Psoriasis Chronic
Conditions
Keywords
moderate to severe chronic plaque psoriasis, adalimumab, Psoriasis Area and Severity Index (PASI), Disease Life Quality Index (DLQI), Nail Psoriasis Severity Index (NAPSI), biologic disease modifying anti-rheumatic drug (BDMARD), antibodies, monoclonals
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Assign Data Management and Biostatistics GmbH
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients for whom adalimumab therapy is indicated and has been prescribed according to the product label * Patients aged 18 years and older * Unsatisfactory response to prior BDMARDS (efalizumab, infliximab, etanercept) in patients with moderate to severe chronic plaque psoriasis or achievement of satisfactory response initially, but loss over time or discontinuation of treatment due to intolerance/side effects(s) or other reasons e.g. restart after regular stop of etanercept * Patients must fulfill Austrian Treatment Recommendations for use of BDMARD in psoriasis (chest X-ray and purified protein derivative \[PPD\] skin test negative for tuberculosis) * Patient is willing to consent to data being collected and provided to Abbott * Patient must be able and willing to self-administer Pen injections or have a qualified person available to administer Pen injections
Exclusion criteria
* Patients who meet contraindications as outlined in the latest version of the Humira-Pen Summary of Product Characteristics (SPC) * Patients who do not meet the criteria for the use of BDMARDs of the Austrian Treatment Recommendations * Patients participating in another study or clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) Score | Inclusion visit (Week 0), Week 4, Week 36, Week 52 | 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) | Inclusion visit (Week 0) to Week 52 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatology Life Quality Index (DLQI) Score | Inclusion visit (Week 0), Week 4, Week 36, Week 52 | 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 | Inclusion visit (Week 0), Week 4, Week 36, and Week 52 | 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 | From the time of participant consent until 70 days after last dose of study drug | 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. |
Countries
Austria
Participant flow
Recruitment details
A total of 46 participants were screened for this PMOS at 9 study sites in Austria. One participant did not meet entry criteria (screening failure), and 45 participants were enrolled and received treatment with adalimumab in the study.
Pre-assignment details
Three participants were excluded from the database because they had been treated with adalimumab prior to their Visit 1. Statistical analysis has been performed for the 42 participants included in the All Treated population.
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Non-compliance | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Adalimumab |
|---|---|
| Age Continuous | 47.1 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment Austria | 42 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 42 |
| serious Total, serious adverse events | 1 / 42 |
Outcome results
Primary
Psoriasis Area and Severity Index (PASI) Score
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).
Time frame: Inclusion visit (Week 0), Week 4, Week 36, Week 52
Population: Analysis was performed on the All Treated population using an observed case approach. PASI score was assessed at Weeks 0, 4, 36, and 52 in 41, 36, 28, and 27 participants, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Treated | Psoriasis Area and Severity Index (PASI) Score | Week 4 | 7.6 units on a scale | Standard Deviation 4.5 |
| All Treated | Psoriasis Area and Severity Index (PASI) Score | Week 36 | 2.5 units on a scale | Standard Deviation 5.2 |
| All Treated | Psoriasis Area and Severity Index (PASI) Score | Week 52 | 2.0 units on a scale | Standard Deviation 4.9 |
| All Treated | Psoriasis Area and Severity Index (PASI) Score | Week 0 | 15.5 units on a scale | Standard Deviation 11.4 |
Primary
Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75)
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).
Time frame: Inclusion visit (Week 0) to Week 52
Population: Analysis was performed on the All Treated population using an observed case approach. PASI response was assessed in 26 participants at Week 52.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| All Treated | Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75) | 23 participants | 4.9 |
Secondary
Dermatology Life Quality Index (DLQI) Score
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).
Time frame: Inclusion visit (Week 0), Week 4, Week 36, Week 52
Population: Analysis was performed on the All Treated population using an observed case approach. DLQI score was assessed at Weeks 0, 4, 36, and 52 in 36, 34, 26, and 27 participants, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Treated | Dermatology Life Quality Index (DLQI) Score | Week 0 | 13.8 units on a scale | Standard Deviation 8.3 |
| All Treated | Dermatology Life Quality Index (DLQI) Score | Week 4 | 7.2 units on a scale | Standard Deviation 5.6 |
| All Treated | Dermatology Life Quality Index (DLQI) Score | Week 36 | 2.2 units on a scale | Standard Deviation 3.4 |
| All Treated | Dermatology Life Quality Index (DLQI) Score | Week 52 | 2.2 units on a scale | Standard Deviation 4.8 |
Secondary
Nail Psoriasis Severity Index (NAPSI) Score
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).
Time frame: Inclusion visit (Week 0), Week 4, Week 36, and Week 52
Population: Analysis was performed using an observed case approach. For the All Treated population, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 34, 30, 24, and 25 participants, respectively. For the Subgroup with nail psoriasis, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 18, 16, 12, and 13 participants, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Treated | Nail Psoriasis Severity Index (NAPSI) Score | Week 0 | 15.4 units on a scale | Standard Deviation 24 |
| All Treated | Nail Psoriasis Severity Index (NAPSI) Score | Week 4 | 14.9 units on a scale | Standard Deviation 22.9 |
| All Treated | Nail Psoriasis Severity Index (NAPSI) Score | Week 36 | 4.0 units on a scale | Standard Deviation 9.6 |
| All Treated | Nail Psoriasis Severity Index (NAPSI) Score | Week 52 | 4.0 units on a scale | Standard Deviation 7.8 |
| Subgroup With Nail Psoriasis | Nail Psoriasis Severity Index (NAPSI) Score | Week 52 | 7.7 units on a scale | Standard Deviation 9.5 |
| Subgroup With Nail Psoriasis | Nail Psoriasis Severity Index (NAPSI) Score | Week 0 | 29.0 units on a scale | Standard Deviation 26.5 |
| Subgroup With Nail Psoriasis | Nail Psoriasis Severity Index (NAPSI) Score | Week 36 | 7.9 units on a scale | Standard Deviation 12.6 |
| Subgroup With Nail Psoriasis | Nail Psoriasis Severity Index (NAPSI) Score | Week 4 | 28.0 units on a scale | Standard Deviation 25 |
Secondary
Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions
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.
Time frame: From the time of participant consent until 70 days after last dose of study drug
Population: Analysis was performed on the All Treated population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated | Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions | Non-serious adverse events | 8 participants |
| All Treated | Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions | Serious adverse events | 1 participants |