Trial Outcomes & Findings for Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings (NCT NCT00708708)
NCT ID: NCT00708708
Last Updated: 2015-07-27
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
926 participants
Primary outcome timeframe
Cycle 1 Week 24 up to Cycle 2 Week 0
Results posted on
2015-07-27
Participant Flow
A total of 955 participants were enrolled for documentation. Of these 955 participants enrolled, only 926 participants were included in analysis.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
955
|
|
Overall Study
COMPLETED
|
213
|
|
Overall Study
NOT COMPLETED
|
742
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Another therapy instead of Enbrel
|
141
|
|
Overall Study
Lost to Follow-up
|
52
|
|
Overall Study
Withdrawal by Subject
|
51
|
|
Overall Study
Intolerance
|
42
|
|
Overall Study
Another therapy along with Enbrel
|
15
|
|
Overall Study
Other unspecified
|
11
|
|
Overall Study
Good effectiveness
|
9
|
|
Overall Study
Ineffectiveness (no systemic therapy)
|
9
|
|
Overall Study
Administrative reasons
|
7
|
|
Overall Study
Lack of effectiveness
|
4
|
|
Overall Study
Lack of compliance
|
3
|
|
Overall Study
Pregnancy
|
3
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Missing values
|
392
|
Baseline Characteristics
Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings
Baseline characteristics by cohort
| Measure |
Etanercept
n=926 Participants
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.
|
|---|---|
|
Age, Continuous
|
47.4 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
339 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
583 participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing values
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Week 24 up to Cycle 2 Week 0Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=120 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Duration of Drug-Free Interval Prior to Treatment Cycle 2
|
12.6 weeks
Interval 10.2 to 15.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 2 Week 24 up to Cycle 3 Week 0Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=39 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Duration of Drug-Free Interval Prior to Treatment Cycle 3
|
10.5 weeks
Interval 8.2 to 12.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 3 Week 24 up to Cycle 4 Week 0Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=9 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Duration of Drug-Free Interval Prior to Treatment Cycle 4
|
25.0 weeks
Interval 11.7 to 38.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 4 Week 24 up to Cycle 5 Week 0Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=5 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Duration of Drug-Free Interval Prior to Treatment Cycle 5
|
20.6 weeks
Interval 3.9 to 37.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 5 Week 24 up to Cycle 6 Week 0Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=2 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Duration of Drug-Free Interval Prior to Treatment Cycle 6
|
14.2 weeks
Interval -1.2 to 29.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, 12, 24 of Cycle 1 to 6Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=720 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 3 Week 24 (n=202)
|
3.6 units on a scale
Standard Deviation 4.5
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 1 Week 0 (n=675)
|
21.0 units on a scale
Standard Deviation 12.1
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 1 Week 12 (n=605)
|
8.8 units on a scale
Standard Deviation 8.5
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 1 Week 24 (n=538)
|
5.9 units on a scale
Standard Deviation 6.6
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 2 Week 0 (n=435)
|
6.7 units on a scale
Standard Deviation 6.5
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 2 Week 12 (n=394)
|
4.9 units on a scale
Standard Deviation 5.0
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 2 Week 24 (n=368)
|
4.8 units on a scale
Standard Deviation 5.2
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 3 Week 0 (n=234)
|
4.9 units on a scale
Standard Deviation 6.1
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 3 Week 12 (n=226)
|
4.2 units on a scale
Standard Deviation 5.5
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 4 Week 0 (n=120)
|
3.9 units on a scale
Standard Deviation 3.9
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 4 Week 12 (n=117)
|
4.2 units on a scale
Standard Deviation 3.6
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 4 Week 24 (n=105)
|
4.1 units on a scale
Standard Deviation 4.8
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 5-week 0 (n=77)
|
3.6 units on a scale
Standard Deviation 3.0
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 5 Week 12 (n=79)
|
4.2 units on a scale
Standard Deviation 4.1
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 5 Week 24 (n=63)
|
3.6 units on a scale
Standard Deviation 3.2
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 6 Week 0 (n=60)
|
3.9 units on a scale
Standard Deviation 3.6
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 6 Week 12 (n=54)
|
3.0 units on a scale
Standard Deviation 3.4
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI) Score
Cycle 6 Week 24 (n=48)
|
2.8 units on a scale
Standard Deviation 2.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, 12, 24 of Cycle 1 to 6Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=298 Participants
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.
|
Participants With Drug-Free Interval
n=147 Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
n=275 Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
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
|
13.6 percentage of BSA
Standard Deviation 15.1
|
15.9 percentage of BSA
Standard Deviation 17.6
|
|
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
|
36.7 percentage of BSA
Standard Deviation 21.3
|
35.1 percentage of BSA
Standard Deviation 23.2
|
|
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
|
20.1 percentage of BSA
Standard Deviation 18.0
|
21.6 percentage of BSA
Standard Deviation 19.8
|
|
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
|
18.7 percentage of BSA
Standard Deviation 15.0
|
11.6 percentage of BSA
Standard Deviation 13.1
|
|
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
|
12.6 percentage of BSA
Standard Deviation 14.3
|
11.1 percentage of BSA
Standard Deviation 13.4
|
|
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
|
10.3 percentage of BSA
Standard Deviation 11.0
|
9.2 percentage of BSA
Standard Deviation 10.1
|
|
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
|
13.9 percentage of BSA
Standard Deviation 13.3
|
10.7 percentage of BSA
Standard Deviation 13.0
|
|
Percentage of Body Surface Area (BSA) Affected by Psoriasis
Cycle 3 Week 12 (n=201,40,43)
|
6.6 percentage of BSA
Standard Deviation 8.0
|
9.9 percentage of BSA
Standard Deviation 12.8
|
9.7 percentage of BSA
Standard Deviation 13.5
|
|
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
|
6.8 percentage of BSA
Standard Deviation 9.1
|
8.8 percentage of BSA
Standard Deviation 11.0
|
|
Percentage of Body Surface Area (BSA) Affected by Psoriasis
Cycle 4 Week 0 (n=144,8,21)
|
6.0 percentage of BSA
Standard Deviation 6.0
|
16.5 percentage of BSA
Standard Deviation 13.8
|
8.2 percentage of BSA
Standard Deviation 9.8
|
|
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
|
7.9 percentage of BSA
Standard Deviation 5.2
|
8.2 percentage of BSA
Standard Deviation 11.4
|
|
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
|
10.3 percentage of BSA
Standard Deviation 8.2
|
5.4 percentage of BSA
Standard Deviation 6.6
|
|
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
|
19.8 percentage of BSA
Standard Deviation 8.8
|
7.2 percentage of BSA
Standard Deviation 8.1
|
|
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
|
17.5 percentage of BSA
Standard Deviation 10.6
|
4.8 percentage of BSA
Standard Deviation 4.5
|
|
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
|
5.0 percentage of BSA
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
3.4 percentage of BSA
Standard Deviation 1.5
|
|
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
|
5.0 percentage of BSA
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
4.0 percentage of BSA
Standard Deviation 3.5
|
|
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
|
NA percentage of BSA
Standard Deviation NA
Data was not reported since no participant was evaluable at this time point.
|
3.0 percentage of BSA
Standard Deviation 1.4
|
|
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
|
NA percentage of BSA
Standard Deviation NA
Data was not reported since no participant was evaluable at this time point.
|
2.0 percentage of BSA
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Week 0, 12, 24 of Cycle 1 to 6Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=720 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 1 Week 0 (n=718)
|
3.1 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 1 Week 12 (n=683)
|
1.9 units on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 1 Week 24 (n=615)
|
1.6 units on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 2 Week 0 (n=514)
|
1.7 units on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 2 Week 12 (n=482)
|
1.5 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 2 Week 24 (n=444)
|
1.5 units on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 3 Week 0 (n=307)
|
1.5 units on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 3 Week 12 (n=291)
|
1.4 units on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 3 Week 24 (n=259)
|
1.3 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 4 Week 0 (n=174)
|
1.4 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 4 Week 12 (n=158)
|
1.5 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 4 Week 24 (n=147)
|
1.5 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 5 Week 0 (n=114)
|
1.5 units on a scale
Standard Deviation 0.8
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 5 Week 12 (n=109)
|
1.6 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 5 Week 24 (n=95)
|
1.5 units on a scale
Standard Deviation 0.8
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 6 Week 0 (n=88)
|
1.5 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 6 Week 12 (n=78)
|
1.3 units on a scale
Standard Deviation 0.8
|
—
|
—
|
|
Static Physician Global Assessment (sPGA) of Disease Activity
Cycle 6 Week 24 (n=71)
|
1.3 units on a scale
Standard Deviation 0.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 of Cycle 1 to 6Population: 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.
Physician assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.
Outcome measures
| Measure |
Etanercept
n=720 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Physician Global Assessment of Efficacy
Cycle 1: very good (n=606)
|
304 participants
0.9
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 1: good (n=606)
|
214 participants
1.0
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 1: moderate (n=606)
|
68 participants
1.0
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 1: insufficient (n=606)
|
20 participants
1.0
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 2: very good (n=440)
|
242 participants
0.9
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 2: good (n=440)
|
151 participants
1.0
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 2: moderate (n=440)
|
39 participants
1.0
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 2: insufficient (n=440)
|
8 participants
1.0
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 3: very good (n=259)
|
153 participants
0.9
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 3: good (n=259)
|
92 participants
0.9
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 3: moderate (n=259)
|
13 participants
0.9
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 3: insufficient (n=259)
|
1 participants
0.9
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 4: very good (n=147)
|
81 participants
0.8
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 4: good (n=147)
|
59 participants
0.9
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 4: moderate (n=147)
|
4 participants
0.8
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 4: insufficient (n=147)
|
3 participants
0.9
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 5: very good (n=96)
|
53 participants
0.8
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 5: good (n=96)
|
40 participants
0.8
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 5: moderate (n=96)
|
3 participants
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 5: insufficient (n=96)
|
0 participants
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 6: very good (n=70)
|
49 participants
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 6: good (n=70)
|
18 participants
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 6: moderate (n=70)
|
3 participants
|
—
|
—
|
|
Physician Global Assessment of Efficacy
Cycle 6: insufficient (n=70)
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 of Cycle 1 to 6Population: 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.
Participant assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.
Outcome measures
| Measure |
Etanercept
n=720 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Patient Global Assessment of Efficacy
Cycle 1: very good (n=605)
|
297 participants
0.9
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 1: good (n=605)
|
216 participants
1.0
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 1: moderate (n=605)
|
65 participants
1.0
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 1: insufficient (n=605)
|
27 participants
1.0
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 2: very good (n=444)
|
229 participants
0.9
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 2: good (n=444)
|
165 participants
1.0
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 2: moderate (n=444)
|
40 participants
1.0
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 2: insufficient (n=444)
|
10 participants
1.0
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 3: very good (n=258)
|
145 participants
0.9
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 3: good (n=258)
|
98 participants
0.9
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 3: moderate (n=258)
|
10 participants
0.9
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 3: insufficient (n=258)
|
5 participants
0.9
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 4: very good (n=147)
|
77 participants
0.8
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 4: good (n=147)
|
61 participants
0.9
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 4: moderate (n=147)
|
7 participants
0.8
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 4: insufficient (n=147)
|
2 participants
0.9
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 5: very good (n=96)
|
39 participants
0.8
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 5: good (n=96)
|
50 participants
0.8
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 5: moderate (n=96)
|
7 participants
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 5: insufficient (n=96)
|
0 participants
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 6: very good (n=71)
|
47 participants
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 6: good (n=71)
|
21 participants
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 6: moderate (n=71)
|
3 participants
|
—
|
—
|
|
Patient Global Assessment of Efficacy
Cycle 6: insufficient (n=71)
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=720 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Number of Injections Per Year
Year 1 (n=675)
|
47.0 injections
Standard Deviation 22.2
|
—
|
—
|
|
Number of Injections Per Year
Year 2 (n=418)
|
30.8 injections
Standard Deviation 22.4
|
—
|
—
|
|
Number of Injections Per Year
Year 3 (n=167)
|
32.1 injections
Standard Deviation 20.3
|
—
|
—
|
|
Number of Injections Per Year
Year 4 (n=53)
|
15.6 injections
Standard Deviation 12.9
|
—
|
—
|
|
Number of Injections Per Year
Year 5 (n=7)
|
11.8 injections
Standard Deviation 10.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=720 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Cumulative Dose of Etanercept Per Year
Year 1 (n=664)
|
2249.2 mg
Standard Deviation 1100.6
|
—
|
—
|
|
Cumulative Dose of Etanercept Per Year
Year 2 (n=418)
|
1474.7 mg
Standard Deviation 1104.6
|
—
|
—
|
|
Cumulative Dose of Etanercept Per Year
Year 3 (n=167)
|
1565.5 mg
Standard Deviation 1027.3
|
—
|
—
|
|
Cumulative Dose of Etanercept Per Year
Year 4 (n=53)
|
729.1 mg
Standard Deviation 589.9
|
—
|
—
|
|
Cumulative Dose of Etanercept Per Year
Year 5 (n=7)
|
399.5 mg
Standard Deviation 354.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 1Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=677 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Percentage of Time on Treatment in First Year
|
96.5 percentage of first year
Standard Deviation 10.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 up to Cycle 6Population: 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.
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).
Outcome measures
| Measure |
Etanercept
n=400 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Percentage of Time on Treatment Over Entire Period
|
94.8 percentage of entire treatment period
Standard Deviation 10.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, 12, 24 of Cycle 1 to 6Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=720 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 1 Week 0 (n=673)
|
3.7 units on a scale
Standard Deviation 1.2
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 1 Week 12 (n=629)
|
2.2 units on a scale
Standard Deviation 1.2
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 1 Week 24 (n=554)
|
1.9 units on a scale
Standard Deviation 1.2
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 2 Week 0 (n=349)
|
2.2 units on a scale
Standard Deviation 1.3
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 2 Week 12 (n=455)
|
1.7 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 2 Week 24 (n=395)
|
1.7 units on a scale
Standard Deviation 1.2
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 3 Week 0 (n=191)
|
1.8 units on a scale
Standard Deviation 1.2
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 3 Week 12 (n=261)
|
1.6 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 3 Week 24 (n=224)
|
1.6 units on a scale
Standard Deviation 1.2
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 4 Week 0 (n=89)
|
1.8 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 4 Week 12 (n=145)
|
1.7 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 4 Week 24 (n=132)
|
1.8 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 5 Week 0 (n=63)
|
1.9 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 5 Week 12 (n=103)
|
1.7 units on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 5 Week 24 (n=92)
|
1.8 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 6 Week 0 (n=43)
|
2.2 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 6 Week 12 (n=76)
|
1.6 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Patient's Global Assessment of Disease Activity (PatGA)
Cycle 6 Week 24 (n=68)
|
1.6 units on a scale
Standard Deviation 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, 12, 24 of Cycle 1 to 6Population: 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.
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).
Outcome measures
| Measure |
Etanercept
n=720 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 1 Week 0 (n=654)
|
14.0 units on a scale
Standard Deviation 7.3
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 1 Week 12 (n=598)
|
6.4 units on a scale
Standard Deviation 5.8
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 1 Week 24 (n=536)
|
4.9 units on a scale
Standard Deviation 5.7
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 2 Week 0 (n=334)
|
6.2 units on a scale
Standard Deviation 6.3
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 2 Week 12 (n=440)
|
4.3 units on a scale
Standard Deviation 5.1
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 2 Week 24 (n=378)
|
4.2 units on a scale
Standard Deviation 5.3
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 3 Week 0 (n=186)
|
4.9 units on a scale
Standard Deviation 5.9
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 3 Week 12 (n= 258)
|
3.9 units on a scale
Standard Deviation 5.1
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 3 Week 24 (n=221)
|
3.7 units on a scale
Standard Deviation 5.0
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 4 Week 0 (n=90)
|
4.7 units on a scale
Standard Deviation 6.4
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 4 Week 12 (n=146)
|
3.6 units on a scale
Standard Deviation 4.4
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 4 Week 24 (n=132)
|
3.8 units on a scale
Standard Deviation 5.1
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 5 Week 0 (n=64)
|
4.5 units on a scale
Standard Deviation 5.4
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 5 Week 12 (n=104)
|
3.8 units on a scale
Standard Deviation 4.8
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 5 Week 24 (n=91)
|
3.7 units on a scale
Standard Deviation 4.3
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 6 Week 0 (n=43)
|
5.0 units on a scale
Standard Deviation 5.1
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 6 Week 12 (n=75)
|
3.5 units on a scale
Standard Deviation 4.6
|
—
|
—
|
|
Dermatology Life Quality Index (DLQI) Score
Cycle 6 Week 24 (n=69)
|
3.9 units on a scale
Standard Deviation 4.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, 12, 24 of Cycle 1 to 6Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=720 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 0.140
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, 12, 24 of Cycle 1 to 6Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=720 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
Cycle 3 Week 0 (n=190)
|
88.3 units on a scale
Standard Deviation 17.0
|
—
|
—
|
|
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
Cycle 3 Week 12 (n= 257)
|
90.3 units on a scale
Standard Deviation 14.0
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Week 0 up to Cycle 6 Week 24Population: Safety analysis set included all participants with available post-baseline safety data.
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.
Outcome measures
| Measure |
Etanercept
n=926 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Number of Participants With at Least 1 Concomitant Medication
|
368 participants
10.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=720 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Annual Costs for Treatment With Etanercept
Year 1 (n=675)
|
20670.0 Euros
Standard Deviation 9743.9
|
—
|
—
|
|
Annual Costs for Treatment With Etanercept
Year 2 (n=418)
|
13509.6 Euros
Standard Deviation 9854.3
|
—
|
—
|
|
Annual Costs for Treatment With Etanercept
Year 3 (n=167)
|
14113.4 Euros
Standard Deviation 8913.8
|
—
|
—
|
|
Annual Costs for Treatment With Etanercept
Year 4 (n=53)
|
6847.4 Euros
Standard Deviation 5648.6
|
—
|
—
|
|
Annual Costs for Treatment With Etanercept
Year 5 (n=7)
|
5173.7 Euros
Standard Deviation 4506.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Year 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=720 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Average Cost of Treatment by Disease Severity
Year 1: Mild (n=290)
|
20707.0 Euros
Standard Deviation 9751.6
|
—
|
—
|
|
Average Cost of Treatment by Disease Severity
Year 1: Moderate (n=80)
|
21627.0 Euros
Standard Deviation 11119.5
|
—
|
—
|
|
Average Cost of Treatment by Disease Severity
Year 1: Severe (n=46)
|
21309.2 Euros
Standard Deviation 11573.3
|
—
|
—
|
|
Average Cost of Treatment by Disease Severity
Year 2: Mild (n=200)
|
13777.1 Euros
Standard Deviation 9864.5
|
—
|
—
|
|
Average Cost of Treatment by Disease Severity
Year 2: Moderate (n=32)
|
9668.8 Euros
Standard Deviation 7638.6
|
—
|
—
|
|
Average Cost of Treatment by Disease Severity
Year 2: Severe (n=9)
|
5479.7 Euros
Standard Deviation 4225.8
|
—
|
—
|
|
Average Cost of Treatment by Disease Severity
Year 3: Mild (n=93)
|
15062.1 Euros
Standard Deviation 8676.5
|
—
|
—
|
|
Average Cost of Treatment by Disease Severity
Year 3: Moderate (n=3)
|
6877.2 Euros
Standard Deviation 3071.3
|
—
|
—
|
|
Average Cost of Treatment by Disease Severity
Year 3: Severe (n=4)
|
6371.3 Euros
Standard Deviation 2565.0
|
—
|
—
|
|
Average Cost of Treatment by Disease Severity
Year 4: Mild (n=25)
|
5809.6 Euros
Standard Deviation 3125.3
|
—
|
—
|
|
Average Cost of Treatment by Disease Severity
Year 4: Moderate (n=1)
|
7467.0 Euros
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Average Cost of Treatment by Disease Severity
Year 4: Severe (n=2)
|
3196.0 Euros
Standard Deviation 575.5
|
—
|
—
|
|
Average Cost of Treatment by Disease Severity
Year 5: Mild (n=6)
|
5309.3 Euros
Standard Deviation 4998.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to study, Year 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=720 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, 12, 24 of Cycle 1 to 6Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=298 Participants
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.
|
Participants With Drug-Free Interval
n=147 Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
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 1.0
|
NA units on a scale
Standard Deviation NA
Data was not reported since no participant was evaluable at this time point.
|
—
|
|
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
|
3.9 units on a scale
Standard Deviation 0.9
|
—
|
|
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
|
2.1 units on a scale
Standard Deviation 1.3
|
—
|
|
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
|
1.8 units on a scale
Standard Deviation 1.3
|
—
|
|
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
|
2.6 units on a scale
Standard Deviation 1.3
|
—
|
|
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
|
1.8 units on a scale
Standard Deviation 1.0
|
—
|
|
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
|
1.7 units on a scale
Standard Deviation 1.3
|
—
|
|
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
|
2.1 units on a scale
Standard Deviation 1.3
|
—
|
|
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
|
1.5 units on a scale
Standard Deviation 1.1
|
—
|
|
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
|
1.2 units on a scale
Standard Deviation 1.2
|
—
|
|
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
|
2.2 units on a scale
Standard Deviation 1.5
|
—
|
|
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
|
2.0 units on a scale
Standard Deviation 1.3
|
—
|
|
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 1.0
|
3.2 units on a scale
Standard Deviation 1.8
|
—
|
|
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
|
3.0 units on a scale
Standard Deviation 1.4
|
—
|
|
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 1.0
|
3.0 units on a scale
Standard Deviation 1.4
|
—
|
|
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
|
3.0 units on a scale
Standard Deviation 1.4
|
—
|
|
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
|
3.5 units on a scale
Standard Deviation 0.7
|
—
|
|
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
|
3.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
SECONDARY outcome
Timeframe: Week 0, 12, 24 of Cycle 1 to 6Population: 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.
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).
Outcome measures
| Measure |
Etanercept
n=298 Participants
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.
|
Participants With Drug-Free Interval
n=147 Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
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
|
1.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
|
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
|
15.5 units on a scale
Standard Deviation 7.2
|
—
|
|
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
|
7.1 units on a scale
Standard Deviation 5.9
|
—
|
|
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
|
4.7 units on a scale
Standard Deviation 5.5
|
—
|
|
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
|
7.6 units on a scale
Standard Deviation 6.5
|
—
|
|
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
|
4.5 units on a scale
Standard Deviation 4.9
|
—
|
|
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
|
4.0 units on a scale
Standard Deviation 4.4
|
—
|
|
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
|
6.4 units on a scale
Standard Deviation 6.5
|
—
|
|
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
|
3.7 units on a scale
Standard Deviation 5.0
|
—
|
|
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
|
2.1 units on a scale
Standard Deviation 3.0
|
—
|
|
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
|
4.5 units on a scale
Standard Deviation 9.1
|
—
|
|
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
|
4.5 units on a scale
Standard Deviation 5.5
|
—
|
|
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
|
5.0 units on a scale
Standard Deviation 5.7
|
—
|
|
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
|
1.7 units on a scale
Standard Deviation 1.5
|
—
|
|
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
|
3.0 units on a scale
Standard Deviation 0.0
|
—
|
|
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
|
3.0 units on a scale
Standard Deviation 1.4
|
—
|
|
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
|
5.5 units on a scale
Standard Deviation 2.1
|
—
|
|
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
|
NA units on a scale
Standard Deviation NA
Data was not reported since no participant was evaluable at this time point.
|
—
|
SECONDARY outcome
Timeframe: Week 0, 12, 24 of Cycle 1 to 6Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=298 Participants
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.
|
Participants With Drug-Free Interval
n=147 Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
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
|
0.920 units on a scale
Standard Deviation 0.144
|
—
|
|
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
|
0.809 units on a scale
Standard Deviation 0.232
|
—
|
|
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
|
0.916 units on a scale
Standard Deviation 0.151
|
—
|
|
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
|
0.944 units on a scale
Standard Deviation 0.117
|
—
|
|
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 0.140
|
0.949 units on a scale
Standard Deviation 0.128
|
—
|
|
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
|
0.948 units on a scale
Standard Deviation 0.123
|
—
|
|
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
|
0.921 units on a scale
Standard Deviation 0.183
|
—
|
|
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
|
0.969 units on a scale
Standard Deviation 0.049
|
—
|
|
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
|
0.972 units on a scale
Standard Deviation 0.068
|
—
|
|
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
|
0.980 units on a scale
Standard Deviation 0.046
|
—
|
|
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
|
0.962 units on a scale
Standard Deviation 0.058
|
—
|
|
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
|
0.954 units on a scale
Standard Deviation 0.061
|
—
|
|
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
|
0.943 units on a scale
Standard Deviation 0.079
|
—
|
|
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
|
0.943 units on a scale
Standard Deviation 0.079
|
—
|
|
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
|
0.943 units on a scale
Standard Deviation 0.079
|
—
|
|
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
|
0.887 units on a scale
Standard Deviation 0.000
|
—
|
|
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 0.100
|
0.887 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was analyzed at this time-point.
|
—
|
|
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
|
NA units on a scale
Standard Deviation NA
Data was not reported since no participant was evaluable at this time point.
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=102 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Participant Perception of Drug-Free Interval: Length of Drug-Free Interval
After Cycle 1 (n=50)
|
0.9 months
Standard Deviation 1.0
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Length of Drug-Free Interval
Before Cycle 2 (n=102)
|
2.4 months
Standard Deviation 2.9
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Length of Drug-Free Interval
After Cycle 2 (n=19)
|
1.4 months
Standard Deviation 1.5
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Length of Drug-Free Interval
Before Cycle 3 (n=37)
|
1.6 months
Standard Deviation 1.6
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Length of Drug-Free Interval
After Cycle 3 (n=2)
|
4.5 months
Standard Deviation 2.1
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Length of Drug-Free Interval
Before Cycle 4 (n=5)
|
1.8 months
Standard Deviation 1.8
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Length of Drug-Free Interval
After Cycle 4 (n=0)
|
NA months
Standard Deviation NA
Mean and standard deviation were not estimable as no participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Length of Drug-Free Interval
Before Cycle 5 (n=1)
|
2.3 months
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Length of Drug-Free Interval
After Cycle 5 (n=0)
|
NA months
Standard Deviation NA
Mean and standard deviation were not estimable as no participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Length of Drug-Free Interval
Before Cycle 6 (n=1)
|
2.8 months
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=116 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 5-scheduled visit (n=1)
|
1 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 5-other reason (n=1)
|
0 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 2- unscheduled visit (n=116)
|
66 participants
2.9
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 2- scheduled visit (n=116)
|
46 participants
1.0
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 2- other reason (n=116)
|
4 participants
1.6
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 3- unscheduled visit (n=43)
|
16 participants
1.5
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 3- scheduled visit (n=43)
|
26 participants
1.8
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 3- other reason (n=43)
|
1 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 4- unscheduled visit(n=7)
|
2 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 4- scheduled visit (n=7)
|
4 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 4-other reason (n=7)
|
1 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 5- unscheduled visit(n=1)
|
0 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 6- unscheduled visit (n=1)
|
0 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 6-scheduled visit (n=1)
|
1 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reason for Returning to Practice
Before Cycle 6-other reason (n=1)
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=113 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval
Before Cycle 4 (n=5)
|
1.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval
Before Cycle 5 (n=1)
|
2.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval
After Cycle 5 (n=1)
|
4.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval
Before Cycle 6 (n=1)
|
2.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=104 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Participant Perception of Drug-Free Interval: Duration
Before Cycle 2 (n=104)
|
2.5 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Duration
Before Cycle 3 (n=35)
|
2.9 units on a scale
Standard Deviation 1.2
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Duration
Before Cycle 4 (n=5)
|
1.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Duration
Before Cycle 5 (n=1)
|
2.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Duration
Before Cycle 6 (n=1)
|
2.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=115 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Participant Perception of Drug-Free Interval: Relapse of Symptoms
After Cycle 1 (n=115)
|
4.4 units on a scale
Standard Deviation 0.8
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Relapse of Symptoms
Before Cycle 2 (n=106)
|
4.1 units on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Relapse of Symptoms
After Cycle 2 (n=41)
|
4.1 units on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Relapse of Symptoms
Before Cycle 3 (n=36)
|
4.0 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Relapse of Symptoms
After Cycle 3 (n=7)
|
4.9 units on a scale
Standard Deviation 0.4
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Relapse of Symptoms
Before Cycle 4 (n=5)
|
4.2 units on a scale
Standard Deviation 1.1
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Relapse of Symptoms
After Cycle 4 (n=3)
|
4.3 units on a scale
Standard Deviation 0.6
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Relapse of Symptoms
Before Cycle 5 (n=1)
|
4.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Relapse of Symptoms
After Cycle 5 (n=1)
|
3.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Relapse of Symptoms
Before Cycle 6 (n=1)
|
3.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=114 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 0.0
|
—
|
—
|
|
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
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval
Before Cycle 5 (n=1)
|
5.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval
After Cycle 5 (n=1)
|
5.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval
Before Cycle 6 (n=1)
|
2.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=102 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Participant Perception of Drug-Free Interval: Disease Activity
Before Cycle 2-first half (n=102)
|
2.4 units on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Disease Activity
Before Cycle 2-second half (n=101)
|
3.3 units on a scale
Standard Deviation 1.0
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Disease Activity
Before Cycle 3-first half (n=36)
|
2.3 units on a scale
Standard Deviation 1.0
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Disease Activity
Before Cycle 5-first half (n=1)
|
2.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Disease Activity
Before Cycle 5-second half (n=1)
|
3.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Disease Activity
Before Cycle 6-first half (n=1)
|
1.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Disease Activity
Before Cycle 6-second half (n=1)
|
2.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=100 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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 1.0
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 1.0
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition
Before Cycle 5-first half (n=1)
|
4.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition
Before Cycle 5-second half (n=1)
|
3.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition
Before Cycle 6-first half (n=1)
|
4.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition
Before Cycle 6-second half (n=1)
|
3.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=110 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions
After Cycle 4 (n=1)
|
3.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions
Before Cycle 5 (n=1)
|
3.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions
After Cycle 5 (n=1)
|
5.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions
Before Cycle 6 (n=1)
|
5.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=104 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Participant Perception of Drug-Free Interval: Reminder of Disease
After Cycle 1 (n=104)
|
2.4 units on a scale
Standard Deviation 1.3
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reminder of Disease
Before Cycle 2 (n=103)
|
2.5 units on a scale
Standard Deviation 1.3
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reminder of Disease
After Cycle 2 (n=39)
|
2.7 units on a scale
Standard Deviation 1.3
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reminder of Disease
Before Cycle 3 (n=38)
|
2.7 units on a scale
Standard Deviation 1.3
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reminder of Disease
After Cycle 3 (n=5)
|
1.6 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reminder of Disease
Before Cycle 4 (n=5)
|
1.6 units on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reminder of Disease
After Cycle 4 (n=3)
|
2.7 units on a scale
Standard Deviation 2.1
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reminder of Disease
Before Cycle 5 (n=1)
|
2.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reminder of Disease
After Cycle 5 (n=1)
|
5.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Reminder of Disease
Before Cycle 6 (n=1)
|
5.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=104 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Comfort in Everyday Life
After Cycle 4 (n=3)
|
1.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Comfort in Everyday Life
Before Cycle 5 (n=1)
|
2.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Comfort in Everyday Life
After Cycle 5 (n=1)
|
5.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Comfort in Everyday Life
Before Cycle 6 (n=1)
|
1.0 units on a scale
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at this time point.
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=106 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
After Cycle 1- No (n=104)
|
9 participants
1.3
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
After Cycle 1- Yes (n=104)
|
95 participants
1.3
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
Before Cycle 2- No (n=106)
|
8 participants
1.1
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
Before Cycle 2- Yes (n=106)
|
98 participants
0.8
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
After Cycle 2- No (n=40)
|
8 participants
0.0
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
After Cycle 2- Yes (n=40)
|
32 participants
NA
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
Before Cycle 3- No (n=42)
|
3 participants
NA
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
Before Cycle 3- Yes (n=42)
|
39 participants
NA
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
After Cycle 3- No (n=7)
|
0 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
After Cycle 3- Yes (n=7)
|
7 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
Before Cycle 4- No (n=6)
|
0 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
Before Cycle 4- Yes (n=6)
|
6 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
After Cycle 4- No (n=3)
|
1 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
After Cycle 4- Yes (n=3)
|
2 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
Before Cycle 5- No (n=1)
|
0 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
Before Cycle 5- Yes (n=1)
|
1 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
After Cycle 5- No (n=1)
|
0 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
After Cycle 5- Yes (n=1)
|
1 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
Before Cycle 6- No (n=1)
|
0 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Preference to Continuous Therapy
Before Cycle 6- Yes (n=1)
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=107 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Participant Perception of Drug-Free Interval: Recommendation of Therapy
After Cycle 2- No (n=40)
|
1 participants
0.0
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Recommendation of Therapy
After Cycle 1- No (n=106)
|
0 participants
1.3
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Recommendation of Therapy
After Cycle 1- Yes (n=106)
|
106 participants
1.3
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Recommendation of Therapy
Before Cycle 2- No (n=107)
|
0 participants
1.1
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Recommendation of Therapy
Before Cycle 2- Yes (n=107)
|
107 participants
0.8
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Recommendation of Therapy
After Cycle 2- Yes (n=40)
|
39 participants
NA
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Recommendation of Therapy
Before Cycle 3- No (n=42)
|
0 participants
NA
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Recommendation of Therapy
Before Cycle 3- Yes (n=42)
|
42 participants
NA
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Recommendation of Therapy
After Cycle 3- No (n=7)
|
0 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Recommendation of Therapy
After Cycle 3- Yes (n=7)
|
7 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Recommendation of Therapy
After Cycle 4- No (n=1)
|
0 participants
|
—
|
—
|
|
Participant Perception of Drug-Free Interval: Recommendation of Therapy
After Cycle 4- Yes (n=1)
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Before Cycle 2, 3, 4, 5, 6Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=144 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Criteria for Treatment Resumption
Before Cycle 3- NDA and other reason (n=43)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 3- POD and other reason (n=43)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 6- other reason (n=1)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 2-new disease activity (NDA) (n=144)
|
90 participants
1.3
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 2- POD (n=144)
|
42 participants
1.3
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 2- other reason (n=144)
|
8 participants
1.1
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 2- NDA and POD (n=144)
|
4 participants
0.8
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 2- NDA and other reason (n=144)
|
0 participants
0.0
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 2- POD and other reason (n=144)
|
0 participants
NA
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 2- NDA, POD and other reason (n=144)
|
0 participants
NA
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 3-NDA (n=43)
|
15 participants
NA
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 3- POD (n=43)
|
25 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 3- other reason (n=43)
|
2 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 3- NDA and POD (n=43)
|
1 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 3- NDA, POD and other reason (n=43)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 4- NDA (n=8)
|
3 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 4- POD (n=8)
|
5 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 4- other reason (n=8)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 4- NDA and POD (n=8)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 4- NDA and other reason (n=8)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 4- POD and other reason (n=8)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 4-NDA, POD and other reason (n=8)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 5- NDA (n=3)
|
2 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 5- POD (n=3)
|
1 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 5- other reason (n=3)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 5- NDA and POD (n=3)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 5- NDA and other reason (n=3)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 5- POD and other reason (n=3)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 5- NDA, POD and other reason (n=3)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 6- NDA (n=1)
|
1 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 6- POD (n=1)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 6- NDA and POD (n=1)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 6- NDA and other reason (n=1)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 6- POD and other reason (n=1)
|
0 participants
|
—
|
—
|
|
Criteria for Treatment Resumption
Before Cycle 6- NDA, POD and other reason (n=1)
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Etanercept
n=926 Participants
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.
|
Participants With Drug-Free Interval
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who were always treated with a drug-free interval during the observational period.
|
Remaining Participants
Participants who had moderate to severe plaque psoriasis and commenced treatment with etanercept (Enbrel) as a systemic monotherapy for the first time, received Enbrel in cycles of 24 weeks duration separated by drug-free intervals based on treating physician's discretion as per Summary of Product Characteristics (SmPC). Treatment was resumed if plaque psoriasis worsened. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. Participants were observed for 60 months. This group included participants who experienced both, treatment with and without drug-free interval during the observational period.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)
AEs
|
273 participants
10.6
|
—
|
—
|
|
Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)
SAEs
|
59 participants
|
—
|
—
|
Adverse Events
Etanercept
Serious events: 59 serious events
Other events: 230 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept
n=926 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Tachycardia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Peritonitis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Ileus
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest discomfort
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chills
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Drowning
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site erythema
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site extravasation
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Necrosis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Erysipelas
|
0.32%
3/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Necrotising fasciitis
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Abdominal infection
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Abscess
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Chronic tonsillitis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Muscle abscess
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Osteomyelitis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Post procedural infection
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urosepsis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Otitis externa
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral infection
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Accident
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Tuberculosis serology test positive
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight decreased
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Sleep disorder
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Scrotal erythema
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Renal transplant
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Vascular graft
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Embolism
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebral infarction
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Epilepsy
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Optic neuritis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Etanercept
n=926 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.32%
3/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Angina pectoris
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Arrhythmia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Hyperthyroidism
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual impairment
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Blepharitis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Diplopia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye pain
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid oedema
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Glaucoma
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.65%
6/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.32%
3/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Periodontitis
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Ascites
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gingivitis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Condition aggravated
|
2.8%
26/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site erythema
|
1.3%
12/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site inflammation
|
0.86%
8/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Rebound effect
|
0.65%
6/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
0.43%
4/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.43%
4/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site pruritus
|
0.32%
3/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site swelling
|
0.32%
3/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest discomfort
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Drug ineffective
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Impaired healing
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site induration
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site reaction
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Application site irritation
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chills
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Drug intolerance
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Feeling cold
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site anaesthesia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site dryness
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site nodule
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site recall reaction
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site warmth
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
26/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Infection
|
1.1%
10/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.65%
6/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
0.65%
6/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastrointestinal infection
|
0.54%
5/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.43%
4/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Erysipelas
|
0.43%
4/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
0.32%
3/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.32%
3/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tonsillitis
|
0.32%
3/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Anogenital warts
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Febrile infection
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.32%
3/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Laryngitis
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Ear infection
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Folliculitis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Molluscum contagiosum
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pilonidal cyst
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth infection
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Drug exposure before pregnancy
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Drug exposure during pregnancy
|
0.54%
5/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Drug exposure via breast milk
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Recall phenomenon
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Anal abscess
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood count abnormal
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Heart rate increased
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Hepatic enzyme increased
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Liver function test abnormal
|
0.43%
4/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Transaminases increased
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Tuberculosis test positive
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
0.43%
4/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cell count decreased
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Gout
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Podagra
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.86%
8/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.32%
3/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.43%
4/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.32%
3/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus syndrome
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Ageusia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.43%
4/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysaesthesia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.54%
5/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Radiculopathy
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.65%
6/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Middle insomnia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Panic attack
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Sleep disorder
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Stress
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal pain
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.54%
5/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.43%
4/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne conglobata
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia effluvium
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis papillaris capillitii
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermographism
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.32%
3/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity allergic reaction
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.43%
4/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
2.5%
23/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.32%
3/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Social circumstances
Immobile
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Cataract operation
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Dental operation
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Knee operation
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Shoulder operation
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Wart excision
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hot flush
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.54%
5/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Thrombophlebitis
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Varicose vein
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site extravasation
|
0.22%
2/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral candidiasis
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral herpes
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth abscess
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.11%
1/926
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER