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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00708708
Enrollment
926
Registered
2008-07-02
Start date
2008-06-30
Completion date
2013-12-31
Last updated
2015-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Plaque-type psoriasis

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.

Detailed description

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

Interventions

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.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Duration of Drug-Free Interval Prior to Treatment Cycle 2Cycle 1 Week 24 up to Cycle 2 Week 0Average 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 3Cycle 2 Week 24 up to Cycle 3 Week 0Average 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 4Cycle 3 Week 24 up to Cycle 4 Week 0Average 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 5Cycle 4 Week 24 up to Cycle 5 Week 0Average 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 6Cycle 5 Week 24 up to Cycle 6 Week 0Average 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

MeasureTime frameDescription
Patient Global Assessment of EfficacyWeek 24 of Cycle 1 to 6Participant 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 YearYear 1, 2, 3, 4, 5Number 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 YearYear 1, 2, 3, 4, 5Cumulative 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 YearYear 1Percentage 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 PeriodCycle 1 up to Cycle 6Percentage 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 6Participants 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) ScoreWeek 0, 12, 24 of Cycle 1 to 6DLQI 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 6EQ-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 6EQ-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 MedicationCycle 1 Week 0 up to Cycle 6 Week 24Number 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 EtanerceptYear 1, 2, 3, 4, 5Costs 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 SeverityYear 1, 2, 3, 4, 5Average 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 MedicationsPrior to study, Year 1, 2, 3, 4, 5Annual 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 Dermatology Life Quality Index (DLQI) ScoreWeek 0, 12, 24 of Cycle 1 to 6Effect 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 6Effect 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.
Effect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Week 0, 12, 24 of Cycle 1 to 6Effect 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.
Participant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 2, 3, 4, 5, 6A 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 IntervalBefore Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5A 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: DurationBefore Cycle 2, 3, 4, 5, 6A 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 SymptomsBefore Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5A 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 IntervalBefore Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5A 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 ActivityBefore Cycle 2, 3, 4, 5, 6A 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 ConditionBefore Cycle 2, 3, 4, 5, 6A 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 ReactionsBefore Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5A 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 DiseaseBefore Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5A 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 LifeBefore Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5A 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 TherapyBefore Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5A 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 TherapyBefore Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5A 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 ResumptionBefore Cycle 2, 3, 4, 5, 6Criteria 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.
Participant Perception of Drug-Free Interval: Length of Drug-Free IntervalBefore Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5A 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.
Psoriasis Area and Severity Index (PASI) ScoreWeek 0, 12, 24 of Cycle 1 to 6Combined 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 PsoriasisWeek 0, 12, 24 of Cycle 1 to 6Percentage 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 ActivityWeek 0, 12, 24 of Cycle 1 to 6Static 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 EfficacyWeek 24 of Cycle 1 to 6Physician assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.

Countries

Germany

Participant flow

Pre-assignment details

A total of 955 participants were enrolled for documentation. Of these 955 participants enrolled, only 926 participants were included in analysis.

Participants by arm

ArmCount
Etanercept
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.
926
Total926

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdministrative reasons7
Overall StudyAdverse Event3
Overall StudyAnother therapy along with Enbrel15
Overall StudyAnother therapy instead of Enbrel141
Overall StudyGood effectiveness9
Overall StudyIneffectiveness (no systemic therapy)9
Overall StudyIntolerance42
Overall StudyLack of compliance3
Overall StudyLack of effectiveness4
Overall StudyLost to Follow-up52
Overall StudyMissing values392
Overall StudyOther unspecified11
Overall StudyPregnancy3
Overall StudyWithdrawal by Subject51

Baseline characteristics

CharacteristicEtanercept
Age, Continuous47.4 years
STANDARD_DEVIATION 12.9
Sex/Gender, Customized
Female
339 participants
Sex/Gender, Customized
Male
583 participants
Sex/Gender, Customized
Missing values
4 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
230 / 926
serious
Total, serious adverse events
59 / 926

Outcome results

Primary

Duration of Drug-Free Interval Prior to Treatment Cycle 2

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

Population: 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.

ArmMeasureValue (MEAN)
EtanerceptDuration of Drug-Free Interval Prior to Treatment Cycle 212.6 weeks
Primary

Duration of Drug-Free Interval Prior to Treatment Cycle 3

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

Population: 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.

ArmMeasureValue (MEAN)
EtanerceptDuration of Drug-Free Interval Prior to Treatment Cycle 310.5 weeks
Primary

Duration of Drug-Free Interval Prior to Treatment Cycle 4

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

Population: 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.

ArmMeasureValue (MEAN)
EtanerceptDuration of Drug-Free Interval Prior to Treatment Cycle 425.0 weeks
Primary

Duration of Drug-Free Interval Prior to Treatment Cycle 5

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

Population: 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.

ArmMeasureValue (MEAN)
EtanerceptDuration of Drug-Free Interval Prior to Treatment Cycle 520.6 weeks
Primary

Duration of Drug-Free Interval Prior to Treatment Cycle 6

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

Population: 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.

ArmMeasureValue (MEAN)
EtanerceptDuration of Drug-Free Interval Prior to Treatment Cycle 614.2 weeks
Secondary

Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptAmount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant MedicationsPrior to Study (n=536)77.1 EurosStandard Deviation 170.6
EtanerceptAmount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant MedicationsYear 1 (n=472)194.8 EurosStandard Deviation 729.3
EtanerceptAmount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant MedicationsYear 2 (n=312)91.2 EurosStandard Deviation 445.7
EtanerceptAmount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant MedicationsYear 3 (n=131)128.8 EurosStandard Deviation 956.9
EtanerceptAmount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant MedicationsYear 4 (n=44)31.5 EurosStandard Deviation 87.6
EtanerceptAmount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant MedicationsYear 5 (n=6)53.6 EurosStandard Deviation 49.9
Secondary

Annual Costs for Treatment With Etanercept

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptAnnual Costs for Treatment With EtanerceptYear 1 (n=675)20670.0 EurosStandard Deviation 9743.9
EtanerceptAnnual Costs for Treatment With EtanerceptYear 2 (n=418)13509.6 EurosStandard Deviation 9854.3
EtanerceptAnnual Costs for Treatment With EtanerceptYear 3 (n=167)14113.4 EurosStandard Deviation 8913.8
EtanerceptAnnual Costs for Treatment With EtanerceptYear 4 (n=53)6847.4 EurosStandard Deviation 5648.6
EtanerceptAnnual Costs for Treatment With EtanerceptYear 5 (n=7)5173.7 EurosStandard Deviation 4506.6
Secondary

Average Cost of Treatment by Disease Severity

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.

Time frame: Year 1, 2, 3, 4, 5

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptAverage Cost of Treatment by Disease SeverityYear 1: Mild (n=290)20707.0 EurosStandard Deviation 9751.6
EtanerceptAverage Cost of Treatment by Disease SeverityYear 1: Moderate (n=80)21627.0 EurosStandard Deviation 11119.5
EtanerceptAverage Cost of Treatment by Disease SeverityYear 1: Severe (n=46)21309.2 EurosStandard Deviation 11573.3
EtanerceptAverage Cost of Treatment by Disease SeverityYear 2: Mild (n=200)13777.1 EurosStandard Deviation 9864.5
EtanerceptAverage Cost of Treatment by Disease SeverityYear 2: Moderate (n=32)9668.8 EurosStandard Deviation 7638.6
EtanerceptAverage Cost of Treatment by Disease SeverityYear 2: Severe (n=9)5479.7 EurosStandard Deviation 4225.8
EtanerceptAverage Cost of Treatment by Disease SeverityYear 3: Mild (n=93)15062.1 EurosStandard Deviation 8676.5
EtanerceptAverage Cost of Treatment by Disease SeverityYear 3: Moderate (n=3)6877.2 EurosStandard Deviation 3071.3
EtanerceptAverage Cost of Treatment by Disease SeverityYear 3: Severe (n=4)6371.3 EurosStandard Deviation 2565
EtanerceptAverage Cost of Treatment by Disease SeverityYear 4: Mild (n=25)5809.6 EurosStandard Deviation 3125.3
EtanerceptAverage Cost of Treatment by Disease SeverityYear 4: Moderate (n=1)7467.0 Euros
EtanerceptAverage Cost of Treatment by Disease SeverityYear 4: Severe (n=2)3196.0 EurosStandard Deviation 575.5
EtanerceptAverage Cost of Treatment by Disease SeverityYear 5: Mild (n=6)5309.3 EurosStandard Deviation 4998.2
Secondary

Criteria for Treatment Resumption

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

Population: 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.

ArmMeasureGroupValue (NUMBER)Dispersion
EtanerceptCriteria for Treatment ResumptionBefore Cycle 6- NDA (n=1)1 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 6- POD (n=1)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 6- other reason (n=1)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 6- NDA and POD (n=1)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 6- NDA and other reason (n=1)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 6- POD and other reason (n=1)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 6- NDA, POD and other reason (n=1)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 2- POD (n=144)42 participants 1.3
EtanerceptCriteria for Treatment ResumptionBefore Cycle 2-new disease activity (NDA) (n=144)90 participants 1.3
EtanerceptCriteria for Treatment ResumptionBefore Cycle 2- other reason (n=144)8 participants 1.1
EtanerceptCriteria for Treatment ResumptionBefore Cycle 2- NDA and POD (n=144)4 participants 0.8
EtanerceptCriteria for Treatment ResumptionBefore Cycle 2- NDA and other reason (n=144)0 participants 0
EtanerceptCriteria for Treatment ResumptionBefore Cycle 2- POD and other reason (n=144)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 2- NDA, POD and other reason (n=144)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 3-NDA (n=43)15 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 3- POD (n=43)25 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 3- other reason (n=43)2 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 3- NDA and POD (n=43)1 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 3- NDA and other reason (n=43)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 3- POD and other reason (n=43)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 3- NDA, POD and other reason (n=43)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 4- NDA (n=8)3 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 4- POD (n=8)5 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 4- other reason (n=8)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 4- NDA and POD (n=8)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 4- NDA and other reason (n=8)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 4- POD and other reason (n=8)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 4-NDA, POD and other reason (n=8)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 5- NDA (n=3)2 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 5- POD (n=3)1 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 5- other reason (n=3)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 5- NDA and POD (n=3)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 5- NDA and other reason (n=3)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 5- POD and other reason (n=3)0 participants
EtanerceptCriteria for Treatment ResumptionBefore Cycle 5- NDA, POD and other reason (n=3)0 participants
Secondary

Cumulative Dose of Etanercept Per Year

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptCumulative Dose of Etanercept Per YearYear 1 (n=664)2249.2 mgStandard Deviation 1100.6
EtanerceptCumulative Dose of Etanercept Per YearYear 2 (n=418)1474.7 mgStandard Deviation 1104.6
EtanerceptCumulative Dose of Etanercept Per YearYear 3 (n=167)1565.5 mgStandard Deviation 1027.3
EtanerceptCumulative Dose of Etanercept Per YearYear 4 (n=53)729.1 mgStandard Deviation 589.9
EtanerceptCumulative Dose of Etanercept Per YearYear 5 (n=7)399.5 mgStandard Deviation 354.5
Secondary

Dermatology Life Quality Index (DLQI) Score

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 1 Week 0 (n=654)14.0 units on a scaleStandard Deviation 7.3
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 1 Week 12 (n=598)6.4 units on a scaleStandard Deviation 5.8
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 1 Week 24 (n=536)4.9 units on a scaleStandard Deviation 5.7
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 2 Week 0 (n=334)6.2 units on a scaleStandard Deviation 6.3
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 2 Week 12 (n=440)4.3 units on a scaleStandard Deviation 5.1
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 2 Week 24 (n=378)4.2 units on a scaleStandard Deviation 5.3
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 3 Week 0 (n=186)4.9 units on a scaleStandard Deviation 5.9
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 3 Week 12 (n= 258)3.9 units on a scaleStandard Deviation 5.1
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 3 Week 24 (n=221)3.7 units on a scaleStandard Deviation 5
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 4 Week 0 (n=90)4.7 units on a scaleStandard Deviation 6.4
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 4 Week 12 (n=146)3.6 units on a scaleStandard Deviation 4.4
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 4 Week 24 (n=132)3.8 units on a scaleStandard Deviation 5.1
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 5 Week 0 (n=64)4.5 units on a scaleStandard Deviation 5.4
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 5 Week 12 (n=104)3.8 units on a scaleStandard Deviation 4.8
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 5 Week 24 (n=91)3.7 units on a scaleStandard Deviation 4.3
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 6 Week 0 (n=43)5.0 units on a scaleStandard Deviation 5.1
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 6 Week 12 (n=75)3.5 units on a scaleStandard Deviation 4.6
EtanerceptDermatology Life Quality Index (DLQI) ScoreCycle 6 Week 24 (n=69)3.9 units on a scaleStandard Deviation 4.4
Secondary

Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 1 Week 0 (n=276,136)13.8 units on a scaleStandard Deviation 7.3
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 1 Week 12 (n=267,126)5.7 units on a scaleStandard Deviation 5.3
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 1 Week 24 (n=263,135)4.7 units on a scaleStandard Deviation 5.6
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 2 Week 0 (n=145,133)5.8 units on a scaleStandard Deviation 6.4
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 2 Week 12 (n=256,128)4.4 units on a scaleStandard Deviation 5.4
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 2 Week 24 (n=227,107)4.4 units on a scaleStandard Deviation 5.8
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 3 Week 0 (n=109,41)5.0 units on a scaleStandard Deviation 6.2
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 3 Week 12 (n= 183,38)4.2 units on a scaleStandard Deviation 5.4
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 3 Week 24 (n=158,36)4.1 units on a scaleStandard Deviation 5.5
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 4 Week 0 (n=72,6)5.0 units on a scaleStandard Deviation 6.4
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 4 Week 12 (n=124,6)3.6 units on a scaleStandard Deviation 4.5
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 4 Week 24 (n=112,5)3.9 units on a scaleStandard Deviation 5.2
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 5 Week 0 (n=53,3)4.8 units on a scaleStandard Deviation 5.8
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 5 Week 12 (n=94,2)3.7 units on a scaleStandard Deviation 4.7
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 5 Week 24 (n=83,2)3.7 units on a scaleStandard Deviation 4.4
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 6 Week 0 (n=39,2)5.1 units on a scaleStandard Deviation 5.3
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 6 Week 12 (n=72,1)3.6 units on a scaleStandard Deviation 4.7
EtanerceptEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 6 Week 24 (n=67,0)4.0 units on a scaleStandard Deviation 4.4
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 5 Week 12 (n=94,2)3.0 units on a scaleStandard Deviation 0
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 1 Week 0 (n=276,136)15.5 units on a scaleStandard Deviation 7.2
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 4 Week 0 (n=72,6)4.5 units on a scaleStandard Deviation 9.1
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 1 Week 12 (n=267,126)7.1 units on a scaleStandard Deviation 5.9
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 6 Week 24 (n=67,0)NA units on a scale
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 1 Week 24 (n=263,135)4.7 units on a scaleStandard Deviation 5.5
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 4 Week 12 (n=124,6)4.5 units on a scaleStandard Deviation 5.5
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 2 Week 0 (n=145,133)7.6 units on a scaleStandard Deviation 6.5
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 5 Week 24 (n=83,2)3.0 units on a scaleStandard Deviation 1.4
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 2 Week 12 (n=256,128)4.5 units on a scaleStandard Deviation 4.9
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 4 Week 24 (n=112,5)5.0 units on a scaleStandard Deviation 5.7
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 2 Week 24 (n=227,107)4.0 units on a scaleStandard Deviation 4.4
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 6 Week 12 (n=72,1)1.0 units on a scale
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 3 Week 0 (n=109,41)6.4 units on a scaleStandard Deviation 6.5
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 5 Week 0 (n=53,3)1.7 units on a scaleStandard Deviation 1.5
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 3 Week 12 (n= 183,38)3.7 units on a scaleStandard Deviation 5
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 6 Week 0 (n=39,2)5.5 units on a scaleStandard Deviation 2.1
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) ScoreCycle 3 Week 24 (n=158,36)2.1 units on a scaleStandard Deviation 3
Secondary

Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 1 Week 0 (n=279,137)0.810 units on a scaleStandard Deviation 0.243
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 1 Week 12 (n=281,137)0.914 units on a scaleStandard Deviation 0.144
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 1 Week 24 (n=272,139)0.921 units on a scaleStandard Deviation 0.149
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 2 Week 0 (n=152,135)0.903 units on a scaleStandard Deviation 0.164
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 2 Week 12 (n=261,129)0.930 units on a scaleStandard Deviation 0.14
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 2 Week 24 (n=238,111)0.934 units on a scaleStandard Deviation 0.148
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 3 Week 0 (n=111,41)0.931 units on a scaleStandard Deviation 0.139
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 3 Week 12 (n= 181,37)0.946 units on a scaleStandard Deviation 0.088
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 3 Week 24 (n=160,35)0.921 units on a scaleStandard Deviation 0.157
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 4 Week 0 (n=71,6)0.894 units on a scaleStandard Deviation 0.184
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 4 Week 12 (n=122,6)0.929 units on a scaleStandard Deviation 0.129
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 4 Week 24 (n=110,5)0.920 units on a scaleStandard Deviation 0.163
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 5 Week 0 (n=53,2)0.907 units on a scaleStandard Deviation 0.168
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 5 Week 12 (n=94,2)0.929 units on a scaleStandard Deviation 0.107
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 5 Week 24 (n=83,2)0.950 units on a scaleStandard Deviation 0.101
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 6 Week 0 (n=39,2)0.932 units on a scaleStandard Deviation 0.101
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 6 Week 12 (n=72,1)0.939 units on a scaleStandard Deviation 0.1
EtanerceptEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 6 Week 24 (n=67,0)0.937 units on a scaleStandard Deviation 0.128
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 5 Week 12 (n=94,2)0.943 units on a scaleStandard Deviation 0.079
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 1 Week 0 (n=279,137)0.809 units on a scaleStandard Deviation 0.232
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 4 Week 0 (n=71,6)0.980 units on a scaleStandard Deviation 0.046
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 1 Week 12 (n=281,137)0.916 units on a scaleStandard Deviation 0.151
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 6 Week 24 (n=67,0)NA units on a scale
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 1 Week 24 (n=272,139)0.944 units on a scaleStandard Deviation 0.117
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 4 Week 12 (n=122,6)0.962 units on a scaleStandard Deviation 0.058
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 2 Week 0 (n=152,135)0.920 units on a scaleStandard Deviation 0.144
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 5 Week 24 (n=83,2)0.943 units on a scaleStandard Deviation 0.079
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 2 Week 12 (n=261,129)0.949 units on a scaleStandard Deviation 0.128
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 4 Week 24 (n=110,5)0.954 units on a scaleStandard Deviation 0.061
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 2 Week 24 (n=238,111)0.948 units on a scaleStandard Deviation 0.123
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 6 Week 12 (n=72,1)0.887 units on a scale
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 3 Week 0 (n=111,41)0.921 units on a scaleStandard Deviation 0.183
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 5 Week 0 (n=53,2)0.943 units on a scaleStandard Deviation 0.079
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 3 Week 12 (n= 181,37)0.969 units on a scaleStandard Deviation 0.049
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 6 Week 0 (n=39,2)0.887 units on a scaleStandard Deviation 0
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)Cycle 3 Week 24 (n=160,35)0.972 units on a scaleStandard Deviation 0.068
Secondary

Effect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 1 Week 0 (n=280, 138)3.7 units on a scaleStandard Deviation 1.2
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 1 Week 12 (n=279, 138)2.1 units on a scaleStandard Deviation 1.2
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 1 Week 24 (n=274, 139)1.9 units on a scaleStandard Deviation 1.1
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 2 Week 0 (n=156, 136)2.0 units on a scaleStandard Deviation 1.2
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 2 Week 12 (n=264, 130)1.8 units on a scaleStandard Deviation 1.2
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 2 Week 24 (n=238, 111)1.7 units on a scaleStandard Deviation 1.2
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 3 Week 0 (n=112, 41)1.8 units on a scaleStandard Deviation 1.2
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 3 Week 12 (n=184, 38)1.7 units on a scaleStandard Deviation 1.2
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 3 Week 24 (n=161, 36)1.7 units on a scaleStandard Deviation 1.2
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 4 Week 0 (n=71, 6)1.8 units on a scaleStandard Deviation 1.1
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 4 Week 12 (n=123, 6)1.7 units on a scaleStandard Deviation 1.1
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 4 Week 24 (n=112, 5)1.8 units on a scaleStandard Deviation 1
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 5 Week 0 (n=53, 2)1.9 units on a scaleStandard Deviation 1.1
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 5 Week 12 (n=94, 2)1.6 units on a scaleStandard Deviation 1
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 5 Week 24 (n=84, 2)1.8 units on a scaleStandard Deviation 0.9
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 6 Week 0 (n=39, 2)2.2 units on a scaleStandard Deviation 0.8
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 6 Week 12 (n=73 1)1.6 units on a scaleStandard Deviation 1.1
EtanerceptEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 6 Week 24(n=66, 0)1.7 units on a scaleStandard Deviation 1
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 5 Week 12 (n=94, 2)3.0 units on a scaleStandard Deviation 1.4
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 1 Week 0 (n=280, 138)3.9 units on a scaleStandard Deviation 0.9
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 4 Week 0 (n=71, 6)2.2 units on a scaleStandard Deviation 1.5
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 1 Week 12 (n=279, 138)2.1 units on a scaleStandard Deviation 1.3
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 6 Week 24(n=66, 0)NA units on a scale
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 1 Week 24 (n=274, 139)1.8 units on a scaleStandard Deviation 1.3
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 4 Week 12 (n=123, 6)2.0 units on a scaleStandard Deviation 1.3
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 2 Week 0 (n=156, 136)2.6 units on a scaleStandard Deviation 1.3
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 5 Week 24 (n=84, 2)3.0 units on a scaleStandard Deviation 1.4
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 2 Week 12 (n=264, 130)1.8 units on a scaleStandard Deviation 1
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 4 Week 24 (n=112, 5)3.2 units on a scaleStandard Deviation 1.8
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 2 Week 24 (n=238, 111)1.7 units on a scaleStandard Deviation 1.3
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 6 Week 12 (n=73 1)3.0 units on a scale
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 3 Week 0 (n=112, 41)2.1 units on a scaleStandard Deviation 1.3
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 5 Week 0 (n=53, 2)3.0 units on a scaleStandard Deviation 1.4
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 3 Week 12 (n=184, 38)1.5 units on a scaleStandard Deviation 1.1
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 6 Week 0 (n=39, 2)3.5 units on a scaleStandard Deviation 0.7
Participants With Drug-Free IntervalEffect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)Cycle 3 Week 24 (n=161, 36)1.2 units on a scaleStandard Deviation 1.2
Secondary

Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 1 Week 0 (n=666 )0.817 units on a scaleStandard Deviation 0.236
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 1 Week 12 (n=628)0.915 units on a scaleStandard Deviation 0.149
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 1 Week 24 (n=549)0.930 units on a scaleStandard Deviation 0.145
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 2 Week 0 (n=344)0.915 units on a scaleStandard Deviation 0.154
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 2 Week 12 (n=451)0.933 units on a scaleStandard Deviation 0.142
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 2 Week 24 (n=393)0.939 units on a scaleStandard Deviation 0.14
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 3 Week 0 (n=190)0.932 units on a scaleStandard Deviation 0.149
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 3 Week 12 (n= 257)0.949 units on a scaleStandard Deviation 0.094
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 3 Week 24 (n=222)0.928 units on a scaleStandard Deviation 0.154
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 4 Week 0 (n=89)0.912 units on a scaleStandard Deviation 0.169
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 4 Week 12 (n=144)0.935 units on a scaleStandard Deviation 0.121
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 4 Week 24 (n=129)0.927 units on a scaleStandard Deviation 0.153
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 5 Week 0 (n=63)0.914 units on a scaleStandard Deviation 0.157
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 5 Week 12 (n=104)0.932 units on a scaleStandard Deviation 0.103
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 5 Week 24 (n=91)0.950 units on a scaleStandard Deviation 0.099
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 6 Week 0 (n=43)0.930 units on a scaleStandard Deviation 0.097
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 6 Week 12 (n=75)0.938 units on a scaleStandard Deviation 0.098
EtanerceptEuro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)Cycle 6 Week 24 (n=69)0.939 units on a scaleStandard Deviation 0.127
Secondary

Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 1 Week 0 (n=666 )73.8 units on a scaleStandard Deviation 20.5
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 1 Week 12 (n=628)85.1 units on a scaleStandard Deviation 16.7
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 1 Week 24 (n=549)87.7 units on a scaleStandard Deviation 16.9
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 2 Week 0 (n=344)85.6 units on a scaleStandard Deviation 17.7
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 2 Week 12 (n=451)88.6 units on a scaleStandard Deviation 15.9
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 2 Week 24 (n=393)89.5 units on a scaleStandard Deviation 16.3
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 3 Week 0 (n=190)88.3 units on a scaleStandard Deviation 17
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 3 Week 12 (n= 257)90.3 units on a scaleStandard Deviation 14
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 3 Week 24 (n=222)88.5 units on a scaleStandard Deviation 17.7
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 4 Week 0 (n=89)85.7 units on a scaleStandard Deviation 18.9
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 4 Week 12 (n=144)88.8 units on a scaleStandard Deviation 15.4
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 4 Week 24 (n=129)87.8 units on a scaleStandard Deviation 17.9
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 5 Week 0 (n=63)85.0 units on a scaleStandard Deviation 18.8
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 5 Week 12 (n=104)87.1 units on a scaleStandard Deviation 15.4
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 5 Week 24 (n=91)89.4 units on a scaleStandard Deviation 14.9
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 6 Week 0 (n=43)85.1 units on a scaleStandard Deviation 16.2
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 6 Week 12 (n=75)87.8 units on a scaleStandard Deviation 13.8
EtanerceptEuro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)Cycle 6 Week 24 (n=69)89.0 units on a scaleStandard Deviation 14.9
Secondary

Number of Injections Per Year

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptNumber of Injections Per YearYear 1 (n=675)47.0 injectionsStandard Deviation 22.2
EtanerceptNumber of Injections Per YearYear 2 (n=418)30.8 injectionsStandard Deviation 22.4
EtanerceptNumber of Injections Per YearYear 3 (n=167)32.1 injectionsStandard Deviation 20.3
EtanerceptNumber of Injections Per YearYear 4 (n=53)15.6 injectionsStandard Deviation 12.9
EtanerceptNumber of Injections Per YearYear 5 (n=7)11.8 injectionsStandard Deviation 10.3
Secondary

Number of Participants With at Least 1 Concomitant Medication

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

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

ArmMeasureValue (NUMBER)Dispersion
EtanerceptNumber of Participants With at Least 1 Concomitant Medication368 participants 10.6
Secondary

Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)

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)

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

ArmMeasureGroupValue (NUMBER)Dispersion
EtanerceptNumber of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)AEs273 participants 10.6
EtanerceptNumber of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)SAEs59 participants
Secondary

Participant Perception of Drug-Free Interval: Comfort in Everyday Life

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptParticipant Perception of Drug-Free Interval: Comfort in Everyday LifeAfter Cycle 1 (n=104)2.3 units on a scaleStandard Deviation 1.2
EtanerceptParticipant Perception of Drug-Free Interval: Comfort in Everyday LifeBefore Cycle 2 (n=103)2.6 units on a scaleStandard Deviation 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Comfort in Everyday LifeAfter Cycle 2 (n=39)2.6 units on a scaleStandard Deviation 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Comfort in Everyday LifeBefore Cycle 3 (n=38)2.6 units on a scaleStandard Deviation 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Comfort in Everyday LifeAfter Cycle 3 (n=5)1.8 units on a scaleStandard Deviation 1.1
EtanerceptParticipant Perception of Drug-Free Interval: Comfort in Everyday LifeBefore Cycle 4 (n=5)1.8 units on a scaleStandard Deviation 0.8
EtanerceptParticipant Perception of Drug-Free Interval: Comfort in Everyday LifeAfter Cycle 4 (n=3)1.0 units on a scaleStandard Deviation 0
EtanerceptParticipant Perception of Drug-Free Interval: Comfort in Everyday LifeBefore Cycle 5 (n=1)2.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Comfort in Everyday LifeAfter Cycle 5 (n=1)5.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Comfort in Everyday LifeBefore Cycle 6 (n=1)1.0 units on a scale
Secondary

Participant Perception of Drug-Free Interval: Disease Activity

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptParticipant Perception of Drug-Free Interval: Disease ActivityBefore Cycle 2-first half (n=102)2.4 units on a scaleStandard Deviation 1
EtanerceptParticipant Perception of Drug-Free Interval: Disease ActivityBefore Cycle 2-second half (n=101)3.3 units on a scaleStandard Deviation 1
EtanerceptParticipant Perception of Drug-Free Interval: Disease ActivityBefore Cycle 3-first half (n=36)2.3 units on a scaleStandard Deviation 1
EtanerceptParticipant Perception of Drug-Free Interval: Disease ActivityBefore Cycle 3-second half (n=36)3.0 units on a scaleStandard Deviation 1.1
EtanerceptParticipant Perception of Drug-Free Interval: Disease ActivityBefore Cycle 4-first half (n=4)2.5 units on a scaleStandard Deviation 0.6
EtanerceptParticipant Perception of Drug-Free Interval: Disease ActivityBefore Cycle 4-second half (n=4)3.3 units on a scaleStandard Deviation 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Disease ActivityBefore Cycle 5-first half (n=1)2.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Disease ActivityBefore Cycle 5-second half (n=1)3.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Disease ActivityBefore Cycle 6-first half (n=1)1.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Disease ActivityBefore Cycle 6-second half (n=1)2.0 units on a scale
Secondary

Participant Perception of Drug-Free Interval: Duration

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptParticipant Perception of Drug-Free Interval: DurationBefore Cycle 2 (n=104)2.5 units on a scaleStandard Deviation 1.1
EtanerceptParticipant Perception of Drug-Free Interval: DurationBefore Cycle 3 (n=35)2.9 units on a scaleStandard Deviation 1.2
EtanerceptParticipant Perception of Drug-Free Interval: DurationBefore Cycle 4 (n=5)1.0 units on a scaleStandard Deviation 0
EtanerceptParticipant Perception of Drug-Free Interval: DurationBefore Cycle 5 (n=1)2.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: DurationBefore Cycle 6 (n=1)2.0 units on a scale
Secondary

Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptParticipant Perception of Drug-Free Interval: Effective Therapy After Drug-Free IntervalAfter Cycle 1 (n=114)4.6 units on a scaleStandard Deviation 0.8
EtanerceptParticipant Perception of Drug-Free Interval: Effective Therapy After Drug-Free IntervalBefore Cycle 2 (n=106)4.4 units on a scaleStandard Deviation 0.8
EtanerceptParticipant Perception of Drug-Free Interval: Effective Therapy After Drug-Free IntervalAfter Cycle 2 (n=41)4.4 units on a scaleStandard Deviation 0.9
EtanerceptParticipant Perception of Drug-Free Interval: Effective Therapy After Drug-Free IntervalBefore Cycle 3 (n=35)4.3 units on a scaleStandard Deviation 1.1
EtanerceptParticipant Perception of Drug-Free Interval: Effective Therapy After Drug-Free IntervalAfter Cycle 3 (n=6)4.7 units on a scaleStandard Deviation 0.8
EtanerceptParticipant Perception of Drug-Free Interval: Effective Therapy After Drug-Free IntervalBefore Cycle 4 (n=5)5.0 units on a scaleStandard Deviation 0
EtanerceptParticipant Perception of Drug-Free Interval: Effective Therapy After Drug-Free IntervalAfter Cycle 4 (n=2)2.5 units on a scaleStandard Deviation 2.1
EtanerceptParticipant Perception of Drug-Free Interval: Effective Therapy After Drug-Free IntervalBefore Cycle 5 (n=1)5.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Effective Therapy After Drug-Free IntervalAfter Cycle 5 (n=1)5.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Effective Therapy After Drug-Free IntervalBefore Cycle 6 (n=1)2.0 units on a scale
Secondary

Participant Perception of Drug-Free Interval: Length of Drug-Free Interval

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptParticipant Perception of Drug-Free Interval: Length of Drug-Free IntervalAfter Cycle 1 (n=50)0.9 monthsStandard Deviation 1
EtanerceptParticipant Perception of Drug-Free Interval: Length of Drug-Free IntervalBefore Cycle 2 (n=102)2.4 monthsStandard Deviation 2.9
EtanerceptParticipant Perception of Drug-Free Interval: Length of Drug-Free IntervalAfter Cycle 2 (n=19)1.4 monthsStandard Deviation 1.5
EtanerceptParticipant Perception of Drug-Free Interval: Length of Drug-Free IntervalBefore Cycle 3 (n=37)1.6 monthsStandard Deviation 1.6
EtanerceptParticipant Perception of Drug-Free Interval: Length of Drug-Free IntervalAfter Cycle 3 (n=2)4.5 monthsStandard Deviation 2.1
EtanerceptParticipant Perception of Drug-Free Interval: Length of Drug-Free IntervalBefore Cycle 4 (n=5)1.8 monthsStandard Deviation 1.8
EtanerceptParticipant Perception of Drug-Free Interval: Length of Drug-Free IntervalAfter Cycle 4 (n=0)NA months
EtanerceptParticipant Perception of Drug-Free Interval: Length of Drug-Free IntervalBefore Cycle 5 (n=1)2.3 months
EtanerceptParticipant Perception of Drug-Free Interval: Length of Drug-Free IntervalAfter Cycle 5 (n=0)NA months
EtanerceptParticipant Perception of Drug-Free Interval: Length of Drug-Free IntervalBefore Cycle 6 (n=1)2.8 months
Secondary

Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptParticipant Perception of Drug-Free Interval: Liking of Drug-Free IntervalAfter Cycle 1 (n=113)2.6 units on a scaleStandard Deviation 1.5
EtanerceptParticipant Perception of Drug-Free Interval: Liking of Drug-Free IntervalBefore Cycle 2 (n=106)2.5 units on a scaleStandard Deviation 1.4
EtanerceptParticipant Perception of Drug-Free Interval: Liking of Drug-Free IntervalAfter Cycle 2 (n=40)3.1 units on a scaleStandard Deviation 1.5
EtanerceptParticipant Perception of Drug-Free Interval: Liking of Drug-Free IntervalBefore Cycle 3 (n=37)2.9 units on a scaleStandard Deviation 1.4
EtanerceptParticipant Perception of Drug-Free Interval: Liking of Drug-Free IntervalAfter Cycle 3 (n=7)2.1 units on a scaleStandard Deviation 1.7
EtanerceptParticipant Perception of Drug-Free Interval: Liking of Drug-Free IntervalBefore Cycle 4 (n=5)1.0 units on a scaleStandard Deviation 0
EtanerceptParticipant Perception of Drug-Free Interval: Liking of Drug-Free IntervalAfter Cycle 4 (n=2)1.5 units on a scaleStandard Deviation 0.7
EtanerceptParticipant Perception of Drug-Free Interval: Liking of Drug-Free IntervalBefore Cycle 5 (n=1)2.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Liking of Drug-Free IntervalAfter Cycle 5 (n=1)4.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Liking of Drug-Free IntervalBefore Cycle 6 (n=1)2.0 units on a scale
Secondary

Participant Perception of Drug-Free Interval: Preference to Continuous Therapy

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

Population: 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.

ArmMeasureGroupValue (NUMBER)Dispersion
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyAfter Cycle 1- No (n=104)9 participants 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyAfter Cycle 1- Yes (n=104)95 participants 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyBefore Cycle 2- No (n=106)8 participants 1.1
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyBefore Cycle 2- Yes (n=106)98 participants 0.8
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyAfter Cycle 2- No (n=40)8 participants 0
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyAfter Cycle 2- Yes (n=40)32 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyBefore Cycle 3- No (n=42)3 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyBefore Cycle 3- Yes (n=42)39 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyAfter Cycle 3- No (n=7)0 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyAfter Cycle 3- Yes (n=7)7 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyBefore Cycle 4- No (n=6)0 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyBefore Cycle 4- Yes (n=6)6 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyAfter Cycle 4- No (n=3)1 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyAfter Cycle 4- Yes (n=3)2 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyBefore Cycle 5- No (n=1)0 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyBefore Cycle 5- Yes (n=1)1 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyAfter Cycle 5- No (n=1)0 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyAfter Cycle 5- Yes (n=1)1 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyBefore Cycle 6- No (n=1)0 participants
EtanerceptParticipant Perception of Drug-Free Interval: Preference to Continuous TherapyBefore Cycle 6- Yes (n=1)1 participants
Secondary

Participant Perception of Drug-Free Interval: Reason for Returning to Practice

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

Population: 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.

ArmMeasureGroupValue (NUMBER)Dispersion
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 2- unscheduled visit (n=116)66 participants 2.9
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 2- scheduled visit (n=116)46 participants 1
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 2- other reason (n=116)4 participants 1.6
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 3- unscheduled visit (n=43)16 participants 1.5
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 3- scheduled visit (n=43)26 participants 1.8
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 3- other reason (n=43)1 participants
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 4- unscheduled visit(n=7)2 participants
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 4- scheduled visit (n=7)4 participants
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 4-other reason (n=7)1 participants
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 5- unscheduled visit(n=1)0 participants
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 5-scheduled visit (n=1)1 participants
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 5-other reason (n=1)0 participants
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 6- unscheduled visit (n=1)0 participants
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 6-scheduled visit (n=1)1 participants
EtanerceptParticipant Perception of Drug-Free Interval: Reason for Returning to PracticeBefore Cycle 6-other reason (n=1)0 participants
Secondary

Participant Perception of Drug-Free Interval: Recommendation of Therapy

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

Population: 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.

ArmMeasureGroupValue (NUMBER)Dispersion
EtanerceptParticipant Perception of Drug-Free Interval: Recommendation of TherapyAfter Cycle 1- No (n=106)0 participants 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Recommendation of TherapyAfter Cycle 1- Yes (n=106)106 participants 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Recommendation of TherapyBefore Cycle 2- No (n=107)0 participants 1.1
EtanerceptParticipant Perception of Drug-Free Interval: Recommendation of TherapyBefore Cycle 2- Yes (n=107)107 participants 0.8
EtanerceptParticipant Perception of Drug-Free Interval: Recommendation of TherapyAfter Cycle 2- No (n=40)1 participants 0
EtanerceptParticipant Perception of Drug-Free Interval: Recommendation of TherapyAfter Cycle 2- Yes (n=40)39 participants
EtanerceptParticipant Perception of Drug-Free Interval: Recommendation of TherapyBefore Cycle 3- No (n=42)0 participants
EtanerceptParticipant Perception of Drug-Free Interval: Recommendation of TherapyBefore Cycle 3- Yes (n=42)42 participants
EtanerceptParticipant Perception of Drug-Free Interval: Recommendation of TherapyAfter Cycle 3- No (n=7)0 participants
EtanerceptParticipant Perception of Drug-Free Interval: Recommendation of TherapyAfter Cycle 3- Yes (n=7)7 participants
EtanerceptParticipant Perception of Drug-Free Interval: Recommendation of TherapyAfter Cycle 4- No (n=1)0 participants
EtanerceptParticipant Perception of Drug-Free Interval: Recommendation of TherapyAfter Cycle 4- Yes (n=1)1 participants
Secondary

Participant Perception of Drug-Free Interval: Relapse of Symptoms

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptParticipant Perception of Drug-Free Interval: Relapse of SymptomsAfter Cycle 1 (n=115)4.4 units on a scaleStandard Deviation 0.8
EtanerceptParticipant Perception of Drug-Free Interval: Relapse of SymptomsBefore Cycle 2 (n=106)4.1 units on a scaleStandard Deviation 1
EtanerceptParticipant Perception of Drug-Free Interval: Relapse of SymptomsAfter Cycle 2 (n=41)4.1 units on a scaleStandard Deviation 1
EtanerceptParticipant Perception of Drug-Free Interval: Relapse of SymptomsBefore Cycle 3 (n=36)4.0 units on a scaleStandard Deviation 0.9
EtanerceptParticipant Perception of Drug-Free Interval: Relapse of SymptomsAfter Cycle 3 (n=7)4.9 units on a scaleStandard Deviation 0.4
EtanerceptParticipant Perception of Drug-Free Interval: Relapse of SymptomsBefore Cycle 4 (n=5)4.2 units on a scaleStandard Deviation 1.1
EtanerceptParticipant Perception of Drug-Free Interval: Relapse of SymptomsAfter Cycle 4 (n=3)4.3 units on a scaleStandard Deviation 0.6
EtanerceptParticipant Perception of Drug-Free Interval: Relapse of SymptomsBefore Cycle 5 (n=1)4.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Relapse of SymptomsAfter Cycle 5 (n=1)3.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Relapse of SymptomsBefore Cycle 6 (n=1)3.0 units on a scale
Secondary

Participant Perception of Drug-Free Interval: Reminder of Disease

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptParticipant Perception of Drug-Free Interval: Reminder of DiseaseAfter Cycle 1 (n=104)2.4 units on a scaleStandard Deviation 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Reminder of DiseaseBefore Cycle 2 (n=103)2.5 units on a scaleStandard Deviation 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Reminder of DiseaseAfter Cycle 2 (n=39)2.7 units on a scaleStandard Deviation 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Reminder of DiseaseBefore Cycle 3 (n=38)2.7 units on a scaleStandard Deviation 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Reminder of DiseaseAfter Cycle 3 (n=5)1.6 units on a scaleStandard Deviation 0.9
EtanerceptParticipant Perception of Drug-Free Interval: Reminder of DiseaseBefore Cycle 4 (n=5)1.6 units on a scaleStandard Deviation 0.9
EtanerceptParticipant Perception of Drug-Free Interval: Reminder of DiseaseAfter Cycle 4 (n=3)2.7 units on a scaleStandard Deviation 2.1
EtanerceptParticipant Perception of Drug-Free Interval: Reminder of DiseaseBefore Cycle 5 (n=1)2.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Reminder of DiseaseAfter Cycle 5 (n=1)5.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Reminder of DiseaseBefore Cycle 6 (n=1)5.0 units on a scale
Secondary

Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptParticipant Perception of Drug-Free Interval: Risk for Adverse Drug ReactionsAfter Cycle 1 (n=110)3.0 units on a scaleStandard Deviation 1.1
EtanerceptParticipant Perception of Drug-Free Interval: Risk for Adverse Drug ReactionsBefore Cycle 2 (n=100)3.2 units on a scaleStandard Deviation 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Risk for Adverse Drug ReactionsAfter Cycle 2 (n=41)2.9 units on a scaleStandard Deviation 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Risk for Adverse Drug ReactionsBefore Cycle 3 (n=38)3.1 units on a scaleStandard Deviation 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Risk for Adverse Drug ReactionsAfter Cycle 3 (n=6)2.3 units on a scaleStandard Deviation 1.4
EtanerceptParticipant Perception of Drug-Free Interval: Risk for Adverse Drug ReactionsBefore Cycle 4 (n=5)1.6 units on a scaleStandard Deviation 0.9
EtanerceptParticipant Perception of Drug-Free Interval: Risk for Adverse Drug ReactionsAfter Cycle 4 (n=1)3.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Risk for Adverse Drug ReactionsBefore Cycle 5 (n=1)3.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Risk for Adverse Drug ReactionsAfter Cycle 5 (n=1)5.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Risk for Adverse Drug ReactionsBefore Cycle 6 (n=1)5.0 units on a scale
Secondary

Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptParticipant Perception of Drug-Free Interval: Satisfaction With Skin ConditionBefore Cycle 2-first half (n=100)3.3 units on a scaleStandard Deviation 1.2
EtanerceptParticipant Perception of Drug-Free Interval: Satisfaction With Skin ConditionBefore Cycle 2-second half (n=100)2.7 units on a scaleStandard Deviation 1
EtanerceptParticipant Perception of Drug-Free Interval: Satisfaction With Skin ConditionBefore Cycle 3-first half (n=36)3.2 units on a scaleStandard Deviation 1.4
EtanerceptParticipant Perception of Drug-Free Interval: Satisfaction With Skin ConditionBefore Cycle 3-second half (n=36)2.8 units on a scaleStandard Deviation 1.1
EtanerceptParticipant Perception of Drug-Free Interval: Satisfaction With Skin ConditionBefore Cycle 4-first half (n=4)3.5 units on a scaleStandard Deviation 1.3
EtanerceptParticipant Perception of Drug-Free Interval: Satisfaction With Skin ConditionBefore Cycle 4-second half (n=4)2.3 units on a scaleStandard Deviation 1
EtanerceptParticipant Perception of Drug-Free Interval: Satisfaction With Skin ConditionBefore Cycle 5-first half (n=1)4.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Satisfaction With Skin ConditionBefore Cycle 5-second half (n=1)3.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Satisfaction With Skin ConditionBefore Cycle 6-first half (n=1)4.0 units on a scale
EtanerceptParticipant Perception of Drug-Free Interval: Satisfaction With Skin ConditionBefore Cycle 6-second half (n=1)3.0 units on a scale
Secondary

Patient Global Assessment of Efficacy

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

Population: 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.

