Quality of Life and Psychosocial Factors Associated With Severe Psoriasis Following Treatment With Adalimumab (Body Image)
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ClinicalTrials.gov Identifier: NCT01328366 |
Recruitment Status
:
Completed
First Posted
: April 4, 2011
Results First Posted
: June 11, 2015
Last Update Posted
: July 9, 2015
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Condition or disease |
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Psoriasis |
Study Type : | Observational |
Actual Enrollment : | 153 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Real World Observational Study to Evaluate the Impact of Adalimumab Therapy on Quality of Life and Psychological Factors Associated With Severe Psoriasis |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Group/Cohort |
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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.
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- Dermatology Life Quality Index (DLQI) Scores [ Time Frame: 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 [ Time Frame: 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.
- Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores [ Time Frame: 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 Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Cutaneous Body Image Scale (CBI) Scores [ Time Frame: 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.
- Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- International Index of Erectile Function Score [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328366
Study Director: | Neil Pumford, MD | AbbVie |
Additional Information:
Responsible Party: | AbbVie (prior sponsor, Abbott) |
ClinicalTrials.gov Identifier: | NCT01328366 History of Changes |
Other Study ID Numbers: |
P12-627 |
First Posted: | April 4, 2011 Key Record Dates |
Results First Posted: | June 11, 2015 |
Last Update Posted: | July 9, 2015 |
Last Verified: | June 2015 |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Quality of Life Psychosocial factors |
Additional relevant MeSH terms:
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |