Psoriasis
Conditions
Keywords
Quality of Life, Psychosocial factors
Brief summary
The impact of psoriasis on an individual's emotional and social well-being goes beyond skin symptoms of the disease. Data suggests patients with severe psoriasis experience a greater prevalence of depressive symptoms, mood disturbances, anxiety and even suicidal ideation. Given the nature of the disease and the treatment failures which are required before a patient commences a biologic therapy such as adalimumab, the patient's mental health at initiation of biologics is an important consideration for clinicians. This study seeks to explore if adalimumab treatment of psoriasis leads to a positive impact on psychosocial factors and disease-related quality of life.
Detailed description
This was a multi-center, prospective, post-marketing observational study of participants with severe chronic plaque psoriasis who began adalimumab therapy in the United Kingdom. Although 153 participants enrolled in the study, data was only analyzed on 143 individuals and there were no interventions or changes to participant management for the study. Prior to initiating adalimumab therapy (baseline), the Dermatology Life Quality Index (DLQI), Self-Administered Psoriasis Area Severity Index (SAPASI), Hospital Anxiety and Depression Scale (HADS), Cutaneous Body Image (CBI) scale, Short Form 12 (SF-12) Health Survey, Female Sexual Function Index (FSFI) (female participants) and International Index of Erectile Function (IIEF) (male participants) questionnaires were completed by participants and at 4 weeks, 16 weeks and 6 months following initiation.
Interventions
None listed
Sponsors
pH Associates
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
* Participants were eligible for adalimumab as determined by the National Institute for Health and Clinical Excellence (NICE) criteria * Participants had severe psoriasis as defined by a Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 * Participant's psoriasis did not respond to standard systemic therapies, to include: ciclosporin, methotrexate, and psoralen and long-wave ultraviolet radiation; or the participant was intolerant of or had a contraindication to these treatments
Exclusion criteria
* Participants were previously treated with another biologic therapy * Participants were unable or unwilling to complete the study questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dermatology Life Quality Index (DLQI) Scores | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation | The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicating a greater impact on a participant's QOL. Data are reported as the mean DLQI score ± standard deviation. |
| Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline | 4 weeks, 16 weeks, and 6 months following adalimumab initiation | The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicated a greater impact on a participant's QOL. Responders to adalimumab had a ≥5 point reduction in DLQI scores or DLQI score of 0. Data are reported as the mean DLQI score ± standard deviation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline | 4 weeks, 16 weeks, and 6 months after adalimumab initiation | The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean change in SAPASI score ± standard deviation. |
| Psoriasis Area and Severity Index (PASI) Scores | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation | The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean PASI score ± standard deviation. |
| Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline | 4 weeks, 16 weeks, and 6 months following adalimumab initiation | The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores range from 0-72, a higher score indicating more severe psoriasis. Data are reported as the mean change in PASI score ± standard deviation. |
| Hospital Anxiety and Depression Scale (HADS) Scores | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation | The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean anxiety or depression score ± standard deviation. |
| Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline | 4 weeks, 16 weeks, and 6 months following adalimumab initiation | The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean change in anxiety or depression score ± standard deviation. |
| Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation | The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean SAPASI score ± standard deviation. |
| Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline | 4 weeks, 16 weeks, and 6 months following adalimumab initiation | The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean change in CBI score ± standard deviation. |
| 12-item Short Form Survey (SF-12) Score | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation | The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean SF-12 score physical or mental ± standard deviation. |
| Change in 12-item Short Form Survey (SF-12) Score From Baseline | 4 weeks, 16 weeks, and 6 months following adalimumab initiation | The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean change SF-12 score physical or mental ± standard deviation. |
| Female Sexual Function Index (FSFI) Score | Baseline; 16 weeks, and 6 months following adalimumab initiation | The Female Sexual Function Index (FSFI) was a participant-reported questionnaire used to measure a female's sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean FSFI score ± standard deviation. |
| Mean Change in Female Sexual Function Index (FSFI) Score From Baseline | 4 week, 16 weeks, and 6 months following adalimumab initiation | The Female Sexual Function Index was a participant-reported questionnaire used to measure a female's sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean change in FSFI score ± standard deviation. |
| Cutaneous Body Image Scale (CBI) Scores | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation | The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean CBI score ± standard deviation. |
| International Index of Erectile Function Score | Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation | The International Index of Erectile Function (IIEF) was a participant-reported questionnaire used to measure a male's erection function. Scores range from 5-75, higher scores indicated better erection quality. Data are reported as the mean IIEF score ± standard deviation. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Severe Psoriasis The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies. | 138 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Participants With Severe Psoriasis |
|---|---|
| Age, Continuous | 24.0 years STANDARD_DEVIATION 12.68 |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 143 |
| serious Total, serious adverse events | 0 / 143 |
Outcome results
Primary
Dermatology Life Quality Index (DLQI) Scores
The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicating a greater impact on a participant's QOL. Data are reported as the mean DLQI score ± standard deviation.
Time frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Population: Participants who completed the DLQI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Severe Psoriasis | Dermatology Life Quality Index (DLQI) Scores | Baseline | 17.25 units on a scale | Standard Deviation 6.51 |
| Participants With Severe Psoriasis | Dermatology Life Quality Index (DLQI) Scores | 4 Weeks (n=43) | 8.65 units on a scale | Standard Deviation 6.51 |
| Participants With Severe Psoriasis | Dermatology Life Quality Index (DLQI) Scores | 16 Weeks (n=80) | 4.51 units on a scale | Standard Deviation 5.88 |
| Participants With Severe Psoriasis | Dermatology Life Quality Index (DLQI) Scores | 6 Months (n=100) | 3.65 units on a scale | Standard Deviation 6.41 |
Primary
Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline
The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicated a greater impact on a participant's QOL. Responders to adalimumab had a ≥5 point reduction in DLQI scores or DLQI score of 0. Data are reported as the mean DLQI score ± standard deviation.
Time frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Population: Participants who completed the DLQI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants With Severe Psoriasis | Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline | 4 Weeks (n=38) | -9.95 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline | 16 Weeks (n=76) | -13.03 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline | 6 Months (n=94) | -13.63 units on a scale |
Secondary
12-item Short Form Survey (SF-12) Score
The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean SF-12 score physical or mental ± standard deviation.
Time frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Population: Participants who completed the SF-12 questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Severe Psoriasis | 12-item Short Form Survey (SF-12) Score | SF-12 Physical Baseline | 43.08 units on a scale | Standard Deviation 11.61 |
| Participants With Severe Psoriasis | 12-item Short Form Survey (SF-12) Score | SF-12 Physical 4 Weeks (n=42) | 46.38 units on a scale | Standard Deviation 11.35 |
| Participants With Severe Psoriasis | 12-item Short Form Survey (SF-12) Score | SF-12 Physical 16 Weeks (n=74) | 50.53 units on a scale | Standard Deviation 8.5 |
| Participants With Severe Psoriasis | 12-item Short Form Survey (SF-12) Score | SF-12 Physical 6 Months (n=97) | 49.53 units on a scale | Standard Deviation 10.05 |
| Participants With Severe Psoriasis | 12-item Short Form Survey (SF-12) Score | SF-12 Mental Baseline | 41.23 units on a scale | Standard Deviation 11.25 |
| Participants With Severe Psoriasis | 12-item Short Form Survey (SF-12) Score | SF-12 Mental 4 Weeks (n=42) | 45.50 units on a scale | Standard Deviation 10.53 |
| Participants With Severe Psoriasis | 12-item Short Form Survey (SF-12) Score | SF-12 Mental 16 Weeks (n=74) | 46.84 units on a scale | Standard Deviation 11.12 |
| Participants With Severe Psoriasis | 12-item Short Form Survey (SF-12) Score | SF-12 6 Months (n=97) | 49.22 units on a scale | Standard Deviation 10.15 |
Secondary
Change in 12-item Short Form Survey (SF-12) Score From Baseline
The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean change SF-12 score physical or mental ± standard deviation.
Time frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Population: Participants who completed the SF-12 questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants With Severe Psoriasis | Change in 12-item Short Form Survey (SF-12) Score From Baseline | SF-12 Physical 4 Weeks (n=36) | 4.60 units on a scale |
| Participants With Severe Psoriasis | Change in 12-item Short Form Survey (SF-12) Score From Baseline | SF-12 Physical 16 Weeks (n=69) | 6.84 units on a scale |
| Participants With Severe Psoriasis | Change in 12-item Short Form Survey (SF-12) Score From Baseline | SF-12 Physical 6 Months (n=89) | 6.46 units on a scale |
| Participants With Severe Psoriasis | Change in 12-item Short Form Survey (SF-12) Score From Baseline | SF-12 Mental 4 Weeks (n=36) | 4.96 units on a scale |
| Participants With Severe Psoriasis | Change in 12-item Short Form Survey (SF-12) Score From Baseline | SF-12 Mental 16 Weeks (n=69) | 6.10 units on a scale |
| Participants With Severe Psoriasis | Change in 12-item Short Form Survey (SF-12) Score From Baseline | SF-12 Mental 6 Months (n=89) | 6.47 units on a scale |
Secondary
Cutaneous Body Image Scale (CBI) Scores
The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean CBI score ± standard deviation.
Time frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Population: Participants who completed the CBI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Severe Psoriasis | Cutaneous Body Image Scale (CBI) Scores | Baseline | 2.73 units on a scale | Standard Deviation 1.83 |
| Participants With Severe Psoriasis | Cutaneous Body Image Scale (CBI) Scores | 4 Weeks (n=42) | 4.38 units on a scale | Standard Deviation 1.92 |
| Participants With Severe Psoriasis | Cutaneous Body Image Scale (CBI) Scores | 16 Weeks (n=80) | 5.58 units on a scale | Standard Deviation 1.85 |
| Participants With Severe Psoriasis | Cutaneous Body Image Scale (CBI) Scores | 6 Months (n=100) | 6.16 units on a scale | Standard Deviation 1.98 |
Secondary
Female Sexual Function Index (FSFI) Score
The Female Sexual Function Index (FSFI) was a participant-reported questionnaire used to measure a female's sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean FSFI score ± standard deviation.
Time frame: Baseline; 16 weeks, and 6 months following adalimumab initiation
Population: Female participants who completed the FSFI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Severe Psoriasis | Female Sexual Function Index (FSFI) Score | 6 Months (n=26) | 20.73 units on a scale | Standard Deviation 11.7 |
| Participants With Severe Psoriasis | Female Sexual Function Index (FSFI) Score | Baseline | 15.77 units on a scale | Standard Deviation 10.5 |
| Participants With Severe Psoriasis | Female Sexual Function Index (FSFI) Score | 16 Weeks (n=18) | 18.65 units on a scale | Standard Deviation 12.7 |
Secondary
Hospital Anxiety and Depression Scale (HADS) Scores
The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean anxiety or depression score ± standard deviation.
Time frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Population: Participants who completed the HADS questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Severe Psoriasis | Hospital Anxiety and Depression Scale (HADS) Scores | HADS-A Baseline | 9.63 units on a scale | Standard Deviation 4.7 |
| Participants With Severe Psoriasis | Hospital Anxiety and Depression Scale (HADS) Scores | HADS-A 4 Weeks (n=43) | 8.21 units on a scale | Standard Deviation 4.95 |
| Participants With Severe Psoriasis | Hospital Anxiety and Depression Scale (HADS) Scores | HADS-A 16 Weeks (n=80) | 6.65 units on a scale | Standard Deviation 4.22 |
| Participants With Severe Psoriasis | Hospital Anxiety and Depression Scale (HADS) Scores | HADS-A 6 Months (n=100) | 6.00 units on a scale | Standard Deviation 4.29 |
| Participants With Severe Psoriasis | Hospital Anxiety and Depression Scale (HADS) Scores | HADS-D Baseline | 7.08 units on a scale | Standard Deviation 4.46 |
| Participants With Severe Psoriasis | Hospital Anxiety and Depression Scale (HADS) Scores | HADS-D 4 Weeks (n=43) | 6.19 units on a scale | Standard Deviation 4.68 |
| Participants With Severe Psoriasis | Hospital Anxiety and Depression Scale (HADS) Scores | HADS-D 16 Weeks (n=80) | 4.18 units on a scale | Standard Deviation 3.67 |
| Participants With Severe Psoriasis | Hospital Anxiety and Depression Scale (HADS) Scores | HADS-D 6 Months (n=100) | 3.43 units on a scale | Standard Deviation 3.63 |
Secondary
International Index of Erectile Function Score
The International Index of Erectile Function (IIEF) was a participant-reported questionnaire used to measure a male's erection function. Scores range from 5-75, higher scores indicated better erection quality. Data are reported as the mean IIEF score ± standard deviation.
Time frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Population: Male participants who completed the IIEF questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Severe Psoriasis | International Index of Erectile Function Score | Baseline | 56.05 units on a scale | Standard Deviation 19.2 |
| Participants With Severe Psoriasis | International Index of Erectile Function Score | 4 Weeks (n=24) | 58.33 units on a scale | Standard Deviation 13.8 |
| Participants With Severe Psoriasis | International Index of Erectile Function Score | 16 Weeks (n=36) | 60.61 units on a scale | Standard Deviation 17.5 |
| Participants With Severe Psoriasis | International Index of Erectile Function Score | 6 Months (n=47) | 54.43 units on a scale | Standard Deviation 22.9 |
Secondary
Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline
The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean change in CBI score ± standard deviation.
Time frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Population: Participants who completed the CBI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants With Severe Psoriasis | Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline | 16 Weeks (n=76) | 2.83 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline | 4 Weeks (n=37) | 2.05 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline | 6 Months (n=95) | 3.45 units on a scale |
Secondary
Mean Change in Female Sexual Function Index (FSFI) Score From Baseline
The Female Sexual Function Index was a participant-reported questionnaire used to measure a female's sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean change in FSFI score ± standard deviation.
Time frame: 4 week, 16 weeks, and 6 months following adalimumab initiation
Population: Female participants who completed the FSFI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants With Severe Psoriasis | Mean Change in Female Sexual Function Index (FSFI) Score From Baseline | 4 Weeks (n=4) | 3.78 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Female Sexual Function Index (FSFI) Score From Baseline | 16 Weeks (n=15) | 0.53 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Female Sexual Function Index (FSFI) Score From Baseline | 6 Months (n=21) | 4.72 units on a scale |
Secondary
Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline
The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean change in anxiety or depression score ± standard deviation.
Time frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Population: Participants who completed the HADS questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants With Severe Psoriasis | Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline | HADS-A 4 Weeks (n=36) | -1.56 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline | HADS-A 16 Weeks (n=74) | -2.81 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline | HADS-A 6 Months (n=93) | -3.32 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline | HADS-D 4 Weeks (n=36) | -1.58 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline | HADS-D 16 Weeks (n=74) | -2.68 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline | HADS-D 6 Months (n=93) | -3.14 units on a scale |
Secondary
Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline
The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores range from 0-72, a higher score indicating more severe psoriasis. Data are reported as the mean change in PASI score ± standard deviation.
Time frame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Population: Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants With Severe Psoriasis | Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline | 4 Weeks (n=24) | -10.90 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline | 16 Weeks (n=80) | -13.93 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline | 6 Months (n=89) | -13.99 units on a scale |
Secondary
Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline
The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean change in SAPASI score ± standard deviation.
Time frame: 4 weeks, 16 weeks, and 6 months after adalimumab initiation
Population: Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants With Severe Psoriasis | Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline | 4 Weeks (n=35) | -16.41 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline | 16 Weeks (n=72) | -18.79 units on a scale |
| Participants With Severe Psoriasis | Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline | 6 Months (n=87) | -17.34 units on a scale |
Secondary
Psoriasis Area and Severity Index (PASI) Scores
The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean PASI score ± standard deviation.
Time frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Population: Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Severe Psoriasis | Psoriasis Area and Severity Index (PASI) Scores | Baseline | 16.98 units on a scale | Standard Deviation 8.47 |
| Participants With Severe Psoriasis | Psoriasis Area and Severity Index (PASI) Scores | 4 Weeks (n=24) | 5.52 units on a scale | Standard Deviation 4.48 |
| Participants With Severe Psoriasis | Psoriasis Area and Severity Index (PASI) Scores | 16 Weeks (n=81) | 3.42 units on a scale | Standard Deviation 5.31 |
| Participants With Severe Psoriasis | Psoriasis Area and Severity Index (PASI) Scores | 6 Months (n=91) | 2.38 units on a scale | Standard Deviation 3.98 |
Secondary
Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores
The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean SAPASI score ± standard deviation.
Time frame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Population: Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Severe Psoriasis | Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores | Baseline (n=128) | 21.02 units on a scale | Standard Deviation 11.42 |
| Participants With Severe Psoriasis | Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores | 4 Weeks (n=43) | 7.37 units on a scale | Standard Deviation 7.13 |
| Participants With Severe Psoriasis | Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores | 16 Weeks (n=78) | 4.42 units on a scale | Standard Deviation 6.54 |
| Participants With Severe Psoriasis | Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores | 6 Months (n=97) | 4.41 units on a scale | Standard Deviation 7.81 |