ArmMeasureGroupValue (NUMBER)Dispersion
EtanerceptPatient Global Assessment of EfficacyCycle 2: good (n=444)165 participants 1
EtanerceptPatient Global Assessment of EfficacyCycle 2: moderate (n=444)40 participants 1
EtanerceptPatient Global Assessment of EfficacyCycle 1: very good (n=605)297 participants 0.9
EtanerceptPatient Global Assessment of EfficacyCycle 1: good (n=605)216 participants 1
EtanerceptPatient Global Assessment of EfficacyCycle 1: moderate (n=605)65 participants 1
EtanerceptPatient Global Assessment of EfficacyCycle 1: insufficient (n=605)27 participants 1
EtanerceptPatient Global Assessment of EfficacyCycle 2: very good (n=444)229 participants 0.9
EtanerceptPatient Global Assessment of EfficacyCycle 2: insufficient (n=444)10 participants 1
EtanerceptPatient Global Assessment of EfficacyCycle 3: very good (n=258)145 participants 0.9
EtanerceptPatient Global Assessment of EfficacyCycle 3: good (n=258)98 participants 0.9
EtanerceptPatient Global Assessment of EfficacyCycle 3: moderate (n=258)10 participants 0.9
EtanerceptPatient Global Assessment of EfficacyCycle 3: insufficient (n=258)5 participants 0.9
EtanerceptPatient Global Assessment of EfficacyCycle 4: very good (n=147)77 participants 0.8
EtanerceptPatient Global Assessment of EfficacyCycle 4: good (n=147)61 participants 0.9
EtanerceptPatient Global Assessment of EfficacyCycle 4: moderate (n=147)7 participants 0.8
EtanerceptPatient Global Assessment of EfficacyCycle 4: insufficient (n=147)2 participants 0.9
EtanerceptPatient Global Assessment of EfficacyCycle 5: very good (n=96)39 participants 0.8
EtanerceptPatient Global Assessment of EfficacyCycle 5: good (n=96)50 participants 0.8
EtanerceptPatient Global Assessment of EfficacyCycle 5: moderate (n=96)7 participants
EtanerceptPatient Global Assessment of EfficacyCycle 5: insufficient (n=96)0 participants
EtanerceptPatient Global Assessment of EfficacyCycle 6: very good (n=71)47 participants
EtanerceptPatient Global Assessment of EfficacyCycle 6: good (n=71)21 participants
EtanerceptPatient Global Assessment of EfficacyCycle 6: moderate (n=71)3 participants
EtanerceptPatient Global Assessment of EfficacyCycle 6: insufficient (n=71)0 participants
Secondary

Patient's Global Assessment of Disease Activity (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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 1 Week 0 (n=673)3.7 units on a scaleStandard Deviation 1.2
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 1 Week 12 (n=629)2.2 units on a scaleStandard Deviation 1.2
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 1 Week 24 (n=554)1.9 units on a scaleStandard Deviation 1.2
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 2 Week 0 (n=349)2.2 units on a scaleStandard Deviation 1.3
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 2 Week 12 (n=455)1.7 units on a scaleStandard Deviation 1.1
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 2 Week 24 (n=395)1.7 units on a scaleStandard Deviation 1.2
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 3 Week 0 (n=191)1.8 units on a scaleStandard Deviation 1.2
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 3 Week 12 (n=261)1.6 units on a scaleStandard Deviation 1.1
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 3 Week 24 (n=224)1.6 units on a scaleStandard Deviation 1.2
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 4 Week 0 (n=89)1.8 units on a scaleStandard Deviation 1.1
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 4 Week 12 (n=145)1.7 units on a scaleStandard Deviation 1.1
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 4 Week 24 (n=132)1.8 units on a scaleStandard Deviation 1.1
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 5 Week 0 (n=63)1.9 units on a scaleStandard Deviation 1.1
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 5 Week 12 (n=103)1.7 units on a scaleStandard Deviation 1
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 5 Week 24 (n=92)1.8 units on a scaleStandard Deviation 0.9
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 6 Week 0 (n=43)2.2 units on a scaleStandard Deviation 0.9
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 6 Week 12 (n=76)1.6 units on a scaleStandard Deviation 1.1
EtanerceptPatient's Global Assessment of Disease Activity (PatGA)Cycle 6 Week 24 (n=68)1.6 units on a scaleStandard Deviation 1
Secondary

Percentage of Body Surface Area (BSA) Affected by Psoriasis

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 2 Week 12 (n=280,127,62)8.4 percentage of BSAStandard Deviation 9.8
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 1 Week 12 (n=293,142,235)14.0 percentage of BSAStandard Deviation 13.6
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 1 Week 24 (n=294,143,168)9.4 percentage of BSAStandard Deviation 10.3
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 2 Week 0 (n=293,143,66)9.4 percentage of BSAStandard Deviation 10.3
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 1 Week 0 (n=293,145,267)28.2 percentage of BSAStandard Deviation 20.8
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 2 Week 24 (n=263,117,53)7.7 percentage of BSAStandard Deviation 9.4
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 3 Week 0 (n=212,44,47)7.3 percentage of BSAStandard Deviation 9.5
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 3 Week 12 (n=201,40,43)6.6 percentage of BSAStandard Deviation 8
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 3 Week 24 (n=181,38,36)6.3 percentage of BSAStandard Deviation 7.2
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 4 Week 0 (n=144,8,21)6.0 percentage of BSAStandard Deviation 6
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 4 Week 12 (n=128,8,20)5.9 percentage of BSAStandard Deviation 5.6
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 4 Week 24 (n=121,7,18)6.2 percentage of BSAStandard Deviation 6.4
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 5 Week 0 (n=100,4,10)6.1 percentage of BSAStandard Deviation 5.8
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 5 Week 12 (n=98,2,9)6.0 percentage of BSAStandard Deviation 6.7
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 5 Week 24 (n=88,1,5)6.0 percentage of BSAStandard Deviation 7.3
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 6 Week 24 (n=68,0,2)5.2 percentage of BSAStandard Deviation 7.4
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 6 Week 0 (n=82,1,3)6.2 percentage of BSAStandard Deviation 7.5
EtanerceptPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 6 Week 12 (n=75,0,2)5.7 percentage of BSAStandard Deviation 6.8
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 6 Week 0 (n=82,1,3)5.0 percentage of BSA
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 1 Week 0 (n=293,145,267)36.7 percentage of BSAStandard Deviation 21.3
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 4 Week 0 (n=144,8,21)16.5 percentage of BSAStandard Deviation 13.8
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 5 Week 0 (n=100,4,10)19.8 percentage of BSAStandard Deviation 8.8
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 1 Week 12 (n=293,142,235)20.1 percentage of BSAStandard Deviation 18
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 3 Week 0 (n=212,44,47)13.9 percentage of BSAStandard Deviation 13.3
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 5 Week 24 (n=88,1,5)5.0 percentage of BSA
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 1 Week 24 (n=294,143,168)13.6 percentage of BSAStandard Deviation 15.1
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 4 Week 12 (n=128,8,20)7.9 percentage of BSAStandard Deviation 5.2
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 3 Week 24 (n=181,38,36)6.8 percentage of BSAStandard Deviation 9.1
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 2 Week 0 (n=293,143,66)18.7 percentage of BSAStandard Deviation 15
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 6 Week 12 (n=75,0,2)NA percentage of BSA
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 5 Week 12 (n=98,2,9)17.5 percentage of BSAStandard Deviation 10.6
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 2 Week 12 (n=280,127,62)12.6 percentage of BSAStandard Deviation 14.3
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 4 Week 24 (n=121,7,18)10.3 percentage of BSAStandard Deviation 8.2
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 3 Week 12 (n=201,40,43)9.9 percentage of BSAStandard Deviation 12.8
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 2 Week 24 (n=263,117,53)10.3 percentage of BSAStandard Deviation 11
Participants With Drug-Free IntervalPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 6 Week 24 (n=68,0,2)NA percentage of BSA
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 2 Week 24 (n=263,117,53)9.2 percentage of BSAStandard Deviation 10.1
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 3 Week 0 (n=212,44,47)10.7 percentage of BSAStandard Deviation 13
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 3 Week 12 (n=201,40,43)9.7 percentage of BSAStandard Deviation 13.5
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 5 Week 24 (n=88,1,5)3.4 percentage of BSAStandard Deviation 1.5
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 3 Week 24 (n=181,38,36)8.8 percentage of BSAStandard Deviation 11
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 4 Week 0 (n=144,8,21)8.2 percentage of BSAStandard Deviation 9.8
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 6 Week 0 (n=82,1,3)4.0 percentage of BSAStandard Deviation 3.5
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 4 Week 12 (n=128,8,20)8.2 percentage of BSAStandard Deviation 11.4
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 4 Week 24 (n=121,7,18)5.4 percentage of BSAStandard Deviation 6.6
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 6 Week 12 (n=75,0,2)3.0 percentage of BSAStandard Deviation 1.4
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 1 Week 0 (n=293,145,267)35.1 percentage of BSAStandard Deviation 23.2
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 1 Week 12 (n=293,142,235)21.6 percentage of BSAStandard Deviation 19.8
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 5 Week 0 (n=100,4,10)7.2 percentage of BSAStandard Deviation 8.1
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 1 Week 24 (n=294,143,168)15.9 percentage of BSAStandard Deviation 17.6
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 6 Week 24 (n=68,0,2)2.0 percentage of BSAStandard Deviation 0
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 2 Week 0 (n=293,143,66)11.6 percentage of BSAStandard Deviation 13.1
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 2 Week 12 (n=280,127,62)11.1 percentage of BSAStandard Deviation 13.4
Remaining ParticipantsPercentage of Body Surface Area (BSA) Affected by PsoriasisCycle 5 Week 12 (n=98,2,9)4.8 percentage of BSAStandard Deviation 4.5
Secondary

Percentage of Time on Treatment in First Year

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

Population: 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.

ArmMeasureValue (MEAN)Dispersion
EtanerceptPercentage of Time on Treatment in First Year96.5 percentage of first yearStandard Deviation 10.6
Secondary

Percentage of Time on Treatment Over Entire Period

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

Population: 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.

ArmMeasureValue (MEAN)Dispersion
EtanerceptPercentage of Time on Treatment Over Entire Period94.8 percentage of entire treatment periodStandard Deviation 10.9
Secondary

Physician Global Assessment of Efficacy

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

Population: 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.

ArmMeasureGroupValue (NUMBER)Dispersion
EtanerceptPhysician Global Assessment of EfficacyCycle 1: very good (n=606)304 participants 0.9
EtanerceptPhysician Global Assessment of EfficacyCycle 1: good (n=606)214 participants 1
EtanerceptPhysician Global Assessment of EfficacyCycle 1: moderate (n=606)68 participants 1
EtanerceptPhysician Global Assessment of EfficacyCycle 1: insufficient (n=606)20 participants 1
EtanerceptPhysician Global Assessment of EfficacyCycle 2: very good (n=440)242 participants 0.9
EtanerceptPhysician Global Assessment of EfficacyCycle 2: good (n=440)151 participants 1
EtanerceptPhysician Global Assessment of EfficacyCycle 2: moderate (n=440)39 participants 1
EtanerceptPhysician Global Assessment of EfficacyCycle 2: insufficient (n=440)8 participants 1
EtanerceptPhysician Global Assessment of EfficacyCycle 3: very good (n=259)153 participants 0.9
EtanerceptPhysician Global Assessment of EfficacyCycle 3: good (n=259)92 participants 0.9
EtanerceptPhysician Global Assessment of EfficacyCycle 3: moderate (n=259)13 participants 0.9
EtanerceptPhysician Global Assessment of EfficacyCycle 3: insufficient (n=259)1 participants 0.9
EtanerceptPhysician Global Assessment of EfficacyCycle 4: very good (n=147)81 participants 0.8
EtanerceptPhysician Global Assessment of EfficacyCycle 4: good (n=147)59 participants 0.9
EtanerceptPhysician Global Assessment of EfficacyCycle 4: moderate (n=147)4 participants 0.8
EtanerceptPhysician Global Assessment of EfficacyCycle 4: insufficient (n=147)3 participants 0.9
EtanerceptPhysician Global Assessment of EfficacyCycle 5: very good (n=96)53 participants 0.8
EtanerceptPhysician Global Assessment of EfficacyCycle 5: good (n=96)40 participants 0.8
EtanerceptPhysician Global Assessment of EfficacyCycle 5: moderate (n=96)3 participants
EtanerceptPhysician Global Assessment of EfficacyCycle 5: insufficient (n=96)0 participants
EtanerceptPhysician Global Assessment of EfficacyCycle 6: very good (n=70)49 participants
EtanerceptPhysician Global Assessment of EfficacyCycle 6: good (n=70)18 participants
EtanerceptPhysician Global Assessment of EfficacyCycle 6: moderate (n=70)3 participants
EtanerceptPhysician Global Assessment of EfficacyCycle 6: insufficient (n=70)0 participants
Secondary

Psoriasis Area and Severity Index (PASI) Score

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.

Time frame: Week 0, 12, 24 of Cycle 1 to 6

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 1 Week 0 (n=675)21.0 units on a scaleStandard Deviation 12.1
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 1 Week 12 (n=605)8.8 units on a scaleStandard Deviation 8.5
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 1 Week 24 (n=538)5.9 units on a scaleStandard Deviation 6.6
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 2 Week 0 (n=435)6.7 units on a scaleStandard Deviation 6.5
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 2 Week 12 (n=394)4.9 units on a scaleStandard Deviation 5
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 2 Week 24 (n=368)4.8 units on a scaleStandard Deviation 5.2
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 3 Week 0 (n=234)4.9 units on a scaleStandard Deviation 6.1
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 3 Week 12 (n=226)4.2 units on a scaleStandard Deviation 5.5
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 3 Week 24 (n=202)3.6 units on a scaleStandard Deviation 4.5
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 4 Week 0 (n=120)3.9 units on a scaleStandard Deviation 3.9
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 4 Week 12 (n=117)4.2 units on a scaleStandard Deviation 3.6
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 4 Week 24 (n=105)4.1 units on a scaleStandard Deviation 4.8
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 5-week 0 (n=77)3.6 units on a scaleStandard Deviation 3
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 5 Week 12 (n=79)4.2 units on a scaleStandard Deviation 4.1
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 5 Week 24 (n=63)3.6 units on a scaleStandard Deviation 3.2
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 6 Week 0 (n=60)3.9 units on a scaleStandard Deviation 3.6
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 6 Week 12 (n=54)3.0 units on a scaleStandard Deviation 3.4
EtanerceptPsoriasis Area and Severity Index (PASI) ScoreCycle 6 Week 24 (n=48)2.8 units on a scaleStandard Deviation 2.7
Secondary

Static Physician Global Assessment (sPGA) of Disease Activity

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 1 Week 0 (n=718)3.1 units on a scaleStandard Deviation 0.9
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 1 Week 12 (n=683)1.9 units on a scaleStandard Deviation 1
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 1 Week 24 (n=615)1.6 units on a scaleStandard Deviation 1
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 2 Week 0 (n=514)1.7 units on a scaleStandard Deviation 1
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 2 Week 12 (n=482)1.5 units on a scaleStandard Deviation 0.9
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 2 Week 24 (n=444)1.5 units on a scaleStandard Deviation 1
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 3 Week 0 (n=307)1.5 units on a scaleStandard Deviation 1
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 3 Week 12 (n=291)1.4 units on a scaleStandard Deviation 1
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 3 Week 24 (n=259)1.3 units on a scaleStandard Deviation 0.9
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 4 Week 0 (n=174)1.4 units on a scaleStandard Deviation 0.9
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 4 Week 12 (n=158)1.5 units on a scaleStandard Deviation 0.9
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 4 Week 24 (n=147)1.5 units on a scaleStandard Deviation 0.9
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 5 Week 0 (n=114)1.5 units on a scaleStandard Deviation 0.8
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 5 Week 12 (n=109)1.6 units on a scaleStandard Deviation 0.9
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 5 Week 24 (n=95)1.5 units on a scaleStandard Deviation 0.8
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 6 Week 0 (n=88)1.5 units on a scaleStandard Deviation 0.9
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 6 Week 12 (n=78)1.3 units on a scaleStandard Deviation 0.8
EtanerceptStatic Physician Global Assessment (sPGA) of Disease ActivityCycle 6 Week 24 (n=71)1.3 units on a scaleStandard Deviation 0.8

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026