20. Secondary Outcome

Title	Annual Costs for Treatment With Etanercept
Description	Costs for treatment with etanercept per year up to 5 years was calculated in Euros. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.
Time Frame	Year 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= participants evaluable at the specified time points for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	720
Year 1 (n=675)	20670.0 (9743.9)
Year 2 (n=418)	13509.6 (9854.3)
Year 3 (n=167)	14113.4 (8913.8)
Year 4 (n=53)	6847.4 (5648.6)
Year 5 (n=7)	5173.7 (4506.6)

21. Secondary Outcome

Title	Average Cost of Treatment by Disease Severity
Description	Average costs for treatment with etanercept up to 5 years was calculated in Euros. Disease severity was categorized as mild (0 to 10 PASI score), moderate (10.1 to 20 PASI score) and severe (20.1 to 72 PASI score) at each year. PASI: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each sectionarea scoreweight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.
Time Frame	Year 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= participants evaluable at the specified time points for the given disease severities.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	720
Year 1: Mild (n=290)	20707.0 (9751.6)
Year 1: Moderate (n=80)	21627.0 (11119.5)
Year 1: Severe (n=46)	21309.2 (11573.3)
Year 2: Mild (n=200)	13777.1 (9864.5)
Year 2: Moderate (n=32)	9668.8 (7638.6)
Year 2: Severe (n=9)	5479.7 (4225.8)
Year 3: Mild (n=93)	15062.1 (8676.5)
Year 3: Moderate (n=3)	6877.2 (3071.3)
Year 3: Severe (n=4)	6371.3 (2565.0)
Year 4: Mild (n=25)	5809.6 (3125.3)
Year 4: Moderate (n=1)	7467.0 (NA)
Year 4: Severe (n=2)	3196.0 (575.5)
Year 5: Mild (n=6)	5309.3 (4998.2)

22. Secondary Outcome

Title	Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications
Description	Annual costs for participants for treatment with etanercept due to out of pocket payments (included payments which were not reimbursed by the health insurance funds) and concomitant medications was reported per month for costs prior to study and per year for each year in the study up to 5 years. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.
Time Frame	Prior to study, Year 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= participants evaluable at the specified time points for this outcome measure.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	720
Prior to Study (n=536)	77.1 (170.6)
Year 1 (n=472)	194.8 (729.3)
Year 2 (n=312)	91.2 (445.7)
Year 3 (n=131)	128.8 (956.9)
Year 4 (n=44)	31.5 (87.6)
Year 5 (n=6)	53.6 (49.9)

23. Secondary Outcome

Title	Effect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)
Description	Effect of drug-free interval on PatGA was determined by comparing the PatGA scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". PatGA: participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity.
Time Frame	Week 0, 12, 24 of Cycle 1 to 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'n'=number of participants evaluable for this measure at the specified time points for each arm, respectively.

Arm/Group Title	Participants Without Drug-Free Interval	Participants With Drug-Free Interval
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
Measure Participants	298	147
Cycle 1 Week 0 (n=280, 138)	3.7 (1.2)	3.9 (0.9)
Cycle 1 Week 12 (n=279, 138)	2.1 (1.2)	2.1 (1.3)
Cycle 1 Week 24 (n=274, 139)	1.9 (1.1)	1.8 (1.3)
Cycle 2 Week 0 (n=156, 136)	2.0 (1.2)	2.6 (1.3)
Cycle 2 Week 12 (n=264, 130)	1.8 (1.2)	1.8 (1.0)
Cycle 2 Week 24 (n=238, 111)	1.7 (1.2)	1.7 (1.3)
Cycle 3 Week 0 (n=112, 41)	1.8 (1.2)	2.1 (1.3)
Cycle 3 Week 12 (n=184, 38)	1.7 (1.2)	1.5 (1.1)
Cycle 3 Week 24 (n=161, 36)	1.7 (1.2)	1.2 (1.2)
Cycle 4 Week 0 (n=71, 6)	1.8 (1.1)	2.2 (1.5)
Cycle 4 Week 12 (n=123, 6)	1.7 (1.1)	2.0 (1.3)
Cycle 4 Week 24 (n=112, 5)	1.8 (1.0)	3.2 (1.8)
Cycle 5 Week 0 (n=53, 2)	1.9 (1.1)	3.0 (1.4)
Cycle 5 Week 12 (n=94, 2)	1.6 (1.0)	3.0 (1.4)
Cycle 5 Week 24 (n=84, 2)	1.8 (0.9)	3.0 (1.4)
Cycle 6 Week 0 (n=39, 2)	2.2 (0.8)	3.5 (0.7)
Cycle 6 Week 12 (n=73 1)	1.6 (1.1)	3.0 (NA)
Cycle 6 Week 24(n=66, 0)	1.7 (1.0)	NA (NA)

24. Secondary Outcome

Title	Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score
Description	Effect of drug free interval on DLQI was determined by comparing the scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Time Frame	Week 0, 12, 24 of Cycle 1 to 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'=number of participants evaluable at the specified time points for the given cycles.

Arm/Group Title	Participants Without Drug-Free Interval	Participants With Drug-Free Interval
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
Measure Participants	298	147
Cycle 1 Week 0 (n=276,136)	13.8 (7.3)	15.5 (7.2)
Cycle 1 Week 12 (n=267,126)	5.7 (5.3)	7.1 (5.9)
Cycle 1 Week 24 (n=263,135)	4.7 (5.6)	4.7 (5.5)
Cycle 2 Week 0 (n=145,133)	5.8 (6.4)	7.6 (6.5)
Cycle 2 Week 12 (n=256,128)	4.4 (5.4)	4.5 (4.9)
Cycle 2 Week 24 (n=227,107)	4.4 (5.8)	4.0 (4.4)
Cycle 3 Week 0 (n=109,41)	5.0 (6.2)	6.4 (6.5)
Cycle 3 Week 12 (n= 183,38)	4.2 (5.4)	3.7 (5.0)
Cycle 3 Week 24 (n=158,36)	4.1 (5.5)	2.1 (3.0)
Cycle 4 Week 0 (n=72,6)	5.0 (6.4)	4.5 (9.1)
Cycle 4 Week 12 (n=124,6)	3.6 (4.5)	4.5 (5.5)
Cycle 4 Week 24 (n=112,5)	3.9 (5.2)	5.0 (5.7)
Cycle 5 Week 0 (n=53,3)	4.8 (5.8)	1.7 (1.5)
Cycle 5 Week 12 (n=94,2)	3.7 (4.7)	3.0 (0.0)
Cycle 5 Week 24 (n=83,2)	3.7 (4.4)	3.0 (1.4)
Cycle 6 Week 0 (n=39,2)	5.1 (5.3)	5.5 (2.1)
Cycle 6 Week 12 (n=72,1)	3.6 (4.7)	1.0 (NA)
Cycle 6 Week 24 (n=67,0)	4.0 (4.4)	NA (NA)

25. Secondary Outcome

Title	Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)
Description	Effect of drug free interval on EQ-5D was determined by comparing the scores of the sub group "Participants Without Drug-Free Interval" to that of the sub group "Participants With Drug-Free Interval". EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state.
Time Frame	Week 0, 12, 24 of Cycle 1 to 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here n'=number of participants evaluable at the specified time points for the given cycles.

Arm/Group Title	Participants Without Drug-Free Interval	Participants With Drug-Free Interval
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who never experienced a drug-free interval during the entire observational period.	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
Measure Participants	298	147
Cycle 1 Week 0 (n=279,137)	0.810 (0.243)	0.809 (0.232)
Cycle 1 Week 12 (n=281,137)	0.914 (0.144)	0.916 (0.151)
Cycle 1 Week 24 (n=272,139)	0.921 (0.149)	0.944 (0.117)
Cycle 2 Week 0 (n=152,135)	0.903 (0.164)	0.920 (0.144)
Cycle 2 Week 12 (n=261,129)	0.930 (0.140)	0.949 (0.128)
Cycle 2 Week 24 (n=238,111)	0.934 (0.148)	0.948 (0.123)
Cycle 3 Week 0 (n=111,41)	0.931 (0.139)	0.921 (0.183)
Cycle 3 Week 12 (n= 181,37)	0.946 (0.088)	0.969 (0.049)
Cycle 3 Week 24 (n=160,35)	0.921 (0.157)	0.972 (0.068)
Cycle 4 Week 0 (n=71,6)	0.894 (0.184)	0.980 (0.046)
Cycle 4 Week 12 (n=122,6)	0.929 (0.129)	0.962 (0.058)
Cycle 4 Week 24 (n=110,5)	0.920 (0.163)	0.954 (0.061)
Cycle 5 Week 0 (n=53,2)	0.907 (0.168)	0.943 (0.079)
Cycle 5 Week 12 (n=94,2)	0.929 (0.107)	0.943 (0.079)
Cycle 5 Week 24 (n=83,2)	0.950 (0.101)	0.943 (0.079)
Cycle 6 Week 0 (n=39,2)	0.932 (0.101)	0.887 (0.000)
Cycle 6 Week 12 (n=72,1)	0.939 (0.100)	0.887 (NA)
Cycle 6 Week 24 (n=67,0)	0.937 (0.128)	NA (NA)

26. Secondary Outcome

Title	Participant Perception of Drug-Free Interval: Length of Drug-Free Interval
Description	A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "How long do you expect the drug-free interval to last for?" After the drug-free interval participants were asked, "How long did the drug-free interval last?" Results are reported for participant's perception of the length of drug-free interval.
Time Frame	Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	102
After Cycle 1 (n=50)	0.9 (1.0)
Before Cycle 2 (n=102)	2.4 (2.9)
After Cycle 2 (n=19)	1.4 (1.5)
Before Cycle 3 (n=37)	1.6 (1.6)
After Cycle 3 (n=2)	4.5 (2.1)
Before Cycle 4 (n=5)	1.8 (1.8)
After Cycle 4 (n=0)	NA (NA)
Before Cycle 5 (n=1)	2.3 (NA)
After Cycle 5 (n=0)	NA (NA)
Before Cycle 6 (n=1)	2.8 (NA)

27. Secondary Outcome

Title	Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Description	A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "Why did you return to the practice today?" Responses included unscheduled visit due to new occurrence of disease, scheduled visit or other reasons (included reasons like treatment of adverse event, get a prescription or examination after external treatment). Results are reported for reasons for returning to the practice.
Time Frame	Before Cycle 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	116
Before Cycle 2- unscheduled visit (n=116)	66 (2.9) 7.1%
Before Cycle 2- scheduled visit (n=116)	46 (1.0) 5%
Before Cycle 2- other reason (n=116)	4 (1.6) 0.4%
Before Cycle 3- unscheduled visit (n=43)	16 (1.5) 1.7%
Before Cycle 3- scheduled visit (n=43)	26 (1.8) 2.8%
Before Cycle 3- other reason (n=43)	1 0.1%
Before Cycle 4- unscheduled visit(n=7)	2 0.2%
Before Cycle 4- scheduled visit (n=7)	4 0.4%
Before Cycle 4-other reason (n=7)	1 0.1%
Before Cycle 5- unscheduled visit(n=1)	0 0%
Before Cycle 5-scheduled visit (n=1)	1 0.1%
Before Cycle 5-other reason (n=1)	0 0%
Before Cycle 6- unscheduled visit (n=1)	0 0%
Before Cycle 6-scheduled visit (n=1)	1 0.1%
Before Cycle 6-other reason (n=1)	0 0%

28. Secondary Outcome

Title	Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval
Description	A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "Do you basically like the idea of a drug-free interval?" After the drug-free interval participants were asked, "How did you like the current drug-free interval?" Participants responded on a scale of 1 (not at all) to 5 (very good). Results are reported for participant's liking of the drug-free interval.
Time Frame	Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	113
After Cycle 1 (n=113)	2.6 (1.5)
Before Cycle 2 (n=106)	2.5 (1.4)
After Cycle 2 (n=40)	3.1 (1.5)
Before Cycle 3 (n=37)	2.9 (1.4)
After Cycle 3 (n=7)	2.1 (1.7)
Before Cycle 4 (n=5)	1.0 (0.0)
After Cycle 4 (n=2)	1.5 (0.7)
Before Cycle 5 (n=1)	2.0 (NA)
After Cycle 5 (n=1)	4.0 (NA)
Before Cycle 6 (n=1)	2.0 (NA)

29. Secondary Outcome

Title	Participant Perception of Drug-Free Interval: Duration
Description	A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How would you assess the length of the current drug-free interval?" Participants responded on a scale of 1 (too long) to 5 (too short). Results are reported for participant's perception of the duration of drug-free interval.
Time Frame	Before Cycle 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	104
Before Cycle 2 (n=104)	2.5 (1.1)
Before Cycle 3 (n=35)	2.9 (1.2)
Before Cycle 4 (n=5)	1.0 (0.0)
Before Cycle 5 (n=1)	2.0 (NA)
Before Cycle 6 (n=1)	2.0 (NA)

30. Secondary Outcome

Title	Participant Perception of Drug-Free Interval: Relapse of Symptoms
Description	A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "How much are you concerned about a relapse of symptoms?" After the drug-free interval participants were asked, "Were you concerned about a relapse of symptoms during the drug-free interval?" Participants responded on a scale of 1 (not concerned) to 5 (very much concerned). Results are reported for participant's perception of relapse of symptoms.
Time Frame	Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	115
After Cycle 1 (n=115)	4.4 (0.8)
Before Cycle 2 (n=106)	4.1 (1.0)
After Cycle 2 (n=41)	4.1 (1.0)
Before Cycle 3 (n=36)	4.0 (0.9)
After Cycle 3 (n=7)	4.9 (0.4)
Before Cycle 4 (n=5)	4.2 (1.1)
After Cycle 4 (n=3)	4.3 (0.6)
Before Cycle 5 (n=1)	4.0 (NA)
After Cycle 5 (n=1)	3.0 (NA)
Before Cycle 6 (n=1)	3.0 (NA)

31. Secondary Outcome

Title	Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval
Description	A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, "To what extend are you relieved by the fact that there is an effective therapy after the drug-free interval?" After the drug-free interval participants were asked, "To what extend were you relieved by the fact that there is an effective therapy after the drug-free interval?" Participants responded on a scale of 1 (not much relieved) to 5 (very much relieved). Results are reported for participant's perception of effective therapy after drug-free interval.
Time Frame	Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	114
After Cycle 1 (n=114)	4.6 (0.8)
Before Cycle 2 (n=106)	4.4 (0.8)
After Cycle 2 (n=41)	4.4 (0.9)
Before Cycle 3 (n=35)	4.3 (1.1)
After Cycle 3 (n=6)	4.7 (0.8)
Before Cycle 4 (n=5)	5.0 (0.0)
After Cycle 4 (n=2)	2.5 (2.1)
Before Cycle 5 (n=1)	5.0 (NA)
After Cycle 5 (n=1)	5.0 (NA)
Before Cycle 6 (n=1)	2.0 (NA)

32. Secondary Outcome

Title	Participant Perception of Drug-Free Interval: Disease Activity
Description	A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How would you assess the activity of your disease during the first half of the drug-free interval?" and "How would you assess the activity of your disease during the second half of the drug-free interval?" Participants responded on a scale of 1 (no activity) to 5 (strongest possible activity). Results are reported for participant's perception of disease activity during the first half and second half of drug-free interval.
Time Frame	Before Cycle 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	102
Before Cycle 2-first half (n=102)	2.4 (1.0)
Before Cycle 2-second half (n=101)	3.3 (1.0)
Before Cycle 3-first half (n=36)	2.3 (1.0)
Before Cycle 3-second half (n=36)	3.0 (1.1)
Before Cycle 4-first half (n=4)	2.5 (0.6)
Before Cycle 4-second half (n=4)	3.3 (1.3)
Before Cycle 5-first half (n=1)	2.0 (NA)
Before Cycle 5-second half (n=1)	3.0 (NA)
Before Cycle 6-first half (n=1)	1.0 (NA)
Before Cycle 6-second half (n=1)	2.0 (NA)

33. Secondary Outcome

Title	Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition
Description	A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, "How much were you satisfied with the condition of your skin during the first half of the drug-free interval?" and "How much were you satisfied with the condition of your skin during the second half of the drug-free interval?" Participants responded on a scale of 1 (very dissatisfied) to 5 (very satisfied). Results are reported for participant's satisfaction with their skin condition during the first half and second half of drug-free interval.
Time Frame	Before Cycle 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	100
Before Cycle 2-first half (n=100)	3.3 (1.2)
Before Cycle 2-second half (n=100)	2.7 (1.0)
Before Cycle 3-first half (n=36)	3.2 (1.4)
Before Cycle 3-second half (n=36)	2.8 (1.1)
Before Cycle 4-first half (n=4)	3.5 (1.3)
Before Cycle 4-second half (n=4)	2.3 (1.0)
Before Cycle 5-first half (n=1)	4.0 (NA)
Before Cycle 5-second half (n=1)	3.0 (NA)
Before Cycle 6-first half (n=1)	4.0 (NA)
Before Cycle 6-second half (n=1)	3.0 (NA)

34. Secondary Outcome

Title	Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions
Description	A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "A drug-free interval reduces the risk for adverse drug reactions." Results are reported for participant's perception of risk of adverse drug reactions.
Time Frame	Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	110
After Cycle 1 (n=110)	3.0 (1.1)
Before Cycle 2 (n=100)	3.2 (1.3)
After Cycle 2 (n=41)	2.9 (1.3)
Before Cycle 3 (n=38)	3.1 (1.3)
After Cycle 3 (n=6)	2.3 (1.4)
Before Cycle 4 (n=5)	1.6 (0.9)
After Cycle 4 (n=1)	3.0 (NA)
Before Cycle 5 (n=1)	3.0 (NA)
After Cycle 5 (n=1)	5.0 (NA)
Before Cycle 6 (n=1)	5.0 (NA)

35. Secondary Outcome

Title	Participant Perception of Drug-Free Interval: Reminder of Disease
Description	A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "During drug-free interval I will not be reminded permanently of my disease." Results are reported for participant's perception of reminder of disease during the drug-free interval.
Time Frame	Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	104
After Cycle 1 (n=104)	2.4 (1.3)
Before Cycle 2 (n=103)	2.5 (1.3)
After Cycle 2 (n=39)	2.7 (1.3)
Before Cycle 3 (n=38)	2.7 (1.3)
After Cycle 3 (n=5)	1.6 (0.9)
Before Cycle 4 (n=5)	1.6 (0.9)
After Cycle 4 (n=3)	2.7 (2.1)
Before Cycle 5 (n=1)	2.0 (NA)
After Cycle 5 (n=1)	5.0 (NA)
Before Cycle 6 (n=1)	5.0 (NA)

36. Secondary Outcome

Title	Participant Perception of Drug-Free Interval: Comfort in Everyday Life
Description	A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, "A drug-free interval means more comfort in my everyday life." Results are reported for participant's perception of comfort of life during the drug-free interval.
Time Frame	Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	104
After Cycle 1 (n=104)	2.3 (1.2)
Before Cycle 2 (n=103)	2.6 (1.3)
After Cycle 2 (n=39)	2.6 (1.3)
Before Cycle 3 (n=38)	2.6 (1.3)
After Cycle 3 (n=5)	1.8 (1.1)
Before Cycle 4 (n=5)	1.8 (0.8)
After Cycle 4 (n=3)	1.0 (0.0)
Before Cycle 5 (n=1)	2.0 (NA)
After Cycle 5 (n=1)	5.0 (NA)
Before Cycle 6 (n=1)	1.0 (NA)

37. Secondary Outcome

Title	Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
Description	A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, "If possible, would you prefer a continuous therapy without drug-free interval?" Participants responded as yes or no to the question. Results are reported for participant's preference towards continuous therapy.
Time Frame	Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	106
After Cycle 1- No (n=104)	9 (1.3) 1%
After Cycle 1- Yes (n=104)	95 (1.3) 10.3%
Before Cycle 2- No (n=106)	8 (1.1) 0.9%
Before Cycle 2- Yes (n=106)	98 (0.8) 10.6%
After Cycle 2- No (n=40)	8 (0.0) 0.9%
After Cycle 2- Yes (n=40)	32 (NA) 3.5%
Before Cycle 3- No (n=42)	3 (NA) 0.3%
Before Cycle 3- Yes (n=42)	39 (NA) 4.2%
After Cycle 3- No (n=7)	0 0%
After Cycle 3- Yes (n=7)	7 0.8%
Before Cycle 4- No (n=6)	0 0%
Before Cycle 4- Yes (n=6)	6 0.6%
After Cycle 4- No (n=3)	1 0.1%
After Cycle 4- Yes (n=3)	2 0.2%
Before Cycle 5- No (n=1)	0 0%
Before Cycle 5- Yes (n=1)	1 0.1%
After Cycle 5- No (n=1)	0 0%
After Cycle 5- Yes (n=1)	1 0.1%
Before Cycle 6- No (n=1)	0 0%
Before Cycle 6- Yes (n=1)	1 0.1%

38. Secondary Outcome

Title	Participant Perception of Drug-Free Interval: Recommendation of Therapy
Description	A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, "Would you recommend therapy with Enbrel to other patients with plaque-psoriasis?" Participants responded as yes or no to the question. Results are reported for participant's likeliness to recommend therapy.
Time Frame	Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points. Results are not reported for before Cycle 4, 5, 6, and after Cycle 5 as no participant was evaluable at these time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	107
After Cycle 1- No (n=106)	0 (1.3) 0%
After Cycle 1- Yes (n=106)	106 (1.3) 11.4%
Before Cycle 2- No (n=107)	0 (1.1) 0%
Before Cycle 2- Yes (n=107)	107 (0.8) 11.6%
After Cycle 2- No (n=40)	1 (0.0) 0.1%
After Cycle 2- Yes (n=40)	39 (NA) 4.2%
Before Cycle 3- No (n=42)	0 (NA) 0%
Before Cycle 3- Yes (n=42)	42 (NA) 4.5%
After Cycle 3- No (n=7)	0 0%
After Cycle 3- Yes (n=7)	7 0.8%
After Cycle 4- No (n=1)	0 0%
After Cycle 4- Yes (n=1)	1 0.1%

39. Secondary Outcome

Title	Criteria for Treatment Resumption
Description	Criteria for resumption of therapy for another cycle by the physician were specified after the 5 drug-free intervals as 1) new disease activity (NDA), 2) prevention of deterioration (POD), 3) other reasons (included reasons like end of adverse event, frequent occurrence of adverse event or pre-specified therapy scheme), 4) new disease activity and prevention of deterioration, 5) new disease activity and other reason, 6) prevention of deterioration and other reason, and 7) new disease activity, prevention of deterioration, and other reasons.
Time Frame	Before Cycle 2, 3, 4, 5, 6

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n' signifies those participants who were evaluable for this measure at the specified time points.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	144
Before Cycle 2-new disease activity (NDA) (n=144)	90 (1.3) 9.7%
Before Cycle 2- POD (n=144)	42 (1.3) 4.5%
Before Cycle 2- other reason (n=144)	8 (1.1) 0.9%
Before Cycle 2- NDA and POD (n=144)	4 (0.8) 0.4%
Before Cycle 2- NDA and other reason (n=144)	0 (0.0) 0%
Before Cycle 2- POD and other reason (n=144)	0 (NA) 0%
Before Cycle 2- NDA, POD and other reason (n=144)	0 (NA) 0%
Before Cycle 3-NDA (n=43)	15 (NA) 1.6%
Before Cycle 3- POD (n=43)	25 2.7%
Before Cycle 3- other reason (n=43)	2 0.2%
Before Cycle 3- NDA and POD (n=43)	1 0.1%
Before Cycle 3- NDA and other reason (n=43)	0 0%
Before Cycle 3- POD and other reason (n=43)	0 0%
Before Cycle 3- NDA, POD and other reason (n=43)	0 0%
Before Cycle 4- NDA (n=8)	3 0.3%
Before Cycle 4- POD (n=8)	5 0.5%
Before Cycle 4- other reason (n=8)	0 0%
Before Cycle 4- NDA and POD (n=8)	0 0%
Before Cycle 4- NDA and other reason (n=8)	0 0%
Before Cycle 4- POD and other reason (n=8)	0 0%
Before Cycle 4-NDA, POD and other reason (n=8)	0 0%
Before Cycle 5- NDA (n=3)	2 0.2%
Before Cycle 5- POD (n=3)	1 0.1%
Before Cycle 5- other reason (n=3)	0 0%
Before Cycle 5- NDA and POD (n=3)	0 0%
Before Cycle 5- NDA and other reason (n=3)	0 0%
Before Cycle 5- POD and other reason (n=3)	0 0%
Before Cycle 5- NDA, POD and other reason (n=3)	0 0%
Before Cycle 6- NDA (n=1)	1 0.1%
Before Cycle 6- POD (n=1)	0 0%
Before Cycle 6- other reason (n=1)	0 0%
Before Cycle 6- NDA and POD (n=1)	0 0%
Before Cycle 6- NDA and other reason (n=1)	0 0%
Before Cycle 6- POD and other reason (n=1)	0 0%
Before Cycle 6- NDA, POD and other reason (n=1)	0 0%

40. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with AEs included participants affected with both SAEs and non-SAEs.
Time Frame	Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24)

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants with available post-baseline safety data.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
Measure Participants	926
AEs	273 (10.6) 29.5%
SAEs	59 6.4%

Adverse Events

	Etanercept
Time Frame
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Arm/Group Title	Etanercept
Arm/Group Description	Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Etanercept
	Affected / at Risk (%)	# Events
Total	59/926 (6.4%)
Cardiac disorders
Angina pectoris	1/926 (0.1%)
Atrial fibrillation	1/926 (0.1%)
Congestive cardiomyopathy	1/926 (0.1%)
Tachycardia	1/926 (0.1%)
Tachyarrhythmia	1/926 (0.1%)
Congenital, familial and genetic disorders
Phimosis	1/926 (0.1%)
Gastrointestinal disorders
Haematochezia	1/926 (0.1%)
Pancreatitis	1/926 (0.1%)
Pancreatitis acute	1/926 (0.1%)
Peritonitis	1/926 (0.1%)
Ileus	1/926 (0.1%)
General disorders
Chest discomfort	1/926 (0.1%)
Chills	1/926 (0.1%)
Drowning	1/926 (0.1%)
Fatigue	1/926 (0.1%)
Injection site erythema	1/926 (0.1%)
Injection site extravasation	1/926 (0.1%)
Necrosis	1/926 (0.1%)
Oedema peripheral	1/926 (0.1%)
Pyrexia	1/926 (0.1%)
Infections and infestations
Erysipelas	3/926 (0.3%)
Herpes zoster	2/926 (0.2%)
Necrotising fasciitis	2/926 (0.2%)
Pneumonia	2/926 (0.2%)
Abdominal infection	1/926 (0.1%)
Abscess	1/926 (0.1%)
Chronic tonsillitis	1/926 (0.1%)
Muscle abscess	1/926 (0.1%)
Osteomyelitis	1/926 (0.1%)
Post procedural infection	1/926 (0.1%)
Urosepsis	1/926 (0.1%)
Otitis externa	1/926 (0.1%)
Viral infection	1/926 (0.1%)
Injury, poisoning and procedural complications
Fall	2/926 (0.2%)
Accident at work	1/926 (0.1%)
Accident	1/926 (0.1%)
Ankle fracture	1/926 (0.1%)
Clavicle fracture	1/926 (0.1%)
Overdose	1/926 (0.1%)
Rib fracture	1/926 (0.1%)
Road traffic accident	1/926 (0.1%)
Laceration	1/926 (0.1%)
Wound dehiscence	1/926 (0.1%)
Investigations
Alanine aminotransferase increased	2/926 (0.2%)
Aspartate aminotransferase increased	1/926 (0.1%)
Blood alkaline phosphatase increased	1/926 (0.1%)
Tuberculosis serology test positive	1/926 (0.1%)
Weight decreased	1/926 (0.1%)
Metabolism and nutrition disorders
Dehydration	1/926 (0.1%)
Musculoskeletal and connective tissue disorders
Lupus-like syndrome	1/926 (0.1%)
Spondylolisthesis	1/926 (0.1%)
Systemic lupus erythematosus	1/926 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma	2/926 (0.2%)
Adenoma benign	1/926 (0.1%)
Basal cell carcinoma	1/926 (0.1%)
Breast cancer	1/926 (0.1%)
Gastric cancer	1/926 (0.1%)
Lung adenocarcinoma	1/926 (0.1%)
Metastases to central nervous system	1/926 (0.1%)
Metastases to peritoneum	1/926 (0.1%)
Renal cancer	1/926 (0.1%)
Renal cell carcinoma	1/926 (0.1%)
B-cell lymphoma	1/926 (0.1%)
Lung neoplasm malignant	1/926 (0.1%)
Nervous system disorders
Cerebral infarction	1/926 (0.1%)
Cerebrovascular accident	2/926 (0.2%)
Epilepsy	1/926 (0.1%)
Optic neuritis	1/926 (0.1%)
Paraesthesia	1/926 (0.1%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/926 (0.1%)
Psychiatric disorders
Sleep disorder	1/926 (0.1%)
Renal and urinary disorders
Renal failure	2/926 (0.2%)
Nephrolithiasis	1/926 (0.1%)
Reproductive system and breast disorders
Scrotal erythema	1/926 (0.1%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/926 (0.1%)
Cough	1/926 (0.1%)
Dyspnoea	1/926 (0.1%)
Paranasal sinus discomfort	1/926 (0.1%)
Pulmonary embolism	1/926 (0.1%)
Respiratory failure	1/926 (0.1%)
Skin and subcutaneous tissue disorders
Psoriasis	2/926 (0.2%)
Cutaneous lupus erythematosus	1/926 (0.1%)
Hidradenitis	1/926 (0.1%)
Photosensitivity reaction	1/926 (0.1%)
Skin ulcer	1/926 (0.1%)
Surgical and medical procedures
Renal transplant	1/926 (0.1%)
Vascular graft	1/926 (0.1%)
Vascular disorders
Deep vein thrombosis	1/926 (0.1%)
Embolism	1/926 (0.1%)
Peripheral arterial occlusive disease	1/926 (0.1%)
Other (Not Including Serious) Adverse Events
	Etanercept
	Affected / at Risk (%)	# Events
Total	230/926 (24.8%)
Blood and lymphatic system disorders
Leukopenia	3/926 (0.3%)
Thrombocytopenia	2/926 (0.2%)
Anaemia	1/926 (0.1%)
Lymphadenopathy	1/926 (0.1%)
Cardiac disorders
Palpitations	2/926 (0.2%)
Angina pectoris	1/926 (0.1%)
Arrhythmia	1/926 (0.1%)
Cardiac failure	1/926 (0.1%)
Ear and labyrinth disorders
External ear inflammation	1/926 (0.1%)
Endocrine disorders
Hyperthyroidism	1/926 (0.1%)
Eye disorders
Visual impairment	2/926 (0.2%)
Blepharitis	1/926 (0.1%)
Diplopia	1/926 (0.1%)
Eye pain	1/926 (0.1%)
Eyelid oedema	1/926 (0.1%)
Vision blurred	1/926 (0.1%)
Glaucoma	1/926 (0.1%)
Gastrointestinal disorders
Diarrhoea	6/926 (0.6%)
Nausea	3/926 (0.3%)
Periodontitis	2/926 (0.2%)
Abdominal discomfort	1/926 (0.1%)
Abdominal pain upper	1/926 (0.1%)
Ascites	1/926 (0.1%)
Colitis ulcerative	1/926 (0.1%)
Crohn's disease	1/926 (0.1%)
Gastric ulcer haemorrhage	1/926 (0.1%)
Gingivitis	1/926 (0.1%)
Intestinal polyp	1/926 (0.1%)
Salivary gland enlargement	1/926 (0.1%)
General disorders
Condition aggravated	26/926 (2.8%)
Injection site erythema	12/926 (1.3%)
Injection site inflammation	8/926 (0.9%)
Rebound effect	6/926 (0.6%)
Fatigue	4/926 (0.4%)
Oedema peripheral	4/926 (0.4%)
Injection site pruritus	3/926 (0.3%)
Injection site swelling	3/926 (0.3%)
Asthenia	2/926 (0.2%)
Chest discomfort	2/926 (0.2%)
Chest pain	2/926 (0.2%)
Drug ineffective	2/926 (0.2%)
Impaired healing	2/926 (0.2%)
Injection site induration	2/926 (0.2%)
Injection site reaction	2/926 (0.2%)
Pyrexia	2/926 (0.2%)
Application site irritation	1/926 (0.1%)
Chills	1/926 (0.1%)
Drug intolerance	1/926 (0.1%)
Feeling cold	1/926 (0.1%)
Injection site anaesthesia	1/926 (0.1%)
Injection site dryness	1/926 (0.1%)
Injection site nodule	1/926 (0.1%)
Injection site recall reaction	1/926 (0.1%)
Injection site warmth	1/926 (0.1%)
Injection site extravasation	2/926 (0.2%)
Infections and infestations
Nasopharyngitis	26/926 (2.8%)
Infection	10/926 (1.1%)
Upper respiratory tract infection	6/926 (0.6%)
Herpes zoster	6/926 (0.6%)
Gastrointestinal infection	5/926 (0.5%)
Bronchitis	4/926 (0.4%)
Erysipelas	4/926 (0.4%)
Cystitis	3/926 (0.3%)
Respiratory tract infection	3/926 (0.3%)
Tonsillitis	3/926 (0.3%)
Anogenital warts	2/926 (0.2%)
Febrile infection	2/926 (0.2%)
Pneumonia	3/926 (0.3%)
Sinusitis	2/926 (0.2%)
Laryngitis	2/926 (0.2%)
Ear infection	1/926 (0.1%)
Folliculitis	1/926 (0.1%)
Molluscum contagiosum	1/926 (0.1%)
Pilonidal cyst	1/926 (0.1%)
Pneumonia primary atypical	1/926 (0.1%)
Subcutaneous abscess	1/926 (0.1%)
Tooth infection	1/926 (0.1%)
Urinary tract infection	1/926 (0.1%)
Wound infection staphylococcal	1/926 (0.1%)
Anal abscess	1/926 (0.1%)
Influenza	1/926 (0.1%)
Oral candidiasis	1/926 (0.1%)
Oral herpes	1/926 (0.1%)
Tooth abscess	1/926 (0.1%)
Injury, poisoning and procedural complications
Abdominal injury	1/926 (0.1%)
Accident at home	1/926 (0.1%)
Drug exposure before pregnancy	1/926 (0.1%)
Drug exposure during pregnancy	5/926 (0.5%)
Drug exposure via breast milk	1/926 (0.1%)
Fall	1/926 (0.1%)
Meniscus lesion	1/926 (0.1%)
Recall phenomenon	1/926 (0.1%)
Skin laceration	1/926 (0.1%)
Investigations
Alanine aminotransferase increased	1/926 (0.1%)
Aspartate aminotransferase increased	1/926 (0.1%)
Blood count abnormal	1/926 (0.1%)
Blood creatinine increased	2/926 (0.2%)
Gamma-glutamyltransferase increased	1/926 (0.1%)
Heart rate increased	1/926 (0.1%)
Hepatic enzyme increased	2/926 (0.2%)
Red blood cell sedimentation rate increased	1/926 (0.1%)
Liver function test abnormal	4/926 (0.4%)
Transaminases increased	2/926 (0.2%)
Tuberculosis test positive	1/926 (0.1%)
Weight increased	4/926 (0.4%)
White blood cell count decreased	1/926 (0.1%)
Metabolism and nutrition disorders
Diabetes mellitus	2/926 (0.2%)
Gout	2/926 (0.2%)
Hyperuricaemia	1/926 (0.1%)
Hypoglycaemia	1/926 (0.1%)
Podagra	1/926 (0.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	8/926 (0.9%)
Back pain	2/926 (0.2%)
Gouty arthritis	1/926 (0.1%)
Joint effusion	1/926 (0.1%)
Monarthritis	1/926 (0.1%)
Muscular weakness	3/926 (0.3%)
Musculoskeletal discomfort	4/926 (0.4%)
Musculoskeletal disorder	1/926 (0.1%)
Musculoskeletal pain	1/926 (0.1%)
Musculoskeletal stiffness	2/926 (0.2%)
Myalgia	3/926 (0.3%)
Myopathy	2/926 (0.2%)
Pain in extremity	1/926 (0.1%)
Psoriatic arthropathy	2/926 (0.2%)
Osteoarthritis	2/926 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus syndrome	1/926 (0.1%)
Skin papilloma	2/926 (0.2%)
Nervous system disorders
Ageusia	1/926 (0.1%)
Dizziness	4/926 (0.4%)
Dysaesthesia	1/926 (0.1%)
Headache	5/926 (0.5%)
Hypoaesthesia	2/926 (0.2%)
Paraesthesia	1/926 (0.1%)
Radiculopathy	1/926 (0.1%)
Transient ischaemic attack	1/926 (0.1%)
Trigeminal neuralgia	1/926 (0.1%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	6/926 (0.6%)
Psychiatric disorders
Anxiety	1/926 (0.1%)
Depression	1/926 (0.1%)
Middle insomnia	1/926 (0.1%)
Panic attack	1/926 (0.1%)
Sleep disorder	1/926 (0.1%)
Stress	1/926 (0.1%)
Renal and urinary disorders
Haematuria	1/926 (0.1%)
Renal pain	1/926 (0.1%)
Reproductive system and breast disorders
Erectile dysfunction	1/926 (0.1%)
Respiratory, thoracic and mediastinal disorders
Cough	5/926 (0.5%)
Dyspnoea	4/926 (0.4%)
Nasal congestion	2/926 (0.2%)
Oropharyngeal pain	1/926 (0.1%)
Throat irritation	1/926 (0.1%)
Skin and subcutaneous tissue disorders
Acne conglobata	1/926 (0.1%)
Alopecia effluvium	1/926 (0.1%)
Blister	1/926 (0.1%)
Dermatitis	1/926 (0.1%)
Dermatitis contact	1/926 (0.1%)
Dermatitis papillaris capillitii	1/926 (0.1%)
Dermographism	1/926 (0.1%)
Eczema	1/926 (0.1%)
Erythema	2/926 (0.2%)
Hyperhidrosis	3/926 (0.3%)
Photosensitivity allergic reaction	1/926 (0.1%)
Pruritus	4/926 (0.4%)
Pruritus generalised	1/926 (0.1%)
Psoriasis	23/926 (2.5%)
Pustular psoriasis	2/926 (0.2%)
Rash	1/926 (0.1%)
Rash generalised	1/926 (0.1%)
Rash maculo-papular	1/926 (0.1%)
Rosacea	1/926 (0.1%)
Urticaria	3/926 (0.3%)
Alopecia	1/926 (0.1%)
Social circumstances
Immobile	1/926 (0.1%)
Surgical and medical procedures
Aortic valve replacement	1/926 (0.1%)
Cataract operation	1/926 (0.1%)
Dental operation	1/926 (0.1%)
Knee arthroplasty	1/926 (0.1%)
Knee operation	1/926 (0.1%)
Shoulder operation	1/926 (0.1%)
Wart excision	1/926 (0.1%)
Vascular disorders
Hot flush	1/926 (0.1%)
Hypertension	5/926 (0.5%)
Thrombophlebitis	2/926 (0.2%)
Varicose vein	2/926 (0.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00708708

Other Study ID Numbers:

0881X1-4499
B1801081

First Posted:

Jul 2, 2008

Last Update Posted:

Jul 27, 2015

Last Verified:

Jul 1, 2015

Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings

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Arms and Interventions

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Study Results

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