Clinical trial NCT01328366: Quality of Life and Psychosocial Factors Associated With Severe Psoriasis Following Treatment With Adalimumab
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Quality of Life
Psychosocial factors
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: pH Associates
First posted: 2011-04-04
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary Care Outpatients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dermatology Life Quality Index (DLQI) Scores
timeFrame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
measure: Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline
timeFrame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Secondary outcomes:
measure: Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores
timeFrame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
measure: Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline
timeFrame: 4 weeks, 16 weeks, and 6 months after adalimumab initiation
measure: Psoriasis Area and Severity Index (PASI) Scores
timeFrame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
measure: Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline
timeFrame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
measure: Hospital Anxiety and Depression Scale (HADS) Scores
timeFrame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
measure: Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline
timeFrame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
measure: Cutaneous Body Image Scale (CBI) Scores
timeFrame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
measure: Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline
timeFrame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
measure: 12-item Short Form Survey (SF-12) Score
timeFrame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
measure: Change in 12-item Short Form Survey (SF-12) Score From Baseline
timeFrame: 4 weeks, 16 weeks, and 6 months following adalimumab initiation
measure: Female Sexual Function Index (FSFI) Score
timeFrame: Baseline; 16 weeks, and 6 months following adalimumab initiation
measure: Mean Change in Female Sexual Function Index (FSFI) Score From Baseline
timeFrame: 4 week, 16 weeks, and 6 months following adalimumab initiation
measure: International Index of Erectile Function Score
timeFrame: Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Neil Pumford, MD
role: STUDY_DIRECTOR
References: