Trial Outcomes & Findings for Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis (NCT NCT01387815)

NCT ID: NCT01387815

Last Updated: 2019-12-05

Results Overview

The Physician global assessment (PGA) score is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: * 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; * 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; * 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; * 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; * 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; * 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity. Percentages based on the total number of intent to treat (ITT) participants who attended each visit.

• Recruitment status: COMPLETED
• Target enrollment: 662 participants
• Primary outcome timeframe: Month 6
• Results posted on: 2019-12-05

Participant Flow

Of the 662 patients enrolled, the Safety Analysis Set included all who signed the inform consent and received at least 1 dose of study medication (N = 658) and the Intent-to-Treat Population included all who signed informed consent, met the inclusion / exclusion criteria, and received at least 1 dose of study medication (N = 595).

Participant milestones

Measure	Topical/Traditional Systemic Agent Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab Participants treated with adalimumab alone or in combination with topical agents.
Overall Study STARTED	302	293
Overall Study COMPLETED	162	189
Overall Study NOT COMPLETED	140	104

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis

Baseline characteristics by cohort

Measure	Topical/Traditional Systemic Agent n=302 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=293 Participants Participants treated with adalimumab alone or in combination with topical agents.	Total n=595 Participants Total of all reporting groups
Age, Continuous	50.3 years STANDARD_DEVIATION 15.06 • n=5 Participants	48.2 years STANDARD_DEVIATION 13.59 • n=7 Participants	49.3 years STANDARD_DEVIATION 14.38 • n=5 Participants
Sex: Female, Male Female	125 Participants n=5 Participants	116 Participants n=7 Participants	241 Participants n=5 Participants
Sex: Female, Male Male	177 Participants n=5 Participants	177 Participants n=7 Participants	354 Participants n=5 Participants
Race/Ethnicity, Customized White	262 Participants n=5 Participants	255 Participants n=7 Participants	517 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	23 Participants n=5 Participants	26 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Population: ITT population: all participants who signed informed consent, met inclusion/exclusion criteria, and received at least 1 dose of study medication.

The Physician global assessment (PGA) score is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

• 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
• 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
• 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
• 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
• 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
• 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

A higher score indicates greater disease severity. Percentages based on the total number of intent to treat (ITT) participants who attended each visit.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=302 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=293 Participants Participants treated with adalimumab alone or in combination with topical agents.
Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6	31.4 percentage of participants	56.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24

Population: ITT population

The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

• 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
• 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
• 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
• 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
• 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
• 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

A higher score indicates greater disease severity.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=302 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=293 Participants Participants treated with adalimumab alone or in combination with topical agents.
Time to Achieving PGA ≤ 1	13.3 Months Interval 11.8 to 22.0	5.7 Months Interval 4.4 to 6.0

SECONDARY outcome

Timeframe: Month 3

Population: ITT population

The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

• 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
• 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
• 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
• 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
• 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
• 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=302 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=293 Participants Participants treated with adalimumab alone or in combination with topical agents.
PGA≤1: Percentage of Participants at Month 3	19.0 percentage of participants	47.5 percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT population

The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

• 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
• 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
• 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
• 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
• 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
• 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=302 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=293 Participants Participants treated with adalimumab alone or in combination with topical agents.
PGA≤1: Percentage of Participants at Month 12	34.5 percentage of participants	57.3 percentage of participants

SECONDARY outcome

Timeframe: Month 18

Population: ITT population

The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

• 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
• 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
• 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
• 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
• 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
• 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=302 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=293 Participants Participants treated with adalimumab alone or in combination with topical agents.
PGA≤1: Percentage of Participants at Month 18	35.7 percentage of participants	61.3 percentage of participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT population

The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:

• 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;
• 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;
• 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;
• 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;
• 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;
• 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.

A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=302 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=293 Participants Participants treated with adalimumab alone or in combination with topical agents.
PGA≤1: Percentage of Participants at Month 24	37.5 percentage of participants	56.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: ITT population of participants who were available for assessment at this visit.

PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=189 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=184 Participants Participants treated with adalimumab alone or in combination with topical agents.
Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3	6.3 score on a scale Standard Deviation 4.28	7.6 score on a scale Standard Deviation 4.48

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: ITT population of participants who were available for assessment at this visit.

PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=161 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=172 Participants Participants treated with adalimumab alone or in combination with topical agents.
PASQ Total Score: Change From Baseline to Month 6	6.3 score on a scale Standard Deviation 4.35	7.5 score on a scale Standard Deviation 4.48

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: ITT population of participants who were available for assessment at this visit.

PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=139 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=147 Participants Participants treated with adalimumab alone or in combination with topical agents.
PASQ Total Score: Change From Baseline to Month 12	6.6 score on a scale Standard Deviation 4.46	7.6 score on a scale Standard Deviation 4.25

SECONDARY outcome

Timeframe: Baseline, Month 18

Population: ITT population of participants who were available for assessment at this visit.

PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=113 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=114 Participants Participants treated with adalimumab alone or in combination with topical agents.
PASQ Total Score: Change From Baseline to Month 18	6.9 score on a scale Standard Deviation 4.05	7.9 score on a scale Standard Deviation 4.22

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: ITT population of participants who were available for assessment at this visit.

PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=108 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=111 Participants Participants treated with adalimumab alone or in combination with topical agents.
PASQ Total Score: Change From Baseline to Month 24	7.2 score on a scale Standard Deviation 4.49	7.4 score on a scale Standard Deviation 4.21

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: ITT population of participants who were available for assessment at this visit.

The Body Surface Area (BSA) is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=195 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=211 Participants Participants treated with adalimumab alone or in combination with topical agents.
Body Surface Area of Psoriasis Involvement: Change From Baseline to Month 6	6.4 percentage estimated body surface area Standard Deviation 7.30	4.9 percentage estimated body surface area Standard Deviation 10.14

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: ITT population of participants who were available for assessment at this visit.

The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=177 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=195 Participants Participants treated with adalimumab alone or in combination with topical agents.
BSA of Psoriasis Involvement: Change From Baseline to Month 12	5.4 percentage estimated body surface area Standard Deviation 7.29	4.1 percentage estimated body surface area Standard Deviation 8.25

SECONDARY outcome

Timeframe: Baseline, Month 18

Population: ITT population of participants who were available for assessment at this visit.

The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=149 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=167 Participants Participants treated with adalimumab alone or in combination with topical agents.
BSA of Psoriasis Involvement: Change From Baseline to Month 18	5.1 percentage estimated body surface area Standard Deviation 6.03	3.1 percentage estimated body surface area Standard Deviation 5.58

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: ITT population of participants who were available for assessment at this visit.

The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=143 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=166 Participants Participants treated with adalimumab alone or in combination with topical agents.
BSA of Psoriasis Involvement: Change From Baseline to Month 24	6.3 percentage estimated body surface area Standard Deviation 10.37	3.7 percentage estimated body surface area Standard Deviation 6.63

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: ITT population

Patient Global Assessment of disease activity (PtGA) was assessed using a visual analog scale (VAS) where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=223 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=215 Participants Participants treated with adalimumab alone or in combination with topical agents.
Patient Global Assessment (PtGA) of Disease Activity Based on a Visual Analog Scale (VAS): Change From Baseline to Month 3	37.3 units on a scale Standard Deviation 27.13	32.8 units on a scale Standard Deviation 27.72

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: ITT population

PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=188 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=201 Participants Participants treated with adalimumab alone or in combination with topical agents.
PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 6	31.8 units on a scale Standard Deviation 27.44	29.9 units on a scale Standard Deviation 28.28

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: ITT population

PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=179 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=180 Participants Participants treated with adalimumab alone or in combination with topical agents.
PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 12	32.9 units on a scale Standard Deviation 27.33	28.2 units on a scale Standard Deviation 27.07

SECONDARY outcome

Timeframe: Baseline, Month 18

Population: ITT population

PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=144 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=153 Participants Participants treated with adalimumab alone or in combination with topical agents.
PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 18	30.2 units on a scale Standard Deviation 27.61	21.8 units on a scale Standard Deviation 24.89

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: ITT population

PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=141 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=143 Participants Participants treated with adalimumab alone or in combination with topical agents.
PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 24	31.9 units on a scale Standard Deviation 27.60	25.1 units on a scale Standard Deviation 26.65

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: ITT population

The Dermatology Quality of Life Index (DLQI) is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=219 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=215 Participants Participants treated with adalimumab alone or in combination with topical agents.
Dermatology Quality of Life Index (DLQI) Total Score: Change From Baseline to Month 3	6.5 score on a scale Standard Deviation 6.31	5.4 score on a scale Standard Deviation 6.18

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: ITT population

The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=185 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=197 Participants Participants treated with adalimumab alone or in combination with topical agents.
DLQI Total Score: Change From Baseline to Month 6	5.3 score on a scale Standard Deviation 6.01	4.3 score on a scale Standard Deviation 6.00

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: ITT population

The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=174 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=179 Participants Participants treated with adalimumab alone or in combination with topical agents.
DLQI Total Score: Change From Baseline to Month 12	5.1 score on a scale Standard Deviation 5.73	3.9 score on a scale Standard Deviation 5.66

SECONDARY outcome

Timeframe: Baseline, Month 18

Population: ITT population

The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=141 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=149 Participants Participants treated with adalimumab alone or in combination with topical agents.
DLQI Total Score: Change From Baseline to Month 18	4.0 score on a scale Standard Deviation 5.05	2.5 score on a scale Standard Deviation 3.70

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: ITT population

The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=143 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=141 Participants Participants treated with adalimumab alone or in combination with topical agents.
DLQI Total Score: Change From Baseline to Month 24	4.3 score on a scale Standard Deviation 5.15	3.3 score on a scale Standard Deviation 5.03

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24

Population: ITT population

The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=277 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=267 Participants Participants treated with adalimumab alone or in combination with topical agents.
Time to Achieving DLQI ≤1	17.7 Months Interval 11.5 to Upper limit could not be calculated.	8.2 Months Interval 6.3 to 12.0

SECONDARY outcome

Timeframe: Month 3

Population: ITT population

The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=302 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=293 Participants Participants treated with adalimumab alone or in combination with topical agents.
DLQI ≤1: Percentage of Participants at Month 3 No effect at all on patient's life (0-1)	18.2 percentage of participants	31.1 percentage of participants
DLQI ≤1: Percentage of Participants at Month 3 Small effect on patient's life (2-5)	33.2 percentage of participants	21.4 percentage of participants
DLQI ≤1: Percentage of Participants at Month 3 Moderate effect on patient's life (6-10)	19.0 percentage of participants	15.6 percentage of participants
DLQI ≤1: Percentage of Participants at Month 3 Very large effect on patient's life (21-30)	13.4 percentage of participants	12.8 percentage of participants
DLQI ≤1: Percentage of Participants at Month 3 Extremely large effect on patient's life (21-30)	4.9 percentage of participants	2.7 percentage of participants
DLQI ≤1: Percentage of Participants at Month 3 Missing	11.3 percentage of participants	16.3 percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT population

The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=302 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=293 Participants Participants treated with adalimumab alone or in combination with topical agents.
DLQI ≤1: Percentage of Participants at Month 6 No effect at all on patient's life (0-1)	26.5 percentage of participants	39.3 percentage of participants
DLQI ≤1: Percentage of Participants at Month 6 Small effect on patient's life (2-5)	28.7 percentage of participants	19.8 percentage of participants
DLQI ≤1: Percentage of Participants at Month 6 Moderate effect on patient's life (6-10)	13.5 percentage of participants	10.1 percentage of participants
DLQI ≤1: Percentage of Participants at Month 6 Very large effect on patient's life (21-30)	11.2 percentage of participants	8.5 percentage of participants
DLQI ≤1: Percentage of Participants at Month 6 Extremely large effect on patient's life (21-30)	3.1 percentage of participants	2.0 percentage of participants
DLQI ≤1: Percentage of Participants at Month 6 Missing	17.0 percentage of participants	20.2 percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT population

The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=302 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=293 Participants Participants treated with adalimumab alone or in combination with topical agents.
DLQI ≤1: Percentage of Participants at Month 12 No effect at all on patient's life (0-1)	28.2 percentage of participants	37.9 percentage of participants
DLQI ≤1: Percentage of Participants at Month 12 Small effect on patient's life (2-5)	27.2 percentage of participants	24.2 percentage of participants
DLQI ≤1: Percentage of Participants at Month 12 Moderate effect on patient's life (6-10)	15.0 percentage of participants	7.5 percentage of participants
DLQI ≤1: Percentage of Participants at Month 12 Very large effect on patient's life (21-30)	12.1 percentage of participants	6.2 percentage of participants
DLQI ≤1: Percentage of Participants at Month 12 Extremely large effect on patient's life (21-30)	1.9 percentage of participants	3.1 percentage of participants
DLQI ≤1: Percentage of Participants at Month 12 Missing	15.5 percentage of participants	21.1 percentage of participants

SECONDARY outcome

Timeframe: Month 18

Population: ITT population

The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=302 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=293 Participants Participants treated with adalimumab alone or in combination with topical agents.
DLQI ≤1: Percentage of Participants at Month 18 Missing	17.5 percentage of participants	25.1 percentage of participants
DLQI ≤1: Percentage of Participants at Month 18 No effect at all on patient's life (0-1)	35.7 percentage of participants	45.7 percentage of participants
DLQI ≤1: Percentage of Participants at Month 18 Small effect on patient's life (2-5)	25.7 percentage of participants	15.6 percentage of participants
DLQI ≤1: Percentage of Participants at Month 18 Moderate effect on patient's life (6-10)	12.9 percentage of participants	11.1 percentage of participants
DLQI ≤1: Percentage of Participants at Month 18 Very large effect on patient's life (21-30)	7.0 percentage of participants	2.0 percentage of participants
DLQI ≤1: Percentage of Participants at Month 18 Extremely large effect on patient's life (21-30)	1.2 percentage of participants	0.5 percentage of participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT population

The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=302 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=293 Participants Participants treated with adalimumab alone or in combination with topical agents.
DLQI ≤1: Percentage of Participants at Month 24 No effect at all on patient's life (0-1)	34.5 percentage of participants	38.1 percentage of participants
DLQI ≤1: Percentage of Participants at Month 24 Small effect on patient's life (2-5)	27.4 percentage of participants	20.1 percentage of participants
DLQI ≤1: Percentage of Participants at Month 24 Moderate effect on patient's life (6-10)	12.5 percentage of participants	9.8 percentage of participants
DLQI ≤1: Percentage of Participants at Month 24 Very large effect on patient's life (21-30)	9.5 percentage of participants	2.6 percentage of participants
DLQI ≤1: Percentage of Participants at Month 24 Extremely large effect on patient's life (21-30)	1.2 percentage of participants	2.1 percentage of participants
DLQI ≤1: Percentage of Participants at Month 24 Missing	14.9 percentage of participants	27.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: ITT population

The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex.

The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63.

The higher the score, the greater the severity of the depression.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=184 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=195 Participants Participants treated with adalimumab alone or in combination with topical agents.
Beck Depression Inventory II (BDI-II): Change From Baseline to Month 6	7.8 score on a scale Standard Deviation 8.95	7.2 score on a scale Standard Deviation 7.80

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: ITT population

The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex.

The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63.

The higher the score, the greater the severity of the depression.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=177 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=178 Participants Participants treated with adalimumab alone or in combination with topical agents.
BDI-II: Change From Baseline to Month 12	7.5 score on a scale Standard Deviation 8.06	7.3 score on a scale Standard Deviation 7.72

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: ITT population

The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex.

The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63.

The higher the score, the greater the severity of the depression.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=140 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=142 Participants Participants treated with adalimumab alone or in combination with topical agents.
BDI-II: Change From Baseline to Month 24	7.2 score on a scale Standard Deviation 7.59	6.6 score on a scale Standard Deviation 7.51

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: ITT population

The Medical Outcomes Study Short Form 12 (SF-12) questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=119 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=120 Participants Participants treated with adalimumab alone or in combination with topical agents.
Medical Outcomes Study Short Form-12 Health Status Survey (SF-12) Mental Component Summary (MCS) Score: Change From Baseline to Month 6	49.8 score on a scale Standard Deviation 10.43	49.7 score on a scale Standard Deviation 10.08

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: ITT population

The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=123 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=113 Participants Participants treated with adalimumab alone or in combination with topical agents.
SF-12 MCS Score: Change From Baseline to Month 12	48.9 score on a scale Standard Deviation 11.37	49.6 score on a scale Standard Deviation 9.99

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: ITT population

The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=121 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=114 Participants Participants treated with adalimumab alone or in combination with topical agents.
SF-12 MCS Score: Change From Baseline to Month 24	50.2 score on a scale Standard Deviation 10.92	51.3 score on a scale Standard Deviation 8.93

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: ITT population

The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=119 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=120 Participants Participants treated with adalimumab alone or in combination with topical agents.
SF-12 Physical Component Summary (PCS) Score: Change From Baseline to Month 6	48.2 score on a scale Standard Deviation 10.14	47.3 score on a scale Standard Deviation 10.35

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: ITT population

The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=123 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=113 Participants Participants treated with adalimumab alone or in combination with topical agents.
SF-12 PCS Score: Change From Baseline to Month 12	47.3 score on a scale Standard Deviation 10.93	47.0 score on a scale Standard Deviation 10.40

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: ITT population

The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=121 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=114 Participants Participants treated with adalimumab alone or in combination with topical agents.
SF-12 PCS Score: Change From Baseline to Month 24	47.8 score on a scale Standard Deviation 9.81	48.8 score on a scale Standard Deviation 9.81

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: ITT population

The Work Limitation Questionnaire (WLQ) is a self-administered questionnaire comprised of 25 questions.

The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=117 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=138 Participants Participants treated with adalimumab alone or in combination with topical agents.
Work Limitation Questionnaire (WLQ) Total Score: Change From Baseline to Month 6	12.4 score on a scale Standard Deviation 15.67	14.0 score on a scale Standard Deviation 16.44

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: ITT population

The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=107 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=109 Participants Participants treated with adalimumab alone or in combination with topical agents.
WLQ Total Score: Change From Baseline to Month 12	13.5 score on a scale Standard Deviation 15.45	14.2 score on a scale Standard Deviation 17.52

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: ITT population

The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=84 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=91 Participants Participants treated with adalimumab alone or in combination with topical agents.
WLQ Total Score: Change From Baseline to Month 24	12.1 score on a scale Standard Deviation 15.51	10.4 score on a scale Standard Deviation 15.86

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: ITT population

The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=117 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=138 Participants Participants treated with adalimumab alone or in combination with topical agents.
WLQ Productivity Loss Score: Change From Baseline to Month 6	3.2 score on a scale Standard Deviation 4.19	3.6 score on a scale Standard Deviation 4.25

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: ITT population

The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=107 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=109 Participants Participants treated with adalimumab alone or in combination with topical agents.
WLQ Productivity Loss Score: Change From Baseline to Month 12	3.5 score on a scale Standard Deviation 4.07	3.7 score on a scale Standard Deviation 4.73

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: ITT population

The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.

The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=84 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=91 Participants Participants treated with adalimumab alone or in combination with topical agents.
WLQ Productivity Loss Score: Change From Baseline to Month 24	3.1 score on a scale Standard Deviation 4.16	2.7 score on a scale Standard Deviation 4.11

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=223 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=247 Participants Participants treated with adalimumab alone or in combination with topical agents.
Healthcare Resource Utilization (HCRU): Number of Participants With Insurance for Prescription Medication at Month 6	156 participants	177 participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=206 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=227 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants With Insurance for Prescription Medication at Month 12	148 participants	157 participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=168 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=194 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants With Insurance for Prescription Medication at Month 24	112 participants	121 participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population of participants who were available for assessment at this visit and answered "yes" to question of having insurance for prescription medication. Note: One patient may have had more than one medical insurance; therefore, the total of the rows will not match the number analyzed.

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=156 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=177 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 RAMQ	14 participants	8 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 Federal Government	8 participants	12 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 OHIP	17 participants	29 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 Blue Cross	26 participants	28 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 Other	74 participants	74 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 Missing: Insurer name not provided	30 participants	42 participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population of participants who were available for assessment at this visit and answered "yes" to question of having insurance for prescription medication. Note: One patient may have had more than one medical insurance; therefore, the total of the rows will not match the number analyzed.

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=148 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=157 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 RAMQ	13 participants	6 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 Federal Government	6 participants	6 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 CSST	1 participants	0 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 OHIP	26 participants	24 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 Blue Cross	23 participants	29 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 Other	66 participants	76 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 Missing: Insurer name not provided	27 participants	38 participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population of participants who were available for assessment at this visit and answered "yes" to question of having insurance for prescription medication. Note: One patient may have had more than one medical insurance; therefore, the total of the rows will not match the number analyzed.

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=112 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=121 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 RAMQ	8 participants	5 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 Federal Government	7 participants	6 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 OHIP	16 participants	27 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 Blue Cross	18 participants	24 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 Other	51 participants	48 participants
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 Missing: Insurer name not provided	24 participants	24 participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=223 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=247 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6 Yes	95 participants	86 participants
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6 No	82 participants	101 participants
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6 Missing	46 participants	60 participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=206 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=227 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12 Yes	89 participants	81 participants
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12 No	81 participants	88 participants
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12 Missing	36 participants	58 participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=168 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=194 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24 Yes	57 participants	55 participants
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24 No	71 participants	78 participants
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24 Missing	40 participants	61 participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=223 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=247 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 Yes	7 participants	5 participants
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 No	71 participants	76 participants
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 Missing	145 participants	166 participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=206 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=227 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 Yes	7 participants	7 participants
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 No	73 participants	69 participants
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 Missing	126 participants	151 participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=168 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=194 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 Yes	3 participants	2 participants
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 No	51 participants	49 participants
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 Missing	114 participants	143 participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=7 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=3 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6	1.9 office visits Standard Deviation 1.46	1.3 office visits Standard Deviation 0.58

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=3 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=1 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12	1.0 office visits Standard Deviation 0.00	NA office visits Standard Deviation NA There was only one participant to analyze, so a mean could not be calculated.

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=3 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=1 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24	7.0 office visits Standard Deviation 1.73	NA office visits Standard Deviation NA The mean could not be calculated because there was only one participant.

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=223 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=247 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Visits to Another Physician at Month 6 Yes	21 participants	20 participants
HCRU: Number of Participants Making Visits to Another Physician at Month 6 No	59 participants	60 participants
HCRU: Number of Participants Making Visits to Another Physician at Month 6 Missing	143 participants	167 participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=206 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=227 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Visits to Another Physician at Month 12 Yes	18 participants	14 participants
HCRU: Number of Participants Making Visits to Another Physician at Month 12 No	58 participants	55 participants
HCRU: Number of Participants Making Visits to Another Physician at Month 12 Missing	130 participants	158 participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=168 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=194 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Visits to Another Physician at Month 24 Yes	15 participants	16 participants
HCRU: Number of Participants Making Visits to Another Physician at Month 24 No	38 participants	35 participants
HCRU: Number of Participants Making Visits to Another Physician at Month 24 Missing	115 participants	143 participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=11 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=7 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Visits to Another Physician at Month 6	1.4 office visits Standard Deviation 1.21	1.4 office visits Standard Deviation 0.53

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=4 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=5 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Visits to Another Physician at Month 12	2.0 office visits Standard Deviation 1.41	2.2 office visits Standard Deviation 2.17

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=5 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=7 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Visits to Another Physician at Month 24	1.2 office visits Standard Deviation 0.45	1.3 office visits Standard Deviation 0.49

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=223 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=247 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6 Missing	147 participants	176 participants
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6 Yes	15 participants	12 participants
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6 No	61 participants	59 participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=206 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=227 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12 Yes	13 participants	12 participants
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12 No	60 participants	55 participants
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12 Missing	133 participants	160 participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=168 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=194 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24 Yes	2 participants	10 participants
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24 No	49 participants	39 participants
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24 Missing	117 participants	145 participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=8 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=2 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Visits to A Healthcare Professional at Month 6	1.3 office visits Standard Deviation 0.71	1.0 office visits Standard Deviation 0.00

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=5 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=2 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Visits to A Healthcare Professional at Month 12	1.8 office visits Standard Deviation 1.79	1.5 office visits Standard Deviation 0.71

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=1 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=3 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Visits to A Healthcare Professional at Month 24	1 office visits Standard Deviation NA Standard deviation not calculated due to insufficient number of participants analyzed.	1.3 office visits Standard Deviation 0.58

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=223 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=247 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6 Yes	3 participants	4 participants
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6 No	83 participants	77 participants
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6 Missing	137 participants	166 participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=206 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=227 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12 Yes	4 participants	5 participants
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12 No	82 participants	73 participants
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12 Missing	120 participants	149 participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=168 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=194 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24 Yes	2 participants	3 participants
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24 No	52 participants	51 participants
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24 Missing	114 participants	140 participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=1 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Visits to a Hospital Emergency Room at Month 6	—	1 visits Standard Deviation NA Standard deviation not calculated due to insufficient number of participants analyzed.

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=1 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=1 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Visits to a Hospital Emergency Room at Month 12	1 visits Standard Deviation NA Standard deviation not calculated due to insufficient number of participants analyzed.	1 visits Standard Deviation NA Standard deviation not calculated due to insufficient number of participants analyzed.

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=1 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Visits to a Hospital Emergency Room at Month 24	—	1 visits Standard Deviation NA Standard deviation not calculated due to insufficient number of participants analyzed.

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=223 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=247 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Use of an Ambulance Service at Month 6 Yes	1 participants	0 participants
HCRU: Number of Participants Making Use of an Ambulance Service at Month 6 No	84 participants	81 participants
HCRU: Number of Participants Making Use of an Ambulance Service at Month 6 Missing	138 participants	166 participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=206 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=227 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Use of an Ambulance Service at Month 12 Yes	1 participants	1 participants
HCRU: Number of Participants Making Use of an Ambulance Service at Month 12 No	85 participants	77 participants
HCRU: Number of Participants Making Use of an Ambulance Service at Month 12 Missing	120 participants	149 participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=168 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=194 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Use of an Ambulance Service at Month 24 No	54 participants	54 participants
HCRU: Number of Participants Making Use of an Ambulance Service at Month 24 Missing	114 participants	140 participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=223 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=247 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6 Yes	3 participants	4 participants
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6 No	84 participants	78 participants
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6 Missing	136 participants	165 participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=206 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=227 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12 Yes	6 participants	4 participants
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12 No	76 participants	73 participants
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12 Missing	124 participants	150 participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=168 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=194 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24 Yes	0 participants	1 participants
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24 No	54 participants	52 participants
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24 Missing	114 participants	141 participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=2 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Complementary/Alternate Therapy Visits at Month 6	3.0 visits Standard Deviation 1.41	—

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=1 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=1 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Complementary/Alternate Therapy Visits at Month 12	1 visits Standard Deviation NA Standard deviation not calculated due to insufficient number of participants analyzed.	1 visits Standard Deviation NA Standard deviation not calculated due to insufficient number of participants analyzed.

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=223 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=247 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6 Yes	3 participants	1 participants
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6 No	177 participants	186 participants
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6 Missing	43 participants	60 participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=206 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=227 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12 Yes	3 participants	3 participants
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12 No	167 participants	172 participants
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12 Missing	36 participants	52 participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=168 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=194 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24 Yes	3 participants	5 participants
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24 No	130 participants	132 participants
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24 Missing	35 participants	57 participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=3 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=1 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 6	8.3 days Standard Deviation 7.51	1 days Standard Deviation NA Standard deviation not calculated due to insufficient number of participants analyzed.

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=1 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=3 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 12	1 days Standard Deviation NA Standard deviation not calculated due to insufficient number of participants analyzed.	2.0 days Standard Deviation 1.00

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=1 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=1 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 24	1 days Standard Deviation NA Standard deviation not calculated due to insufficient number of participants analyzed.	1 days Standard Deviation NA Standard deviation not calculated due to insufficient number of participants analyzed.

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=223 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=247 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6 Yes	1 participants	0 participants
HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6 Missing	222 participants	247 participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=206 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=227 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12 Yes	0 participants	1 participants
HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12 Missing	206 participants	226 participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population. Data not collected.

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=86 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=86 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payment for Over the Counter Medications at Month 6	35.0 dollars Standard Deviation 77.82	8.7 dollars Standard Deviation 37.85

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=66 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=82 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payment for Over the Counter Medications at Month 12	17.8 dollars Standard Deviation 48.28	22.1 dollars Standard Deviation 73.15

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=49 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=63 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payment for Over the Counter Medications at Month 24	10.8 dollars Standard Deviation 21.43	17.3 dollars Standard Deviation 69.10

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=68 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=81 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments to Healthcare Professionals at Month 6	4.0 dollars Standard Deviation 28.34	4.4 dollars Standard Deviation 25.12

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=63 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=77 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments to Healthcare Professionals at Month 12	31.2 dollars Standard Deviation 147.48	3.5 dollars Standard Deviation 21.48

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=40 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=53 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments to Healthcare Professionals at Month 24	7.9 dollars Standard Deviation 42.44	1.5 dollars Standard Deviation 10.99

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=68 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=81 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 6	2.0 dollars Standard Deviation 12.20	2.6 dollars Standard Deviation 19.35

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=59 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=76 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 12	0.0 dollars Standard Deviation 0.00	0.5 dollars Standard Deviation 3.61

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=40 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=54 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 24	0.4 dollars Standard Deviation 2.37	8.2 dollars Standard Deviation 42.50

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=68 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=80 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments for Medical Devices at Month 6	0.00 dollars Standard Deviation 0.00	0.4 dollars Standard Deviation 3.35

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=59 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=76 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments for Medical Devices at Month 12	0.0 dollars Standard Deviation 0.00	0.0 dollars Standard Deviation 0.00

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=41 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=54 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments for Medical Devices at Month 24	1.0 dollars Standard Deviation 4.36	1.5 dollars Standard Deviation 10.89

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=68 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=79 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 6	5.9 dollars Standard Deviation 48.51	0.0 dollars Standard Deviation 0.00

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=59 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=77 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 12	0.0 dollars Standard Deviation 0.00	1.4 dollars Standard Deviation 8.87

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=40 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=54 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 24	2.5 dollars Standard Deviation 15.81	18.5 dollars Standard Deviation 136.08

SECONDARY outcome

Timeframe: Month 6

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=84 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=92 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments for Transportation at Month 6	20.4 dollars Standard Deviation 59.74	14.7 dollars Standard Deviation 45.31

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=74 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=87 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments for Transportation at Month 12	13.1 dollars Standard Deviation 31.69	15.5 dollars Standard Deviation 56.74

SECONDARY outcome

Timeframe: Month 24

Population: ITT Population

Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=59 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=60 Participants Participants treated with adalimumab alone or in combination with topical agents.
HCRU: Cost of Payments for Transportation at Month 24	22.1 dollars Standard Deviation 50.70	12.9 dollars Standard Deviation 44.53

SECONDARY outcome

Timeframe: Month 3

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=126 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=53 Participants Participants treated with adalimumab alone or in combination with topical agents.
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3	2.8 doses Standard Deviation 8.94	2.2 doses Standard Deviation 11.66

SECONDARY outcome

Timeframe: Month 6

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=107 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=58 Participants Participants treated with adalimumab alone or in combination with topical agents.
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6	4.8 doses Standard Deviation 16.90	3.3 doses Standard Deviation 16.58

SECONDARY outcome

Timeframe: Month 12

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=91 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=50 Participants Participants treated with adalimumab alone or in combination with topical agents.
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12	3.8 doses Standard Deviation 13.40	0.6 doses Standard Deviation 4.24

SECONDARY outcome

Timeframe: Month 18

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=59 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=57 Participants Participants treated with adalimumab alone or in combination with topical agents.
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18	5.0 doses Standard Deviation 28.31	0.3 doses Standard Deviation 1.99

SECONDARY outcome

Timeframe: Month 24

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=62 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=50 Participants Participants treated with adalimumab alone or in combination with topical agents.
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24	0.2 doses Standard Deviation 0.95	0.1 doses Standard Deviation 0.71

SECONDARY outcome

Timeframe: Month 3

Population: ITT population

Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=31 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=4 Participants Participants treated with adalimumab alone or in combination with topical agents.
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 3	3.3 sessions Standard Deviation 9.11	2.5 sessions Standard Deviation 3.79

SECONDARY outcome

Timeframe: Month 6

Population: ITT population

Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=20 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=3 Participants Participants treated with adalimumab alone or in combination with topical agents.
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 6	1.8 sessions Standard Deviation 4.18	4.7 sessions Standard Deviation 4.16

SECONDARY outcome

Timeframe: Month 12

Population: ITT population

Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=22 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=3 Participants Participants treated with adalimumab alone or in combination with topical agents.
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 12	1.6 sessions Standard Deviation 3.24	1.3 sessions Standard Deviation 2.31

SECONDARY outcome

Timeframe: Month 18

Population: ITT population

Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=15 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=3 Participants Participants treated with adalimumab alone or in combination with topical agents.
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 18	0.3 sessions Standard Deviation 1.05	2.7 sessions Standard Deviation 3.06

SECONDARY outcome

Timeframe: Month 24

Population: ITT population

Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=15 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=2 Participants Participants treated with adalimumab alone or in combination with topical agents.
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 24	1.1 sessions Standard Deviation 2.40	10.0 sessions Standard Deviation 0.00

SECONDARY outcome

Timeframe: Month 3

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=135 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=22 Participants Participants treated with adalimumab alone or in combination with topical agents.
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3	2.7 doses Standard Deviation 10.10	0.0 doses Standard Deviation 0.21

SECONDARY outcome

Timeframe: Month 6

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=107 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=18 Participants Participants treated with adalimumab alone or in combination with topical agents.
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6	3.0 doses Standard Deviation 12.98	0.1 doses Standard Deviation 0.47

SECONDARY outcome

Timeframe: Month 12

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=88 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=20 Participants Participants treated with adalimumab alone or in combination with topical agents.
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12	2.0 doses Standard Deviation 11.27	0.1 doses Standard Deviation 0.31

SECONDARY outcome

Timeframe: Month 18

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=63 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=19 Participants Participants treated with adalimumab alone or in combination with topical agents.
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18	0.6 doses Standard Deviation 4.04	0.1 doses Standard Deviation 0.23

SECONDARY outcome

Timeframe: Month 24

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=63 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=16 Participants Participants treated with adalimumab alone or in combination with topical agents.
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24	1.4 doses Standard Deviation 5.93	4.3 doses Standard Deviation 15.02

SECONDARY outcome

Timeframe: Month 3

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=9 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=224 Participants Participants treated with adalimumab alone or in combination with topical agents.
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3	0.0 doses Standard Deviation 0.00	0.2 doses Standard Deviation 0.54

SECONDARY outcome

Timeframe: Month 6

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=17 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=207 Participants Participants treated with adalimumab alone or in combination with topical agents.
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6	1.2 doses Standard Deviation 3.33	0.4 doses Standard Deviation 1.37

SECONDARY outcome

Timeframe: Month 12

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=28 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=177 Participants Participants treated with adalimumab alone or in combination with topical agents.
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12	0.9 doses Standard Deviation 2.61	0.6 doses Standard Deviation 1.59

SECONDARY outcome

Timeframe: Month 18

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=32 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=160 Participants Participants treated with adalimumab alone or in combination with topical agents.
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18	0.1 doses Standard Deviation 0.35	0.6 doses Standard Deviation 2.36

SECONDARY outcome

Timeframe: Month 24

Population: ITT population

Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=29 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=154 Participants Participants treated with adalimumab alone or in combination with topical agents.
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24	0.0 doses Standard Deviation 0.19	0.4 doses Standard Deviation 1.17

SECONDARY outcome

Timeframe: Month 3

Population: ITT population of participants who were available for assessment at this visit.

Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=247 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=257 Participants Participants treated with adalimumab alone or in combination with topical agents.
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 Yes	76 participants	88 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 No	167 participants	162 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 Not done	4 participants	6 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 Missing	0 participants	1 participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT population of participants who were available for assessment at this visit.

Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=223 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=247 Participants Participants treated with adalimumab alone or in combination with topical agents.
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 Yes	75 participants	75 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 No	145 participants	168 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 Not done	2 participants	3 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 Missing	1 participants	1 participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT population of participants who were available for assessment at this visit.

Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=206 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=227 Participants Participants treated with adalimumab alone or in combination with topical agents.
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 Yes	55 participants	58 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 No	139 participants	158 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 Not done	7 participants	5 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 Missing	5 participants	6 participants

SECONDARY outcome

Timeframe: Month 18

Population: ITT population of participants who were available for assessment at this visit.

Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=171 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=199 Participants Participants treated with adalimumab alone or in combination with topical agents.
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 Yes	53 participants	37 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 No	113 participants	158 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 Not done	2 participants	1 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 Missing	3 participants	3 participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT population of participants who were available for assessment at this visit.

Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=168 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=194 Participants Participants treated with adalimumab alone or in combination with topical agents.
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 Yes	51 participants	41 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 No	111 participants	143 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 Not done	2 participants	8 participants
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 Missing	4 participants	2 participants

SECONDARY outcome

Timeframe: Month 3

Population: ITT population of participants who were available for assessment at this visit.

Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=247 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=257 Participants Participants treated with adalimumab alone or in combination with topical agents.
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 Yes	106 participants	88 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 No	139 participants	166 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 Not done	1 participants	1 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 Missing	1 participants	2 participants

SECONDARY outcome

Timeframe: Month 6

Population: ITT population of participants who were available for assessment at this visit.

Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=223 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=257 Participants Participants treated with adalimumab alone or in combination with topical agents.
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 Yes	108 participants	68 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 No	113 participants	177 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 Not done	1 participants	1 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 Missing	1 participants	1 participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT population of participants who were available for assessment at this visit.

Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=206 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=227 Participants Participants treated with adalimumab alone or in combination with topical agents.
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 Missing	5 participants	6 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 Yes	88 participants	63 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 No	108 participants	157 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 Not done	5 participants	1 participants

SECONDARY outcome

Timeframe: Month 18

Population: ITT population of participants who were available for assessment at this visit.

Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=171 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=199 Participants Participants treated with adalimumab alone or in combination with topical agents.
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 Yes	65 participants	53 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 No	102 participants	143 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 Not done	1 participants	0 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 Missing	3 participants	3 participants

SECONDARY outcome

Timeframe: Month 24

Population: ITT population of participants who were available for assessment at this visit.

Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.

Outcome measures

Measure	Topical/Traditional Systemic Agent n=168 Participants Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=194 Participants Participants treated with adalimumab alone or in combination with topical agents.
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 Yes	71 participants	44 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 No	93 participants	145 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 Not done	0 participants	3 participants
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 Missing	4 participants	2 participants

Adverse Events

Topical/Traditional

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Adalimumab

Serious events: 23 serious events

Other events: 14 other events

Deaths: 1 deaths

Serious adverse events

Measure	Topical/Traditional n=330 participants at risk Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=328 participants at risk Participants treated with adalimumab alone or in combination with topical agents.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Cardiac disorders MYOCARDIAL INFARCTION	0.30% 1/330 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Cardiac disorders SUPRAVENTRICULAR EXTRASYSTOLES	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Endocrine disorders ADRENAL INSUFFICIENCY	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Gastrointestinal disorders ABDOMINAL MASS	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Gastrointestinal disorders INGUINAL HERNIA	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Gastrointestinal disorders VOMITING	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.61% 2/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
General disorders ASTHENIA	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
General disorders CHEST PAIN	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
General disorders CHILLS	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.61% 2/328 • Number of events 3 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
General disorders FATIGUE	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
General disorders PYREXIA	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.61% 2/328 • Number of events 3 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Infections and infestations HERPES ZOSTER	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Infections and infestations INFECTION	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Infections and infestations PAROTID ABSCESS	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Infections and infestations PAROTITIS	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Infections and infestations PNEUMONIA	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Investigations HEPATIC ENZYME INCREASED	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Musculoskeletal and connective tissue disorders NECK PAIN	0.30% 1/330 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.00% 0/328 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.61% 2/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRAIN NEOPLASM MALIGNANT	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.61% 2/328 • Number of events 4 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN CANCER	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.30% 1/330 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.00% 0/328 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Nervous system disorders CAROTID ARTERY OCCLUSION	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Nervous system disorders CARPAL TUNNEL SYNDROME	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Nervous system disorders HEADACHE	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Nervous system disorders TREMOR	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Pregnancy, puerperium and perinatal conditions ECTOPIC PREGNANCY	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Psychiatric disorders AGITATION	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Renal and urinary disorders RENAL FAILURE	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Renal and urinary disorders RENAL FAILURE CHRONIC	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Reproductive system and breast disorders BREAST MASS	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 3 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Respiratory, thoracic and mediastinal disorders PULMONARY INFARCTION	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Skin and subcutaneous tissue disorders DERMATITIS EXFOLIATIVE	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Skin and subcutaneous tissue disorders NAIL DISORDER	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Skin and subcutaneous tissue disorders PSORIASIS	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Surgical and medical procedures ARTHRODESIS	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Surgical and medical procedures CARPAL TUNNEL DECOMPRESSION	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Surgical and medical procedures HEART VALVE REPLACEMENT	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Surgical and medical procedures INGUINAL HERNIA REPAIR	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Surgical and medical procedures NAIL OPERATION	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 3 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).

Other adverse events

Measure	Topical/Traditional n=330 participants at risk Participants who initiated treatment with a new topical agent that was not used before or already being treated with topical agent and not responding, thereby requiring a change of treatment type, frequency, or dose and all participants who initiated treatment with a new systemic agent that was not used before alone or in combination with topical agents.	Adalimumab n=328 participants at risk Participants treated with adalimumab alone or in combination with topical agents.
Gastrointestinal disorders SENSITIVITY OF TEETH	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
General disorders DRUG INEFFECTIVE	0.30% 1/330 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	2.4% 8/328 • Number of events 10 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
General disorders INJECTION SITE REACTION	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
General disorders PAIN	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Infections and infestations HERPES ZOSTER	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Infections and infestations INFECTION	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Investigations BLOOD CREATININE INCREASED	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Investigations GLOMERULAR FILTRATION RATE DECREASED	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Musculoskeletal and connective tissue disorders PSORIATIC ARTHROPATHY	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Skin and subcutaneous tissue disorders NAIL BED INFLAMMATION	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 2 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Skin and subcutaneous tissue disorders NEURODERMATITIS	0.30% 1/330 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.00% 0/328 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Skin and subcutaneous tissue disorders PSORIASIS	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.91% 3/328 • Number of events 4 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).
Skin and subcutaneous tissue disorders PUSTULAR PSORIASIS	0.00% 0/330 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).	0.30% 1/328 • Number of events 1 • Safety was assessed with the incidence of treatment-emergent adverse events (AEs) as recorded by the treating physician through the spontaneously reported events during the 24 months of treatment. Serious adverse events were reported to AbbVie from the time the physician obtained the participant's authorization to use and disclose information (or the participant's informed consent) until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 658).

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: abbvieclinicaltrials@abbvie.com

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER