An observational study in Psoriasis, sponsored by AbbVie (prior sponsor, Abbott). Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-09.
Sponsored by AbbVie (prior sponsor, Abbott) · Observational
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.
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 153 is below the median of 200 across 396 observational studies indexed under Psoriasis.
Browse Psoriasis studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Secondary Care Outpatients
Exclusion Criteria:
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Participants With Severe Psoriasis |
|---|---|
| Started | 153 |
| Completed | 143 |
| Not completed | 10 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 7 |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| Baseline | 17.25 ± 6.51 |
| 4 Weeks (n=43) | 8.65 ± 6.51 |
| 16 Weeks (n=80) | 4.51 ± 5.88 |
| 6 Months (n=100) | 3.65 ± 6.41 |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| 4 Weeks (n=38) | -9.95 (-12.07 to -7.82) |
| 16 Weeks (n=76) | -13.03 (-14.69 to -11.36) |
| 6 Months (n=94) | -13.63 (-15.29 to -11.97) |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| Baseline (n=128) | 21.02 ± 11.42 |
| 4 Weeks (n=43) | 7.37 ± 7.13 |
| 16 Weeks (n=78) | 4.42 ± 6.54 |
| 6 Months (n=97) | 4.41 ± 7.81 |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| 4 Weeks (n=35) | -16.41 (-20.18 to -12.65) |
| 16 Weeks (n=72) | -18.79 (-21.78 to -15.80) |
| 6 Months (n=87) | -17.34 (-19.94 to -14.74) |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| Baseline | 16.98 ± 8.47 |
| 4 Weeks (n=24) | 5.52 ± 4.48 |
| 16 Weeks (n=81) | 3.42 ± 5.31 |
| 6 Months (n=91) | 2.38 ± 3.98 |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| 4 Weeks (n=24) | -10.90 (-14.05 to -7.75) |
| 16 Weeks (n=80) | -13.93 (-15.90 to -11.96) |
| 6 Months (n=89) | -13.99 (-15.75 to -12.22) |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| HADS-A Baseline | 9.63 ± 4.70 |
| HADS-A 4 Weeks (n=43) | 8.21 ± 4.95 |
| HADS-A 16 Weeks (n=80) | 6.65 ± 4.22 |
| HADS-A 6 Months (n=100) | 6.00 ± 4.29 |
| HADS-D Baseline | 7.08 ± 4.46 |
| HADS-D 4 Weeks (n=43) | 6.19 ± 4.68 |
| HADS-D 16 Weeks (n=80) | 4.18 ± 3.67 |
| HADS-D 6 Months (n=100) | 3.43 ± 3.63 |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| HADS-A 4 Weeks (n=36) | -1.56 (-2.87 to -0.24) |
| HADS-A 16 Weeks (n=74) | -2.81 (-3.70 to -1.92) |
| HADS-A 6 Months (n=93) | -3.32 (-4.17 to -2.48) |
| HADS-D 4 Weeks (n=36) | -1.58 (-2.83 to -0.34) |
| HADS-D 16 Weeks (n=74) | -2.68 (-3.56 to -1.79) |
| HADS-D 6 Months (n=93) | -3.14 (-3.97 to -2.31) |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| Baseline | 2.73 ± 1.83 |
| 4 Weeks (n=42) | 4.38 ± 1.92 |
| 16 Weeks (n=80) | 5.58 ± 1.85 |
| 6 Months (n=100) | 6.16 ± 1.98 |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| 4 Weeks (n=37) | 2.05 (1.28 to 2.82) |
| 16 Weeks (n=76) | 2.83 (2.29 to 3.38) |
| 6 Months (n=95) | 3.45 (2.92 to 3.97) |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| SF-12 Physical Baseline | 43.08 ± 11.61 |
| SF-12 Physical 4 Weeks (n=42) | 46.38 ± 11.35 |
| SF-12 Physical 16 Weeks (n=74) | 50.53 ± 8.50 |
| SF-12 Physical 6 Months (n=97) | 49.53 ± 10.05 |
| SF-12 Mental Baseline | 41.23 ± 11.25 |
| SF-12 Mental 4 Weeks (n=42) | 45.50 ± 10.53 |
| SF-12 Mental 16 Weeks (n=74) | 46.84 ± 11.12 |
| SF-12 6 Months (n=97) | 49.22 ± 10.15 |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| SF-12 Physical 4 Weeks (n=36) | 4.60 (1.77 to 7.44) |
| SF-12 Physical 16 Weeks (n=69) | 6.84 (4.60 to 9.08) |
| SF-12 Physical 6 Months (n=89) | 6.46 (4.39 to 8.54) |
| SF-12 Mental 4 Weeks (n=36) | 4.96 (1.21 to 8.71) |
| SF-12 Mental 16 Weeks (n=69) | 6.10 (3.32 to 8.88) |
| SF-12 Mental 6 Months (n=89) | 6.47 (4.11 to 8.84) |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| Baseline | 15.77 ± 10.50 |
| 16 Weeks (n=18) | 18.65 ± 12.70 |
| 6 Months (n=26) | 20.73 ± 11.70 |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| 4 Weeks (n=4) | 3.78 (-8.76 to 16.31) |
| 16 Weeks (n=15) | 0.53 (-5.73 to 6.80) |
| 6 Months (n=21) | 4.72 (1.33 to 8.11) |
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.
| units on a scale | Participants With Severe Psoriasis |
|---|---|
| Baseline | 56.05 ± 19.20 |
| 4 Weeks (n=24) | 58.33 ± 13.80 |
| 16 Weeks (n=36) | 60.61 ± 17.50 |
| 6 Months (n=47) | 54.43 ± 22.90 |
Collected over From informed consent to completion of final study questionnaire. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Severe Psoriasis | — | 0/143 (0%) | 5/143 (3.5%) |
| Event | Participants With Severe Psoriasis |
|---|---|
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 2/143 |
| Rhinitis allergicRespiratory, thoracic and mediastinal disorders | 2/143 |
| HeadacheNervous system disorders | 1/143 |
| Rash pustularSkin and subcutaneous tissue disorders | 1/143 |
| FatigueGeneral disorders | 1/143 |
| Dry mouthGastrointestinal disorders | 1/143 |
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. Baseline demographic data was not available for all participants.
| Age, Continuous(years) | Participants With Severe Psoriasis |
|---|---|
| Mean | 24.0 ± 12.68 |
| Sex: Female, Male(Participants) | Participants With Severe Psoriasis |
|---|---|
| Female | 51 |
| Male | 87 |
No study locations are listed for this record.
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AbbVie (prior sponsor, Abbott)