Psoriasis
Conditions
Keywords
Effectiveness, Psoriasis, Observational, Prospective, Adalimumab, Traditional Systemic Agents, Topical Agents, Comparative
Brief summary
This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design that compared the real - life effectiveness of adalimumab to topical and traditional systemic agents in the management of psoriasis and its impact on the patient's quality of life and societal burden of illness.
Detailed description
This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design. Participants were entered into one of two study cohorts (adalimumab cohort or topical/traditional systemic cohort) at the time of change of their psoriasis treatment for any reason and were followed for a maximum of 24 months with recommended assessments at 3, 6, 12, 18 and 24 months after baseline. Treatment of the participants and follow up were according to the physician's judgment, regional regulations, and the product monograph. Off-label use was not permitted, and these participants were not included in the study. Dose changes including escalation were allowed as per the physician's judgment for participants that were treated as per indication when they were enrolled in the study.
Interventions
BIOLOGICALAdalimumab
Adalimumab administered by subcutaneous injection.
Sponsors
Cato Research
JSS Medical Research Inc.
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active moderate or severe plaque psoriasis according to the judgment of the treating physician. * The treating physician has decided to change the current treatment or add additional treatments for any reason including but not limited to inadequate response, intolerance, sub-optimal compliance or participant preference.
Exclusion criteria
* Had currently participated in another prospective study with similar objectives. * Participant could not or would not sign informed consent. * Presence of other condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscured the assessment of the treatment of plaque psoriasis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6 | Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PGA≤1: Percentage of Participants at Month 3 | Month 3 | 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. |
| PGA≤1: Percentage of Participants at Month 12 | Month 12 | 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. |
| PGA≤1: Percentage of Participants at Month 18 | Month 18 | 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. |
| PGA≤1: Percentage of Participants at Month 24 | Month 24 | 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. |
| Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3 | Baseline, Month 3 | 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. |
| PASQ Total Score: Change From Baseline to Month 6 | Baseline, Month 6 | 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. |
| PASQ Total Score: Change From Baseline to Month 12 | Baseline, Month 12 | 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. |
| PASQ Total Score: Change From Baseline to Month 18 | Baseline, Month 18 | 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. |
| PASQ Total Score: Change From Baseline to Month 24 | Baseline, Month 24 | 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. |
| Body Surface Area of Psoriasis Involvement: Change From Baseline to Month 6 | Baseline, Month 6 | 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. |
| BSA of Psoriasis Involvement: Change From Baseline to Month 12 | Baseline, Month 12 | 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. |
| BSA of Psoriasis Involvement: Change From Baseline to Month 18 | Baseline, Month 18 | 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. |
| BSA of Psoriasis Involvement: Change From Baseline to Month 24 | Baseline, Month 24 | 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. |
| Patient Global Assessment (PtGA) of Disease Activity Based on a Visual Analog Scale (VAS): Change From Baseline to Month 3 | Baseline, Month 3 | 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. |
| PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 6 | Baseline, Month 6 | 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. |
| PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 12 | Baseline, Month 12 | 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. |
| PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 18 | Baseline, Month 18 | 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. |
| PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 24 | Baseline, Month 24 | 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. |
| Dermatology Quality of Life Index (DLQI) Total Score: Change From Baseline to Month 3 | Baseline, Month 3 | 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. |
| DLQI Total Score: Change From Baseline to Month 6 | Baseline, Month 6 | 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. |
| DLQI Total Score: Change From Baseline to Month 12 | Baseline, Month 12 | 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. |
| DLQI Total Score: Change From Baseline to Month 18 | Baseline, Month 18 | 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. |
| DLQI Total Score: Change From Baseline to Month 24 | Baseline, Month 24 | 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. |
| Time to Achieving DLQI ≤1 | Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24 | 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. |
| DLQI ≤1: Percentage of Participants at Month 3 | Month 3 | 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. |
| DLQI ≤1: Percentage of Participants at Month 6 | Month 6 | 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. |
| DLQI ≤1: Percentage of Participants at Month 12 | Month 12 | 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. |
| DLQI ≤1: Percentage of Participants at Month 18 | Month 18 | 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. |
| DLQI ≤1: Percentage of Participants at Month 24 | Month 24 | 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. |
| Beck Depression Inventory II (BDI-II): Change From Baseline to Month 6 | Baseline, Month 6 | 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. |
| BDI-II: Change From Baseline to Month 12 | Baseline, Month 12 | 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. |
| BDI-II: Change From Baseline to Month 24 | Baseline, Month 24 | 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. |
| Medical Outcomes Study Short Form-12 Health Status Survey (SF-12) Mental Component Summary (MCS) Score: Change From Baseline to Month 6 | Baseline, Month 6 | 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. |
| SF-12 MCS Score: Change From Baseline to Month 12 | Baseline, Month 12 | 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. |
| SF-12 MCS Score: Change From Baseline to Month 24 | Baseline, Month 24 | 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. |
| SF-12 Physical Component Summary (PCS) Score: Change From Baseline to Month 6 | Baseline, Month 6 | 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. |
| SF-12 PCS Score: Change From Baseline to Month 12 | Baseline, Month 12 | 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. |
| SF-12 PCS Score: Change From Baseline to Month 24 | Baseline, Month 24 | 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. |
| Work Limitation Questionnaire (WLQ) Total Score: Change From Baseline to Month 6 | Baseline, Month 6 | 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. |
| WLQ Total Score: Change From Baseline to Month 12 | Baseline, Month 12 | 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. |
| WLQ Total Score: Change From Baseline to Month 24 | Baseline, Month 24 | 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. |
| WLQ Productivity Loss Score: Change From Baseline to Month 6 | Baseline, Month 6 | 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. |
| WLQ Productivity Loss Score: Change From Baseline to Month 12 | Baseline, Month 12 | 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. |
| WLQ Productivity Loss Score: Change From Baseline to Month 24 | Baseline, Month 24 | 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. |
| Healthcare Resource Utilization (HCRU): Number of Participants With Insurance for Prescription Medication at Month 6 | Month 6 | 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. |
| HCRU: Number of Participants With Insurance for Prescription Medication at Month 12 | Month 12 | 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. |
| HCRU: Number of Participants With Insurance for Prescription Medication at Month 24 | Month 24 | 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. |
| HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 | Month 6 | 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. |
| HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | Month 12 | 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. |
| HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 | Month 24 | 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. |
| HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6 | Month 6 | 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. |
| HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12 | Month 12 | 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. |
| HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24 | Month 24 | 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. |
| HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 | Month 6 | 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. |
| HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 | Month 12 | 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. |
| HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 | Month 24 | 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. |
| HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 | Month 6 | 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. |
| HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 | Month 12 | 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. |
| HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 | Month 24 | 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. |
| HCRU: Number of Participants Making Visits to Another Physician at Month 6 | Month 6 | 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. |
| HCRU: Number of Participants Making Visits to Another Physician at Month 12 | Month 12 | 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. |
| HCRU: Number of Participants Making Visits to Another Physician at Month 24 | Month 24 | 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. |
| HCRU: Number of Visits to Another Physician at Month 6 | Month 6 | 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. |
| HCRU: Number of Visits to Another Physician at Month 12 | Month 12 | 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. |
| HCRU: Number of Visits to Another Physician at Month 24 | Month 24 | 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. |
| HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6 | Month 6 | 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. |
| HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12 | Month 12 | 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. |
| HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24 | Month 24 | 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. |
| HCRU: Number of Visits to A Healthcare Professional at Month 6 | Month 6 | 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. |
| HCRU: Number of Visits to A Healthcare Professional at Month 12 | Month 12 | 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. |
| HCRU: Number of Visits to A Healthcare Professional at Month 24 | Month 24 | 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. |
| HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6 | Month 6 | 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. |
| HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12 | Month 12 | 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. |
| Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 | Month 3 | 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. |
| HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24 | Month 24 | 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. |
| HCRU: Number of Visits to a Hospital Emergency Room at Month 6 | Month 6 | 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. |
| HCRU: Number of Visits to a Hospital Emergency Room at Month 12 | Month 12 | 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. |
| HCRU: Number of Visits to a Hospital Emergency Room at Month 24 | Month 24 | 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. |
| HCRU: Number of Participants Making Use of an Ambulance Service at Month 6 | Month 6 | 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. |
| HCRU: Number of Participants Making Use of an Ambulance Service at Month 12 | Month 12 | 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. |
| HCRU: Number of Participants Making Use of an Ambulance Service at Month 24 | Month 24 | 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. |
| HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6 | Month 6 | 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. |
| HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12 | Month 12 | 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. |
| HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24 | Month 24 | 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. |
| HCRU: Number of Complementary/Alternate Therapy Visits at Month 6 | Month 6 | 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. |
| HCRU: Number of Complementary/Alternate Therapy Visits at Month 12 | Month 12 | 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. |
| HCRU: Number of Complementary/Alternate Therapy Visits at Month 24 | Month 24 | 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. |
| HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6 | Month 6 | 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. |
| HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12 | Month 12 | 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. |
| HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24 | Month 24 | 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. |
| HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 6 | Month 6 | 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. |
| HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 12 | Month 12 | 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. |
| HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 24 | Month 24 | 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. |
| HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6 | Month 6 | 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. |
| Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 | Month 6 | 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. |
| HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12 | Month 12 | 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. |
| HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 24 | Month 24 | 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. |
| HCRU: Cost of Payment for Over the Counter Medications at Month 6 | Month 6 | 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. |
| HCRU: Cost of Payment for Over the Counter Medications at Month 12 | Month 12 | 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. |
| HCRU: Cost of Payment for Over the Counter Medications at Month 24 | Month 24 | 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. |
| HCRU: Cost of Payments to Healthcare Professionals at Month 6 | Month 6 | 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. |
| HCRU: Cost of Payments to Healthcare Professionals at Month 12 | Month 12 | 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. |
| HCRU: Cost of Payments to Healthcare Professionals at Month 24 | Month 24 | 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. |
| HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 6 | Month 6 | 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. |
| HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 12 | Month 12 | 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. |
| HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 24 | Month 24 | 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. |
| HCRU: Cost of Payments for Medical Devices at Month 6 | Month 6 | 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. |
| HCRU: Cost of Payments for Medical Devices at Month 12 | Month 12 | 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. |
| HCRU: Cost of Payments for Medical Devices at Month 24 | Month 24 | 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. |
| HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 6 | Month 6 | 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. |
| HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 12 | Month 12 | 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. |
| HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 24 | Month 24 | 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. |
| HCRU: Cost of Payments for Transportation at Month 6 | Month 6 | 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. |
| HCRU: Cost of Payments for Transportation at Month 12 | Month 12 | 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. |
| HCRU: Cost of Payments for Transportation at Month 24 | Month 24 | 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. |
| Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3 | Month 3 | 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. |
| Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 | Month 12 | 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. |
| Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6 | Month 6 | 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. |
| Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12 | Month 12 | 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. |
| Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18 | Month 18 | 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. |
| Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24 | Month 24 | 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. |
| Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 3 | Month 3 | 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. |
| Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 6 | Month 6 | 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. |
| Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 12 | Month 12 | 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. |
| Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 18 | Month 18 | 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. |
| Time to Achieving PGA ≤ 1 | Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24 | 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. |
| Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3 | Month 3 | 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. |
| Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 | Month 18 | 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. |
| Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6 | Month 6 | 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. |
| Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12 | Month 12 | 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. |
| Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18 | Month 18 | 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. |
| Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24 | Month 24 | 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. |
| Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3 | Month 3 | 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. |
| Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6 | Month 6 | 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. |
| Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12 | Month 12 | 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. |
| Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18 | Month 18 | 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. |
| Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24 | Month 24 | 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. |
| Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 | Month 24 | 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. |
| Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 | Month 3 | 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. |
| Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 | Month 6 | 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. |
| Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 | Month 12 | 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. |
| Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 | Month 18 | 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. |
| Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 | Month 24 | 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. |
| Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 24 | Month 24 | 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. |
Countries
Canada
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 302 |
| Adalimumab Participants treated with adalimumab alone or in combination with topical agents. | 293 |
| Total | 595 |
Baseline characteristics
| Characteristic | Topical/Traditional Systemic Agent | Adalimumab | Total |
|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 15.06 | 48.2 years STANDARD_DEVIATION 13.59 | 49.3 years STANDARD_DEVIATION 14.38 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 23 Participants | 26 Participants | 49 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 11 Participants | 9 Participants | 20 Participants |
| Race/Ethnicity, Customized White | 262 Participants | 255 Participants | 517 Participants |
| Sex: Female, Male Female | 125 Participants | 116 Participants | 241 Participants |
| Sex: Female, Male Male | 177 Participants | 177 Participants | 354 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 330 | 1 / 328 |
| other Total, other adverse events | 1 / 330 | 14 / 328 |
| serious Total, serious adverse events | 2 / 330 | 23 / 328 |
Outcome results
Primary
Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6
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.
Time frame: Month 6
Population: ITT population: all participants who signed informed consent, met inclusion/exclusion criteria, and received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical/Traditional Systemic Agent | Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6 | 31.4 percentage of participants |
| Adalimumab | Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6 | 56.3 percentage of participants |
Comparison: Comparison does not include missing.p-value: <0.001Chi-squared
Secondary
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12
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.
Time frame: Month 12
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12 | 0.9 doses | Standard Deviation 2.61 |
| Adalimumab | Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12 | 0.6 doses | Standard Deviation 1.59 |
Secondary
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18
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.
Time frame: Month 18
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18 | 0.1 doses | Standard Deviation 0.35 |
| Adalimumab | Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18 | 0.6 doses | Standard Deviation 2.36 |
Secondary
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24
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.
Time frame: Month 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24 | 0.0 doses | Standard Deviation 0.19 |
| Adalimumab | Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24 | 0.4 doses | Standard Deviation 1.17 |
Secondary
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3
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.
Time frame: Month 3
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3 | 0.0 doses | Standard Deviation 0 |
| Adalimumab | Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3 | 0.2 doses | Standard Deviation 0.54 |
Secondary
Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6
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.
Time frame: Month 6
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6 | 1.2 doses | Standard Deviation 3.33 |
| Adalimumab | Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6 | 0.4 doses | Standard Deviation 1.37 |
Secondary
BDI-II: Change From Baseline to Month 12
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.
Time frame: Baseline, Month 12
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | BDI-II: Change From Baseline to Month 12 | 7.5 score on a scale | Standard Deviation 8.06 |
| Adalimumab | BDI-II: Change From Baseline to Month 12 | 7.3 score on a scale | Standard Deviation 7.72 |
p-value: 0.807t-test, 2 sided
Secondary
BDI-II: Change From Baseline to Month 24
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.
Time frame: Baseline, Month 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | BDI-II: Change From Baseline to Month 24 | 7.2 score on a scale | Standard Deviation 7.59 |
| Adalimumab | BDI-II: Change From Baseline to Month 24 | 6.6 score on a scale | Standard Deviation 7.51 |
p-value: 0.479t-test, 2 sided
Secondary
Beck Depression Inventory II (BDI-II): Change From Baseline to Month 6
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.
Time frame: Baseline, Month 6
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Beck Depression Inventory II (BDI-II): Change From Baseline to Month 6 | 7.8 score on a scale | Standard Deviation 8.95 |
| Adalimumab | Beck Depression Inventory II (BDI-II): Change From Baseline to Month 6 | 7.2 score on a scale | Standard Deviation 7.8 |
p-value: 0.501t-test, 2 sided
Secondary
Body Surface Area of Psoriasis Involvement: Change From Baseline to Month 6
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.
Time frame: Baseline, Month 6
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Body Surface Area of Psoriasis Involvement: Change From Baseline to Month 6 | 6.4 percentage estimated body surface area | Standard Deviation 7.3 |
| Adalimumab | Body Surface Area of Psoriasis Involvement: Change From Baseline to Month 6 | 4.9 percentage estimated body surface area | Standard Deviation 10.14 |
p-value: 0.091t-test, 2 sided
Secondary
BSA of Psoriasis Involvement: Change From Baseline to Month 12
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.
Time frame: Baseline, Month 12
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | BSA of Psoriasis Involvement: Change From Baseline to Month 12 | 5.4 percentage estimated body surface area | Standard Deviation 7.29 |
| Adalimumab | BSA of Psoriasis Involvement: Change From Baseline to Month 12 | 4.1 percentage estimated body surface area | Standard Deviation 8.25 |
p-value: 0.106t-test, 2 sided
Secondary
BSA of Psoriasis Involvement: Change From Baseline to Month 18
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.
Time frame: Baseline, Month 18
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | BSA of Psoriasis Involvement: Change From Baseline to Month 18 | 5.1 percentage estimated body surface area | Standard Deviation 6.03 |
| Adalimumab | BSA of Psoriasis Involvement: Change From Baseline to Month 18 | 3.1 percentage estimated body surface area | Standard Deviation 5.58 |
p-value: 0.003t-test, 2 sided
Secondary
BSA of Psoriasis Involvement: Change From Baseline to Month 24
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.
Time frame: Baseline, Month 24
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | BSA of Psoriasis Involvement: Change From Baseline to Month 24 | 6.3 percentage estimated body surface area | Standard Deviation 10.37 |
| Adalimumab | BSA of Psoriasis Involvement: Change From Baseline to Month 24 | 3.7 percentage estimated body surface area | Standard Deviation 6.63 |
p-value: 0.008t-test, 2 sided
Secondary
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12
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.
Time frame: Month 12
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 | Yes | 88 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 | No | 108 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 | Not done | 5 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 | Missing | 5 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 | Missing | 6 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 | Yes | 63 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 | Not done | 1 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12 | No | 157 participants |
Secondary
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18
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.
Time frame: Month 18
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 | Yes | 65 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 | No | 102 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 | Not done | 1 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 | Missing | 3 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 | Missing | 3 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 | Yes | 53 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 | Not done | 0 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18 | No | 143 participants |
Secondary
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24
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.
Time frame: Month 24
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 | Yes | 71 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 | No | 93 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 | Not done | 0 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 | Missing | 4 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 | Missing | 2 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 | Yes | 44 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 | Not done | 3 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24 | No | 145 participants |
Secondary
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3
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.
Time frame: Month 3
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 | Yes | 106 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 | No | 139 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 | Not done | 1 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 | Missing | 1 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 | Missing | 2 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 | Yes | 88 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 | Not done | 1 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3 | No | 166 participants |
Secondary
Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6
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.
Time frame: Month 6
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 | Yes | 108 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 | No | 113 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 | Not done | 1 participants |
| Topical/Traditional Systemic Agent | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 | Missing | 1 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 | Missing | 1 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 | Yes | 68 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 | Not done | 1 participants |
| Adalimumab | Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6 | No | 177 participants |
Secondary
Dermatology Quality of Life Index (DLQI) Total Score: Change From Baseline to Month 3
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.
Time frame: Baseline, Month 3
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Dermatology Quality of Life Index (DLQI) Total Score: Change From Baseline to Month 3 | 6.5 score on a scale | Standard Deviation 6.31 |
| Adalimumab | Dermatology Quality of Life Index (DLQI) Total Score: Change From Baseline to Month 3 | 5.4 score on a scale | Standard Deviation 6.18 |
p-value: 0.084t-test, 2 sided
Secondary
DLQI ≤1: Percentage of Participants at Month 12
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.
Time frame: Month 12
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 12 | No effect at all on patient's life (0-1) | 28.2 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 12 | Small effect on patient's life (2-5) | 27.2 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 12 | Moderate effect on patient's life (6-10) | 15.0 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 12 | Very large effect on patient's life (21-30) | 12.1 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 12 | Extremely large effect on patient's life (21-30) | 1.9 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 12 | Missing | 15.5 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 12 | Extremely large effect on patient's life (21-30) | 3.1 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 12 | No effect at all on patient's life (0-1) | 37.9 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 12 | Very large effect on patient's life (21-30) | 6.2 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 12 | Small effect on patient's life (2-5) | 24.2 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 12 | Missing | 21.1 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 12 | Moderate effect on patient's life (6-10) | 7.5 percentage of participants |
p-value: 0.01Chi-squared
Secondary
DLQI ≤1: Percentage of Participants at Month 18
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.
Time frame: Month 18
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 18 | No effect at all on patient's life (0-1) | 35.7 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 18 | Small effect on patient's life (2-5) | 25.7 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 18 | Moderate effect on patient's life (6-10) | 12.9 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 18 | Very large effect on patient's life (21-30) | 7.0 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 18 | Extremely large effect on patient's life (21-30) | 1.2 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 18 | Missing | 17.5 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 18 | Extremely large effect on patient's life (21-30) | 0.5 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 18 | No effect at all on patient's life (0-1) | 45.7 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 18 | Very large effect on patient's life (21-30) | 2.0 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 18 | Small effect on patient's life (2-5) | 15.6 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 18 | Missing | 25.1 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 18 | Moderate effect on patient's life (6-10) | 11.1 percentage of participants |
Comparison: Comparison does not include the Missing category.p-value: 0.015Chi-squared
Secondary
DLQI ≤1: Percentage of Participants at Month 24
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.
Time frame: Month 24
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 24 | No effect at all on patient's life (0-1) | 34.5 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 24 | Small effect on patient's life (2-5) | 27.4 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 24 | Moderate effect on patient's life (6-10) | 12.5 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 24 | Very large effect on patient's life (21-30) | 9.5 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 24 | Extremely large effect on patient's life (21-30) | 1.2 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 24 | Missing | 14.9 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 24 | Extremely large effect on patient's life (21-30) | 2.1 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 24 | No effect at all on patient's life (0-1) | 38.1 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 24 | Very large effect on patient's life (21-30) | 2.6 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 24 | Small effect on patient's life (2-5) | 20.1 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 24 | Missing | 27.3 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 24 | Moderate effect on patient's life (6-10) | 9.8 percentage of participants |
Comparison: Comparison does not include the Missing category.p-value: 0.06Chi-squared
Secondary
DLQI ≤1: Percentage of Participants at Month 3
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.
Time frame: Month 3
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 3 | No effect at all on patient's life (0-1) | 18.2 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 3 | Small effect on patient's life (2-5) | 33.2 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 3 | Moderate effect on patient's life (6-10) | 19.0 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 3 | Very large effect on patient's life (21-30) | 13.4 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 3 | Extremely large effect on patient's life (21-30) | 4.9 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 3 | Missing | 11.3 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 3 | Extremely large effect on patient's life (21-30) | 2.7 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 3 | No effect at all on patient's life (0-1) | 31.1 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 3 | Very large effect on patient's life (21-30) | 12.8 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 3 | Small effect on patient's life (2-5) | 21.4 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 3 | Missing | 16.3 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 3 | Moderate effect on patient's life (6-10) | 15.6 percentage of participants |
Comparison: Comparison does not include the Missing category.p-value: 0.002Chi-squared
Secondary
DLQI ≤1: Percentage of Participants at Month 6
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.
Time frame: Month 6
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 6 | Small effect on patient's life (2-5) | 28.7 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 6 | Very large effect on patient's life (21-30) | 11.2 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 6 | Extremely large effect on patient's life (21-30) | 3.1 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 6 | No effect at all on patient's life (0-1) | 26.5 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 6 | Missing | 17.0 percentage of participants |
| Topical/Traditional Systemic Agent | DLQI ≤1: Percentage of Participants at Month 6 | Moderate effect on patient's life (6-10) | 13.5 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 6 | Missing | 20.2 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 6 | No effect at all on patient's life (0-1) | 39.3 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 6 | Small effect on patient's life (2-5) | 19.8 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 6 | Moderate effect on patient's life (6-10) | 10.1 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 6 | Extremely large effect on patient's life (21-30) | 2.0 percentage of participants |
| Adalimumab | DLQI ≤1: Percentage of Participants at Month 6 | Very large effect on patient's life (21-30) | 8.5 percentage of participants |
p-value: 0.017Chi-squared
Secondary
DLQI Total Score: Change From Baseline to Month 12
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.
Time frame: Baseline, Month 12
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | DLQI Total Score: Change From Baseline to Month 12 | 5.1 score on a scale | Standard Deviation 5.73 |
| Adalimumab | DLQI Total Score: Change From Baseline to Month 12 | 3.9 score on a scale | Standard Deviation 5.66 |
p-value: 0.059t-test, 2 sided
Secondary
DLQI Total Score: Change From Baseline to Month 18
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.
Time frame: Baseline, Month 18
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | DLQI Total Score: Change From Baseline to Month 18 | 4.0 score on a scale | Standard Deviation 5.05 |
| Adalimumab | DLQI Total Score: Change From Baseline to Month 18 | 2.5 score on a scale | Standard Deviation 3.7 |
p-value: 0.004t-test, 2 sided
Secondary
DLQI Total Score: Change From Baseline to Month 24
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.
Time frame: Baseline, Month 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | DLQI Total Score: Change From Baseline to Month 24 | 4.3 score on a scale | Standard Deviation 5.15 |
| Adalimumab | DLQI Total Score: Change From Baseline to Month 24 | 3.3 score on a scale | Standard Deviation 5.03 |
p-value: 0.115t-test, 2 sided
Secondary
DLQI Total Score: Change From Baseline to Month 6
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.
Time frame: Baseline, Month 6
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | DLQI Total Score: Change From Baseline to Month 6 | 5.3 score on a scale | Standard Deviation 6.01 |
| Adalimumab | DLQI Total Score: Change From Baseline to Month 6 | 4.3 score on a scale | Standard Deviation 6 |
p-value: 0.09t-test, 2 sided
Secondary
HCRU: Cost of Payment for Over the Counter Medications at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payment for Over the Counter Medications at Month 12 | 17.8 dollars | Standard Deviation 48.28 |
| Adalimumab | HCRU: Cost of Payment for Over the Counter Medications at Month 12 | 22.1 dollars | Standard Deviation 73.15 |
p-value: 0.672t-test, 2 sided
Secondary
HCRU: Cost of Payment for Over the Counter Medications at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payment for Over the Counter Medications at Month 24 | 10.8 dollars | Standard Deviation 21.43 |
| Adalimumab | HCRU: Cost of Payment for Over the Counter Medications at Month 24 | 17.3 dollars | Standard Deviation 69.1 |
p-value: 0.482t-test, 2 sided
Secondary
HCRU: Cost of Payment for Over the Counter Medications at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payment for Over the Counter Medications at Month 6 | 35.0 dollars | Standard Deviation 77.82 |
| Adalimumab | HCRU: Cost of Payment for Over the Counter Medications at Month 6 | 8.7 dollars | Standard Deviation 37.85 |
p-value: 0.006t-test, 2 sided
Secondary
HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 12 | 0.0 dollars | Standard Deviation 0 |
| Adalimumab | HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 12 | 1.4 dollars | Standard Deviation 8.87 |
p-value: 0.181t-test, 2 sided
Secondary
HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 24 | 2.5 dollars | Standard Deviation 15.81 |
| Adalimumab | HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 24 | 18.5 dollars | Standard Deviation 136.08 |
p-value: 0.395t-test, 2 sided
Secondary
HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 6 | 5.9 dollars | Standard Deviation 48.51 |
| Adalimumab | HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 6 | 0.0 dollars | Standard Deviation 0 |
p-value: 0.321t-test, 2 sided
Secondary
HCRU: Cost of Payments for Medical Devices at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments for Medical Devices at Month 12 | 0.0 dollars | Standard Deviation 0 |
| Adalimumab | HCRU: Cost of Payments for Medical Devices at Month 12 | 0.0 dollars | Standard Deviation 0 |
Secondary
HCRU: Cost of Payments for Medical Devices at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments for Medical Devices at Month 24 | 1.0 dollars | Standard Deviation 4.36 |
| Adalimumab | HCRU: Cost of Payments for Medical Devices at Month 24 | 1.5 dollars | Standard Deviation 10.89 |
p-value: 0.757t-test, 2 sided
Secondary
HCRU: Cost of Payments for Medical Devices at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments for Medical Devices at Month 6 | 0.00 dollars | Standard Deviation 0 |
| Adalimumab | HCRU: Cost of Payments for Medical Devices at Month 6 | 0.4 dollars | Standard Deviation 3.35 |
p-value: 0.305t-test, 2 sided
Secondary
HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 12 | 0.0 dollars | Standard Deviation 0 |
| Adalimumab | HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 12 | 0.5 dollars | Standard Deviation 3.61 |
p-value: 0.208t-test, 2 sided
Secondary
HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 24 | 0.4 dollars | Standard Deviation 2.37 |
| Adalimumab | HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 24 | 8.2 dollars | Standard Deviation 42.5 |
p-value: 0.184t-test, 2 sided
Secondary
HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 6 | 2.0 dollars | Standard Deviation 12.2 |
| Adalimumab | HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 6 | 2.6 dollars | Standard Deviation 19.35 |
p-value: 0.808t-test, 2 sided
Secondary
HCRU: Cost of Payments for Transportation at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments for Transportation at Month 12 | 13.1 dollars | Standard Deviation 31.69 |
| Adalimumab | HCRU: Cost of Payments for Transportation at Month 12 | 15.5 dollars | Standard Deviation 56.74 |
p-value: 0.739t-test, 2 sided
Secondary
HCRU: Cost of Payments for Transportation at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments for Transportation at Month 24 | 22.1 dollars | Standard Deviation 50.7 |
| Adalimumab | HCRU: Cost of Payments for Transportation at Month 24 | 12.9 dollars | Standard Deviation 44.53 |
p-value: 0.291t-test, 2 sided
Secondary
HCRU: Cost of Payments for Transportation at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments for Transportation at Month 6 | 20.4 dollars | Standard Deviation 59.74 |
| Adalimumab | HCRU: Cost of Payments for Transportation at Month 6 | 14.7 dollars | Standard Deviation 45.31 |
Secondary
HCRU: Cost of Payments to Healthcare Professionals at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments to Healthcare Professionals at Month 12 | 31.2 dollars | Standard Deviation 147.48 |
| Adalimumab | HCRU: Cost of Payments to Healthcare Professionals at Month 12 | 3.5 dollars | Standard Deviation 21.48 |
p-value: 0.144t-test, 2 sided
Secondary
HCRU: Cost of Payments to Healthcare Professionals at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments to Healthcare Professionals at Month 24 | 7.9 dollars | Standard Deviation 42.44 |
| Adalimumab | HCRU: Cost of Payments to Healthcare Professionals at Month 24 | 1.5 dollars | Standard Deviation 10.99 |
p-value: 0.36t-test, 2 sided
Secondary
HCRU: Cost of Payments to Healthcare Professionals at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Cost of Payments to Healthcare Professionals at Month 6 | 4.0 dollars | Standard Deviation 28.34 |
| Adalimumab | HCRU: Cost of Payments to Healthcare Professionals at Month 6 | 4.4 dollars | Standard Deviation 25.12 |
p-value: 0.938t-test, 2 sided
Secondary
HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 12 | 1 days | — |
| Adalimumab | HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 12 | 2.0 days | Standard Deviation 1 |
Secondary
HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 24 | 1 days |
| Adalimumab | HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 24 | 1 days |
Secondary
HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 6 | 8.3 days | Standard Deviation 7.51 |
| Adalimumab | HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 6 | 1 days | — |
Secondary
HCRU: Number of Complementary/Alternate Therapy Visits at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Complementary/Alternate Therapy Visits at Month 12 | 1 visits |
| Adalimumab | HCRU: Number of Complementary/Alternate Therapy Visits at Month 12 | 1 visits |
Secondary
HCRU: Number of Complementary/Alternate Therapy Visits at Month 24
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.
Time frame: Month 24
Population: ITT Population
Secondary
HCRU: Number of Complementary/Alternate Therapy Visits at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Complementary/Alternate Therapy Visits at Month 6 | 3.0 visits | Standard Deviation 1.41 |
Secondary
HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | 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 |
| Adalimumab | HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 | NA office visits | — |
Secondary
HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | 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 |
| Adalimumab | HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 | NA office visits | — |
Secondary
HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | 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 |
| Adalimumab | HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 | 1.3 office visits | Standard Deviation 0.58 |
p-value: 0.575Chi-squared
Secondary
HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12 | Yes | 0 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12 | Missing | 206 participants |
| Adalimumab | HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12 | Yes | 1 participants |
| Adalimumab | HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12 | Missing | 226 participants |
Secondary
HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 24
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.
Time frame: Month 24
Population: ITT Population. Data not collected.
Secondary
HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6 | Yes | 1 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6 | Missing | 222 participants |
| Adalimumab | HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6 | Yes | 0 participants |
| Adalimumab | HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6 | Missing | 247 participants |
Secondary
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | CSST | 1 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | Blue Cross | 23 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | Federal Government | 6 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | Other | 66 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | OHIP | 26 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | Missing: Insurer name not provided | 27 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | RAMQ | 13 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | Missing: Insurer name not provided | 38 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | RAMQ | 6 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | Federal Government | 6 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | CSST | 0 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | OHIP | 24 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | Blue Cross | 29 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12 | Other | 76 participants |
Secondary
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 | RAMQ | 8 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 | Federal Government | 7 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 | OHIP | 16 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 | Blue Cross | 18 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 | Other | 51 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 | Missing: Insurer name not provided | 24 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 | Other | 48 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 | RAMQ | 5 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 | Blue Cross | 24 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 | Federal Government | 6 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 | Missing: Insurer name not provided | 24 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24 | OHIP | 27 participants |
Secondary
HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 | RAMQ | 14 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 | Federal Government | 8 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 | OHIP | 17 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 | Blue Cross | 26 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 | Other | 74 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 | Missing: Insurer name not provided | 30 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 | Other | 74 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 | RAMQ | 8 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 | Blue Cross | 28 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 | Federal Government | 12 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 | Missing: Insurer name not provided | 42 participants |
| Adalimumab | HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6 | OHIP | 29 participants |
Secondary
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12 | Yes | 3 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12 | No | 167 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12 | Missing | 36 participants |
| Adalimumab | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12 | Yes | 3 participants |
| Adalimumab | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12 | No | 172 participants |
| Adalimumab | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12 | Missing | 52 participants |
p-value: >0.999Fisher Exact
Secondary
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24 | Yes | 3 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24 | No | 130 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24 | Missing | 35 participants |
| Adalimumab | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24 | Yes | 5 participants |
| Adalimumab | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24 | No | 132 participants |
| Adalimumab | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24 | Missing | 57 participants |
p-value: 0.723Fisher Exact
Secondary
HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6 | Yes | 3 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6 | No | 177 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6 | Missing | 43 participants |
| Adalimumab | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6 | Yes | 1 participants |
| Adalimumab | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6 | No | 186 participants |
| Adalimumab | HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6 | Missing | 60 participants |
p-value: 0.364Fisher Exact
Secondary
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12 | Yes | 6 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12 | No | 76 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12 | Missing | 124 participants |
| Adalimumab | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12 | Yes | 4 participants |
| Adalimumab | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12 | No | 73 participants |
| Adalimumab | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12 | Missing | 150 participants |
p-value: 0.747Fisher Exact
Secondary
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24 | Yes | 0 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24 | No | 54 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24 | Missing | 114 participants |
| Adalimumab | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24 | Yes | 1 participants |
| Adalimumab | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24 | No | 52 participants |
| Adalimumab | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24 | Missing | 141 participants |
p-value: 0.495Fisher Exact
Secondary
HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6 | Yes | 3 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6 | No | 84 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6 | Missing | 136 participants |
| Adalimumab | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6 | Yes | 4 participants |
| Adalimumab | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6 | No | 78 participants |
| Adalimumab | HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6 | Missing | 165 participants |
p-value: 0.714Fisher Exact
Secondary
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 | Yes | 7 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 | No | 73 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 | Missing | 126 participants |
| Adalimumab | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 | Yes | 7 participants |
| Adalimumab | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 | No | 69 participants |
| Adalimumab | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12 | Missing | 151 participants |
p-value: 0.92Chi-squared
Secondary
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 | Yes | 3 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 | No | 51 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 | Missing | 114 participants |
| Adalimumab | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 | Yes | 2 participants |
| Adalimumab | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 | No | 49 participants |
| Adalimumab | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24 | Missing | 143 participants |
p-value: >0.999Fisher Exact
Secondary
HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 | Yes | 7 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 | No | 71 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 | Missing | 145 participants |
| Adalimumab | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 | Yes | 5 participants |
| Adalimumab | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 | No | 76 participants |
| Adalimumab | HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6 | Missing | 166 participants |
p-value: 0.504Fisher Exact
Secondary
HCRU: Number of Participants Making Use of an Ambulance Service at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Use of an Ambulance Service at Month 12 | Yes | 1 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Use of an Ambulance Service at Month 12 | No | 85 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Use of an Ambulance Service at Month 12 | Missing | 120 participants |
| Adalimumab | HCRU: Number of Participants Making Use of an Ambulance Service at Month 12 | Yes | 1 participants |
| Adalimumab | HCRU: Number of Participants Making Use of an Ambulance Service at Month 12 | No | 77 participants |
| Adalimumab | HCRU: Number of Participants Making Use of an Ambulance Service at Month 12 | Missing | 149 participants |
p-value: >0.999Fisher Exact
Secondary
HCRU: Number of Participants Making Use of an Ambulance Service at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Use of an Ambulance Service at Month 24 | No | 54 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Use of an Ambulance Service at Month 24 | Missing | 114 participants |
| Adalimumab | HCRU: Number of Participants Making Use of an Ambulance Service at Month 24 | No | 54 participants |
| Adalimumab | HCRU: Number of Participants Making Use of an Ambulance Service at Month 24 | Missing | 140 participants |
Secondary
HCRU: Number of Participants Making Use of an Ambulance Service at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Use of an Ambulance Service at Month 6 | Yes | 1 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Use of an Ambulance Service at Month 6 | No | 84 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Use of an Ambulance Service at Month 6 | Missing | 138 participants |
| Adalimumab | HCRU: Number of Participants Making Use of an Ambulance Service at Month 6 | Yes | 0 participants |
| Adalimumab | HCRU: Number of Participants Making Use of an Ambulance Service at Month 6 | No | 81 participants |
| Adalimumab | HCRU: Number of Participants Making Use of an Ambulance Service at Month 6 | Missing | 166 participants |
p-value: >0.999Fisher Exact
Secondary
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12 | Yes | 13 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12 | No | 60 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12 | Missing | 133 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12 | Yes | 12 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12 | No | 55 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12 | Missing | 160 participants |
p-value: 0.987Chi-squared
Secondary
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24 | Yes | 2 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24 | No | 49 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24 | Missing | 117 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24 | Yes | 10 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24 | No | 39 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24 | Missing | 145 participants |
p-value: 0.011Fisher Exact
Secondary
HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6 | Yes | 15 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6 | No | 61 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6 | Missing | 147 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6 | Yes | 12 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6 | No | 59 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6 | Missing | 176 participants |
p-value: 0.657Chi-squared
Secondary
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12 | Yes | 4 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12 | No | 82 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12 | Missing | 120 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12 | Yes | 5 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12 | No | 73 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12 | Missing | 149 participants |
p-value: 0.737Fisher Exact
Secondary
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24 | Yes | 2 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24 | No | 52 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24 | Missing | 114 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24 | Yes | 3 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24 | No | 51 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24 | Missing | 140 participants |
p-value: >0.999Fisher Exact
Secondary
HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6 | Yes | 3 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6 | No | 83 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6 | Missing | 137 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6 | Yes | 4 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6 | No | 77 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6 | Missing | 166 participants |
p-value: 0.714Fisher Exact
Secondary
HCRU: Number of Participants Making Visits to Another Physician at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to Another Physician at Month 12 | Yes | 18 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to Another Physician at Month 12 | No | 58 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to Another Physician at Month 12 | Missing | 130 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to Another Physician at Month 12 | Yes | 14 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to Another Physician at Month 12 | No | 55 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to Another Physician at Month 12 | Missing | 158 participants |
p-value: 0.623Chi-squared
Secondary
HCRU: Number of Participants Making Visits to Another Physician at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to Another Physician at Month 24 | Yes | 15 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to Another Physician at Month 24 | No | 38 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to Another Physician at Month 24 | Missing | 115 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to Another Physician at Month 24 | Yes | 16 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to Another Physician at Month 24 | No | 35 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to Another Physician at Month 24 | Missing | 143 participants |
p-value: 0.732Chi-squared
Secondary
HCRU: Number of Participants Making Visits to Another Physician at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to Another Physician at Month 6 | Yes | 21 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to Another Physician at Month 6 | No | 59 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Making Visits to Another Physician at Month 6 | Missing | 143 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to Another Physician at Month 6 | Yes | 20 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to Another Physician at Month 6 | No | 60 participants |
| Adalimumab | HCRU: Number of Participants Making Visits to Another Physician at Month 6 | Missing | 167 participants |
p-value: 0.856Chi-squared
Secondary
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6 | Yes | 95 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6 | No | 82 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6 | Missing | 46 participants |
| Adalimumab | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6 | Yes | 86 participants |
| Adalimumab | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6 | No | 101 participants |
| Adalimumab | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6 | Missing | 60 participants |
p-value: 0.143Chi-squared
Secondary
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12 | Yes | 89 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12 | No | 81 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12 | Missing | 36 participants |
| Adalimumab | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12 | Yes | 81 participants |
| Adalimumab | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12 | No | 88 participants |
| Adalimumab | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12 | Missing | 58 participants |
p-value: 0.415Chi-squared
Secondary
HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24 | Yes | 57 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24 | No | 71 participants |
| Topical/Traditional Systemic Agent | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24 | Missing | 40 participants |
| Adalimumab | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24 | Yes | 55 participants |
| Adalimumab | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24 | No | 78 participants |
| Adalimumab | HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24 | Missing | 61 participants |
p-value: 0.604Chi-squared
Secondary
HCRU: Number of Participants With Insurance for Prescription Medication at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants With Insurance for Prescription Medication at Month 12 | 148 participants |
| Adalimumab | HCRU: Number of Participants With Insurance for Prescription Medication at Month 12 | 157 participants |
p-value: 0.181t-test, 2 sided
Secondary
HCRU: Number of Participants With Insurance for Prescription Medication at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Participants With Insurance for Prescription Medication at Month 24 | 112 participants |
| Adalimumab | HCRU: Number of Participants With Insurance for Prescription Medication at Month 24 | 121 participants |
p-value: 0.252t-test, 2 sided
Secondary
HCRU: Number of Visits to A Healthcare Professional at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Visits to A Healthcare Professional at Month 12 | 1.8 office visits | Standard Deviation 1.79 |
| Adalimumab | HCRU: Number of Visits to A Healthcare Professional at Month 12 | 1.5 office visits | Standard Deviation 0.71 |
p-value: 0.835t-test, 2 sided
Secondary
HCRU: Number of Visits to A Healthcare Professional at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Visits to A Healthcare Professional at Month 24 | 1 office visits | — |
| Adalimumab | HCRU: Number of Visits to A Healthcare Professional at Month 24 | 1.3 office visits | Standard Deviation 0.58 |
Secondary
HCRU: Number of Visits to A Healthcare Professional at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Visits to A Healthcare Professional at Month 6 | 1.3 office visits | Standard Deviation 0.71 |
| Adalimumab | HCRU: Number of Visits to A Healthcare Professional at Month 6 | 1.0 office visits | Standard Deviation 0 |
p-value: 0.351t-test, 2 sided
Secondary
HCRU: Number of Visits to a Hospital Emergency Room at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Visits to a Hospital Emergency Room at Month 12 | 1 visits |
| Adalimumab | HCRU: Number of Visits to a Hospital Emergency Room at Month 12 | 1 visits |
Secondary
HCRU: Number of Visits to a Hospital Emergency Room at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adalimumab | HCRU: Number of Visits to a Hospital Emergency Room at Month 24 | 1 visits |
Secondary
HCRU: Number of Visits to a Hospital Emergency Room at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Adalimumab | HCRU: Number of Visits to a Hospital Emergency Room at Month 6 | 1 visits |
Secondary
HCRU: Number of Visits to Another Physician at Month 12
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.
Time frame: Month 12
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Visits to Another Physician at Month 12 | 2.0 office visits | Standard Deviation 1.41 |
| Adalimumab | HCRU: Number of Visits to Another Physician at Month 12 | 2.2 office visits | Standard Deviation 2.17 |
p-value: 0.879t-test, 2 sided
Secondary
HCRU: Number of Visits to Another Physician at Month 24
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.
Time frame: Month 24
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Visits to Another Physician at Month 24 | 1.2 office visits | Standard Deviation 0.45 |
| Adalimumab | HCRU: Number of Visits to Another Physician at Month 24 | 1.3 office visits | Standard Deviation 0.49 |
p-value: 0.763t-test, 2 sided
Secondary
HCRU: Number of Visits to Another Physician at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | HCRU: Number of Visits to Another Physician at Month 6 | 1.4 office visits | Standard Deviation 1.21 |
| Adalimumab | HCRU: Number of Visits to Another Physician at Month 6 | 1.4 office visits | Standard Deviation 0.53 |
p-value: 0.896t-test, 2 sided
Secondary
Healthcare Resource Utilization (HCRU): Number of Participants With Insurance for Prescription Medication at Month 6
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.
Time frame: Month 6
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical/Traditional Systemic Agent | Healthcare Resource Utilization (HCRU): Number of Participants With Insurance for Prescription Medication at Month 6 | 156 participants |
| Adalimumab | Healthcare Resource Utilization (HCRU): Number of Participants With Insurance for Prescription Medication at Month 6 | 177 participants |
p-value: 0.008t-test, 2 sided
Secondary
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12
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.
Time frame: Month 12
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 | Yes | 55 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 | No | 139 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 | Not done | 7 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 | Missing | 5 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 | Missing | 6 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 | Yes | 58 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 | Not done | 5 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12 | No | 158 participants |
Secondary
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18
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.
Time frame: Month 18
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 | Yes | 53 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 | Not done | 2 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 | Missing | 3 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 | No | 113 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 | Missing | 3 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 | Yes | 37 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 | No | 158 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18 | Not done | 1 participants |
Secondary
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24
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.
Time frame: Month 24
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 | Yes | 51 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 | No | 111 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 | Not done | 2 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 | Missing | 4 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 | Missing | 2 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 | Yes | 41 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 | Not done | 8 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24 | No | 143 participants |
Secondary
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3
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.
Time frame: Month 3
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 | Yes | 76 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 | No | 167 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 | Not done | 4 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 | Missing | 0 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 | Missing | 1 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 | Yes | 88 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 | Not done | 6 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3 | No | 162 participants |
Secondary
Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6
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.
Time frame: Month 6
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 | Yes | 75 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 | No | 145 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 | Not done | 2 participants |
| Topical/Traditional Systemic Agent | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 | Missing | 1 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 | Missing | 1 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 | Yes | 75 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 | Not done | 3 participants |
| Adalimumab | Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6 | No | 168 participants |
Secondary
Medical Outcomes Study Short Form-12 Health Status Survey (SF-12) Mental Component Summary (MCS) Score: Change From Baseline to Month 6
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.
Time frame: Baseline, Month 6
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | 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 |
| Adalimumab | Medical Outcomes Study Short Form-12 Health Status Survey (SF-12) Mental Component Summary (MCS) Score: Change From Baseline to Month 6 | 49.7 score on a scale | Standard Deviation 10.08 |
p-value: 0.918t-test, 2 sided
Secondary
PASQ Total Score: Change From Baseline to Month 12
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.
Time frame: Baseline, Month 12
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | PASQ Total Score: Change From Baseline to Month 12 | 6.6 score on a scale | Standard Deviation 4.46 |
| Adalimumab | PASQ Total Score: Change From Baseline to Month 12 | 7.6 score on a scale | Standard Deviation 4.25 |
p-value: 0.06t-test, 2 sided
Secondary
PASQ Total Score: Change From Baseline to Month 18
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.
Time frame: Baseline, Month 18
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | PASQ Total Score: Change From Baseline to Month 18 | 6.9 score on a scale | Standard Deviation 4.05 |
| Adalimumab | PASQ Total Score: Change From Baseline to Month 18 | 7.9 score on a scale | Standard Deviation 4.22 |
p-value: 0.056t-test, 2 sided
Secondary
PASQ Total Score: Change From Baseline to Month 24
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.
Time frame: Baseline, Month 24
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | PASQ Total Score: Change From Baseline to Month 24 | 7.2 score on a scale | Standard Deviation 4.49 |
| Adalimumab | PASQ Total Score: Change From Baseline to Month 24 | 7.4 score on a scale | Standard Deviation 4.21 |
p-value: 0.755t-test, 2 sided
Secondary
PASQ Total Score: Change From Baseline to Month 6
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.
Time frame: Baseline, Month 6
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | PASQ Total Score: Change From Baseline to Month 6 | 6.3 score on a scale | Standard Deviation 4.35 |
| Adalimumab | PASQ Total Score: Change From Baseline to Month 6 | 7.5 score on a scale | Standard Deviation 4.48 |
p-value: 0.016t-test, 2 sided
Secondary
Patient Global Assessment (PtGA) of Disease Activity Based on a Visual Analog Scale (VAS): Change From Baseline to Month 3
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.
Time frame: Baseline, Month 3
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | 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 |
| Adalimumab | Patient Global Assessment (PtGA) of Disease Activity Based on a Visual Analog Scale (VAS): Change From Baseline to Month 3 | 32.8 units on a scale | Standard Deviation 27.72 |
p-value: 0.083t-test, 2 sided
Secondary
PGA≤1: Percentage of Participants at Month 12
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.
Time frame: Month 12
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical/Traditional Systemic Agent | PGA≤1: Percentage of Participants at Month 12 | 34.5 percentage of participants |
| Adalimumab | PGA≤1: Percentage of Participants at Month 12 | 57.3 percentage of participants |
p-value: <0.001Chi-squared
Secondary
PGA≤1: Percentage of Participants at Month 18
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.
Time frame: Month 18
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical/Traditional Systemic Agent | PGA≤1: Percentage of Participants at Month 18 | 35.7 percentage of participants |
| Adalimumab | PGA≤1: Percentage of Participants at Month 18 | 61.3 percentage of participants |
p-value: <0.001Chi-squared
Secondary
PGA≤1: Percentage of Participants at Month 24
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.
Time frame: Month 24
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical/Traditional Systemic Agent | PGA≤1: Percentage of Participants at Month 24 | 37.5 percentage of participants |
| Adalimumab | PGA≤1: Percentage of Participants at Month 24 | 56.7 percentage of participants |
p-value: <0.001Chi-squared
Secondary
PGA≤1: Percentage of Participants at Month 3
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.
Time frame: Month 3
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical/Traditional Systemic Agent | PGA≤1: Percentage of Participants at Month 3 | 19.0 percentage of participants |
| Adalimumab | PGA≤1: Percentage of Participants at Month 3 | 47.5 percentage of participants |
p-value: <0.001Chi-squared
Secondary
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 12
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.
Time frame: Month 12
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 12 | 1.6 sessions | Standard Deviation 3.24 |
| Adalimumab | Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 12 | 1.3 sessions | Standard Deviation 2.31 |
Secondary
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 18
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.
Time frame: Month 18
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 18 | 0.3 sessions | Standard Deviation 1.05 |
| Adalimumab | Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 18 | 2.7 sessions | Standard Deviation 3.06 |
Secondary
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 24
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.
Time frame: Month 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 24 | 1.1 sessions | Standard Deviation 2.4 |
| Adalimumab | Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 24 | 10.0 sessions | Standard Deviation 0 |
Secondary
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 3
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.
Time frame: Month 3
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 3 | 3.3 sessions | Standard Deviation 9.11 |
| Adalimumab | Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 3 | 2.5 sessions | Standard Deviation 3.79 |
Secondary
Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 6
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.
Time frame: Month 6
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 6 | 1.8 sessions | Standard Deviation 4.18 |
| Adalimumab | Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 6 | 4.7 sessions | Standard Deviation 4.16 |
Secondary
Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3
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.
Time frame: Baseline, Month 3
Population: ITT population of participants who were available for assessment at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3 | 6.3 score on a scale | Standard Deviation 4.28 |
| Adalimumab | Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3 | 7.6 score on a scale | Standard Deviation 4.48 |
p-value: 0.003t-test, 2 sided
Secondary
PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 12
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.
Time frame: Baseline, Month 12
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 12 | 32.9 units on a scale | Standard Deviation 27.33 |
| Adalimumab | PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 12 | 28.2 units on a scale | Standard Deviation 27.07 |
p-value: 0.097t-test, 2 sided
Secondary
PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 18
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.
Time frame: Baseline, Month 18
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 18 | 30.2 units on a scale | Standard Deviation 27.61 |
| Adalimumab | PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 18 | 21.8 units on a scale | Standard Deviation 24.89 |
p-value: 0.006t-test, 2 sided
Secondary
PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 24
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.
Time frame: Baseline, Month 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 24 | 31.9 units on a scale | Standard Deviation 27.6 |
| Adalimumab | PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 24 | 25.1 units on a scale | Standard Deviation 26.65 |
p-value: 0.037t-test, 2 sided
Secondary
PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 6
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.
Time frame: Baseline, Month 6
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 6 | 31.8 units on a scale | Standard Deviation 27.44 |
| Adalimumab | PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 6 | 29.9 units on a scale | Standard Deviation 28.28 |
p-value: 0.495t-test, 2 sided
Secondary
SF-12 MCS Score: Change From Baseline to Month 12
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.
Time frame: Baseline, Month 12
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | SF-12 MCS Score: Change From Baseline to Month 12 | 48.9 score on a scale | Standard Deviation 11.37 |
| Adalimumab | SF-12 MCS Score: Change From Baseline to Month 12 | 49.6 score on a scale | Standard Deviation 9.99 |
p-value: 0.609t-test, 2 sided
Secondary
SF-12 MCS Score: Change From Baseline to Month 24
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.
Time frame: Baseline, Month 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | SF-12 MCS Score: Change From Baseline to Month 24 | 50.2 score on a scale | Standard Deviation 10.92 |
| Adalimumab | SF-12 MCS Score: Change From Baseline to Month 24 | 51.3 score on a scale | Standard Deviation 8.93 |
p-value: 0.367t-test, 2 sided
Secondary
SF-12 PCS Score: Change From Baseline to Month 12
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.
Time frame: Baseline, Month 12
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | SF-12 PCS Score: Change From Baseline to Month 12 | 47.3 score on a scale | Standard Deviation 10.93 |
| Adalimumab | SF-12 PCS Score: Change From Baseline to Month 12 | 47.0 score on a scale | Standard Deviation 10.4 |
p-value: 0.793t-test, 2 sided
Secondary
SF-12 PCS Score: Change From Baseline to Month 24
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.
Time frame: Baseline, Month 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | SF-12 PCS Score: Change From Baseline to Month 24 | 47.8 score on a scale | Standard Deviation 9.81 |
| Adalimumab | SF-12 PCS Score: Change From Baseline to Month 24 | 48.8 score on a scale | Standard Deviation 9.81 |
p-value: 0.442t-test, 2 sided
Secondary
SF-12 Physical Component Summary (PCS) Score: Change From Baseline to Month 6
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.
Time frame: Baseline, Month 6
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | SF-12 Physical Component Summary (PCS) Score: Change From Baseline to Month 6 | 48.2 score on a scale | Standard Deviation 10.14 |
| Adalimumab | SF-12 Physical Component Summary (PCS) Score: Change From Baseline to Month 6 | 47.3 score on a scale | Standard Deviation 10.35 |
p-value: 0.521t-test, 2 sided
Secondary
Time to Achieving DLQI ≤1
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.
Time frame: Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Topical/Traditional Systemic Agent | Time to Achieving DLQI ≤1 | 17.7 Months |
| Adalimumab | Time to Achieving DLQI ≤1 | 8.2 Months |
p-value: 0.002Log Rank
Secondary
Time to Achieving PGA ≤ 1
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.
Time frame: Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Topical/Traditional Systemic Agent | Time to Achieving PGA ≤ 1 | 13.3 Months |
| Adalimumab | Time to Achieving PGA ≤ 1 | 5.7 Months |
p-value: <0.001Log Rank
Secondary
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12
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.
Time frame: Month 12
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12 | 3.8 doses | Standard Deviation 13.4 |
| Adalimumab | Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12 | 0.6 doses | Standard Deviation 4.24 |
Secondary
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18
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.
Time frame: Month 18
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18 | 5.0 doses | Standard Deviation 28.31 |
| Adalimumab | Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18 | 0.3 doses | Standard Deviation 1.99 |
Secondary
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24
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.
Time frame: Month 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24 | 0.2 doses | Standard Deviation 0.95 |
| Adalimumab | Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24 | 0.1 doses | Standard Deviation 0.71 |
Secondary
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3
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.
Time frame: Month 3
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3 | 2.8 doses | Standard Deviation 8.94 |
| Adalimumab | Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3 | 2.2 doses | Standard Deviation 11.66 |
Secondary
Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6
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.
Time frame: Month 6
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6 | 4.8 doses | Standard Deviation 16.9 |
| Adalimumab | Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6 | 3.3 doses | Standard Deviation 16.58 |
Secondary
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12
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.
Time frame: Month 12
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | 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 |
| Adalimumab | Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12 | 0.1 doses | Standard Deviation 0.31 |
Secondary
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18
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.
Time frame: Month 18
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | 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 |
| Adalimumab | Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18 | 0.1 doses | Standard Deviation 0.23 |
Secondary
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24
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.
Time frame: Month 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | 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 |
| Adalimumab | Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24 | 4.3 doses | Standard Deviation 15.02 |
Secondary
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3
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.
Time frame: Month 3
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3 | 2.7 doses | Standard Deviation 10.1 |
| Adalimumab | Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3 | 0.0 doses | Standard Deviation 0.21 |
Secondary
Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6
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.
Time frame: Month 6
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | 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 |
| Adalimumab | Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6 | 0.1 doses | Standard Deviation 0.47 |
Secondary
WLQ Productivity Loss Score: Change From Baseline to Month 12
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.
Time frame: Baseline, Month 12
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | WLQ Productivity Loss Score: Change From Baseline to Month 12 | 3.5 score on a scale | Standard Deviation 4.07 |
| Adalimumab | WLQ Productivity Loss Score: Change From Baseline to Month 12 | 3.7 score on a scale | Standard Deviation 4.73 |
p-value: 0.695t-test, 2 sided
Secondary
WLQ Productivity Loss Score: Change From Baseline to Month 24
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.
Time frame: Baseline, Month 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | WLQ Productivity Loss Score: Change From Baseline to Month 24 | 3.1 score on a scale | Standard Deviation 4.16 |
| Adalimumab | WLQ Productivity Loss Score: Change From Baseline to Month 24 | 2.7 score on a scale | Standard Deviation 4.11 |
p-value: 0.452t-test, 2 sided
Secondary
WLQ Productivity Loss Score: Change From Baseline to Month 6
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.
Time frame: Baseline, Month 6
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | WLQ Productivity Loss Score: Change From Baseline to Month 6 | 3.2 score on a scale | Standard Deviation 4.19 |
| Adalimumab | WLQ Productivity Loss Score: Change From Baseline to Month 6 | 3.6 score on a scale | Standard Deviation 4.25 |
p-value: 0.419t-test, 2 sided
Secondary
WLQ Total Score: Change From Baseline to Month 12
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.
Time frame: Baseline, Month 12
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | WLQ Total Score: Change From Baseline to Month 12 | 13.5 score on a scale | Standard Deviation 15.45 |
| Adalimumab | WLQ Total Score: Change From Baseline to Month 12 | 14.2 score on a scale | Standard Deviation 17.52 |
p-value: 0.752t-test, 2 sided
Secondary
WLQ Total Score: Change From Baseline to Month 24
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.
Time frame: Baseline, Month 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | WLQ Total Score: Change From Baseline to Month 24 | 12.1 score on a scale | Standard Deviation 15.51 |
| Adalimumab | WLQ Total Score: Change From Baseline to Month 24 | 10.4 score on a scale | Standard Deviation 15.86 |
p-value: 0.469t-test, 2 sided
Secondary
Work Limitation Questionnaire (WLQ) Total Score: Change From Baseline to Month 6
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.
Time frame: Baseline, Month 6
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical/Traditional Systemic Agent | Work Limitation Questionnaire (WLQ) Total Score: Change From Baseline to Month 6 | 12.4 score on a scale | Standard Deviation 15.67 |
| Adalimumab | Work Limitation Questionnaire (WLQ) Total Score: Change From Baseline to Month 6 | 14.0 score on a scale | Standard Deviation 16.44 |
p-value: 0.434t-test, 2 sided