Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic Disease Modifying Anti-rheumatic Drugs (QUALITY)
The aim of this post-marketing observational study (PMOS) was to obtain further data on long-term safety, efficacy, and quality of life outcomes for adalimumab in routine clinical use in participants with moderate to severe chronic plaque psoriasis after unsustainable clinical response to other biologic disease modifying anti-rheumatic drugs (BDMARDs). There are few data so far showing the effects of switching from other BDMARDs to adalimumab in patients with moderate to severe chronic plaque psoriasis. This study was designed to evaluate the long-term effectiveness of adalimumab in participants with moderate to severe chronic plaque psoriasis using the Psoriasis Area and Severity Index (PASI) in participants previously treated with efalizumab, infliximab, or etanercept and who either never achieved satisfactory response, achieved satisfactory response initially but lost it over time, or discontinued treatment due to intolerance/side effect(s) or other reasons, for example after regular stop of etanercept.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Post-marketing Observational Study of the Quality of Life in Adalimumab Treated Psoriasis Patients Failing Other Biologic DMARDs Over a Period of 1 Year (QUALITY)|
- Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Inclusion visit (Week 0), Week 4, Week 36, Week 52 ] [ Designated as safety issue: No ]Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
- Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75) [ Time Frame: Inclusion visit (Week 0) to Week 52 ] [ Designated as safety issue: No ]PASI75 is the number of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52 (final visit). PASI score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
- Dermatology Life Quality Index (DLQI) Score [ Time Frame: Inclusion visit (Week 0), Week 4, Week 36, Week 52 ] [ Designated as safety issue: No ]Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).
- Nail Psoriasis Severity Index (NAPSI) Score [ Time Frame: Inclusion visit (Week 0), Week 4, Week 36, and Week 52 ] [ Designated as safety issue: No ]The nails are graded for nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Per nail, the NAPSI score ranges from 0 (no nail psoriasis) to 4 (most severe nail psoriasis).
- Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions [ Time Frame: From the time of participant consent until 70 days after last dose of study drug ] [ Designated as safety issue: Yes ]Tolerability and safety were assessed by collecting adverse events during the course of the study up to 70 days following the last dose of physician-prescribed adalimumab. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.
|Study Start Date:||November 2008|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
This was a non-interventional PMOS conducted in a prospective, single-country, multicenter format to assess the quality of life of psoriasis patients taking adalimumab as prescribed by their physician in accordance with the terms of the local marketing authorization with regard to dose, population, and indication. The prescription of adalimumab was clearly separated from the decision to include the participant in this study. No procedures other than standard of care were to have been performed. Visits were non-interventional and timing of participant appointments was left to each physician. After therapy initiation, visits occurred over 12 months usually close to Weeks 4, 12, 24, 36, and 52 for a total of 6 visits (Visits 1 through 6 including Screening). Because participant visits were left to the physician, participant failure to meet the suggested visit weeks did not constitute a breach of the protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084668
|Site Reference ID/Investigator# 27435|
|Feldkirch, Austria, 6807|
|Site Reference ID/Investigator# 27436|
|Graz, Austria, 8010|
|Site Reference ID/Investigator# 38445|
|Graz, Austria, 8036|
|Site Reference ID/Investigator# 27443|
|Linz, Austria, 4020|
|Site Reference ID/Investigator# 27442|
|Vienna, Austria, 1030|
|Site Reference ID/Investigator# 27439|
|Vienna, Austria, A-1090|
|Site Reference ID/Investigator# 27437|
|Vienna, Austria, 1160|
|Site Reference ID/Investigator# 27440|
|Vienna, Austria, 1130|
|Site Reference ID/Investigator# 23309|
|Wels, Austria, 4600|
|Study Director:||Astrid Dworan-Timler, MD||Abbott Austria|