Quality of Life and Psychosocial Factors Associated With Severe Psoriasis Following Treatment With Adalimumab

Psoriasis Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328366
• Other study ID #: P12-627
• Status: Completed
• Phase: N/A
• First received: April 1, 2011
• Last updated: June 11, 2015
• Start date: May 2011
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	pH Associates

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation	No
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.	4 weeks, 16 weeks, and 6 months following adalimumab initiation	No
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.	Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation	No
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.	4 weeks, 16 weeks, and 6 months after adalimumab initiation	No
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.	Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation	No
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.	4 weeks, 16 weeks, and 6 months following adalimumab initiation	No
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.	Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation	No
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.	4 weeks, 16 weeks, and 6 months following adalimumab initiation	No
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.	Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation	No
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.	4 weeks, 16 weeks, and 6 months following adalimumab initiation	No
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.	Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation	No
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.	4 weeks, 16 weeks, and 6 months following adalimumab initiation	No
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.	Baseline; 16 weeks, and 6 months following adalimumab initiation	No
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.	4 week, 16 weeks, and 6 months following adalimumab initiation	No
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.	Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation	No

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