Psoriasis Vulgaris, Plaque Psoriasis
Conditions
Keywords
Psoriasis, Psoriasis vulgaris, Plaque Psoriasis, Daivobet® Gel, Germany
Brief summary
The purpose of this observational study is to document the course of disease and relapse management during treatment with Daivobet® Gel under consideration of patient's individual application habits under daily use conditions.
Interventions
DRUGDaivobet® Gel
Once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
Sponsors
LEO Pharma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with light to moderate psoriasis vulgaris of trunk and extremities and treatment with Daivobet® Gel was planned anyway. * Minimum of 3 years diagnosed psoriasis vulgaris.
Exclusion criteria
* Previous therapy with Daivobet® Gel * Systemic therapy of psoriasis vulgaris * Contraindications of Daivobet® Gel in the German package insert * people that are incapable to give free consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions. | 1 year | Number of exacerbations and relapses during one year observation time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Baseline | 6--point verbal rating scale |
| Side Effects | 1 year | Number of participants with serious and non-serious adverse drug reactions. |
Countries
Germany
Participant flow
Recruitment details
The study was conducted in Germany between 8th September 2011 (retrospective data) and 15th May 2014. The planned observation period for each patient was about 12 months. The total planned sample size of this NIS was 1000 (analysable 750) patients.
Participants by arm
| Arm | Count |
|---|---|
| All Eligible Patients Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance. | 561 |
| Total | 561 |
Baseline characteristics
| Characteristic | All Eligible Patients | — |
|---|---|---|
| Affected body surface area (BSA) at admission >10% | 51 Participants | — |
| Affected body surface area (BSA) at admission <2% | 45 Participants | — |
| Affected body surface area (BSA) at admission 2-4% | 119 Participants | — |
| Affected body surface area (BSA) at admission 4-6% | 138 Participants | — |
| Affected body surface area (BSA) at admission 6-8% | 125 Participants | — |
| Affected body surface area (BSA) at admission 8-10% | 83 Participants | — |
| Age, Continuous | 51.05 years STANDARD_DEVIATION 16.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 561 Participants | — |
| Sex: Female, Male Female | 283 Participants | — |
| Sex: Female, Male Male | 278 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 561 |
| other Total, other adverse events | 50 / 561 |
| serious Total, serious adverse events | 3 / 561 |
Outcome results
Primary
The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions.
Number of exacerbations and relapses during one year observation time
Time frame: 1 year
Population: Participants with at least one observation after baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Patients | The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions. | No relapse | 277 Participants |
| All Eligible Patients | The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions. | 1 relapse | 121 Participants |
| All Eligible Patients | The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions. | 2 relapses | 59 Participants |
| All Eligible Patients | The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions. | 3 relapses | 24 Participants |
| All Eligible Patients | The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions. | More than 3 relapses | 48 Participants |
Secondary
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
6--point verbal rating scale
Time frame: Baseline
Population: Participants with at least one severity assessment after baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Patients | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Mild | 108 Participants |
| All Eligible Patients | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Moderate | 350 Participants |
| All Eligible Patients | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Severe | 60 Participants |
| All Eligible Patients | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Very severe | 5 Participants |
| All Eligible Patients | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Free of symptoms | 0 Participants |
| All Eligible Patients | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Almost free of symptoms | 5 Participants |
Secondary
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Assessment on 6-step scale from no visible disease (O) to very severe disease (5)
Time frame: 1 year
Population: Participants with at least one observation after baseline (last observation carried forward)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Patients | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Free of symptoms | 66 Participants |
| All Eligible Patients | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Almost free of symptoms | 177 Participants |
| All Eligible Patients | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Symptoms mild | 153 Participants |
| All Eligible Patients | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Symptoms moderate | 115 Participants |
| All Eligible Patients | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Symptoms severe | 16 Participants |
| All Eligible Patients | PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity) | Symptoms very severe | 1 Participants |
Secondary
Side Effects
Number of participants with serious and non-serious adverse drug reactions.
Time frame: 1 year
Population: All enrolled
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Eligible Patients | Side Effects | Non-serious, causal relation possible | 5 Number of events recorded |
| All Eligible Patients | Side Effects | Serious with causal relation probable | 0 Number of events recorded |
| All Eligible Patients | Side Effects | Serious with causal relation possible | 0 Number of events recorded |
| All Eligible Patients | Side Effects | Serious, not related | 2 Number of events recorded |
| All Eligible Patients | Side Effects | Serious, causality not assessible | 1 Number of events recorded |
| All Eligible Patients | Side Effects | Non-serious, causal relation probable | 8 Number of events recorded |
| All Eligible Patients | Side Effects | Non-serious, not related | 17 Number of events recorded |
| All Eligible Patients | Side Effects | Non-serious, causality not assessible | 29 Number of events recorded |