Psoriasis
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Duration of Drug-Free Interval Prior to Treatment Cycle 2 | Cycle 1 Week 24 up to Cycle 2 Week 0 | Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. |
| Duration of Drug-Free Interval Prior to Treatment Cycle 3 | Cycle 2 Week 24 up to Cycle 3 Week 0 | Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. |
| Duration of Drug-Free Interval Prior to Treatment Cycle 4 | Cycle 3 Week 24 up to Cycle 4 Week 0 | Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. |
| Duration of Drug-Free Interval Prior to Treatment Cycle 5 | Cycle 4 Week 24 up to Cycle 5 Week 0 | Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. |
| Duration of Drug-Free Interval Prior to Treatment Cycle 6 | Cycle 5 Week 24 up to Cycle 6 Week 0 | Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Assessment of Efficacy | Week 24 of Cycle 1 to 6 | Participant assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient. |
| Number of Injections Per Year | Year 1, 2, 3, 4, 5 | Number of etanercept injections per year were calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing. |
| Cumulative Dose of Etanercept Per Year | Year 1, 2, 3, 4, 5 | Cumulative dose of etanercept per year was calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing. |
| Percentage of Time on Treatment in First Year | Year 1 | Percentage of time on etanercept treatment for first year was calculated. It was calculated as 100% \* (365- sum of durations of drug-free intervals in the first year)/365. Analysis was not possible for participants with missing data of visit 1 (Week 0) of Cycle 1. |
| Percentage of Time on Treatment Over Entire Period | Cycle 1 up to Cycle 6 | Percentage of time on etanercept treatment over entire treatment period was calculated. It was calculated as 100% \* (\[Date of last application - Date of first application + 1\] - Sum of duration of drug-free intervals \[days\])/(Date of last application - Date of first application + 1). |
| Patient's Global Assessment of Disease Activity (PatGA) | Week 0, 12, 24 of Cycle 1 to 6 | Participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity. |
| Dermatology Life Quality Index (DLQI) Score | Week 0, 12, 24 of Cycle 1 to 6 | DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst). |
| Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Week 0, 12, 24 of Cycle 1 to 6 | EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state. |
| Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Week 0, 12, 24 of Cycle 1 to 6 | EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state. |
| Number of Participants With at Least 1 Concomitant Medication | Cycle 1 Week 0 up to Cycle 6 Week 24 | Number of participants taking any non-study medications which were administered during the period of etanercept treatment for the management of an adverse event or for the treatment of any other disease and not plaque psoriasis were reported. |
| Annual Costs for Treatment With Etanercept | Year 1, 2, 3, 4, 5 | Costs for treatment with etanercept per year up to 5 years was calculated in Euros. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing. |
| Average Cost of Treatment by Disease Severity | Year 1, 2, 3, 4, 5 | Average costs for treatment with etanercept up to 5 years was calculated in Euros. Disease severity was categorized as mild (0 to 10 PASI score), moderate (10.1 to 20 PASI score) and severe (20.1 to 72 PASI score) at each year. PASI: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing. |
| Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications | Prior to study, Year 1, 2, 3, 4, 5 | Annual costs for participants for treatment with etanercept due to out of pocket payments (included payments which were not reimbursed by the health insurance funds) and concomitant medications was reported per month for costs prior to study and per year for each year in the study up to 5 years. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing. |
| Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Week 0, 12, 24 of Cycle 1 to 6 | Effect of drug free interval on DLQI was determined by comparing the scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst). |
| Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO) | Week 0, 12, 24 of Cycle 1 to 6 | Effect of drug free interval on EQ-5D was determined by comparing the scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state. |
| Effect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA) | Week 0, 12, 24 of Cycle 1 to 6 | Effect of drug-free interval on PatGA was determined by comparing the PatGA scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. PatGA: participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity. |
| Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 2, 3, 4, 5, 6 | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, Why did you return to the practice today? Responses included unscheduled visit due to new occurrence of disease, scheduled visit or other reasons (included reasons like treatment of adverse event, get a prescription or examination after external treatment). Results are reported for reasons for returning to the practice. |
| Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, Do you basically like the idea of a drug-free interval? After the drug-free interval participants were asked, How did you like the current drug-free interval? Participants responded on a scale of 1 (not at all) to 5 (very good). Results are reported for participant's liking of the drug-free interval. |
| Participant Perception of Drug-Free Interval: Duration | Before Cycle 2, 3, 4, 5, 6 | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, How would you assess the length of the current drug-free interval? Participants responded on a scale of 1 (too long) to 5 (too short). Results are reported for participant's perception of the duration of drug-free interval. |
| Participant Perception of Drug-Free Interval: Relapse of Symptoms | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, How much are you concerned about a relapse of symptoms? After the drug-free interval participants were asked, Were you concerned about a relapse of symptoms during the drug-free interval? Participants responded on a scale of 1 (not concerned) to 5 (very much concerned). Results are reported for participant's perception of relapse of symptoms. |
| Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, To what extend are you relieved by the fact that there is an effective therapy after the drug-free interval? After the drug-free interval participants were asked, To what extend were you relieved by the fact that there is an effective therapy after the drug-free interval? Participants responded on a scale of 1 (not much relieved) to 5 (very much relieved). Results are reported for participant's perception of effective therapy after drug-free interval. |
| Participant Perception of Drug-Free Interval: Disease Activity | Before Cycle 2, 3, 4, 5, 6 | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, How would you assess the activity of your disease during the first half of the drug-free interval? and How would you assess the activity of your disease during the second half of the drug-free interval? Participants responded on a scale of 1 (no activity) to 5 (strongest possible activity). Results are reported for participant's perception of disease activity during the first half and second half of drug-free interval. |
| Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition | Before Cycle 2, 3, 4, 5, 6 | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, How much were you satisfied with the condition of your skin during the first half of the drug-free interval? and How much were you satisfied with the condition of your skin during the second half of the drug-free interval? Participants responded on a scale of 1 (very dissatisfied) to 5 (very satisfied). Results are reported for participant's satisfaction with their skin condition during the first half and second half of drug-free interval. |
| Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, A drug-free interval reduces the risk for adverse drug reactions. Results are reported for participant's perception of risk of adverse drug reactions. |
| Participant Perception of Drug-Free Interval: Reminder of Disease | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, During drug-free interval I will not be reminded permanently of my disease. Results are reported for participant's perception of reminder of disease during the drug-free interval. |
| Participant Perception of Drug-Free Interval: Comfort in Everyday Life | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, A drug-free interval means more comfort in my everyday life. Results are reported for participant's perception of comfort of life during the drug-free interval. |
| Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, If possible, would you prefer a continuous therapy without drug-free interval? Participants responded as yes or no to the question. Results are reported for participant's preference towards continuous therapy. |
| Participant Perception of Drug-Free Interval: Recommendation of Therapy | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, Would you recommend therapy with Enbrel to other patients with plaque-psoriasis? Participants responded as yes or no to the question. Results are reported for participant's likeliness to recommend therapy. |
| Criteria for Treatment Resumption | Before Cycle 2, 3, 4, 5, 6 | Criteria for resumption of therapy for another cycle by the physician were specified after the 5 drug-free intervals as 1) new disease activity (NDA), 2) prevention of deterioration (POD), 3) other reasons (included reasons like end of adverse event, frequent occurrence of adverse event or pre-specified therapy scheme), 4) new disease activity and prevention of deterioration, 5) new disease activity and other reason, 6) prevention of deterioration and other reason, and 7) new disease activity, prevention of deterioration, and other reasons. |
| Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) | Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with AEs included participants affected with both SAEs and non-SAEs. |
| Participant Perception of Drug-Free Interval: Length of Drug-Free Interval | Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5 | A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, How long do you expect the drug-free interval to last for? After the drug-free interval participants were asked, How long did the drug-free interval last? Results are reported for participant's perception of the length of drug-free interval. |
| Psoriasis Area and Severity Index (PASI) Score | Week 0, 12, 24 of Cycle 1 to 6 | Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent (%) area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. PASI score at Week 0 of each cycle signifies the disease activity at the time of resumption of etanercept therapy. |
| Percentage of Body Surface Area (BSA) Affected by Psoriasis | Week 0, 12, 24 of Cycle 1 to 6 | Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1% of total BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected. The results of this outcome measure was summarized separately for participants without drug-free interval, participants with drug-free interval and remaining participants, as per planned analysis. |
| Static Physician Global Assessment (sPGA) of Disease Activity | Week 0, 12, 24 of Cycle 1 to 6 | Static physician global assessment (sPGA) of disease activity was assessed as 0 (no psoriasis) to 5 (severe disease) based on severity of induration, scaling, and erythema across all psoriatic lesions. |
| Physician Global Assessment of Efficacy | Week 24 of Cycle 1 to 6 | Physician assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 926 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative reasons | 7 |
| Overall Study | Adverse Event | 3 |
| Overall Study | Another therapy along with Enbrel | 15 |
| Overall Study | Another therapy instead of Enbrel | 141 |
| Overall Study | Good effectiveness | 9 |
| Overall Study | Ineffectiveness (no systemic therapy) | 9 |
| Overall Study | Intolerance | 42 |
| Overall Study | Lack of compliance | 3 |
| Overall Study | Lack of effectiveness | 4 |
| Overall Study | Lost to Follow-up | 52 |
| Overall Study | Missing values | 392 |
| Overall Study | Other unspecified | 11 |
| Overall Study | Pregnancy | 3 |
| Overall Study | Withdrawal by Subject | 51 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age, Continuous | 47.4 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 type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 230 / 926 |
| serious Total, serious adverse events | 59 / 926 |
Outcome results
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept | Duration of Drug-Free Interval Prior to Treatment Cycle 2 | 12.6 weeks |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept | Duration of Drug-Free Interval Prior to Treatment Cycle 3 | 10.5 weeks |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept | Duration of Drug-Free Interval Prior to Treatment Cycle 4 | 25.0 weeks |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept | Duration of Drug-Free Interval Prior to Treatment Cycle 5 | 20.6 weeks |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept | Duration of Drug-Free Interval Prior to Treatment Cycle 6 | 14.2 weeks |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications | Prior to Study (n=536) | 77.1 Euros | Standard Deviation 170.6 |
| Etanercept | Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications | Year 1 (n=472) | 194.8 Euros | Standard Deviation 729.3 |
| Etanercept | Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications | Year 2 (n=312) | 91.2 Euros | Standard Deviation 445.7 |
| Etanercept | Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications | Year 3 (n=131) | 128.8 Euros | Standard Deviation 956.9 |
| Etanercept | Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications | Year 4 (n=44) | 31.5 Euros | Standard Deviation 87.6 |
| Etanercept | Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications | Year 5 (n=6) | 53.6 Euros | Standard Deviation 49.9 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Annual Costs for Treatment With Etanercept | Year 1 (n=675) | 20670.0 Euros | Standard Deviation 9743.9 |
| Etanercept | Annual Costs for Treatment With Etanercept | Year 2 (n=418) | 13509.6 Euros | Standard Deviation 9854.3 |
| Etanercept | Annual Costs for Treatment With Etanercept | Year 3 (n=167) | 14113.4 Euros | Standard Deviation 8913.8 |
| Etanercept | Annual Costs for Treatment With Etanercept | Year 4 (n=53) | 6847.4 Euros | Standard Deviation 5648.6 |
| Etanercept | Annual Costs for Treatment With Etanercept | Year 5 (n=7) | 5173.7 Euros | Standard Deviation 4506.6 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Average Cost of Treatment by Disease Severity | Year 1: Mild (n=290) | 20707.0 Euros | Standard Deviation 9751.6 |
| Etanercept | Average Cost of Treatment by Disease Severity | Year 1: Moderate (n=80) | 21627.0 Euros | Standard Deviation 11119.5 |
| Etanercept | Average Cost of Treatment by Disease Severity | Year 1: Severe (n=46) | 21309.2 Euros | Standard Deviation 11573.3 |
| Etanercept | Average Cost of Treatment by Disease Severity | Year 2: Mild (n=200) | 13777.1 Euros | Standard Deviation 9864.5 |
| Etanercept | Average Cost of Treatment by Disease Severity | Year 2: Moderate (n=32) | 9668.8 Euros | Standard Deviation 7638.6 |
| Etanercept | Average Cost of Treatment by Disease Severity | Year 2: Severe (n=9) | 5479.7 Euros | Standard Deviation 4225.8 |
| Etanercept | Average Cost of Treatment by Disease Severity | Year 3: Mild (n=93) | 15062.1 Euros | Standard Deviation 8676.5 |
| Etanercept | Average Cost of Treatment by Disease Severity | Year 3: Moderate (n=3) | 6877.2 Euros | Standard Deviation 3071.3 |
| Etanercept | Average Cost of Treatment by Disease Severity | Year 3: Severe (n=4) | 6371.3 Euros | Standard Deviation 2565 |
| Etanercept | Average Cost of Treatment by Disease Severity | Year 4: Mild (n=25) | 5809.6 Euros | Standard Deviation 3125.3 |
| Etanercept | Average Cost of Treatment by Disease Severity | Year 4: Moderate (n=1) | 7467.0 Euros | — |
| Etanercept | Average Cost of Treatment by Disease Severity | Year 4: Severe (n=2) | 3196.0 Euros | Standard Deviation 575.5 |
| Etanercept | Average Cost of Treatment by Disease Severity | Year 5: Mild (n=6) | 5309.3 Euros | Standard Deviation 4998.2 |
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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Etanercept | Criteria for Treatment Resumption | Before Cycle 6- NDA (n=1) | 1 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 6- POD (n=1) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 6- other reason (n=1) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 6- NDA and POD (n=1) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 6- NDA and other reason (n=1) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 6- POD and other reason (n=1) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 6- NDA, POD and other reason (n=1) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 2- POD (n=144) | 42 participants | 1.3 |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 2-new disease activity (NDA) (n=144) | 90 participants | 1.3 |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 2- other reason (n=144) | 8 participants | 1.1 |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 2- NDA and POD (n=144) | 4 participants | 0.8 |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 2- NDA and other reason (n=144) | 0 participants | 0 |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 2- POD and other reason (n=144) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 2- NDA, POD and other reason (n=144) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 3-NDA (n=43) | 15 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 3- POD (n=43) | 25 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 3- other reason (n=43) | 2 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 3- NDA and POD (n=43) | 1 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 3- NDA and other reason (n=43) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 3- POD and other reason (n=43) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 3- NDA, POD and other reason (n=43) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 4- NDA (n=8) | 3 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 4- POD (n=8) | 5 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 4- other reason (n=8) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 4- NDA and POD (n=8) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 4- NDA and other reason (n=8) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 4- POD and other reason (n=8) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 4-NDA, POD and other reason (n=8) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 5- NDA (n=3) | 2 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 5- POD (n=3) | 1 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 5- other reason (n=3) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 5- NDA and POD (n=3) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 5- NDA and other reason (n=3) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 5- POD and other reason (n=3) | 0 participants | — |
| Etanercept | Criteria for Treatment Resumption | Before Cycle 5- NDA, POD and other reason (n=3) | 0 participants | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Cumulative Dose of Etanercept Per Year | Year 1 (n=664) | 2249.2 mg | Standard Deviation 1100.6 |
| Etanercept | Cumulative Dose of Etanercept Per Year | Year 2 (n=418) | 1474.7 mg | Standard Deviation 1104.6 |
| Etanercept | Cumulative Dose of Etanercept Per Year | Year 3 (n=167) | 1565.5 mg | Standard Deviation 1027.3 |
| Etanercept | Cumulative Dose of Etanercept Per Year | Year 4 (n=53) | 729.1 mg | Standard Deviation 589.9 |
| Etanercept | Cumulative Dose of Etanercept Per Year | Year 5 (n=7) | 399.5 mg | Standard Deviation 354.5 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 1 Week 0 (n=654) | 14.0 units on a scale | Standard Deviation 7.3 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 1 Week 12 (n=598) | 6.4 units on a scale | Standard Deviation 5.8 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 1 Week 24 (n=536) | 4.9 units on a scale | Standard Deviation 5.7 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 2 Week 0 (n=334) | 6.2 units on a scale | Standard Deviation 6.3 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 2 Week 12 (n=440) | 4.3 units on a scale | Standard Deviation 5.1 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 2 Week 24 (n=378) | 4.2 units on a scale | Standard Deviation 5.3 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 3 Week 0 (n=186) | 4.9 units on a scale | Standard Deviation 5.9 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 3 Week 12 (n= 258) | 3.9 units on a scale | Standard Deviation 5.1 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 3 Week 24 (n=221) | 3.7 units on a scale | Standard Deviation 5 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 4 Week 0 (n=90) | 4.7 units on a scale | Standard Deviation 6.4 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 4 Week 12 (n=146) | 3.6 units on a scale | Standard Deviation 4.4 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 4 Week 24 (n=132) | 3.8 units on a scale | Standard Deviation 5.1 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 5 Week 0 (n=64) | 4.5 units on a scale | Standard Deviation 5.4 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 5 Week 12 (n=104) | 3.8 units on a scale | Standard Deviation 4.8 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 5 Week 24 (n=91) | 3.7 units on a scale | Standard Deviation 4.3 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 6 Week 0 (n=43) | 5.0 units on a scale | Standard Deviation 5.1 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 6 Week 12 (n=75) | 3.5 units on a scale | Standard Deviation 4.6 |
| Etanercept | Dermatology Life Quality Index (DLQI) Score | Cycle 6 Week 24 (n=69) | 3.9 units on a scale | Standard Deviation 4.4 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 1 Week 0 (n=276,136) | 13.8 units on a scale | Standard Deviation 7.3 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 1 Week 12 (n=267,126) | 5.7 units on a scale | Standard Deviation 5.3 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 1 Week 24 (n=263,135) | 4.7 units on a scale | Standard Deviation 5.6 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 2 Week 0 (n=145,133) | 5.8 units on a scale | Standard Deviation 6.4 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 2 Week 12 (n=256,128) | 4.4 units on a scale | Standard Deviation 5.4 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 2 Week 24 (n=227,107) | 4.4 units on a scale | Standard Deviation 5.8 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 3 Week 0 (n=109,41) | 5.0 units on a scale | Standard Deviation 6.2 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 3 Week 12 (n= 183,38) | 4.2 units on a scale | Standard Deviation 5.4 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 3 Week 24 (n=158,36) | 4.1 units on a scale | Standard Deviation 5.5 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 4 Week 0 (n=72,6) | 5.0 units on a scale | Standard Deviation 6.4 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 4 Week 12 (n=124,6) | 3.6 units on a scale | Standard Deviation 4.5 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 4 Week 24 (n=112,5) | 3.9 units on a scale | Standard Deviation 5.2 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 5 Week 0 (n=53,3) | 4.8 units on a scale | Standard Deviation 5.8 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 5 Week 12 (n=94,2) | 3.7 units on a scale | Standard Deviation 4.7 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 5 Week 24 (n=83,2) | 3.7 units on a scale | Standard Deviation 4.4 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 6 Week 0 (n=39,2) | 5.1 units on a scale | Standard Deviation 5.3 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 6 Week 12 (n=72,1) | 3.6 units on a scale | Standard Deviation 4.7 |
| Etanercept | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 6 Week 24 (n=67,0) | 4.0 units on a scale | Standard Deviation 4.4 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 5 Week 12 (n=94,2) | 3.0 units on a scale | Standard Deviation 0 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 1 Week 0 (n=276,136) | 15.5 units on a scale | Standard Deviation 7.2 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 4 Week 0 (n=72,6) | 4.5 units on a scale | Standard Deviation 9.1 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 1 Week 12 (n=267,126) | 7.1 units on a scale | Standard Deviation 5.9 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 6 Week 24 (n=67,0) | NA units on a scale | — |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 1 Week 24 (n=263,135) | 4.7 units on a scale | Standard Deviation 5.5 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 4 Week 12 (n=124,6) | 4.5 units on a scale | Standard Deviation 5.5 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 2 Week 0 (n=145,133) | 7.6 units on a scale | Standard Deviation 6.5 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 5 Week 24 (n=83,2) | 3.0 units on a scale | Standard Deviation 1.4 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 2 Week 12 (n=256,128) | 4.5 units on a scale | Standard Deviation 4.9 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 4 Week 24 (n=112,5) | 5.0 units on a scale | Standard Deviation 5.7 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 2 Week 24 (n=227,107) | 4.0 units on a scale | Standard Deviation 4.4 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 6 Week 12 (n=72,1) | 1.0 units on a scale | — |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 3 Week 0 (n=109,41) | 6.4 units on a scale | Standard Deviation 6.5 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 5 Week 0 (n=53,3) | 1.7 units on a scale | Standard Deviation 1.5 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 3 Week 12 (n= 183,38) | 3.7 units on a scale | Standard Deviation 5 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 6 Week 0 (n=39,2) | 5.5 units on a scale | Standard Deviation 2.1 |
| Participants With Drug-Free Interval | Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score | Cycle 3 Week 24 (n=158,36) | 2.1 units on a scale | Standard Deviation 3 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Effect 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 scale | Standard Deviation 0.243 |
| Etanercept | Effect 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 scale | Standard Deviation 0.144 |
| Etanercept | Effect 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 scale | Standard Deviation 0.149 |
| Etanercept | Effect 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 scale | Standard Deviation 0.164 |
| Etanercept | Effect 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 scale | Standard Deviation 0.14 |
| Etanercept | Effect 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 scale | Standard Deviation 0.148 |
| Etanercept | Effect 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 scale | Standard Deviation 0.139 |
| Etanercept | Effect 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 scale | Standard Deviation 0.088 |
| Etanercept | Effect 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 scale | Standard Deviation 0.157 |
| Etanercept | Effect 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 scale | Standard Deviation 0.184 |
| Etanercept | Effect 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 scale | Standard Deviation 0.129 |
| Etanercept | Effect 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 scale | Standard Deviation 0.163 |
| Etanercept | Effect 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 scale | Standard Deviation 0.168 |
| Etanercept | Effect 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 scale | Standard Deviation 0.107 |
| Etanercept | Effect 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 scale | Standard Deviation 0.101 |
| Etanercept | Effect 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 scale | Standard Deviation 0.101 |
| Etanercept | Effect 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 scale | Standard Deviation 0.1 |
| Etanercept | Effect 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 scale | Standard Deviation 0.128 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.079 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.232 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.046 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.151 |
| Participants With Drug-Free Interval | Effect 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 Interval | Effect 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 scale | Standard Deviation 0.117 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.058 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.144 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.079 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.128 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.061 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.123 |
| Participants With Drug-Free Interval | Effect 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 Interval | Effect 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 scale | Standard Deviation 0.183 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.079 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.049 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.068 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Effect 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 scale | Standard Deviation 1.2 |
| Etanercept | Effect 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 scale | Standard Deviation 1.2 |
| Etanercept | Effect 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 scale | Standard Deviation 1.1 |
| Etanercept | Effect 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 scale | Standard Deviation 1.2 |
| Etanercept | Effect 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 scale | Standard Deviation 1.2 |
| Etanercept | Effect 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 scale | Standard Deviation 1.2 |
| Etanercept | Effect 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 scale | Standard Deviation 1.2 |
| Etanercept | Effect 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 scale | Standard Deviation 1.2 |
| Etanercept | Effect 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 scale | Standard Deviation 1.2 |
| Etanercept | Effect 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 scale | Standard Deviation 1.1 |
| Etanercept | Effect 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 scale | Standard Deviation 1.1 |
| Etanercept | Effect 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 scale | Standard Deviation 1 |
| Etanercept | Effect 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 scale | Standard Deviation 1.1 |
| Etanercept | Effect 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 scale | Standard Deviation 1 |
| Etanercept | Effect 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 scale | Standard Deviation 0.9 |
| Etanercept | Effect 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 scale | Standard Deviation 0.8 |
| Etanercept | Effect 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 scale | Standard Deviation 1.1 |
| Etanercept | Effect 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 scale | Standard Deviation 1 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 1.4 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.9 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 1.5 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 1.3 |
| Participants With Drug-Free Interval | Effect 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 Interval | Effect 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 scale | Standard Deviation 1.3 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 1.3 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 1.3 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 1.4 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 1 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 1.8 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 1.3 |
| Participants With Drug-Free Interval | Effect 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 Interval | Effect 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 scale | Standard Deviation 1.3 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 1.4 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 1.1 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 0.7 |
| Participants With Drug-Free Interval | Effect 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 scale | Standard Deviation 1.2 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 1 Week 0 (n=666 ) | 0.817 units on a scale | Standard Deviation 0.236 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 1 Week 12 (n=628) | 0.915 units on a scale | Standard Deviation 0.149 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 1 Week 24 (n=549) | 0.930 units on a scale | Standard Deviation 0.145 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 2 Week 0 (n=344) | 0.915 units on a scale | Standard Deviation 0.154 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 2 Week 12 (n=451) | 0.933 units on a scale | Standard Deviation 0.142 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 2 Week 24 (n=393) | 0.939 units on a scale | Standard Deviation 0.14 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 3 Week 0 (n=190) | 0.932 units on a scale | Standard Deviation 0.149 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 3 Week 12 (n= 257) | 0.949 units on a scale | Standard Deviation 0.094 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 3 Week 24 (n=222) | 0.928 units on a scale | Standard Deviation 0.154 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 4 Week 0 (n=89) | 0.912 units on a scale | Standard Deviation 0.169 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 4 Week 12 (n=144) | 0.935 units on a scale | Standard Deviation 0.121 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 4 Week 24 (n=129) | 0.927 units on a scale | Standard Deviation 0.153 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 5 Week 0 (n=63) | 0.914 units on a scale | Standard Deviation 0.157 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 5 Week 12 (n=104) | 0.932 units on a scale | Standard Deviation 0.103 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 5 Week 24 (n=91) | 0.950 units on a scale | Standard Deviation 0.099 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 6 Week 0 (n=43) | 0.930 units on a scale | Standard Deviation 0.097 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 6 Week 12 (n=75) | 0.938 units on a scale | Standard Deviation 0.098 |
| Etanercept | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Cycle 6 Week 24 (n=69) | 0.939 units on a scale | Standard Deviation 0.127 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 1 Week 0 (n=666 ) | 73.8 units on a scale | Standard Deviation 20.5 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 1 Week 12 (n=628) | 85.1 units on a scale | Standard Deviation 16.7 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 1 Week 24 (n=549) | 87.7 units on a scale | Standard Deviation 16.9 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 2 Week 0 (n=344) | 85.6 units on a scale | Standard Deviation 17.7 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 2 Week 12 (n=451) | 88.6 units on a scale | Standard Deviation 15.9 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 2 Week 24 (n=393) | 89.5 units on a scale | Standard Deviation 16.3 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 3 Week 0 (n=190) | 88.3 units on a scale | Standard Deviation 17 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 3 Week 12 (n= 257) | 90.3 units on a scale | Standard Deviation 14 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 3 Week 24 (n=222) | 88.5 units on a scale | Standard Deviation 17.7 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 4 Week 0 (n=89) | 85.7 units on a scale | Standard Deviation 18.9 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 4 Week 12 (n=144) | 88.8 units on a scale | Standard Deviation 15.4 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 4 Week 24 (n=129) | 87.8 units on a scale | Standard Deviation 17.9 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 5 Week 0 (n=63) | 85.0 units on a scale | Standard Deviation 18.8 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 5 Week 12 (n=104) | 87.1 units on a scale | Standard Deviation 15.4 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 5 Week 24 (n=91) | 89.4 units on a scale | Standard Deviation 14.9 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 6 Week 0 (n=43) | 85.1 units on a scale | Standard Deviation 16.2 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 6 Week 12 (n=75) | 87.8 units on a scale | Standard Deviation 13.8 |
| Etanercept | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | Cycle 6 Week 24 (n=69) | 89.0 units on a scale | Standard Deviation 14.9 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Number of Injections Per Year | Year 1 (n=675) | 47.0 injections | Standard Deviation 22.2 |
| Etanercept | Number of Injections Per Year | Year 2 (n=418) | 30.8 injections | Standard Deviation 22.4 |
| Etanercept | Number of Injections Per Year | Year 3 (n=167) | 32.1 injections | Standard Deviation 20.3 |
| Etanercept | Number of Injections Per Year | Year 4 (n=53) | 15.6 injections | Standard Deviation 12.9 |
| Etanercept | Number of Injections Per Year | Year 5 (n=7) | 11.8 injections | Standard Deviation 10.3 |
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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Etanercept | Number of Participants With at Least 1 Concomitant Medication | 368 participants | 10.6 |
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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Etanercept | Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) | AEs | 273 participants | 10.6 |
| Etanercept | Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) | SAEs | 59 participants | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Participant Perception of Drug-Free Interval: Comfort in Everyday Life | After Cycle 1 (n=104) | 2.3 units on a scale | Standard Deviation 1.2 |
| Etanercept | Participant Perception of Drug-Free Interval: Comfort in Everyday Life | Before Cycle 2 (n=103) | 2.6 units on a scale | Standard Deviation 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Comfort in Everyday Life | After Cycle 2 (n=39) | 2.6 units on a scale | Standard Deviation 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Comfort in Everyday Life | Before Cycle 3 (n=38) | 2.6 units on a scale | Standard Deviation 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Comfort in Everyday Life | After Cycle 3 (n=5) | 1.8 units on a scale | Standard Deviation 1.1 |
| Etanercept | Participant Perception of Drug-Free Interval: Comfort in Everyday Life | Before Cycle 4 (n=5) | 1.8 units on a scale | Standard Deviation 0.8 |
| Etanercept | Participant Perception of Drug-Free Interval: Comfort in Everyday Life | After Cycle 4 (n=3) | 1.0 units on a scale | Standard Deviation 0 |
| Etanercept | Participant Perception of Drug-Free Interval: Comfort in Everyday Life | Before Cycle 5 (n=1) | 2.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Comfort in Everyday Life | After Cycle 5 (n=1) | 5.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Comfort in Everyday Life | Before Cycle 6 (n=1) | 1.0 units on a scale | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Participant Perception of Drug-Free Interval: Disease Activity | Before Cycle 2-first half (n=102) | 2.4 units on a scale | Standard Deviation 1 |
| Etanercept | Participant Perception of Drug-Free Interval: Disease Activity | Before Cycle 2-second half (n=101) | 3.3 units on a scale | Standard Deviation 1 |
| Etanercept | Participant Perception of Drug-Free Interval: Disease Activity | Before Cycle 3-first half (n=36) | 2.3 units on a scale | Standard Deviation 1 |
| Etanercept | Participant Perception of Drug-Free Interval: Disease Activity | Before Cycle 3-second half (n=36) | 3.0 units on a scale | Standard Deviation 1.1 |
| Etanercept | Participant Perception of Drug-Free Interval: Disease Activity | Before Cycle 4-first half (n=4) | 2.5 units on a scale | Standard Deviation 0.6 |
| Etanercept | Participant Perception of Drug-Free Interval: Disease Activity | Before Cycle 4-second half (n=4) | 3.3 units on a scale | Standard Deviation 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Disease Activity | Before Cycle 5-first half (n=1) | 2.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Disease Activity | Before Cycle 5-second half (n=1) | 3.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Disease Activity | Before Cycle 6-first half (n=1) | 1.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Disease Activity | Before Cycle 6-second half (n=1) | 2.0 units on a scale | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Participant Perception of Drug-Free Interval: Duration | Before Cycle 2 (n=104) | 2.5 units on a scale | Standard Deviation 1.1 |
| Etanercept | Participant Perception of Drug-Free Interval: Duration | Before Cycle 3 (n=35) | 2.9 units on a scale | Standard Deviation 1.2 |
| Etanercept | Participant Perception of Drug-Free Interval: Duration | Before Cycle 4 (n=5) | 1.0 units on a scale | Standard Deviation 0 |
| Etanercept | Participant Perception of Drug-Free Interval: Duration | Before Cycle 5 (n=1) | 2.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Duration | Before Cycle 6 (n=1) | 2.0 units on a scale | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval | After Cycle 1 (n=114) | 4.6 units on a scale | Standard Deviation 0.8 |
| Etanercept | Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval | Before Cycle 2 (n=106) | 4.4 units on a scale | Standard Deviation 0.8 |
| Etanercept | Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval | After Cycle 2 (n=41) | 4.4 units on a scale | Standard Deviation 0.9 |
| Etanercept | Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval | Before Cycle 3 (n=35) | 4.3 units on a scale | Standard Deviation 1.1 |
| Etanercept | Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval | After Cycle 3 (n=6) | 4.7 units on a scale | Standard Deviation 0.8 |
| Etanercept | Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval | Before Cycle 4 (n=5) | 5.0 units on a scale | Standard Deviation 0 |
| Etanercept | Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval | After Cycle 4 (n=2) | 2.5 units on a scale | Standard Deviation 2.1 |
| Etanercept | Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval | Before Cycle 5 (n=1) | 5.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval | After Cycle 5 (n=1) | 5.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval | Before Cycle 6 (n=1) | 2.0 units on a scale | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Participant Perception of Drug-Free Interval: Length of Drug-Free Interval | After Cycle 1 (n=50) | 0.9 months | Standard Deviation 1 |
| Etanercept | Participant Perception of Drug-Free Interval: Length of Drug-Free Interval | Before Cycle 2 (n=102) | 2.4 months | Standard Deviation 2.9 |
| Etanercept | Participant Perception of Drug-Free Interval: Length of Drug-Free Interval | After Cycle 2 (n=19) | 1.4 months | Standard Deviation 1.5 |
| Etanercept | Participant Perception of Drug-Free Interval: Length of Drug-Free Interval | Before Cycle 3 (n=37) | 1.6 months | Standard Deviation 1.6 |
| Etanercept | Participant Perception of Drug-Free Interval: Length of Drug-Free Interval | After Cycle 3 (n=2) | 4.5 months | Standard Deviation 2.1 |
| Etanercept | Participant Perception of Drug-Free Interval: Length of Drug-Free Interval | Before Cycle 4 (n=5) | 1.8 months | Standard Deviation 1.8 |
| Etanercept | Participant Perception of Drug-Free Interval: Length of Drug-Free Interval | After Cycle 4 (n=0) | NA months | — |
| Etanercept | Participant Perception of Drug-Free Interval: Length of Drug-Free Interval | Before Cycle 5 (n=1) | 2.3 months | — |
| Etanercept | Participant Perception of Drug-Free Interval: Length of Drug-Free Interval | After Cycle 5 (n=0) | NA months | — |
| Etanercept | Participant Perception of Drug-Free Interval: Length of Drug-Free Interval | Before Cycle 6 (n=1) | 2.8 months | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval | After Cycle 1 (n=113) | 2.6 units on a scale | Standard Deviation 1.5 |
| Etanercept | Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval | Before Cycle 2 (n=106) | 2.5 units on a scale | Standard Deviation 1.4 |
| Etanercept | Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval | After Cycle 2 (n=40) | 3.1 units on a scale | Standard Deviation 1.5 |
| Etanercept | Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval | Before Cycle 3 (n=37) | 2.9 units on a scale | Standard Deviation 1.4 |
| Etanercept | Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval | After Cycle 3 (n=7) | 2.1 units on a scale | Standard Deviation 1.7 |
| Etanercept | Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval | Before Cycle 4 (n=5) | 1.0 units on a scale | Standard Deviation 0 |
| Etanercept | Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval | After Cycle 4 (n=2) | 1.5 units on a scale | Standard Deviation 0.7 |
| Etanercept | Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval | Before Cycle 5 (n=1) | 2.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval | After Cycle 5 (n=1) | 4.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval | Before Cycle 6 (n=1) | 2.0 units on a scale | — |
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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | After Cycle 1- No (n=104) | 9 participants | 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | After Cycle 1- Yes (n=104) | 95 participants | 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | Before Cycle 2- No (n=106) | 8 participants | 1.1 |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | Before Cycle 2- Yes (n=106) | 98 participants | 0.8 |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | After Cycle 2- No (n=40) | 8 participants | 0 |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | After Cycle 2- Yes (n=40) | 32 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | Before Cycle 3- No (n=42) | 3 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | Before Cycle 3- Yes (n=42) | 39 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | After Cycle 3- No (n=7) | 0 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | After Cycle 3- Yes (n=7) | 7 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | Before Cycle 4- No (n=6) | 0 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | Before Cycle 4- Yes (n=6) | 6 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | After Cycle 4- No (n=3) | 1 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | After Cycle 4- Yes (n=3) | 2 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | Before Cycle 5- No (n=1) | 0 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | Before Cycle 5- Yes (n=1) | 1 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | After Cycle 5- No (n=1) | 0 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | After Cycle 5- Yes (n=1) | 1 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | Before Cycle 6- No (n=1) | 0 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Preference to Continuous Therapy | Before Cycle 6- Yes (n=1) | 1 participants | — |
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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 2- unscheduled visit (n=116) | 66 participants | 2.9 |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 2- scheduled visit (n=116) | 46 participants | 1 |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 2- other reason (n=116) | 4 participants | 1.6 |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 3- unscheduled visit (n=43) | 16 participants | 1.5 |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 3- scheduled visit (n=43) | 26 participants | 1.8 |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 3- other reason (n=43) | 1 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 4- unscheduled visit(n=7) | 2 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 4- scheduled visit (n=7) | 4 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 4-other reason (n=7) | 1 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 5- unscheduled visit(n=1) | 0 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 5-scheduled visit (n=1) | 1 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 5-other reason (n=1) | 0 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 6- unscheduled visit (n=1) | 0 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 6-scheduled visit (n=1) | 1 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Reason for Returning to Practice | Before Cycle 6-other reason (n=1) | 0 participants | — |
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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Etanercept | Participant Perception of Drug-Free Interval: Recommendation of Therapy | After Cycle 1- No (n=106) | 0 participants | 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Recommendation of Therapy | After Cycle 1- Yes (n=106) | 106 participants | 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Recommendation of Therapy | Before Cycle 2- No (n=107) | 0 participants | 1.1 |
| Etanercept | Participant Perception of Drug-Free Interval: Recommendation of Therapy | Before Cycle 2- Yes (n=107) | 107 participants | 0.8 |
| Etanercept | Participant Perception of Drug-Free Interval: Recommendation of Therapy | After Cycle 2- No (n=40) | 1 participants | 0 |
| Etanercept | Participant Perception of Drug-Free Interval: Recommendation of Therapy | After Cycle 2- Yes (n=40) | 39 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Recommendation of Therapy | Before Cycle 3- No (n=42) | 0 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Recommendation of Therapy | Before Cycle 3- Yes (n=42) | 42 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Recommendation of Therapy | After Cycle 3- No (n=7) | 0 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Recommendation of Therapy | After Cycle 3- Yes (n=7) | 7 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Recommendation of Therapy | After Cycle 4- No (n=1) | 0 participants | — |
| Etanercept | Participant Perception of Drug-Free Interval: Recommendation of Therapy | After Cycle 4- Yes (n=1) | 1 participants | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Participant Perception of Drug-Free Interval: Relapse of Symptoms | After Cycle 1 (n=115) | 4.4 units on a scale | Standard Deviation 0.8 |
| Etanercept | Participant Perception of Drug-Free Interval: Relapse of Symptoms | Before Cycle 2 (n=106) | 4.1 units on a scale | Standard Deviation 1 |
| Etanercept | Participant Perception of Drug-Free Interval: Relapse of Symptoms | After Cycle 2 (n=41) | 4.1 units on a scale | Standard Deviation 1 |
| Etanercept | Participant Perception of Drug-Free Interval: Relapse of Symptoms | Before Cycle 3 (n=36) | 4.0 units on a scale | Standard Deviation 0.9 |
| Etanercept | Participant Perception of Drug-Free Interval: Relapse of Symptoms | After Cycle 3 (n=7) | 4.9 units on a scale | Standard Deviation 0.4 |
| Etanercept | Participant Perception of Drug-Free Interval: Relapse of Symptoms | Before Cycle 4 (n=5) | 4.2 units on a scale | Standard Deviation 1.1 |
| Etanercept | Participant Perception of Drug-Free Interval: Relapse of Symptoms | After Cycle 4 (n=3) | 4.3 units on a scale | Standard Deviation 0.6 |
| Etanercept | Participant Perception of Drug-Free Interval: Relapse of Symptoms | Before Cycle 5 (n=1) | 4.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Relapse of Symptoms | After Cycle 5 (n=1) | 3.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Relapse of Symptoms | Before Cycle 6 (n=1) | 3.0 units on a scale | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Participant Perception of Drug-Free Interval: Reminder of Disease | After Cycle 1 (n=104) | 2.4 units on a scale | Standard Deviation 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Reminder of Disease | Before Cycle 2 (n=103) | 2.5 units on a scale | Standard Deviation 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Reminder of Disease | After Cycle 2 (n=39) | 2.7 units on a scale | Standard Deviation 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Reminder of Disease | Before Cycle 3 (n=38) | 2.7 units on a scale | Standard Deviation 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Reminder of Disease | After Cycle 3 (n=5) | 1.6 units on a scale | Standard Deviation 0.9 |
| Etanercept | Participant Perception of Drug-Free Interval: Reminder of Disease | Before Cycle 4 (n=5) | 1.6 units on a scale | Standard Deviation 0.9 |
| Etanercept | Participant Perception of Drug-Free Interval: Reminder of Disease | After Cycle 4 (n=3) | 2.7 units on a scale | Standard Deviation 2.1 |
| Etanercept | Participant Perception of Drug-Free Interval: Reminder of Disease | Before Cycle 5 (n=1) | 2.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Reminder of Disease | After Cycle 5 (n=1) | 5.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Reminder of Disease | Before Cycle 6 (n=1) | 5.0 units on a scale | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions | After Cycle 1 (n=110) | 3.0 units on a scale | Standard Deviation 1.1 |
| Etanercept | Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions | Before Cycle 2 (n=100) | 3.2 units on a scale | Standard Deviation 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions | After Cycle 2 (n=41) | 2.9 units on a scale | Standard Deviation 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions | Before Cycle 3 (n=38) | 3.1 units on a scale | Standard Deviation 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions | After Cycle 3 (n=6) | 2.3 units on a scale | Standard Deviation 1.4 |
| Etanercept | Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions | Before Cycle 4 (n=5) | 1.6 units on a scale | Standard Deviation 0.9 |
| Etanercept | Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions | After Cycle 4 (n=1) | 3.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions | Before Cycle 5 (n=1) | 3.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions | After Cycle 5 (n=1) | 5.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions | Before Cycle 6 (n=1) | 5.0 units on a scale | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition | Before Cycle 2-first half (n=100) | 3.3 units on a scale | Standard Deviation 1.2 |
| Etanercept | Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition | Before Cycle 2-second half (n=100) | 2.7 units on a scale | Standard Deviation 1 |
| Etanercept | Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition | Before Cycle 3-first half (n=36) | 3.2 units on a scale | Standard Deviation 1.4 |
| Etanercept | Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition | Before Cycle 3-second half (n=36) | 2.8 units on a scale | Standard Deviation 1.1 |
| Etanercept | Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition | Before Cycle 4-first half (n=4) | 3.5 units on a scale | Standard Deviation 1.3 |
| Etanercept | Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition | Before Cycle 4-second half (n=4) | 2.3 units on a scale | Standard Deviation 1 |
| Etanercept | Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition | Before Cycle 5-first half (n=1) | 4.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition | Before Cycle 5-second half (n=1) | 3.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition | Before Cycle 6-first half (n=1) | 4.0 units on a scale | — |
| Etanercept | Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition | Before Cycle 6-second half (n=1) | 3.0 units on a scale | — |
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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Etanercept | Patient Global Assessment of Efficacy | Cycle 2: good (n=444) | 165 participants | 1 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 2: moderate (n=444) | 40 participants | 1 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 1: very good (n=605) | 297 participants | 0.9 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 1: good (n=605) | 216 participants | 1 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 1: moderate (n=605) | 65 participants | 1 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 1: insufficient (n=605) | 27 participants | 1 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 2: very good (n=444) | 229 participants | 0.9 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 2: insufficient (n=444) | 10 participants | 1 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 3: very good (n=258) | 145 participants | 0.9 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 3: good (n=258) | 98 participants | 0.9 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 3: moderate (n=258) | 10 participants | 0.9 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 3: insufficient (n=258) | 5 participants | 0.9 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 4: very good (n=147) | 77 participants | 0.8 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 4: good (n=147) | 61 participants | 0.9 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 4: moderate (n=147) | 7 participants | 0.8 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 4: insufficient (n=147) | 2 participants | 0.9 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 5: very good (n=96) | 39 participants | 0.8 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 5: good (n=96) | 50 participants | 0.8 |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 5: moderate (n=96) | 7 participants | — |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 5: insufficient (n=96) | 0 participants | — |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 6: very good (n=71) | 47 participants | — |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 6: good (n=71) | 21 participants | — |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 6: moderate (n=71) | 3 participants | — |
| Etanercept | Patient Global Assessment of Efficacy | Cycle 6: insufficient (n=71) | 0 participants | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 1 Week 0 (n=673) | 3.7 units on a scale | Standard Deviation 1.2 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 1 Week 12 (n=629) | 2.2 units on a scale | Standard Deviation 1.2 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 1 Week 24 (n=554) | 1.9 units on a scale | Standard Deviation 1.2 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 2 Week 0 (n=349) | 2.2 units on a scale | Standard Deviation 1.3 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 2 Week 12 (n=455) | 1.7 units on a scale | Standard Deviation 1.1 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 2 Week 24 (n=395) | 1.7 units on a scale | Standard Deviation 1.2 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 3 Week 0 (n=191) | 1.8 units on a scale | Standard Deviation 1.2 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 3 Week 12 (n=261) | 1.6 units on a scale | Standard Deviation 1.1 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 3 Week 24 (n=224) | 1.6 units on a scale | Standard Deviation 1.2 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 4 Week 0 (n=89) | 1.8 units on a scale | Standard Deviation 1.1 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 4 Week 12 (n=145) | 1.7 units on a scale | Standard Deviation 1.1 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 4 Week 24 (n=132) | 1.8 units on a scale | Standard Deviation 1.1 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 5 Week 0 (n=63) | 1.9 units on a scale | Standard Deviation 1.1 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 5 Week 12 (n=103) | 1.7 units on a scale | Standard Deviation 1 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 5 Week 24 (n=92) | 1.8 units on a scale | Standard Deviation 0.9 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 6 Week 0 (n=43) | 2.2 units on a scale | Standard Deviation 0.9 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 6 Week 12 (n=76) | 1.6 units on a scale | Standard Deviation 1.1 |
| Etanercept | Patient's Global Assessment of Disease Activity (PatGA) | Cycle 6 Week 24 (n=68) | 1.6 units on a scale | Standard Deviation 1 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 2 Week 12 (n=280,127,62) | 8.4 percentage of BSA | Standard Deviation 9.8 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 1 Week 12 (n=293,142,235) | 14.0 percentage of BSA | Standard Deviation 13.6 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 1 Week 24 (n=294,143,168) | 9.4 percentage of BSA | Standard Deviation 10.3 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 2 Week 0 (n=293,143,66) | 9.4 percentage of BSA | Standard Deviation 10.3 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 1 Week 0 (n=293,145,267) | 28.2 percentage of BSA | Standard Deviation 20.8 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 2 Week 24 (n=263,117,53) | 7.7 percentage of BSA | Standard Deviation 9.4 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 3 Week 0 (n=212,44,47) | 7.3 percentage of BSA | Standard Deviation 9.5 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 3 Week 12 (n=201,40,43) | 6.6 percentage of BSA | Standard Deviation 8 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 3 Week 24 (n=181,38,36) | 6.3 percentage of BSA | Standard Deviation 7.2 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 4 Week 0 (n=144,8,21) | 6.0 percentage of BSA | Standard Deviation 6 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 4 Week 12 (n=128,8,20) | 5.9 percentage of BSA | Standard Deviation 5.6 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 4 Week 24 (n=121,7,18) | 6.2 percentage of BSA | Standard Deviation 6.4 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 5 Week 0 (n=100,4,10) | 6.1 percentage of BSA | Standard Deviation 5.8 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 5 Week 12 (n=98,2,9) | 6.0 percentage of BSA | Standard Deviation 6.7 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 5 Week 24 (n=88,1,5) | 6.0 percentage of BSA | Standard Deviation 7.3 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 6 Week 24 (n=68,0,2) | 5.2 percentage of BSA | Standard Deviation 7.4 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 6 Week 0 (n=82,1,3) | 6.2 percentage of BSA | Standard Deviation 7.5 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 6 Week 12 (n=75,0,2) | 5.7 percentage of BSA | Standard Deviation 6.8 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 6 Week 0 (n=82,1,3) | 5.0 percentage of BSA | — |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 1 Week 0 (n=293,145,267) | 36.7 percentage of BSA | Standard Deviation 21.3 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 4 Week 0 (n=144,8,21) | 16.5 percentage of BSA | Standard Deviation 13.8 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 5 Week 0 (n=100,4,10) | 19.8 percentage of BSA | Standard Deviation 8.8 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 1 Week 12 (n=293,142,235) | 20.1 percentage of BSA | Standard Deviation 18 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 3 Week 0 (n=212,44,47) | 13.9 percentage of BSA | Standard Deviation 13.3 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 5 Week 24 (n=88,1,5) | 5.0 percentage of BSA | — |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 1 Week 24 (n=294,143,168) | 13.6 percentage of BSA | Standard Deviation 15.1 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 4 Week 12 (n=128,8,20) | 7.9 percentage of BSA | Standard Deviation 5.2 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 3 Week 24 (n=181,38,36) | 6.8 percentage of BSA | Standard Deviation 9.1 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 2 Week 0 (n=293,143,66) | 18.7 percentage of BSA | Standard Deviation 15 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 6 Week 12 (n=75,0,2) | NA percentage of BSA | — |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 5 Week 12 (n=98,2,9) | 17.5 percentage of BSA | Standard Deviation 10.6 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 2 Week 12 (n=280,127,62) | 12.6 percentage of BSA | Standard Deviation 14.3 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 4 Week 24 (n=121,7,18) | 10.3 percentage of BSA | Standard Deviation 8.2 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 3 Week 12 (n=201,40,43) | 9.9 percentage of BSA | Standard Deviation 12.8 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 2 Week 24 (n=263,117,53) | 10.3 percentage of BSA | Standard Deviation 11 |
| Participants With Drug-Free Interval | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 6 Week 24 (n=68,0,2) | NA percentage of BSA | — |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 2 Week 24 (n=263,117,53) | 9.2 percentage of BSA | Standard Deviation 10.1 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 3 Week 0 (n=212,44,47) | 10.7 percentage of BSA | Standard Deviation 13 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 3 Week 12 (n=201,40,43) | 9.7 percentage of BSA | Standard Deviation 13.5 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 5 Week 24 (n=88,1,5) | 3.4 percentage of BSA | Standard Deviation 1.5 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 3 Week 24 (n=181,38,36) | 8.8 percentage of BSA | Standard Deviation 11 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 4 Week 0 (n=144,8,21) | 8.2 percentage of BSA | Standard Deviation 9.8 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 6 Week 0 (n=82,1,3) | 4.0 percentage of BSA | Standard Deviation 3.5 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 4 Week 12 (n=128,8,20) | 8.2 percentage of BSA | Standard Deviation 11.4 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 4 Week 24 (n=121,7,18) | 5.4 percentage of BSA | Standard Deviation 6.6 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 6 Week 12 (n=75,0,2) | 3.0 percentage of BSA | Standard Deviation 1.4 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 1 Week 0 (n=293,145,267) | 35.1 percentage of BSA | Standard Deviation 23.2 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 1 Week 12 (n=293,142,235) | 21.6 percentage of BSA | Standard Deviation 19.8 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 5 Week 0 (n=100,4,10) | 7.2 percentage of BSA | Standard Deviation 8.1 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 1 Week 24 (n=294,143,168) | 15.9 percentage of BSA | Standard Deviation 17.6 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 6 Week 24 (n=68,0,2) | 2.0 percentage of BSA | Standard Deviation 0 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 2 Week 0 (n=293,143,66) | 11.6 percentage of BSA | Standard Deviation 13.1 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 2 Week 12 (n=280,127,62) | 11.1 percentage of BSA | Standard Deviation 13.4 |
| Remaining Participants | Percentage of Body Surface Area (BSA) Affected by Psoriasis | Cycle 5 Week 12 (n=98,2,9) | 4.8 percentage of BSA | Standard Deviation 4.5 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Percentage of Time on Treatment in First Year | 96.5 percentage of first year | Standard Deviation 10.6 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Percentage of Time on Treatment Over Entire Period | 94.8 percentage of entire treatment period | Standard Deviation 10.9 |
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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Etanercept | Physician Global Assessment of Efficacy | Cycle 1: very good (n=606) | 304 participants | 0.9 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 1: good (n=606) | 214 participants | 1 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 1: moderate (n=606) | 68 participants | 1 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 1: insufficient (n=606) | 20 participants | 1 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 2: very good (n=440) | 242 participants | 0.9 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 2: good (n=440) | 151 participants | 1 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 2: moderate (n=440) | 39 participants | 1 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 2: insufficient (n=440) | 8 participants | 1 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 3: very good (n=259) | 153 participants | 0.9 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 3: good (n=259) | 92 participants | 0.9 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 3: moderate (n=259) | 13 participants | 0.9 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 3: insufficient (n=259) | 1 participants | 0.9 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 4: very good (n=147) | 81 participants | 0.8 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 4: good (n=147) | 59 participants | 0.9 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 4: moderate (n=147) | 4 participants | 0.8 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 4: insufficient (n=147) | 3 participants | 0.9 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 5: very good (n=96) | 53 participants | 0.8 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 5: good (n=96) | 40 participants | 0.8 |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 5: moderate (n=96) | 3 participants | — |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 5: insufficient (n=96) | 0 participants | — |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 6: very good (n=70) | 49 participants | — |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 6: good (n=70) | 18 participants | — |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 6: moderate (n=70) | 3 participants | — |
| Etanercept | Physician Global Assessment of Efficacy | Cycle 6: insufficient (n=70) | 0 participants | — |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 1 Week 0 (n=675) | 21.0 units on a scale | Standard Deviation 12.1 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 1 Week 12 (n=605) | 8.8 units on a scale | Standard Deviation 8.5 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 1 Week 24 (n=538) | 5.9 units on a scale | Standard Deviation 6.6 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 2 Week 0 (n=435) | 6.7 units on a scale | Standard Deviation 6.5 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 2 Week 12 (n=394) | 4.9 units on a scale | Standard Deviation 5 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 2 Week 24 (n=368) | 4.8 units on a scale | Standard Deviation 5.2 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 3 Week 0 (n=234) | 4.9 units on a scale | Standard Deviation 6.1 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 3 Week 12 (n=226) | 4.2 units on a scale | Standard Deviation 5.5 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 3 Week 24 (n=202) | 3.6 units on a scale | Standard Deviation 4.5 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 4 Week 0 (n=120) | 3.9 units on a scale | Standard Deviation 3.9 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 4 Week 12 (n=117) | 4.2 units on a scale | Standard Deviation 3.6 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 4 Week 24 (n=105) | 4.1 units on a scale | Standard Deviation 4.8 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 5-week 0 (n=77) | 3.6 units on a scale | Standard Deviation 3 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 5 Week 12 (n=79) | 4.2 units on a scale | Standard Deviation 4.1 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 5 Week 24 (n=63) | 3.6 units on a scale | Standard Deviation 3.2 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 6 Week 0 (n=60) | 3.9 units on a scale | Standard Deviation 3.6 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 6 Week 12 (n=54) | 3.0 units on a scale | Standard Deviation 3.4 |
| Etanercept | Psoriasis Area and Severity Index (PASI) Score | Cycle 6 Week 24 (n=48) | 2.8 units on a scale | Standard Deviation 2.7 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 1 Week 0 (n=718) | 3.1 units on a scale | Standard Deviation 0.9 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 1 Week 12 (n=683) | 1.9 units on a scale | Standard Deviation 1 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 1 Week 24 (n=615) | 1.6 units on a scale | Standard Deviation 1 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 2 Week 0 (n=514) | 1.7 units on a scale | Standard Deviation 1 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 2 Week 12 (n=482) | 1.5 units on a scale | Standard Deviation 0.9 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 2 Week 24 (n=444) | 1.5 units on a scale | Standard Deviation 1 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 3 Week 0 (n=307) | 1.5 units on a scale | Standard Deviation 1 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 3 Week 12 (n=291) | 1.4 units on a scale | Standard Deviation 1 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 3 Week 24 (n=259) | 1.3 units on a scale | Standard Deviation 0.9 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 4 Week 0 (n=174) | 1.4 units on a scale | Standard Deviation 0.9 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 4 Week 12 (n=158) | 1.5 units on a scale | Standard Deviation 0.9 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 4 Week 24 (n=147) | 1.5 units on a scale | Standard Deviation 0.9 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 5 Week 0 (n=114) | 1.5 units on a scale | Standard Deviation 0.8 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 5 Week 12 (n=109) | 1.6 units on a scale | Standard Deviation 0.9 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 5 Week 24 (n=95) | 1.5 units on a scale | Standard Deviation 0.8 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 6 Week 0 (n=88) | 1.5 units on a scale | Standard Deviation 0.9 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 6 Week 12 (n=78) | 1.3 units on a scale | Standard Deviation 0.8 |
| Etanercept | Static Physician Global Assessment (sPGA) of Disease Activity | Cycle 6 Week 24 (n=71) | 1.3 units on a scale | Standard Deviation 0.8 |