Trial Outcomes & Findings for Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis (NCT NCT01313221)

NCT ID: NCT01313221

Last Updated: 2017-03-15

Results Overview

The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 to Week 24 is presented as a percentage of the Week 12 value: Week 12 value - Week 24 value / Week 12 value \* 100 so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 310 participants
• Primary outcome timeframe: Week 12 and Week 24
• Results posted on: 2017-03-15

Participant Flow

First patient enrollment :29 April 2011; last patient enrollment: 4 June 2012.

A total of 414 patients were screened,310 patients were enrolled and 287 randomized in this study; 144 in the etanercept monotherapy group (group A) and 143 in the etanercept plus an as-needed topical agent group (group B). 23 patients were not randomized because they did not complete the 12-week open-label treatment period before randomization.

Participant milestones

Measure	Etanercept 50 mg BIW Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.	Non-randomized Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.
Overall Study STARTED	144	143	23
Overall Study Randomized	144	143	0
Overall Study COMPLETED	132	135	0
Overall Study NOT COMPLETED	12	8	23

Reasons for withdrawal

Measure	Etanercept 50 mg BIW Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.	Non-randomized Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.
Overall Study Protocol Violation	0	1	1
Overall Study Non-compliance	3	0	2
Overall Study Withdrawal by Subject	2	3	5
Overall Study Requirement for alternative therapy	0	1	1
Overall Study Lost to Follow-up	6	3	1
Overall Study Other	1	0	0
Overall Study Adverse Event	0	0	7
Overall Study Disease progression	0	0	2
Overall Study Physician Decision	0	0	2
Overall Study Pregnancy	0	0	2

Baseline Characteristics

Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent in Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.	Non-randomized n=23 Participants Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.	Total n=310 Participants Total of all reporting groups
Age, Continuous	45.7 years STANDARD_DEVIATION 13.1 • n=5 Participants	46.3 years STANDARD_DEVIATION 14.6 • n=7 Participants	36.6 years STANDARD_DEVIATION 11.2 • n=5 Participants	45.3 years STANDARD_DEVIATION 13.9 • n=4 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	49 Participants n=7 Participants	14 Participants n=5 Participants	109 Participants n=4 Participants
Sex: Female, Male Male	98 Participants n=5 Participants	94 Participants n=7 Participants	9 Participants n=5 Participants	201 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Asian	14 participants n=5 Participants	5 participants n=7 Participants	0 participants n=5 Participants	19 participants n=4 Participants
Race/Ethnicity, Customized Mixed Race	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized White	120 participants n=5 Participants	130 participants n=7 Participants	22 participants n=5 Participants	272 participants n=4 Participants
Race/Ethnicity, Customized Other	8 participants n=5 Participants	8 participants n=7 Participants	1 participants n=5 Participants	17 participants n=4 Participants
Body Mass Index (BMI) ≤ 30	81 participants n=5 Participants	80 participants n=7 Participants	13 participants n=5 Participants	174 participants n=4 Participants
Body Mass Index (BMI) > 30	63 participants n=5 Participants	63 participants n=7 Participants	10 participants n=5 Participants	136 participants n=4 Participants
Prior anti-Tumor Necrosis Factor (TNF) Treatment Prior exposure	24 participants n=5 Participants	22 participants n=7 Participants	NA participants n=5 Participants	NA participants n=4 Participants
Prior anti-Tumor Necrosis Factor (TNF) Treatment Naive	116 participants n=5 Participants	120 participants n=7 Participants	NA participants n=5 Participants	NA participants n=4 Participants

PRIMARY outcome

Timeframe: Week 12 and Week 24

Population: Efficacy Evaluable set, which included all randomized participants who had taken at least 1 dose of study drug and had at least 1 post-randomization efficacy evaluation, and with available data at Week 12 and Week 24.

The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 to Week 24 is presented as a percentage of the Week 12 value: Week 12 value - Week 24 value / Week 12 value * 100 so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.

Outcome measures

Measure	Etanercept 50 mg BIW n=139 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=140 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24	17.02 percent change Standard Error 7.06	0.86 percent change Standard Error 7.06

SECONDARY outcome

Timeframe: Week 12, Week 16 and Week 20

Population: Efficacy Evaluable set with available data at each time point (indicated by n)

The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.

Outcome measures

Measure	Etanercept 50 mg BIW n=140 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=142 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Percent Change in PASI From Week 12 to Weeks 16 and 20 Change from Week 12 to Week 16 (n=136, 137)	16.03 percent change Standard Error 5.89	4.80 percent change Standard Error 5.87
Percent Change in PASI From Week 12 to Weeks 16 and 20 Change from Week 12 to Week 20 (n=139, 140)	19.79 percent change Standard Error 6.74	3.23 percent change Standard Error 6.74

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 16, 20, and 24

Population: Full analysis set, (all enrolled participants who had taken at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation) and with available data. Last Observation Carried Forward (LOCF) imputation was used.

The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement.

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24 Change at Week 12 (n=143, 142)	62.12 percent change Standard Deviation 28.62	65.48 percent change Standard Deviation 28.59
Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24 Change at Week 16 (n=138, 138)	68.25 percent change Standard Deviation 27.08	72.67 percent change Standard Deviation 25.06
Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24 Change at Week 20 (n=142, 141)	70.98 percent change Standard Deviation 27.43	73.25 percent change Standard Deviation 25.35
Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24 Change at Week 24 (n=142, 141)	71.71 percent change Standard Deviation 27.56	72.56 percent change Standard Deviation 27.76

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 16, 20 and 24

Population: Full analysis set with a non-missing response; LOCF was used.

The percentage of participants with a 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Percentage of Participants With a PASI 50 Response Week 12 (n=143, 142)	71.3 percentage of participants Interval 63.9 to 78.7	75.4 percentage of participants Interval 68.3 to 82.4
Percentage of Participants With a PASI 50 Response Week 16 (n=138, 138)	76.1 percentage of participants Interval 69.0 to 83.2	86.2 percentage of participants Interval 80.5 to 92.0
Percentage of Participants With a PASI 50 Response Week 20 (n=142,141)	80.3 percentage of participants Interval 73.7 to 86.8	86.5 percentage of participants Interval 80.9 to 92.2
Percentage of Participants With a PASI 50 Response Week 24 (n=142, 141)	78.2 percentage of participants Interval 71.4 to 85.0	88.7 percentage of participants Interval 83.4 to 93.9

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 16, 20 and 24

Population: Full analysis set with a non-missing response; LOCF was used.

The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Percentage of Participants With a PASI 75 Response Week 12 (n=143, 142)	44.1 percentage of participants Interval 35.9 to 52.2	52.1 percentage of participants Interval 43.9 to 60.3
Percentage of Participants With a PASI 75 Response Week 16 (n=138, 138)	52.2 percentage of participants Interval 43.8 to 60.5	58.7 percentage of participants Interval 50.5 to 66.9
Percentage of Participants With a PASI 75 Response Week 20 (n=142,141)	54.9 percentage of participants Interval 46.7 to 63.1	58.9 percentage of participants Interval 50.7 to 67.0
Percentage of Participants With a PASI 75 Response Week 24 (n=142, 141)	59.2 percentage of participants Interval 51.1 to 67.2	60.3 percentage of participants Interval 52.2 to 68.4

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 16, 20 and 24

Population: Full analysis set with a non-missing response; LOCF was used.

The percentage of participants with a 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Percentage of Participants With a PASI 90 Response Week 12 (n=143, 142)	17.5 percentage of participants Interval 11.3 to 23.7	12.7 percentage of participants Interval 7.2 to 18.1
Percentage of Participants With a PASI 90 Response Week 16 (n=138, 138)	23.2 percentage of participants Interval 16.1 to 30.2	22.5 percentage of participants Interval 15.5 to 29.4
Percentage of Participants With a PASI 90 Response Week 20 (n=142,141)	28.9 percentage of participants Interval 21.4 to 36.3	22.0 percentage of participants Interval 15.1 to 28.8
Percentage of Participants With a PASI 90 Response Week 24 (n=142, 141)	32.4 percentage of participants Interval 24.7 to 40.1	27.0 percentage of participants Interval 19.6 to 34.3

SECONDARY outcome

Timeframe: Weeks 12, 16, 20, and 24

Population: Full Analysis Set, LOCF was used.

The sPGA scale is completed by the same blinded assessor performing the PASI assessments and is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) Week 12 (n=143, 142)	40.6 percentage of participants Interval 32.5 to 48.6	45.8 percentage of participants Interval 37.6 to 54.0
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) Week 16 (n=139, 139)	50.4 percentage of participants Interval 42.0 to 58.7	50.4 percentage of participants Interval 42.0 to 58.7
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) Week 20 (n=142, 141)	51.4 percentage of participants Interval 43.2 to 59.6	48.9 percentage of participants Interval 40.7 to 57.2
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) Week 24 (n=142, 141)	53.5 percentage of participants Interval 45.3 to 61.7	45.4 percentage of participants Interval 37.2 to 53.6

SECONDARY outcome

Timeframe: Weeks 12, 16, 20, and 24

Population: Efficacy analysis set with available data

The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments. Change from Week 12 is presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement.

Change was adjusted for treatment using a mixed model.

Outcome measures

Measure	Etanercept 50 mg BIW n=140 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=142 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24 Change from Week 12 to Week 20 (n=138, 140)	22.89 percent change Standard Error 7.65	16.04 percent change Standard Error 7.61
Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24 Change from Week 12 to Week 16 (n=135, 138)	18.77 percent change Standard Error 5.77	12.83 percent change Standard Error 5.72
Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24 Change from Week 12 to Week 24 (n=138, 140)	15.60 percent change Standard Error 10.17	10.71 percent change Standard Error 10.15

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 16, 20, and 24

Population: Full analysis set with available data; LOCF was used

The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments.

Change from Baseline \ is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement.

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24 Change at Week 20 (n=142, 141)	70.37 percent change Standard Deviation 30.30	75.86 percent change Standard Deviation 26.70
Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24 Change at Week 12 (n=142, 142)	58.13 percent change Standard Deviation 33.18	62.47 percent change Standard Deviation 36.10
Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24 Change at Week 16 (n=138, 139)	65.75 percent change Standard Deviation 30.95	72.88 percent change Standard Deviation 27.90
Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24 Change at Week 24 (n=142, 141)	71.80 percent change Standard Deviation 29.72	75.39 percent change Standard Deviation 29.52

SECONDARY outcome

Timeframe: Week 12 and Week 24

Population: Efficacy Evaluable set with available data

The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Week 12 to Week 24 is calculated as: Week 12 value - Week 24 value so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.

Outcome measures

Measure	Etanercept 50 mg BIW n=134 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=127 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Change From Week 12 to Week 24 in Dermatology Quality of Life Index (DQLI) Total Score	0.52 units on a scale Standard Error 0.38	-0.03 units on a scale Standard Error 0.39

SECONDARY outcome

Timeframe: Baseline and Week 12 and Week 24

Population: Full analysis set with available data; LOCF was used

The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline was calculated as Baseline value - postbaseline value so that a positive change indicates improvement.

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score Change at Week 12 (n=141, 139)	10.01 units on a scale Standard Deviation 7.03	9.71 units on a scale Standard Deviation 6.15
Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score Change at Week 24 (n=135, 129)	10.71 units on a scale Standard Deviation 7.80	9.87 units on a scale Standard Deviation 6.91

SECONDARY outcome

Timeframe: Week 12 and Week 24

Population: Efficacy Evaluable with available data; n indicates the number of patients with available data for each scale.

TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as Week 24 - Week 12 so that a positive change indicates improvement over time. Change was adjusted for treatment using a mixed model.

Outcome measures

Measure	Etanercept 50 mg BIW n=140 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=142 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24 Effectiveness (n=135, 127)	-3.05 units on a scale Standard Error 2.64	0.09 units on a scale Standard Error 2.74
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24 Convenience (n=135, 128)	-1.27 units on a scale Standard Error 1.19	2.57 units on a scale Standard Error 1.23
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24 Side effects (n=135, 126)	-0.43 units on a scale Standard Error 1.30	2.22 units on a scale Standard Error 1.35
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24 Global Satisfaction (n=135, 128)	-4.09 units on a scale Standard Error 1.59	1.34 units on a scale Standard Error 1.64

SECONDARY outcome

Timeframe: Baseline and Weeks 12 and 24

Population: Full analysis set; LOCF was used; n indicates the number of patients with available data for each scale at each time point.

The TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as postbaseline value - Baseline value so that a positive change indicates improvement.

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24 Week 12: Effectiveness (n=133, 129)	31.37 units on a scale Standard Deviation 34.50	32.64 units on a scale Standard Deviation 36.66
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24 Week 12: Convenience (n=132, 129)	15.87 units on a scale Standard Deviation 26.86	16.47 units on a scale Standard Deviation 30.39
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24 Week 12: Side effects (n=132, 125)	0.0 units on a scale Standard Deviation 19.07	-0.15 units on a scale Standard Deviation 20.75
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24 Week 12: Global Satisfaction (n=133, 129)	31.10 units on a scale Standard Deviation 32.99	27.09 units on a scale Standard Deviation 32.48
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24 Week 24: Effectiveness (n=127, 120)	27.08 units on a scale Standard Deviation 36.10	32.45 units on a scale Standard Deviation 40.29
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24 Week 24: Convenience (n=127, 121)	14.83 units on a scale Standard Deviation 25.88	18.53 units on a scale Standard Deviation 29.00
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24 Week 24: Side effects (n=127, 119)	-0.74 units on a scale Standard Deviation 22.04	1.26 units on a scale Standard Deviation 19.44
Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24 Week 24: Global Satisfaction (n=128, 120)	26.73 units on a scale Standard Deviation 32.54	28.39 units on a scale Standard Deviation 35.94

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Full Analysis Set with available data; LOCF was used.

Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of visits to a healthcare provider, participants answered the following questions regarding the past 4 weeks: How many times have you been to any physician's office or urgent care clinic? How many times have you seen a nurse practitioner, a physician assistant, a psychologist, a naturopath, an acupuncturist, a chiropractor, or other healthcare professional (HCP)? The number of participants with one or more visits is reported.

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Week 24: Other HCP Visits (n=25, 35)	6 participants	11 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Baseline: Any Physician Visit (n=137, 135)	52 participants	45 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Week 24: Any Physician Visit (n=131, 124)	28 participants	25 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Baseline: Nurse Practitioner Visits (n=126, 130)	9 participants	14 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Week 24: Nurse Practitioner Visits (n=121, 116)	3 participants	9 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Baseline: Physician Assistant Visits (n=123, 124)	10 participants	8 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Week 24: Physician Assistant Visits (n=123, 113)	7 participants	5 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Baseline: Psychologist Visits (n=122, 125)	1 participants	2 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Week 24: Psychologist Visits (n=121, 112)	1 participants	2 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Baseline: Naturopath Visits (n=125, 125	4 participants	2 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Week 24: Naturopath Visits (n=121, 111)	1 participants	2 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Baseline: Acupuncturist Visits (n=122, 125)	0 participants	1 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Week 24: Acupuncturist Visits (n=121, 111)	2 participants	2 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Baseline: Chiropractor Visits (n=124, 125)	6 participants	5 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Week 24: Chiropractor Visits (n=122, 112)	7 participants	9 participants
Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider Baseline: Other HCP Visits (n=31, 42)	12 participants	20 participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Full Analysis Set with available data; LOCF was used.

Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of homecare visits, participants answered the following question regarding the past 4 weeks: How many times have you received care from a health professional in your home? The number of participants with one or more visits is reported.

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Health Resource Utilization: Number of Participants With Home Healthcare Visits Baseline: Homecare Visits (n=138, 135)	1 participants	2 participants
Health Resource Utilization: Number of Participants With Home Healthcare Visits Week 24: Homecare Visits (n=133, 127)	1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Full Analysis Set with available data; LOCF was used.

Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of participants who needed paid help with chores, participants answered the following question regarding the past 4 weeks: How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)? The number of participants who paid for help one or more times is reported.

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Health Resource Utilization: Number of Participants Requiring Paid Help With Chores Baseline (n=134, 135)	12 participants	13 participants
Health Resource Utilization: Number of Participants Requiring Paid Help With Chores Week 24 (n=132, 127)	5 participants	5 participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Full Analysis Set with available data; LOCF was used.

Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. Participants answered the following question regarding the past 4 weeks: How many hours have you had a friend or family member take time off work to provide care or transportation? The number of participants who had paid or non-paid help for one or more hours is reported.

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Health Resource Utilization: Number of Participants Who Needed Friend or Family Care Week 24: Provided Non-paid Work (n=118, 114)	4 participants	4 participants
Health Resource Utilization: Number of Participants Who Needed Friend or Family Care Baseline: Provided Paid Work (n=123, 121)	5 participants	6 participants
Health Resource Utilization: Number of Participants Who Needed Friend or Family Care Week 24: Provided Paid Work (n=118, 113)	7 participants	6 participants
Health Resource Utilization: Number of Participants Who Needed Friend or Family Care Baseline: Provided Non-paid Work (n=120, 124)	6 participants	8 participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Full Analysis Set with available data; LOCF was used.

Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess out of pocket expenses, participants answered the following question regarding the past 4 weeks: Not counting study mandated visits, what out-of-pocket expenses did you spend for the management of psoriasis (i.e. costs due to travelling to doctor appointment, hospital or clinic parking costs, alternative medications)?

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Health Resource Utilization: Out of Pocket Expenses Baseline (n=129, 132)	1.0 Canadian dollars Interval 0.0 to 70.0	0.0 Canadian dollars Interval 0.0 to 50.0
Health Resource Utilization: Out of Pocket Expenses Week 24 (n=117, 120)	0.0 Canadian dollars Interval 0.0 to 3.0	0.0 Canadian dollars Interval 0.0 to 3.1

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Full Analysis Set; LOCF was used.

Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. Participants were asked their employment status at Baseline and at Week 24.

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Health Resource Utilization: Employment Status Baseline: Employed full time	81 participants	72 participants
Health Resource Utilization: Employment Status Baseline: Employed part time	26 participants	21 participants
Health Resource Utilization: Employment Status Baseline: Unemployed	16 participants	21 participants
Health Resource Utilization: Employment Status Baseline: Retired	19 participants	28 participants
Health Resource Utilization: Employment Status Baseline: Unknown/Missing	2 participants	1 participants
Health Resource Utilization: Employment Status Week 24: Employed full time	81 participants	67 participants
Health Resource Utilization: Employment Status Week 24: Employed part time	21 participants	19 participants
Health Resource Utilization: Employment Status Week 24: Unemployed	16 participants	13 participants
Health Resource Utilization: Employment Status Week 24: Retired	18 participants	30 participants
Health Resource Utilization: Employment Status Week 24: Unknown/Missing	8 participants	14 participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Full Analysis Set who were employed and with available data at each time point; LOCF was used. For the Etanercept 50 mg BIW group there were 106 and 100 participants with available data at Baseline and Week 24 respectively. For the Etanercept + Topical group there were 93 and 85 participants respectively.

Participants who were employed were asked: How much did your psoriasis affect your productivity while you were working? Possible responses were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Health Resource Utilization: Productivity While Working Week 24: Minimally	24 participants	12 participants
Health Resource Utilization: Productivity While Working Week 24: Not at all	64 participants	57 participants
Health Resource Utilization: Productivity While Working Baseline: A great deal	7 participants	6 participants
Health Resource Utilization: Productivity While Working Baseline: Quite a bit	16 participants	13 participants
Health Resource Utilization: Productivity While Working Baseline: Somewhat	37 participants	28 participants
Health Resource Utilization: Productivity While Working Baseline: Minimally	20 participants	21 participants
Health Resource Utilization: Productivity While Working Baseline: Not at all	26 participants	25 participants
Health Resource Utilization: Productivity While Working Week 24: A great deal	1 participants	3 participants
Health Resource Utilization: Productivity While Working Week 24: Quite a bit	4 participants	1 participants
Health Resource Utilization: Productivity While Working Week 24: Somewhat	7 participants	12 participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Full Analysis Set who were employed and with available data; LOCF was used.

Participants who were employed answered the following question regarding the past 4 weeks: How many hours per week did you miss from work because of your psoriasis? The number of participants with one or more missed hours of work per week is reported.

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Health Resource Utilization: Number of Participants With Missed Hours From Work Baseline: Hours Missed From Work (n=101, 92)	15 participants	19 participants
Health Resource Utilization: Number of Participants With Missed Hours From Work Week 24: Hours Missed From Work (n=96, 83)	5 participants	6 participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Full Analysis Set; LOCF was used.

Participants were asked: How much did your psoriasis affect your ability to do your daily activities or household chores? Possible answers were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.

Outcome measures

Measure	Etanercept 50 mg BIW n=144 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=143 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Health Resource Utilization: Ability to Perform Daily Activities Week 24: A great deal	2 participants	2 participants
Health Resource Utilization: Ability to Perform Daily Activities Week 24: Quite a bit	5 participants	6 participants
Health Resource Utilization: Ability to Perform Daily Activities Week 24: Not at all	56 participants	64 participants
Health Resource Utilization: Ability to Perform Daily Activities Week 24: Unknown/Missing	56 participants	57 participants
Health Resource Utilization: Ability to Perform Daily Activities Baseline: A great deal	11 participants	11 participants
Health Resource Utilization: Ability to Perform Daily Activities Baseline: Quite a bit	14 participants	16 participants
Health Resource Utilization: Ability to Perform Daily Activities Baseline: Somewhat	23 participants	27 participants
Health Resource Utilization: Ability to Perform Daily Activities Baseline: Minimally	29 participants	25 participants
Health Resource Utilization: Ability to Perform Daily Activities Baseline: Not at all	34 participants	30 participants
Health Resource Utilization: Ability to Perform Daily Activities Baseline: Unknown/Missing	33 participants	34 participants
Health Resource Utilization: Ability to Perform Daily Activities Week 24: Somewhat	9 participants	7 participants
Health Resource Utilization: Ability to Perform Daily Activities Week 24: Minimally	16 participants	7 participants

SECONDARY outcome

Timeframe: 32 weeks

Population: Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.

An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard.

Outcome measures

Measure	Etanercept 50 mg BIW n=177 Participants Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.	Etanercept 50 mg QW + Topical n=133 Participants Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
Number of Participants With Adverse Events Any adverse event	112 participants	92 participants
Number of Participants With Adverse Events Serious adverse event	4 participants	0 participants
Number of Participants With Adverse Events AE leading to discontinuation of study treatment	11 participants	0 participants
Number of Participants With Adverse Events AE leading to discontinuation from study	8 participants	0 participants
Number of Participants With Adverse Events Fatal adverse event	0 participants	0 participants

Adverse Events

Etanercept Monotherapy

Serious events: 4 serious events

Other events: 65 other events

Deaths: 0 deaths

Etanercept + Topical

Serious events: 0 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Measure	Etanercept Monotherapy n=177 participants at risk All participants who received etanercept at any time during the study, who never used a topical agent, regardless of treatment assignment, including those participants who were not randomized at Week 12.	Etanercept + Topical n=133 participants at risk All participants who used a topical agent at least once during the study, regardless of treatment group assignment.
Gastrointestinal disorders Crohn's disease	0.56% 1/177 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.	0.00% 0/133 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.
Gastrointestinal disorders Inguinal hernia	0.56% 1/177 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.	0.00% 0/133 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.
Infections and infestations Gastroenteritis	0.56% 1/177 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.	0.00% 0/133 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.56% 1/177 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.	0.00% 0/133 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.

Other adverse events

Measure	Etanercept Monotherapy n=177 participants at risk All participants who received etanercept at any time during the study, who never used a topical agent, regardless of treatment assignment, including those participants who were not randomized at Week 12.	Etanercept + Topical n=133 participants at risk All participants who used a topical agent at least once during the study, regardless of treatment group assignment.
General disorders Fatigue	4.0% 7/177 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.	6.0% 8/133 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.
General disorders Injection site erythema	7.3% 13/177 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.	5.3% 7/133 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.
General disorders Injection site haematoma	1.1% 2/177 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.	5.3% 7/133 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.
General disorders Injection site reaction	9.0% 16/177 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.	12.8% 17/133 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.
Infections and infestations Nasopharyngitis	13.6% 24/177 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.	15.0% 20/133 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.
Infections and infestations Upper respiratory tract infection	6.8% 12/177 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.	9.8% 13/133 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.
Nervous system disorders Headache	10.7% 19/177 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.	6.8% 9/133 • 32 weeks Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER