Chronic Plaque Psoriasis
Conditions
Brief summary
The main purpose of this study is to assess the effect of smoking status on the success of Etanercept therapy in patients with moderate-to-severe psoriasis.
Detailed description
Study hypothesis was based on the following rationale: * Psoriasis vulgaris is a chronic inflammatory skin disease with several extracutaneous manifestations and significant comorbidities (among others cardiovascular disease, metabolic syndrome, obesity and depression). * An increased prevalence of smoking among psoriasis patients, as compared with healthy subjects, has been observed in several studies * More recent studies suggest that cigarette smoking may trigger the development of psoriasis through oxidative, inflammatory and genetic mechanisms.Furthermore, smoking is associated with the clinical severity of psoriasis * Smoking also contributes to higher morbidity and mortality from smoking related disorders in these patients There is now some evidence that patients with psoriasis who smoke tend to be less responsive to treatment
Interventions
BEHAVIORALQUESTIONNAIRE ON SMOKING HABITS
Data on smoking will include the age at which cigarette smoking began and ceased and the average amount smoked daily. Intensity (number of cigarettes smoked per day), duration of smoking (years), and time since cessation (years) will be categorized. Also, the smoking status of the patient prior psoriasis diagnosis will be assessed (smoker or non-smoker and years of smoking prior to psoriasis diagnosis). Smoking habit evaluation: baseline and changes in smoking habit at 12 and 24-weeks follow-up time points.
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients aged ≥18 years at the time of screening * Clinical diagnosis of chronic plaque type psoriasis for at least 6 months as determined by the subjects medical history, and confirmation of the diagnosis through physical examination by the investigator * Patients who are scheduled by their dermatologist to initiate treatment with Etanercept prescribed independently by the investigator as per local clinical practice guideline * Stable plaque psoriasis for at least 2 months prior to Baseline * Diagnosis of severe psoriasis defined as PASI \> 10 * Eligible for Etanercept treatment according to Summary of Product Characteristics (SmPC) * Smokers with smoking \>10 cigarettes daily for smokers group (Group 1) or non-smokers for non-smoking group (Group 2) * Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study
Exclusion criteria
* Previous or current treatment with antipsoriatic biologic drugs, such as Etanercept, infliximab, adalimumab, ustekinumab, alefacept, efalizumab. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 | Baseline, Week 24 | PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Dermatology Life Quality Index (DLQI) | Baseline, Week 12, 24 | The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. |
| Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 | Week 12, 24 | PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline. |
| Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24 | Week 12, 24 | PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI50 response was defined as at least a 50% reduction in PASI relative to baseline. |
| Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12 | Week 12 | PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). |
| Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants | Baseline, Week 12, 24 | PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). Participants who had bone marrow index \>30 kilogram per meter square were said to be obese in this outcome measure. |
Countries
Romania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept: Non Smokers Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. | 96 |
| Etanercept: Smokers Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. | 68 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Inclusion/exclusion criteria deviation | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Protocol deviation | 4 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Etanercept: Non Smokers | Etanercept: Smokers | Total |
|---|---|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 13.5 | 49.1 years STANDARD_DEVIATION 14.5 | 51.0 years STANDARD_DEVIATION 14 |
| Sex: Female, Male Female | 38 Participants | 31 Participants | 69 Participants |
| Sex: Female, Male Male | 58 Participants | 37 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 1 / 68 |
| other Total, other adverse events | 4 / 96 | 4 / 68 |
| serious Total, serious adverse events | 2 / 96 | 3 / 68 |
Outcome results
Primary
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24
PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time frame: Baseline, Week 24
Population: Per protocol set included all treated participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Non Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 | Baseline | 23.1 units on a scale | Standard Deviation 6.2 |
| Etanercept: Non Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 | Change at Week 24 | 16.5 units on a scale | Standard Deviation 5.2 |
| Etanercept: Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 | Baseline | 23.4 units on a scale | Standard Deviation 6.1 |
| Etanercept: Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 | Change at Week 24 | 17.1 units on a scale | Standard Deviation 5.4 |
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI)
The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.
Time frame: Baseline, Week 12, 24
Population: Per protocol set included all treated participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Non Smokers | Change From Baseline in Dermatology Life Quality Index (DLQI) | Baseline | 22.0 units on a scale | Standard Deviation 5.3 |
| Etanercept: Non Smokers | Change From Baseline in Dermatology Life Quality Index (DLQI) | Change at Week 12 | 12.3 units on a scale | Standard Deviation 6 |
| Etanercept: Non Smokers | Change From Baseline in Dermatology Life Quality Index (DLQI) | Change at Week 24 | 16.4 units on a scale | Standard Deviation 6 |
| Etanercept: Smokers | Change From Baseline in Dermatology Life Quality Index (DLQI) | Baseline | 21.7 units on a scale | Standard Deviation 4.8 |
| Etanercept: Smokers | Change From Baseline in Dermatology Life Quality Index (DLQI) | Change at Week 12 | 12.8 units on a scale | Standard Deviation 4.9 |
| Etanercept: Smokers | Change From Baseline in Dermatology Life Quality Index (DLQI) | Change at Week 24 | 16.8 units on a scale | Standard Deviation 4.6 |
Secondary
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12
PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time frame: Week 12
Population: Per protocol set included all treated participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept: Non Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12 | 12.6 units on a scale | Standard Deviation 4.4 |
| Etanercept: Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12 | 12.8 units on a scale | Standard Deviation 4.6 |
Secondary
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants
PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). Participants who had bone marrow index \>30 kilogram per meter square were said to be obese in this outcome measure.
Time frame: Baseline, Week 12, 24
Population: Per protocol set included all treated participants. Here, N (overall number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept: Non Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants | Baseline | 24.2 units on a scale | Standard Deviation 6.12 |
| Etanercept: Non Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants | Change at Week 24 | 17.1 units on a scale | Standard Deviation 5.79 |
| Etanercept: Non Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants | Change at Week 12 | 12.2 units on a scale | Standard Deviation 4.52 |
| Etanercept: Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants | Baseline | 23.9 units on a scale | Standard Deviation 7.14 |
| Etanercept: Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants | Change at Week 24 | 16.8 units on a scale | Standard Deviation 4.26 |
| Etanercept: Smokers | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants | Change at Week 12 | 12.1 units on a scale | Standard Deviation 5.21 |
Secondary
Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24
PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI50 response was defined as at least a 50% reduction in PASI relative to baseline.
Time frame: Week 12, 24
Population: Per protocol set included all treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept: Non Smokers | Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24 | Week 12 | 77.0 percentage of participants |
| Etanercept: Non Smokers | Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24 | Week 24 | 97.9 percentage of participants |
| Etanercept: Smokers | Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24 | Week 24 | 98.5 percentage of participants |
| Etanercept: Smokers | Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24 | Week 12 | 82.3 percentage of participants |
Secondary
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24
PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline.
Time frame: Week 12, 24
Population: Per protocol set included all treated participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept: Non Smokers | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 | Week 12 | 9.3 percentage of participants |
| Etanercept: Non Smokers | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 | Week 24 | 45.8 percentage of participants |
| Etanercept: Smokers | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 | Week 12 | 4.4 percentage of participants |
| Etanercept: Smokers | Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 | Week 24 | 44.1 percentage of participants |